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Novartis & Confidential & Page 10 of 144 \\\\\n\\hline \\multicolumn{2}{|l|}{Amended Protocol Version 03 (Clean)} & Protocol No. CACZ885T2301 \\\\\n\\hline OS & overall survival & \\\\\n\\hline PD & Pharmacodynamics & \\\\\n\\hline PK & Pharmacokinetics & \\\\\n\\hline PHI & Protected Health Information & \\\\\n\\hline PPS & Per protocol set & \\\\\n\\hline PRO & Patient-Reported Outcome & \\\\\n\\hline PT & Prothrombin Time & \\\\\n\\hline PTS & Post treatment surveillance & \\\\\n\\hline q3w & Every 3 weeks & \\\\\n\\hline QFT-PLUS & QuantiFERON®-TB Gold Plus assay & \\\\\n\\hline QLQ & Quality of Life Questionnaire & \\\\\n\\hline QoL & Quality of Life & \\\\\n\\hline R0 & Completely resected & \\\\\n\\hline RDE & Recommended dose for expansion & \\\\\n\\hline REB & Research Ethics Board & \\\\\n\\hline RNA & Ribonucleic Acid & \\\\\n\\hline R Value & ALT/ALP in x ULN & \\\\\n\\hline SAE & Serious Adverse Event & \\\\\n\\hline SAP & Statistical Analysis Plan & \\\\\n\\hline S.C. & 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Novartis Amended Protocol Version 03 (Clean) & Confidential \\\\\n\\hline Re-screening & If a subject fails the initial screening and is considered as a Screen Failure, he/she can be invited once for a new Screening visit after medical judgment and as specified by the protocol \\\\\n\\hline Remote & Describes any trial activities performed at a location that is not the investigative site. \\\\\n\\hline Screen Failure & A subject who did not meet one or more criteria that were required for participation in the study \\\\\n\\hline Source Data/Document & Source data refers to the initial record, document, or primary location from where data comes. 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Title & A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) \\\\\n\\hline Brief title & Study of efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancer \\\\\n\\hline Sponsor and Clinical Phase & \\begin{tabular}{l}\nNovartis, \\\\\nPhase III\n\\end{tabular} \\\\\n\\hline Investigation type & Drug \\\\\n\\hline Study type & Interventional \\\\\n\\hline Purpose and rationale & This is a multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and the subset of IIIB with (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC). \\\\\n\\hline Primary Objective(s) and Key Secondary Objective & \\begin{tabular}{l}\nThe primary objective is to compare the Disease-free survival (DFS) in the canakinumab versus placebo arms as determined by local investigator assessment. \\\\\nThe key secondary objective is to compare overall survival (OS) in the canakinumab arm versus placebo arm\n\\end{tabular} \\\\\n\\hline Secondary Objectives & \\begin{tabular}{l}\n1. To compare DFS by local investigator assessment and OS in the canakinumab versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels, respectively. \\\\\n2. To compare lung cancer specific survival in the canakinumab arm versus placebo arm \\\\\n3. To characterize the safety profile of canakinumab \\\\\n4. To characterize the pharmacokinetics of canakinumab therapy \\\\\n5. To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab \\\\\n6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related quality of life\n\\end{tabular} \\\\\n\\hline Study design & This phase III, multicenter, randomized, double blind study will evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC). Subjects may be screened after undergoing complete surgical resection of their NSCLC and having R0 status confirmed (negative margins on pathologic review), after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation therapy is allowed if indicated as per local guidelines or practice). And after all entry criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW) \\\\\n\\hline Population & \\begin{tabular}{l}\nThis phase III study will enroll approximately 1500 adult subjects with completely resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease. These groups have been included to allow all subjects that are able to achieve complete resection of their cancer with negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials. \\\\\nApplicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Title & A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) \\\\\n\\hline Brief title & Study of efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancer \\\\\n\\hline Sponsor and Clinical Phase & \\begin{tabular}{l}\nNovartis, \\\\\nPhase III\n\\end{tabular} \\\\\n\\hline Investigation type & Drug \\\\\n\\hline Study type & Interventional \\\\\n\\hline Purpose and rationale & This is a multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and the subset of IIIB with (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC). \\\\\n\\hline Primary Objective(s) and Key Secondary Objective & \\begin{tabular}{l}\nThe primary objective is to compare the Disease-free survival (DFS) in the canakinumab versus placebo arms as determined by local investigator assessment. \\\\\nThe key secondary objective is to compare overall survival (OS) in the canakinumab arm versus placebo arm\n\\end{tabular} \\\\\n\\hline Secondary Objectives & \\begin{tabular}{l}\n1. To compare DFS by local investigator assessment and OS in the canakinumab versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels, respectively. \\\\\n2. To compare lung cancer specific survival in the canakinumab arm versus placebo arm \\\\\n3. To characterize the safety profile of canakinumab \\\\\n4. To characterize the pharmacokinetics of canakinumab therapy \\\\\n5. To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab \\\\\n6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related quality of life\n\\end{tabular} \\\\\n\\hline Study design & This phase III, multicenter, randomized, double blind study will evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC). Subjects may be screened after undergoing complete surgical resection of their NSCLC and having R0 status confirmed (negative margins on pathologic review), after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation therapy is allowed if indicated as per local guidelines or practice). And after all entry criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW) \\\\\n\\hline Population & \\begin{tabular}{l}\nThis phase III study will enroll approximately 1500 adult subjects with completely resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease. These groups have been included to allow all subjects that are able to achieve complete resection of their cancer with negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials. \\\\\nApplicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery\n\\end{tabular} 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To compare DFS by local investigator assessment and OS in the canakinumab versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels, respectively. \\\\\n2. To compare lung cancer specific survival in the canakinumab arm versus placebo arm \\\\\n3. To characterize the safety profile of canakinumab \\\\\n4. To characterize the pharmacokinetics of canakinumab therapy \\\\\n5. To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab \\\\\n6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related quality of life\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. To compare DFS by local investigator assessment and OS in the canakinumab versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels, respectively. \\\\\n2. To compare lung cancer specific survival in the canakinumab arm versus placebo arm \\\\\n3. To characterize the safety profile of canakinumab \\\\\n4. To characterize the pharmacokinetics of canakinumab therapy \\\\\n5. To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab \\\\\n6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related quality of life\n\\end{tabular}","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.97607421875,"confidence_rate":0.9999768042425324},{"cnt":[[634,1220],[1778,1220],[1778,1259],[634,1259]],"region":{"top_left_x":634,"top_left_y":1219,"width":1144,"height":40},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8355159d7d5d4e128ef1af06f264f75b","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"1. To compare DFS by local investigator assessment and OS in the canakinumab","text_display":"1. To compare DFS by local investigator assessment and OS in the canakinumab","confidence":0.97607421875,"confidence_rate":0.9997216864184927},{"cnt":[[695,1257],[1819,1257],[1819,1293],[695,1293]],"region":{"top_left_x":694,"top_left_y":1256,"width":1125,"height":38},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06c4615e54a944be990ab6b7ecc5b205","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels,","text_display":" versus placebo arms in subgroups defined by PD-L1 and CD8 expression levels,","confidence":1,"confidence_rate":1},{"cnt":[[695,1291],[875,1291],[875,1332],[695,1332]],"region":{"top_left_x":694,"top_left_y":1291,"width":181,"height":42},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b849c934489d4f99bb0e463a6b66a96c","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"respectively.","text_display":" respectively.","confidence":1,"confidence_rate":1},{"cnt":[[632,1334],[1812,1334],[1812,1373],[632,1373]],"region":{"top_left_x":631,"top_left_y":1334,"width":1182,"height":40},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af60aecc5a6246e2a657707298d27487","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"2. To compare lung cancer specific survival in the canakinumab arm versus placebo","text_display":"\n2. To compare lung cancer specific survival in the canakinumab arm versus placebo","confidence":1,"confidence_rate":1},{"cnt":[[695,1371],[760,1371],[760,1406],[695,1406]],"region":{"top_left_x":694,"top_left_y":1371,"width":66,"height":35},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48f29a0126ec4e98ba4aae25a1fba1ae","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"arm","text_display":" arm","confidence":1,"confidence_rate":1},{"cnt":[[630,1412],[1386,1412],[1386,1454],[630,1454]],"region":{"top_left_x":629,"top_left_y":1412,"width":757,"height":42},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a23327d17e9c476d94745646b027dde9","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"3. To characterize the safety profile of canakinumab","text_display":"\n3. To characterize the safety profile of canakinumab","confidence":1,"confidence_rate":1},{"cnt":[[630,1456],[1565,1456],[1565,1495],[630,1495]],"region":{"top_left_x":629,"top_left_y":1455,"width":937,"height":40},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0d77fe60fa2471aaf0d751b4ac2410e","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"4. To characterize the pharmacokinetics of canakinumab therapy","text_display":"\n4. To characterize the pharmacokinetics of canakinumab therapy","confidence":1,"confidence_rate":1},{"cnt":[[630,1499],[1736,1499],[1736,1538],[630,1538]],"region":{"top_left_x":629,"top_left_y":1499,"width":1108,"height":40},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"914194b643614a46a49153e38e687b6a","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"5. To characterize the prevalence and incidence of immunogenicity (anti-drug","text_display":"\n5. To characterize the prevalence and incidence of immunogenicity (anti-drug","confidence":1,"confidence_rate":1},{"cnt":[[647,1534],[1117,1534],[1117,1575],[647,1575]],"region":{"top_left_x":647,"top_left_y":1533,"width":471,"height":42},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9c67a0a71de4090823d283932689f33","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"antibodies, ADA) of canakinumab","text_display":" antibodies, ADA) of canakinumab","confidence":1,"confidence_rate":1},{"cnt":[[630,1577],[1836,1577],[1836,1616],[630,1616]],"region":{"top_left_x":629,"top_left_y":1577,"width":1207,"height":40},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e9a057e671d44d09a3100c0794d173f","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30","text_display":"\n6. To assess the effect of canakinumab versus placebo on PROs (EORTC QLQ-C30","confidence":1,"confidence_rate":1},{"cnt":[[645,1614],[1780,1614],[1780,1653],[645,1653]],"region":{"top_left_x":644,"top_left_y":1613,"width":1136,"height":40},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95b393e1504a4461ae1219a1c7493e10","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related","text_display":" with QLQ-LC13 incorporated and EQ-5D) including functioning and health-related","confidence":1,"confidence_rate":1},{"cnt":[[647,1651],[827,1651],[827,1687],[647,1687]],"region":{"top_left_x":647,"top_left_y":1650,"width":180,"height":38},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84f4a45c90594031915d22b509970ccc","type":"text","conversion_output":false,"parent_id":"4ad376121862445dbbec5348a092bae3","text":"quality of life","text_display":" quality of life","confidence":1,"confidence_rate":1},{"cnt":[[311,1696],[515,1696],[515,1735],[311,1735]],"region":{"top_left_x":311,"top_left_y":1696,"width":205,"height":40},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2de751861dc483e92297e7289cd3fc2","type":"simple_cell","conversion_output":false,"parent_id":"e53f7d6e2afb4dd79bf95c247416fc0e","text":"Study design","text_display":"Study design","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[625,1696],[1858,1696],[1858,2207],[625,2207]],"region":{"top_left_x":625,"top_left_y":1696,"width":1233,"height":512},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5afe490c974411e97e54d014d879242","type":"complex_cell","conversion_output":false,"parent_id":"e53f7d6e2afb4dd79bf95c247416fc0e","children_ids":["7987a3fa0bc347f3a6449ba9b13ea8de","5316fd5f7dcb4ac7ab082f559d014f15","64ec28f6666d4e1da75fa8d7a586ce28","ff6194982ecc4aa48a6f8ca57787592e","87ec83d5f8914480b891f9d04091e6af","e639971e20824080b897e4c2bc8827e6","20c651ed4f5b4e06823aa4dfdba6d0da","681df0a3a54047598d051870ff3f6c8d","cf12f8f180fd4e458bec849b5d748c20","6b5f0c107566473fb767d08ec56d5ada","af60ef4d41b74cdba845fc9f63a3deb9","4cf424277b2f44efb29736510638c412","ffea0ac64fb8420191a024f421f3ed03","f21cd8eb302c42d199354d5951a7cd08"],"text":"This phase III, multicenter, randomized, double blind study will evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC). Subjects may be screened after undergoing complete surgical resection of their NSCLC and having R0 status confirmed (negative margins on pathologic review), after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation therapy is allowed if indicated as per local guidelines or practice). And after all entry criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW)","text_display":"This phase III, multicenter, randomized, double blind study will evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC). Subjects may be screened after undergoing complete surgical resection of their NSCLC and having R0 status confirmed (negative margins on pathologic review), after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation therapy is allowed if indicated as per local guidelines or practice). And after all entry criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW)","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7574424743652344,"confidence_rate":0.9997380492757377},{"cnt":[[630,1698],[1853,1698],[1853,1735],[630,1735]],"region":{"top_left_x":629,"top_left_y":1698,"width":1225,"height":38},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7987a3fa0bc347f3a6449ba9b13ea8de","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"This phase III, multicenter, randomized, double blind study will evaluate the efficacy and","text_display":"This phase III, multicenter, randomized, double blind study will evaluate the efficacy and","confidence":1,"confidence_rate":1},{"cnt":[[630,1733],[1836,1733],[1836,1772],[630,1772]],"region":{"top_left_x":629,"top_left_y":1732,"width":1207,"height":40},"line":79,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5316fd5f7dcb4ac7ab082f559d014f15","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v.","text_display":" safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v.","confidence":1,"confidence_rate":1},{"cnt":[[630,1770],[1758,1770],[1758,1809],[630,1809]],"region":{"top_left_x":629,"top_left_y":1769,"width":1130,"height":40},"line":80,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64ec28f6666d4e1da75fa8d7a586ce28","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer","text_display":" 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer","confidence":0.9690050361678004,"confidence_rate":0.999629651304},{"cnt":[[630,1807],[1810,1807],[1810,1843],[630,1843]],"region":{"top_left_x":629,"top_left_y":1806,"width":1182,"height":38},"line":81,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff6194982ecc4aa48a6f8ca57787592e","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"(NSCLC). Subjects may be screened after undergoing complete surgical resection of","text_display":" (NSCLC). Subjects may be screened after undergoing complete surgical resection of","confidence":1,"confidence_rate":1},{"cnt":[[630,1841],[1829,1841],[1829,1880],[630,1880]],"region":{"top_left_x":629,"top_left_y":1841,"width":1201,"height":40},"line":82,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87ec83d5f8914480b891f9d04091e6af","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"their NSCLC and having R0 status confirmed (negative margins on pathologic review),","text_display":" their NSCLC and having R0 status confirmed (negative margins on pathologic review),","confidence":1,"confidence_rate":1},{"cnt":[[630,1878],[1855,1878],[1855,1917],[630,1917]],"region":{"top_left_x":629,"top_left_y":1878,"width":1227,"height":40},"line":83,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e639971e20824080b897e4c2bc8827e6","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation","text_display":" after completing adjuvant cisplatin-based doublet chemotherapy if applicable, (Radiation","confidence":1,"confidence_rate":1},{"cnt":[[630,1913],[1793,1913],[1793,1952],[630,1952]],"region":{"top_left_x":629,"top_left_y":1912,"width":1164,"height":40},"line":84,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20c651ed4f5b4e06823aa4dfdba6d0da","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"therapy is allowed if indicated as per local guidelines or practice). And after all entry","text_display":" therapy is allowed if indicated as per local guidelines or practice). And after all entry","confidence":1,"confidence_rate":1},{"cnt":[[630,1949],[1827,1949],[1827,1991],[630,1991]],"region":{"top_left_x":629,"top_left_y":1949,"width":1199,"height":42},"line":85,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"681df0a3a54047598d051870ff3f6c8d","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy","text_display":" criteria are met. Subjects must not have had preoperative neo-adjuvant chemotherapy","confidence":1,"confidence_rate":1},{"cnt":[[630,1984],[1702,1984],[1702,2025],[630,2025]],"region":{"top_left_x":629,"top_left_y":1984,"width":1073,"height":42},"line":86,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf12f8f180fd4e458bec849b5d748c20","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be","text_display":" or radiotherapy to achieve the R0 status. Approximately 1500 subjects will be","confidence":0.9980475902557373,"confidence_rate":0.9999770082857181},{"cnt":[[630,2019],[1754,2019],[1754,2060],[630,2060]],"region":{"top_left_x":629,"top_left_y":2018,"width":1125,"height":42},"line":87,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b5f0c107566473fb767d08ec56d5ada","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or","text_display":" randomized \\(1: 1\\) to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or","confidence":0.7574424743652344,"confidence_rate":0.9969849057938406},{"cnt":[[630,2053],[1827,2053],[1827,2095],[630,2095]],"region":{"top_left_x":629,"top_left_y":2053,"width":1199,"height":42},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af60ef4d41b74cdba845fc9f63a3deb9","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by","text_display":" matching placebo, s.c., every 3 weeks (Figure 4-1). Randomization will be stratified by","confidence":1,"confidence_rate":1},{"cnt":[[630,2092],[1814,2092],[1814,2129],[630,2129]],"region":{"top_left_x":629,"top_left_y":2092,"width":1186,"height":38},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4cf424277b2f44efb29736510638c412","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease;","text_display":" AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease;","confidence":0.977607424155849,"confidence_rate":0.9997538662053915},{"cnt":[[630,2127],[1810,2127],[1810,2168],[630,2168]],"region":{"top_left_x":629,"top_left_y":2127,"width":1182,"height":42},"line":90,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffea0ac64fb8420191a024f421f3ed03","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"Histology: squamous versus non-squamous; and Region: Western Europe and North","text_display":" Histology: squamous versus non-squamous; and Region: Western Europe and North","confidence":1,"confidence_rate":1},{"cnt":[[630,2166],[1375,2166],[1375,2203],[630,2203]],"region":{"top_left_x":629,"top_left_y":2166,"width":746,"height":37},"line":91,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f21cd8eb302c42d199354d5951a7cd08","type":"text","conversion_output":false,"parent_id":"b5afe490c974411e97e54d014d879242","text":"America vs. eastern Asia vs. Rest of the world (RoW)","text_display":" America vs. eastern Asia vs. Rest of the world (RoW)","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[311,2209],[480,2209],[480,2251],[311,2251]],"region":{"top_left_x":311,"top_left_y":2209,"width":170,"height":42},"line":92,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51873ad0f29e4819bac6b082e5803b2a","type":"simple_cell","conversion_output":false,"parent_id":"e53f7d6e2afb4dd79bf95c247416fc0e","text":"Population","text_display":"Population","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[625,2209],[1858,2209],[1858,2510],[625,2510]],"region":{"top_left_x":625,"top_left_y":2209,"width":1233,"height":302},"line":93,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b9ab7ab13ab407bb83982cad42b511f","type":"complex_cell","conversion_output":false,"parent_id":"e53f7d6e2afb4dd79bf95c247416fc0e","children_ids":["22cc344c1758468ebb320c31e7d58056","30094f41c1eb4546a991109d1a3f8eda","b529362d932b48a0b6ddeab8492ec660","5a328982ebc34fa59ee200b47d160292","a8f5415605394f39871046dee30b80b2","aaec942c6cb24584831a962e927d8b24","de38a010e65c4fbaa8f156cd58c84dc9","7b8f214c53cc4c12a5e4af4d524b1f1d"],"text":"\\begin{tabular}{l}\nThis phase III study will enroll approximately 1500 adult subjects with completely resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease. These groups have been included to allow all subjects that are able to achieve complete resection of their cancer with negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials. \\\\\nApplicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThis phase III study will enroll approximately 1500 adult subjects with completely resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease. These groups have been included to allow all subjects that are able to achieve complete resection of their cancer with negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials. \\\\\nApplicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery\n\\end{tabular}","cell_row":9,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.735146548316834,"confidence_rate":0.9995994481925914},{"cnt":[[630,2214],[1749,2214],[1749,2251],[630,2251]],"region":{"top_left_x":629,"top_left_y":2213,"width":1121,"height":38},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22cc344c1758468ebb320c31e7d58056","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"This phase III study will enroll approximately 1500 adult subjects with completely","text_display":"This phase III study will enroll approximately 1500 adult subjects with completely","confidence":1,"confidence_rate":1},{"cnt":[[630,2285],[630,2247],[1784,2249],[1784,2287]],"region":{"top_left_x":629,"top_left_y":2246,"width":1156,"height":42},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30094f41c1eb4546a991109d1a3f8eda","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease.","text_display":" resected (R0) NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB ( \\(T >5 cm\\) N2) disease.","confidence":0.735146548316834,"confidence_rate":0.9968000743126907},{"cnt":[[630,2285],[1855,2285],[1855,2324],[630,2324]],"region":{"top_left_x":629,"top_left_y":2285,"width":1227,"height":40},"line":96,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b529362d932b48a0b6ddeab8492ec660","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"These groups have been included to allow all subjects that are able to achieve complete","text_display":" These groups have been included to allow all subjects that are able to achieve complete","confidence":1,"confidence_rate":1},{"cnt":[[630,2322],[1767,2322],[1767,2359],[630,2359]],"region":{"top_left_x":629,"top_left_y":2321,"width":1138,"height":38},"line":97,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a328982ebc34fa59ee200b47d160292","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"resection of their cancer with negative margins (R0 status). The inclusion of these","text_display":" resection of their cancer with negative margins (R0 status). The inclusion of these","confidence":1,"confidence_rate":1},{"cnt":[[630,2357],[1858,2357],[1858,2396],[630,2396]],"region":{"top_left_x":629,"top_left_y":2356,"width":1229,"height":40},"line":98,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8f5415605394f39871046dee30b80b2","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk","text_display":" subjects is consistent with other adjuvant NSCLC studies as they are at a significant risk","confidence":1,"confidence_rate":1},{"cnt":[[630,2391],[1260,2391],[1260,2432],[630,2432]],"region":{"top_left_x":629,"top_left_y":2391,"width":631,"height":42},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aaec942c6cb24584831a962e927d8b24","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"of relapse to merit inclusion in adjuvant trials.","text_display":" of relapse to merit inclusion in adjuvant trials.","confidence":1,"confidence_rate":1},{"cnt":[[630,2435],[1832,2435],[1832,2471],[630,2471]],"region":{"top_left_x":629,"top_left_y":2434,"width":1203,"height":38},"line":100,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de38a010e65c4fbaa8f156cd58c84dc9","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"Applicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC","text_display":"\nApplicable for Sub-study (CACZ885T2301A)*: Will enroll adult subjects with NSCLC","confidence":1,"confidence_rate":1},{"cnt":[[630,2469],[1849,2469],[1849,2510],[630,2510]],"region":{"top_left_x":629,"top_left_y":2469,"width":1220,"height":42},"line":101,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b8f214c53cc4c12a5e4af4d524b1f1d","type":"text","conversion_output":false,"parent_id":"1b9ab7ab13ab407bb83982cad42b511f","text":"Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery","text_display":" Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-014","page":14,"lines":[{"cnt":[[288,202],[887,202],[887,299],[288,299]],"region":{"top_left_x":287,"top_left_y":201,"width":601,"height":98},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c74ea8c524524618a9a5ee76b7a09991","type":"page_info","conversion_output":false,"text":"Novartis\nAmended Protocol Version 03 (Clean)","text_display":"","confidence":0.9810447692871094,"confidence_rate":0.999710084699023},{"cnt":[[988,202],[1179,202],[1179,247],[988,247]],"region":{"top_left_x":988,"top_left_y":201,"width":192,"height":47},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"838050aaaeaf4634b611f72f6d57cf63","type":"text","conversion_output":true,"text":"Confidential","text_display":"\n\nConfidential","confidence":1,"confidence_rate":1},{"cnt":[[1629,202],[1876,202],[1876,251],[1629,251]],"region":{"top_left_x":1628,"top_left_y":201,"width":248,"height":51},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad0bbcd8b96047e4956176b55c0acb2c","type":"text","conversion_output":true,"text":"Page 14 of 144","text_display":"\nPage 14 of 144","confidence":1,"confidence_rate":1},{"cnt":[[1414,249],[1876,249],[1876,294],[1414,294]],"region":{"top_left_x":1413,"top_left_y":249,"width":463,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72743993354e459b9de992961aeec213","type":"text","conversion_output":true,"text":"Protocol No. CACZ885T2301","text_display":"\nProtocol No. CACZ885T2301","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[286,335],[1880,335],[1880,2533],[286,2533]],"region":{"top_left_x":285,"top_left_y":335,"width":1595,"height":2199},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"279830d0a4eb4e77af04fdd2e0ad004e","type":"table","conversion_output":true,"children_ids":["8d70e8fbe8ef400690546bc2d646e04b","ac60fbf48f2a4a59bd4ac0ef2e5e8d66","5a39ba9cea3f4c5494945fb379aae285","19ce6ea5dd8647d680d669498cb0f992","ac8e35c27ade4300b1f1447221aa8aba","d8e41675d4ba4669905bdfefc52369a4","b90bded5552141e7b944b0ffc175a4d2"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker samples pre- and post-surgery will be collected from these subjects. \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).\n\\end{tabular} \\\\\n\\hline Inclusion criteria (applicable for main study) & \\begin{tabular}{l}\n1. Written informed consent must be obtained prior to any screening procedures. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm, N2 disease only). Minimal treatments considered adequate prior to study enrollment are:\n![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-014.jpg?height=876\\&width=1233\\&top_left_y=700\\&top_left_x=631) \\\\\nThe maximum number of days allowed from surgery to randomization is: \\\\\n- 70 days if subjects were treated with surgery, but did not receive chemotherapy or radiation. \\\\\n- 182 days if subjects were treated with surgery and chemotherapy, but no radiation. \\\\\n- \\(2 5 9\\) days if subjects were treated with surgery, chemotherapy and radiation. \\\\\nNote: \\\\\n- Subjects may enter the study earlier than the maximum number of days allowed, if fully recovered from surgery and adjuvant therapies. \\\\\n- A window of +7 days is allowed to accommodate subject scheduling if needed. \\\\\n- In case of chemotherapy treatment delays due to toxicities, additional window of +14 days is allowed. \\\\\n4. Criterion removed. \\\\\n5. Criterion removed. \\\\\n6. Criterion removed. \\\\\n7a. Subjects must have recovered from all toxicities related to prior systemic therapy to grade \\(\\leq 1\\) (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications described in inclusion 8. \\\\\n8. Subjects must have adequate organ function including the following laboratory values at the screening visit: \\\\\n- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\) \\\\\n- Platelets \\(\\geq 100 \\times 109 / L\\)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker samples pre- and post-surgery will be collected from these subjects. \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).\n\\end{tabular} \\\\\n\\hline Inclusion criteria (applicable for main study) & \\begin{tabular}{l}\n1. Written informed consent must be obtained prior to any screening procedures. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm, N2 disease only). Minimal treatments considered adequate prior to study enrollment are:\n![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-014.jpg?height=876\\&width=1233\\&top_left_y=700\\&top_left_x=631) \\\\\nThe maximum number of days allowed from surgery to randomization is: \\\\\n- 70 days if subjects were treated with surgery, but did not receive chemotherapy or radiation. \\\\\n- 182 days if subjects were treated with surgery and chemotherapy, but no radiation. \\\\\n- \\(2 5 9\\) days if subjects were treated with surgery, chemotherapy and radiation. \\\\\nNote: \\\\\n- Subjects may enter the study earlier than the maximum number of days allowed, if fully recovered from surgery and adjuvant therapies. \\\\\n- A window of +7 days is allowed to accommodate subject scheduling if needed. \\\\\n- In case of chemotherapy treatment delays due to toxicities, additional window of +14 days is allowed. \\\\\n4. Criterion removed. \\\\\n5. Criterion removed. \\\\\n6. Criterion removed. \\\\\n7a. Subjects must have recovered from all toxicities related to prior systemic therapy to grade \\(\\leq 1\\) (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications described in inclusion 8. \\\\\n8. Subjects must have adequate organ function including the following laboratory values at the screening visit: \\\\\n- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\) \\\\\n- Platelets \\(\\geq 100 \\times 109 / L\\)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.92626953125,"confidence_rate":0.9999310480632126},{"cnt":[[307,335],[538,335],[538,2531],[307,2531]],"region":{"top_left_x":306,"top_left_y":335,"width":233,"height":2196},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d70e8fbe8ef400690546bc2d646e04b","type":"table_column","conversion_output":false,"parent_id":"279830d0a4eb4e77af04fdd2e0ad004e","text":"","text_display":""},{"cnt":[[621,2529],[625,335],[1870,337],[1866,2531]],"region":{"top_left_x":620,"top_left_y":334,"width":1250,"height":2197},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac60fbf48f2a4a59bd4ac0ef2e5e8d66","type":"table_column","conversion_output":false,"parent_id":"279830d0a4eb4e77af04fdd2e0ad004e","text":"","text_display":""},{"cnt":[[285,339],[1881,339],[1881,504],[285,504]],"region":{"top_left_x":285,"top_left_y":339,"width":1596,"height":165},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a39ba9cea3f4c5494945fb379aae285","type":"table_row","conversion_output":false,"parent_id":"279830d0a4eb4e77af04fdd2e0ad004e","text":"","text_display":""},{"cnt":[[285,502],[1874,502],[1874,2526],[285,2526]],"region":{"top_left_x":285,"top_left_y":501,"width":1590,"height":2026},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19ce6ea5dd8647d680d669498cb0f992","type":"table_row","conversion_output":false,"parent_id":"279830d0a4eb4e77af04fdd2e0ad004e","text":"","text_display":""},{"cnt":[[627,344],[1842,344],[1842,502],[627,502]],"region":{"top_left_x":627,"top_left_y":343,"width":1215,"height":159},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac8e35c27ade4300b1f1447221aa8aba","type":"complex_cell","conversion_output":false,"parent_id":"279830d0a4eb4e77af04fdd2e0ad004e","children_ids":["953d6cad80d44954a3f26fb2a3588878","8fc186ccd52a476a8eb12ce3b2a144e3","8f09be487ad14dffa8d6d940a62798f3","dceb7de58bb64b9887578e5749fdd005"],"text":"\\begin{tabular}{l}\n(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker samples pre- and post-surgery will be collected from these subjects. \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker samples pre- and post-surgery will be collected from these subjects. \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99462890625,"confidence_rate":0.9999828517669186},{"cnt":[[631,346],[1833,346],[1833,385],[631,385]],"region":{"top_left_x":631,"top_left_y":345,"width":1203,"height":40},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"953d6cad80d44954a3f26fb2a3588878","type":"text","conversion_output":false,"parent_id":"ac8e35c27ade4300b1f1447221aa8aba","text":"(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker","text_display":"(and therefore prospective candidates for the main study, CACZ885T2301). Biomarker","confidence":1,"confidence_rate":1},{"cnt":[[631,383],[1576,383],[1576,419],[631,419]],"region":{"top_left_x":631,"top_left_y":382,"width":945,"height":38},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fc186ccd52a476a8eb12ce3b2a144e3","type":"text","conversion_output":false,"parent_id":"ac8e35c27ade4300b1f1447221aa8aba","text":"samples pre- and post-surgery will be collected from these subjects.","text_display":" samples pre- and post-surgery will be collected from these subjects.","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[631,426],[1788,426],[1788,463],[631,463]],"region":{"top_left_x":631,"top_left_y":425,"width":1157,"height":38},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f09be487ad14dffa8d6d940a62798f3","type":"text","conversion_output":false,"parent_id":"ac8e35c27ade4300b1f1447221aa8aba","text":"*For China only: biomarker collection is conditional upon approval from HA, EC and","text_display":"\n*For China only: biomarker collection is conditional upon approval from HA, EC and","confidence":0.99462890625,"confidence_rate":0.999938098813284},{"cnt":[[631,465],[1123,465],[1123,497],[631,497]],"region":{"top_left_x":631,"top_left_y":464,"width":493,"height":34},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dceb7de58bb64b9887578e5749fdd005","type":"text","conversion_output":false,"parent_id":"ac8e35c27ade4300b1f1447221aa8aba","text":"additional authorities (i.e. HGRAC).","text_display":" additional authorities (i.e. 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Written informed consent must be obtained prior to any screening procedures. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm, N2 disease only). Minimal treatments considered adequate prior to study enrollment are:\n![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-014.jpg?height=876\\&width=1233\\&top_left_y=700\\&top_left_x=631) \\\\\nThe maximum number of days allowed from surgery to randomization is: \\\\\n- 70 days if subjects were treated with surgery, but did not receive chemotherapy or radiation. \\\\\n- 182 days if subjects were treated with surgery and chemotherapy, but no radiation. \\\\\n- \\(2 5 9\\) days if subjects were treated with surgery, chemotherapy and radiation. \\\\\nNote: \\\\\n- Subjects may enter the study earlier than the maximum number of days allowed, if fully recovered from surgery and adjuvant therapies. \\\\\n- A window of +7 days is allowed to accommodate subject scheduling if needed. \\\\\n- In case of chemotherapy treatment delays due to toxicities, additional window of +14 days is allowed. \\\\\n4. Criterion removed. \\\\\n5. Criterion removed. \\\\\n6. Criterion removed. \\\\\n7a. Subjects must have recovered from all toxicities related to prior systemic therapy to grade \\(\\leq 1\\) (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications described in inclusion 8. \\\\\n8. Subjects must have adequate organ function including the following laboratory values at the screening visit: \\\\\n- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\) \\\\\n- Platelets \\(\\geq 100 \\times 109 / L\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. Written informed consent must be obtained prior to any screening procedures. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm, N2 disease only). Minimal treatments considered adequate prior to study enrollment are:\n![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-014.jpg?height=876\\&width=1233\\&top_left_y=700\\&top_left_x=631) \\\\\nThe maximum number of days allowed from surgery to randomization is: \\\\\n- 70 days if subjects were treated with surgery, but did not receive chemotherapy or radiation. \\\\\n- 182 days if subjects were treated with surgery and chemotherapy, but no radiation. \\\\\n- \\(2 5 9\\) days if subjects were treated with surgery, chemotherapy and radiation. \\\\\nNote: \\\\\n- Subjects may enter the study earlier than the maximum number of days allowed, if fully recovered from surgery and adjuvant therapies. \\\\\n- A window of +7 days is allowed to accommodate subject scheduling if needed. \\\\\n- In case of chemotherapy treatment delays due to toxicities, additional window of +14 days is allowed. \\\\\n4. Criterion removed. \\\\\n5. Criterion removed. \\\\\n6. Criterion removed. \\\\\n7a. Subjects must have recovered from all toxicities related to prior systemic therapy to grade \\(\\leq 1\\) (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications described in inclusion 8. \\\\\n8. Subjects must have adequate organ function including the following laboratory values at the screening visit: \\\\\n- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\) \\\\\n- Platelets \\(\\geq 100 \\times 109 / L\\)\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.92626953125,"confidence_rate":0.9998103034325392},{"cnt":[[634,510],[1764,510],[1764,545],[634,545]],"region":{"top_left_x":633,"top_left_y":510,"width":1132,"height":36},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a094428b56eb45a18ba073efbc9251c3","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"1. Written informed consent must be obtained prior to any screening procedures.","text_display":"1. 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Age \\(\\geq 18\\) years","confidence":1,"confidence_rate":1},{"cnt":[[631,595],[1812,595],[1812,632],[631,632]],"region":{"top_left_x":631,"top_left_y":594,"width":1181,"height":38},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ded55c54a8548c98925690b12baa988","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm,","text_display":"\n3aCompletely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA- IIIA and IIIB (T>5cm,","confidence":0.9513088446431084,"confidence_rate":0.9994329277623503},{"cnt":[[668,634],[1833,634],[1833,668],[668,668]],"region":{"top_left_x":668,"top_left_y":633,"width":1166,"height":36},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"875badb8276e4b6ba9acb14edc545d82","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"N2 disease only). Minimal treatments considered adequate prior to study enrollment","text_display":" N2 disease only). 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Criterion removed.","text_display":"\n4. Criterion removed.","confidence":1,"confidence_rate":1},{"cnt":[[631,2124],[941,2124],[941,2156],[631,2156]],"region":{"top_left_x":631,"top_left_y":2123,"width":311,"height":34},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"059e20525d624b52863158d0f242b807","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"5. Criterion removed.","text_display":"\n5. Criterion removed.","confidence":1,"confidence_rate":1},{"cnt":[[631,2167],[941,2167],[941,2199],[631,2199]],"region":{"top_left_x":631,"top_left_y":2167,"width":311,"height":33},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79f78793a8524207b14b79c8e1daac56","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"6. Criterion removed.","text_display":"\n6. Criterion removed.","confidence":1,"confidence_rate":1},{"cnt":[[631,2210],[1857,2210],[1857,2247],[631,2247]],"region":{"top_left_x":631,"top_left_y":2210,"width":1227,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1756a4db97446d1a53a919b503b88d5","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"7a. Subjects must have recovered from all toxicities related to prior systemic therapy to","text_display":"\n7a. 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Exception to this criterion: subjects with any grade of","confidence":0.97021484375,"confidence_rate":0.9996525001207227},{"cnt":[[683,2280],[1857,2280],[1857,2316],[683,2316]],"region":{"top_left_x":683,"top_left_y":2279,"width":1175,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f9bc5b959114610887fea0151a49122","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications","text_display":" alopecia, neuropathy (grade \\(\\leq 2\\) ), and subjects meeting the laboratory specifications","confidence":1,"confidence_rate":1},{"cnt":[[683,2319],[1021,2319],[1021,2351],[683,2351]],"region":{"top_left_x":683,"top_left_y":2318,"width":339,"height":34},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab6324d9c82341089a1fa2ee0ee1c812","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"described in inclusion 8.","text_display":" described in inclusion 8.","confidence":1,"confidence_rate":1},{"cnt":[[631,2358],[1768,2358],[1768,2399],[631,2399]],"region":{"top_left_x":631,"top_left_y":2357,"width":1138,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e92350e0f7d44af880dce6e5d98dee0","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"8. Subjects must have adequate organ function including the following laboratory","text_display":"\n8. Subjects must have adequate organ function including the following laboratory","confidence":1,"confidence_rate":1},{"cnt":[[683,2397],[1080,2397],[1080,2433],[683,2433]],"region":{"top_left_x":683,"top_left_y":2396,"width":397,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdc9fbd7b0d2493280bf3ce81a387b4d","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"values at the screening visit:","text_display":" values at the screening visit:","confidence":1,"confidence_rate":1},{"cnt":[[683,2440],[1392,2440],[1392,2479],[683,2479]],"region":{"top_left_x":683,"top_left_y":2439,"width":709,"height":40},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ce29162bdc84dfabd5fc3ac41425b20","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\)","text_display":"\n- Absolute neutrophil count (ANC) \\(\\geq 1.5 \\times 109 / L\\)","confidence":0.9863631725311279,"confidence_rate":0.9997308075513995},{"cnt":[[686,2485],[1071,2485],[1071,2520],[686,2520]],"region":{"top_left_x":685,"top_left_y":2485,"width":387,"height":35},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b81a20c451c4a818b411213e2f8b6b7","type":"text","conversion_output":false,"parent_id":"b90bded5552141e7b944b0ffc175a4d2","text":"- Platelets \\(\\geq 100 \\times 109 / L\\)","text_display":"\n- Platelets \\(\\geq 100 \\times 109 / L\\)","confidence":0.9980475902557373,"confidence_rate":0.9999326119885842}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-015","page":15,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2c8bbb60bb3476c9b978490e90762b4","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60b7430baba94e609392bb5fe81f55e1","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"189e7938941f42e6b223fe4b22f0dc3f","type":"page_info","conversion_output":false,"text":"Page 15 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05a66ff26188410b9aaabb04e606843e","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,254],[1871,254],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":253,"width":457,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a071c73b6898480a9737c84af2e57a02","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,339],[1876,339],[1876,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":339,"width":1589,"height":2147},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ccaec83d6174f4e842d17dea424860c","type":"table","conversion_output":true,"children_ids":["768a942b41a748d2b695b989752e1408","76d2b8e2c19d43ee8aff75b8a57cc332","ace0afcf769f4fae96efec693bd1e6f1","c9d3edf46eae4622819e7b090ff0565b","402eec26057e4091a0407b0557937d15","41e7ebfe61db4718ba5be041f66f944e","c71a543545f643c6ae118faabd67dcd6","b732cea9e36a490a993464cf1498d669","23e4781d3be9456181724d30c42da9ab","f242cc16e95746e6bfcea9da137aee8c"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n- Hemoglobin \\(( Hgb )>9 g / dL\\) \\\\\n- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula \\\\\n- Total bilirubin \\(\\leq 1.5 \\times\\) ULN \\\\\n- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN \\\\\n- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN \\\\\n9. ECOG performance status (PS) of 0 or 1 . \\\\\n10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\\end{tabular} \\\\\n\\hline Inclusion criteria applicable for substudy (CACZ885T2301A): & \\begin{tabular}{l}\n1. Written informed consent to sub-study must be obtained prior to any collections. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are candidates for complete resection surgery.\n\\end{tabular} \\\\\n\\hline Exclusion criteria (applicable for main study) & \\begin{tabular}{l}\n1. Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery. \\\\\n2. Subjects who received any neoadjuvant treatment. \\\\\n3a. Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \\(>3\\) years. \\\\\n4a. History of clinically significant interstitial lung disease ( \\(\\geq\\) grade 2). If radiological changes alone are present at baseline (CTC grade 1 interstitial lung disease) should be added to past medical history/concurrent medical conditions at baseline. \\\\\n5a. History or current diagnosis of cardiac disease, including any of the following: \\\\\n- recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months, \\\\\n- uncontrolled congestive heart failure (CHF), \\\\\n- unstable angina (within last 6 months), \\\\\n- clinically significant (symptomatic) cardiac arrhythmias. \\\\\n6a. Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. \\\\\n7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to randomization or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subjects can be enrolled in the study \\(\\geq 1\\) week after the procedure. \\\\\n8. Uncontrolled diabetes as defined by the investigator. \\\\\n9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results \\\\\n10a. Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. In subjects without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or Institutional Review Board (IRB) in which case curative treatment must be completed prior to screening) \\\\\n11a. Subjects with suspected or proven immunocompromised state or infections, including: \\\\\na. Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. \\\\\nb. Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy. Note: Subjects with localized condition unlikely to lead to a systemic infection (e.g. chronic nail fungal infection) are eligible. \\\\\nc. Allogeneic bone marrow or solid organ transplant\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\n- Hemoglobin \\(( Hgb )>9 g / dL\\) \\\\\n- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula \\\\\n- Total bilirubin \\(\\leq 1.5 \\times\\) ULN \\\\\n- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN \\\\\n- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN \\\\\n9. ECOG performance status (PS) of 0 or 1 . \\\\\n10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\\end{tabular} \\\\\n\\hline Inclusion criteria applicable for substudy (CACZ885T2301A): & \\begin{tabular}{l}\n1. Written informed consent to sub-study must be obtained prior to any collections. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are candidates for complete resection surgery.\n\\end{tabular} \\\\\n\\hline Exclusion criteria (applicable for main study) & \\begin{tabular}{l}\n1. Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery. \\\\\n2. Subjects who received any neoadjuvant treatment. \\\\\n3a. Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \\(>3\\) years. \\\\\n4a. History of clinically significant interstitial lung disease ( \\(\\geq\\) grade 2). If radiological changes alone are present at baseline (CTC grade 1 interstitial lung disease) should be added to past medical history/concurrent medical conditions at baseline. \\\\\n5a. History or current diagnosis of cardiac disease, including any of the following: \\\\\n- recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months, \\\\\n- uncontrolled congestive heart failure (CHF), \\\\\n- unstable angina (within last 6 months), \\\\\n- clinically significant (symptomatic) cardiac arrhythmias. \\\\\n6a. Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. \\\\\n7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to randomization or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subjects can be enrolled in the study \\(\\geq 1\\) week after the procedure. \\\\\n8. Uncontrolled diabetes as defined by the investigator. \\\\\n9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results \\\\\n10a. Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. In subjects without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or Institutional Review Board (IRB) in which case curative treatment must be completed prior to screening) \\\\\n11a. Subjects with suspected or proven immunocompromised state or infections, including: \\\\\na. Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. \\\\\nb. Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy. Note: Subjects with localized condition unlikely to lead to a systemic infection (e.g. chronic nail fungal infection) are eligible. \\\\\nc. Allogeneic bone marrow or solid organ transplant\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.7012643814086914,"confidence_rate":0.999476908358121},{"cnt":[[306,339],[605,339],[605,2483],[306,2483]],"region":{"top_left_x":306,"top_left_y":339,"width":300,"height":2144},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"768a942b41a748d2b695b989752e1408","type":"table_column","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","text":"","text_display":""},{"cnt":[[612,339],[1872,339],[1872,2483],[612,2483]],"region":{"top_left_x":611,"top_left_y":339,"width":1262,"height":2144},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76d2b8e2c19d43ee8aff75b8a57cc332","type":"table_column","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","text":"","text_display":""},{"cnt":[[287,345],[1874,345],[1874,662],[287,662]],"region":{"top_left_x":287,"top_left_y":345,"width":1588,"height":317},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ace0afcf769f4fae96efec693bd1e6f1","type":"table_row","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","text":"","text_display":""},{"cnt":[[287,664],[1874,664],[1874,837],[287,837]],"region":{"top_left_x":287,"top_left_y":663,"width":1588,"height":175},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9d3edf46eae4622819e7b090ff0565b","type":"table_row","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","text":"","text_display":""},{"cnt":[[287,835],[1876,835],[1876,2483],[287,2483]],"region":{"top_left_x":287,"top_left_y":834,"width":1590,"height":1649},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"402eec26057e4091a0407b0557937d15","type":"table_row","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","text":"","text_display":""},{"cnt":[[620,348],[1859,348],[1859,662],[620,662]],"region":{"top_left_x":620,"top_left_y":347,"width":1240,"height":315},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41e7ebfe61db4718ba5be041f66f944e","type":"complex_cell","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","children_ids":["91ee952783984f5586c9372f841c8ab0","87105c4ac971488d9b1b567ad4b924eb","b65311c1695b45eba0f0cc6c71383e97","4d805ecd13d3400e893fb5baad113531","f8c5c190d42d43da8141e2ab8624a51b","09354978ba814c2faf27c6356c47e729","4a16e12df67b4c96a9ca3df73f6bc37b"],"text":"\\begin{tabular}{l}\n- Hemoglobin \\(( Hgb )>9 g / dL\\) \\\\\n- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula \\\\\n- Total bilirubin \\(\\leq 1.5 \\times\\) ULN \\\\\n- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN \\\\\n- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN \\\\\n9. ECOG performance status (PS) of 0 or 1 . \\\\\n10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Hemoglobin \\(( Hgb )>9 g / dL\\) \\\\\n- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula \\\\\n- Total bilirubin \\(\\leq 1.5 \\times\\) ULN \\\\\n- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN \\\\\n- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN \\\\\n9. ECOG performance status (PS) of 0 or 1 . \\\\\n10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7012643814086914,"confidence_rate":0.9977306839090391},{"cnt":[[681,352],[1129,352],[1129,393],[681,393]],"region":{"top_left_x":681,"top_left_y":351,"width":449,"height":43},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91ee952783984f5586c9372f841c8ab0","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"- Hemoglobin \\(( Hgb )>9 g / dL\\)","text_display":"- Hemoglobin \\(( Hgb )>9 g / dL\\)","confidence":0.94091796875,"confidence_rate":0.9983554262892043},{"cnt":[[681,395],[1796,395],[1796,436],[681,436]],"region":{"top_left_x":681,"top_left_y":395,"width":1116,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87105c4ac971488d9b1b567ad4b924eb","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula","text_display":"\n- Creatinine clearance greater than \\(45 mL / min\\) using Cockcroft-Gault formula","confidence":0.77490234375,"confidence_rate":0.9971062601232019},{"cnt":[[681,439],[1112,439],[1112,475],[681,475]],"region":{"top_left_x":681,"top_left_y":438,"width":432,"height":38},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b65311c1695b45eba0f0cc6c71383e97","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"- Total bilirubin \\(\\leq 1.5 \\times\\) ULN","text_display":"\n- Total bilirubin \\(\\leq 1.5 \\times\\) ULN","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[681,486],[1320,486],[1320,527],[681,527]],"region":{"top_left_x":681,"top_left_y":486,"width":639,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d805ecd13d3400e893fb5baad113531","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN","text_display":"\n- Aspartate transaminase (AST) \\(\\leq 3 \\times\\) ULN","confidence":1,"confidence_rate":1},{"cnt":[[681,532],[1290,532],[1290,571],[681,571]],"region":{"top_left_x":681,"top_left_y":531,"width":609,"height":40},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8c5c190d42d43da8141e2ab8624a51b","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN","text_display":"\n- Alanine transaminase (ALT) \\(\\leq 3 \\times\\) ULN","confidence":0.810546875,"confidence_rate":0.9952376012451875},{"cnt":[[629,573],[1259,573],[1259,614],[629,614]],"region":{"top_left_x":629,"top_left_y":572,"width":631,"height":43},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09354978ba814c2faf27c6356c47e729","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"9. ECOG performance status (PS) of 0 or 1 .","text_display":"\n9. ECOG performance status (PS) of 0 or 1 .","confidence":0.7012643814086914,"confidence_rate":0.9934498737320764},{"cnt":[[623,621],[1855,621],[1855,659],[623,659]],"region":{"top_left_x":622,"top_left_y":620,"width":1233,"height":40},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a16e12df67b4c96a9ca3df73f6bc37b","type":"text","conversion_output":false,"parent_id":"41e7ebfe61db4718ba5be041f66f944e","text":"10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.","text_display":"\n10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.","confidence":1,"confidence_rate":1},{"cnt":[[306,664],[601,664],[601,820],[306,820]],"region":{"top_left_x":306,"top_left_y":663,"width":295,"height":157},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c71a543545f643c6ae118faabd67dcd6","type":"complex_cell","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","children_ids":["cb0a02bff19b4e24926dcd8dd5624d68","3e0c4c1dd0b3467abbd0e2088afd092a","3728daa2d2654f9fa6a92a5c4c8540ea","cdb2eb12051b457cac2ba265bd367a49"],"text":"Inclusion criteria applicable for substudy (CACZ885T2301A):","text_display":"Inclusion criteria applicable for substudy (CACZ885T2301A):","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[313,668],[569,668],[569,701],[313,701]],"region":{"top_left_x":312,"top_left_y":668,"width":257,"height":33},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb0a02bff19b4e24926dcd8dd5624d68","type":"text","conversion_output":false,"parent_id":"c71a543545f643c6ae118faabd67dcd6","text":"Inclusion criteria","text_display":"Inclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[313,703],[601,703],[601,744],[313,744]],"region":{"top_left_x":312,"top_left_y":702,"width":289,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e0c4c1dd0b3467abbd0e2088afd092a","type":"text","conversion_output":false,"parent_id":"c71a543545f643c6ae118faabd67dcd6","text":"applicable for sub-","text_display":" applicable for sub","confidence":1,"confidence_rate":1},{"cnt":[[313,742],[402,742],[402,779],[313,779]],"region":{"top_left_x":312,"top_left_y":741,"width":90,"height":38},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3728daa2d2654f9fa6a92a5c4c8540ea","type":"text","conversion_output":false,"parent_id":"c71a543545f643c6ae118faabd67dcd6","text":"study","text_display":"study","confidence":1,"confidence_rate":1},{"cnt":[[313,776],[601,776],[601,815],[313,815]],"region":{"top_left_x":312,"top_left_y":776,"width":289,"height":40},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdb2eb12051b457cac2ba265bd367a49","type":"text","conversion_output":false,"parent_id":"c71a543545f643c6ae118faabd67dcd6","text":"(CACZ885T2301A):","text_display":" (CACZ885T2301A):","confidence":1,"confidence_rate":1},{"cnt":[[623,664],[1792,664],[1792,835],[623,835]],"region":{"top_left_x":622,"top_left_y":663,"width":1171,"height":172},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b732cea9e36a490a993464cf1498d669","type":"complex_cell","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","children_ids":["7bdb3b6c463944e9b82d43dfd19e9791","131878fff61241869ee5efacea9f6d20","07565e95c2ed4938bd6e73637e1f5f4e","6ebed857033d4d1e81fd2b3353de04ad"],"text":"\\begin{tabular}{l}\n1. Written informed consent to sub-study must be obtained prior to any collections. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are candidates for complete resection surgery.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. Written informed consent to sub-study must be obtained prior to any collections. \\\\\n2. Age \\(\\geq 18\\) years \\\\\n3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are candidates for complete resection surgery.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8999276275280863,"confidence_rate":0.9997135167703854},{"cnt":[[629,668],[1788,668],[1788,709],[629,709]],"region":{"top_left_x":629,"top_left_y":668,"width":1159,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7bdb3b6c463944e9b82d43dfd19e9791","type":"text","conversion_output":false,"parent_id":"b732cea9e36a490a993464cf1498d669","text":"1. Written informed consent to sub-study must be obtained prior to any collections.","text_display":"1. Written informed consent to sub-study must be obtained prior to any collections.","confidence":1,"confidence_rate":1},{"cnt":[[629,711],[896,711],[896,750],[629,750]],"region":{"top_left_x":629,"top_left_y":711,"width":267,"height":40},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"131878fff61241869ee5efacea9f6d20","type":"text","conversion_output":false,"parent_id":"b732cea9e36a490a993464cf1498d669","text":"2. Age \\(\\geq 18\\) years","text_display":"\n2. Age \\(\\geq 18\\) years","confidence":1,"confidence_rate":1},{"cnt":[[629,755],[1731,755],[1731,796],[629,796]],"region":{"top_left_x":629,"top_left_y":754,"width":1103,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07565e95c2ed4938bd6e73637e1f5f4e","type":"text","conversion_output":false,"parent_id":"b732cea9e36a490a993464cf1498d669","text":"3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are","text_display":"\n3. Subjects with NSCLC Stage IIA-IIIA, IIIB ( \\(T >5 cm\\), N2 disease only) who are","confidence":0.8999276275280863,"confidence_rate":0.998854559423344},{"cnt":[[681,794],[1277,794],[1277,833],[681,833]],"region":{"top_left_x":681,"top_left_y":793,"width":596,"height":40},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ebed857033d4d1e81fd2b3353de04ad","type":"text","conversion_output":false,"parent_id":"b732cea9e36a490a993464cf1498d669","text":"candidates for complete resection surgery.","text_display":" candidates for complete resection surgery.","confidence":1,"confidence_rate":1},{"cnt":[[309,837],[584,837],[584,956],[309,956]],"region":{"top_left_x":308,"top_left_y":837,"width":276,"height":120},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23e4781d3be9456181724d30c42da9ab","type":"complex_cell","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","children_ids":["01d8d8efda934546befb39097bf1d16d","0256146e570542bfbd1cd22c7014b803","c87d4e2d3654469ea56e6c7e1dc695c0"],"text":"Exclusion criteria (applicable for main study)","text_display":"Exclusion criteria (applicable for main study)","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[313,841],[579,841],[579,874],[313,874]],"region":{"top_left_x":312,"top_left_y":841,"width":268,"height":33},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01d8d8efda934546befb39097bf1d16d","type":"text","conversion_output":false,"parent_id":"23e4781d3be9456181724d30c42da9ab","text":"Exclusion criteria","text_display":"Exclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[313,876],[532,876],[532,917],[313,917]],"region":{"top_left_x":312,"top_left_y":876,"width":220,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0256146e570542bfbd1cd22c7014b803","type":"text","conversion_output":false,"parent_id":"23e4781d3be9456181724d30c42da9ab","text":"(applicable for","text_display":" (applicable for","confidence":1,"confidence_rate":1},{"cnt":[[313,915],[493,915],[493,952],[313,952]],"region":{"top_left_x":312,"top_left_y":915,"width":181,"height":37},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c87d4e2d3654469ea56e6c7e1dc695c0","type":"text","conversion_output":false,"parent_id":"23e4781d3be9456181724d30c42da9ab","text":"main study)","text_display":" main study)","confidence":1,"confidence_rate":1},{"cnt":[[616,837],[1866,837],[1866,2483],[616,2483]],"region":{"top_left_x":616,"top_left_y":837,"width":1250,"height":1646},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f242cc16e95746e6bfcea9da137aee8c","type":"complex_cell","conversion_output":false,"parent_id":"7ccaec83d6174f4e842d17dea424860c","children_ids":["34684d14fa3d44f2ab3d1d8b8ebd980d","c39b6e34b739464ba6864a413db92738","a0d830294fca45ae862666a8baeef62a","dbedf72828864ff8a9b9a2e790baecf8","33c8c2f4ee7a44f8bf1b52aebe5ae86b","8189c76476a3491494bd471114e30d87","3f2e774b771b45aa9d450c41e35a988a","2fed272134cd41e69b78a6cb3ac1708b","0caebbb2698749b48f17797305efc3d9","5e54f1cfb86e4309be11257c79b03cf0","2aa413d667974709868e0e5bb90888c0","1250b1802b124be89d9e45e07443ba49","a74ecd3c3d8e4f1ab5d9161ab1a69220","33e2d36f1d444447a64d0eea3ad4f553","816ffd383e104553a57d0fe038b8c4f2","8c87da58d8224ef8b7d85060bccf8de0","a3d3ed9c01684711808650c0696ae566","6e4b13c0ce654a8c822f3ba42de24662","1256c56f452d4d7fa1a1062ec23fc429","695afd67156047cc8da6569d44d104ff","b4e16c0a211747cebf61849598fa1972","eecfb14655194650841bb203e8ce9e00","7be38eaa995c43248c3a0bf1ea2880e4","69e49449c0c54cdb8cfee803f6876bd8","57390225618d430fb8d814a4844b8fdb","2669e753729f4751a7ce106968cc7105","cede3a5ee7f04d3c866f5cdaf8a34e3c","1964b3875843442389ac0a057c2084bd","f834100adf66458fac64daccabd45a53","01110c844b8c421c9e2485c9f671cec3","6e889abd8bcd4165b387289db671ce49","b00c5d0efe9b47c7b54c275f3514ec0d","36963c2b02aa4823bf82f5aea90eeffd","ead86e28415c4db4be7996671a75b1e2","fc93122da2f54bb3ad0bca59e606b5db","b3d91f107ede48af8bbb50f1f1ea4503","5cdf83d050e349838903c325396c2dae","4f1ab0c0230f46948920e6e7b0d36402","787290db40dc47d1b59a1ef6cee67af0","7a1fe3e865c2440db8b2b87ba4ee1561","000889a2460f452f91c2b0a11e63982a","db604e40d178444dae66b1092c702fff"],"text":"\\begin{tabular}{l}\n1. Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery. \\\\\n2. Subjects who received any neoadjuvant treatment. \\\\\n3a. Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \\(>3\\) years. \\\\\n4a. History of clinically significant interstitial lung disease ( \\(\\geq\\) grade 2). If radiological changes alone are present at baseline (CTC grade 1 interstitial lung disease) should be added to past medical history/concurrent medical conditions at baseline. \\\\\n5a. History or current diagnosis of cardiac disease, including any of the following: \\\\\n- recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months, \\\\\n- uncontrolled congestive heart failure (CHF), \\\\\n- unstable angina (within last 6 months), \\\\\n- clinically significant (symptomatic) cardiac arrhythmias. \\\\\n6a. Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. \\\\\n7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to randomization or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subjects can be enrolled in the study \\(\\geq 1\\) week after the procedure. \\\\\n8. Uncontrolled diabetes as defined by the investigator. \\\\\n9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results \\\\\n10a. Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. In subjects without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or Institutional Review Board (IRB) in which case curative treatment must be completed prior to screening) \\\\\n11a. Subjects with suspected or proven immunocompromised state or infections, including: \\\\\na. Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. \\\\\nb. Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy. Note: Subjects with localized condition unlikely to lead to a systemic infection (e.g. chronic nail fungal infection) are eligible. \\\\\nc. Allogeneic bone marrow or solid organ transplant\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery. \\\\\n2. Subjects who received any neoadjuvant treatment. \\\\\n3a. Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \\(>3\\) years. \\\\\n4a. History of clinically significant interstitial lung disease ( \\(\\geq\\) grade 2). If radiological changes alone are present at baseline (CTC grade 1 interstitial lung disease) should be added to past medical history/concurrent medical conditions at baseline. \\\\\n5a. History or current diagnosis of cardiac disease, including any of the following: \\\\\n- recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months, \\\\\n- uncontrolled congestive heart failure (CHF), \\\\\n- unstable angina (within last 6 months), \\\\\n- clinically significant (symptomatic) cardiac arrhythmias. \\\\\n6a. Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. \\\\\n7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to randomization or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subjects can be enrolled in the study \\(\\geq 1\\) week after the procedure. \\\\\n8. Uncontrolled diabetes as defined by the investigator. \\\\\n9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results \\\\\n10a. Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. In subjects without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or Institutional Review Board (IRB) in which case curative treatment must be completed prior to screening) \\\\\n11a. Subjects with suspected or proven immunocompromised state or infections, including: \\\\\na. Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. \\\\\nb. Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy. Note: Subjects with localized condition unlikely to lead to a systemic infection (e.g. chronic nail fungal infection) are eligible. \\\\\nc. Allogeneic bone marrow or solid organ transplant\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7880859375,"confidence_rate":0.9999422783203977},{"cnt":[[629,841],[1857,841],[1857,883],[629,883]],"region":{"top_left_x":629,"top_left_y":841,"width":1228,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34684d14fa3d44f2ab3d1d8b8ebd980d","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"1. Subjects with unresectable or metastatic disease, positive microscopic margins on the","text_display":"1. Subjects with unresectable or metastatic disease, positive microscopic margins on the","confidence":1,"confidence_rate":1},{"cnt":[[681,880],[1679,880],[1679,917],[681,917]],"region":{"top_left_x":681,"top_left_y":880,"width":999,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c39b6e34b739464ba6864a413db92738","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"pathology report, and/or gross disease remaining at the time of surgery.","text_display":" pathology report, and/or gross disease remaining at the time of surgery.","confidence":0.99853515625,"confidence_rate":0.999980962289239},{"cnt":[[629,919],[1387,919],[1387,960],[629,960]],"region":{"top_left_x":629,"top_left_y":919,"width":759,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0d830294fca45ae862666a8baeef62a","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"2. Subjects who received any neoadjuvant treatment.","text_display":"\n2. Subjects who received any neoadjuvant treatment.","confidence":1,"confidence_rate":1},{"cnt":[[629,963],[1857,963],[1857,1004],[629,1004]],"region":{"top_left_x":629,"top_left_y":962,"width":1228,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbedf72828864ff8a9b9a2e790baecf8","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"3a. Presence or history of a malignant disease, other than the resected NSCLC, that has","text_display":"\n3a. Presence or history of a malignant disease, other than the resected NSCLC, that has","confidence":1,"confidence_rate":1},{"cnt":[[681,1002],[1857,1002],[1857,1038],[681,1038]],"region":{"top_left_x":681,"top_left_y":1001,"width":1176,"height":38},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33c8c2f4ee7a44f8bf1b52aebe5ae86b","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"been diagnosed and/or required therapy within the past 3 years. Exceptions to this","text_display":" been diagnosed and/or required therapy within the past 3 years. 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History or current diagnosis of cardiac disease, including any of the following:","text_display":"\n5a. 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Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects","text_display":"\n6a. 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Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior","text_display":"\n7. 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Subjects must be evaluated for tuberculosis as per local treatment guidelines or","text_display":"\n10a. Subjects must be evaluated for tuberculosis as per local treatment guidelines or","confidence":1,"confidence_rate":1},{"cnt":[[681,1911],[1857,1911],[1857,1952],[681,1952]],"region":{"top_left_x":681,"top_left_y":1911,"width":1176,"height":42},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1964b3875843442389ac0a057c2084bd","type":"text","conversion_output":false,"parent_id":"f242cc16e95746e6bfcea9da137aee8c","text":"clinical practice. Subjects with active tuberculosis are not eligible. In subjects without","text_display":" clinical practice. Subjects with active tuberculosis are not eligible. 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Prednisone \\(>20 mg\\) (or equivalent) oral or intravenous daily for \\(>14\\) days;","text_display":"\ni. Prednisone \\(>20 mg\\) (or equivalent) oral or intravenous daily for \\(>14\\) days;","confidence":1,"confidence_rate":1},{"cnt":[[752,468],[1772,468],[1772,513],[752,513]],"region":{"top_left_x":751,"top_left_y":468,"width":1022,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78a0d9917f0c4e969db634c3bea83089","type":"text","conversion_output":true,"text":"ii. Prednisone \\(>5 mg\\) and \\(\\leq 20 mg\\) (or equivalent) daily for \\(>30\\) days;","text_display":"\nii. 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For UK: with spermicidal foam/gel/film/cream/ vaginal","text_display":" cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal","confidence":1,"confidence_rate":1},{"cnt":[[752,1753],[926,1753],[926,1794],[752,1794]],"region":{"top_left_x":751,"top_left_y":1753,"width":175,"height":41},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"832c5fdbb6fe466a8af99b6abc6777b9","type":"text","conversion_output":true,"text":"suppository","text_display":" suppository","confidence":1,"confidence_rate":1},{"cnt":[[692,1796],[1858,1796],[1858,1837],[692,1837]],"region":{"top_left_x":691,"top_left_y":1796,"width":1168,"height":41},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b44a225c77f4422aa4de69769162e6c4","type":"text","conversion_output":true,"text":"- Use of oral, injected or implanted hormonal methods of contraception or other","text_display":"\n- Use of oral, injected or implanted hormonal methods of contraception or other","confidence":1,"confidence_rate":1},{"cnt":[[752,1835],[1858,1835],[1858,1876],[752,1876]],"region":{"top_left_x":751,"top_left_y":1834,"width":1108,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d79b9edd59b44f8ba4ef7bacd53e82b2","type":"text","conversion_output":true,"text":"forms of hormonal contraception that have comparable efficacy (failure rate","text_display":" forms of hormonal contraception that have comparable efficacy (failure rate","confidence":1,"confidence_rate":1},{"cnt":[[752,1869],[1858,1869],[1858,1910],[752,1910]],"region":{"top_left_x":751,"top_left_y":1869,"width":1108,"height":41},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"585ec5559ea0473bacbf28f6a93829e2","type":"text","conversion_output":true,"text":"\\(<1 \\%\\) ), for example hormone vaginal ring or transdermal hormone contraception","text_display":" \\(<1 \\%\\) ), for example hormone vaginal ring or transdermal hormone contraception","confidence":0.9970715045928955,"confidence_rate":0.9999633407739673},{"cnt":[[752,1908],[1762,1908],[1762,1949],[752,1949]],"region":{"top_left_x":751,"top_left_y":1907,"width":1011,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8ec043a254c4c36bd11775a2c89a095","type":"text","conversion_output":true,"text":"or placement of an intrauterine device (IUD) or intrauterine system (IUS)","text_display":" or placement of an intrauterine device (IUD) or intrauterine system (IUS)","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[627,1946],[1858,1946],[1858,1987],[627,1987]],"region":{"top_left_x":627,"top_left_y":1946,"width":1232,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd3b5a43ad404da5b02ee4c1bf25aa7b","type":"text","conversion_output":true,"text":"In case of use of oral contraception women should have been stable on the same pill for","text_display":"\nIn case of use of oral contraception women should have been stable on the same pill for","confidence":1,"confidence_rate":1},{"cnt":[[627,1985],[1858,1985],[1858,2026],[627,2026]],"region":{"top_left_x":627,"top_left_y":1985,"width":1232,"height":41},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a4230d5a6dd4d639c3185e75c3de630","type":"text","conversion_output":true,"text":"a minimum of 3 months before taking study treatment. Prior to entry into this study,","text_display":" a minimum of 3 months before taking study treatment. Prior to entry into this study,","confidence":1,"confidence_rate":1},{"cnt":[[629,2020],[1858,2020],[1858,2060],[629,2060]],"region":{"top_left_x":629,"top_left_y":2019,"width":1230,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"751dd4542f754b0b93741c04689b5bdd","type":"text","conversion_output":true,"text":"cisplatin-based chemotherapy, which may be toxic to the fetus, may be given. The time","text_display":" cisplatin-based chemotherapy, which may be toxic to the fetus, may be given. The time","confidence":1,"confidence_rate":1},{"cnt":[[629,2058],[1858,2058],[1858,2097],[629,2097]],"region":{"top_left_x":629,"top_left_y":2058,"width":1230,"height":39},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0030629dd3034bb7807779d7ba378f64","type":"text","conversion_output":true,"text":"between the end of cisplatin-based chemotherapy and the start canakinumab/placebo","text_display":" between the end of cisplatin-based chemotherapy and the start canakinumab/placebo","confidence":1,"confidence_rate":1},{"cnt":[[627,2093],[1858,2093],[1858,2133],[627,2133]],"region":{"top_left_x":627,"top_left_y":2092,"width":1232,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"749c73c9f5984b03ae5915c9856d156f","type":"text","conversion_output":true,"text":"treatment is variable, resulting in a variable need for continuation of highly effective","text_display":" treatment is variable, resulting in a variable need for continuation of highly effective","confidence":1,"confidence_rate":1},{"cnt":[[629,2127],[836,2127],[836,2168],[629,2168]],"region":{"top_left_x":629,"top_left_y":2126,"width":207,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"067f5c29a5d9404b950d66a874573356","type":"text","conversion_output":true,"text":"contraception.","text_display":" contraception.","confidence":1,"confidence_rate":1},{"cnt":[[627,2170],[1858,2170],[1858,2211],[627,2211]],"region":{"top_left_x":627,"top_left_y":2169,"width":1232,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffc2b9203d5c4bff9aa47ea137e4950c","type":"text","conversion_output":true,"text":"Women are considered post-menopausal and not of childbearing potential if they have","text_display":"\nWomen are considered post-menopausal and not of childbearing potential if they have","confidence":1,"confidence_rate":1},{"cnt":[[629,2209],[1858,2209],[1858,2247],[629,2247]],"region":{"top_left_x":629,"top_left_y":2208,"width":1230,"height":40},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"080c54f8a4f54062b56b79567b22c6d5","type":"text","conversion_output":true,"text":"had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile","text_display":" had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile","confidence":1,"confidence_rate":1},{"cnt":[[632,2243],[1858,2243],[1858,2284],[632,2284]],"region":{"top_left_x":631,"top_left_y":2242,"width":1228,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd45922a505e443f88c853def88a27ac","type":"text","conversion_output":true,"text":"(i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral","text_display":" (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral","confidence":1,"confidence_rate":1},{"cnt":[[629,2282],[1858,2282],[1858,2322],[629,2322]],"region":{"top_left_x":629,"top_left_y":2281,"width":1230,"height":42},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec46bffac1024b2fa19602e969e05a6f","type":"text","conversion_output":true,"text":"oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation","text_display":" oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation","confidence":1,"confidence_rate":1},{"cnt":[[629,2316],[1858,2316],[1858,2357],[629,2357]],"region":{"top_left_x":629,"top_left_y":2316,"width":1230,"height":41},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dea6c0c1d1a9483497bf3b3f645c277a","type":"text","conversion_output":true,"text":"at least six weeks prior to first dose of study drug. In the case of oophorectomy alone,","text_display":" at least six weeks prior to first dose of study drug. In the case of oophorectomy alone,","confidence":1,"confidence_rate":1},{"cnt":[[632,2350],[1858,2350],[1858,2391],[632,2391]],"region":{"top_left_x":631,"top_left_y":2350,"width":1228,"height":42},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbec6b60779e4876b192468ab3a91728","type":"text","conversion_output":true,"text":"only when the reproductive status of the woman has been confirmed by follow up","text_display":" only when the reproductive status of the woman has been confirmed by follow up","confidence":1,"confidence_rate":1},{"cnt":[[629,2387],[1858,2387],[1858,2428],[629,2428]],"region":{"top_left_x":629,"top_left_y":2386,"width":1230,"height":42},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c54d9d2ff30d466ea3e8c3a5b6b2f803","type":"text","conversion_output":true,"text":"hormone level assessment is she considered not of childbearing potential. If local","text_display":" hormone level assessment is she considered not of childbearing potential. If local","confidence":1,"confidence_rate":1},{"cnt":[[629,2423],[1858,2423],[1858,2464],[629,2464]],"region":{"top_left_x":629,"top_left_y":2423,"width":1230,"height":42},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"32215cd99b7b4626a2f3487bcdbc197c","type":"text","conversion_output":true,"text":"regulations deviate from the contraception methods listed above to prevent pregnancy,","text_display":" regulations deviate from the contraception methods listed above to prevent pregnancy,","confidence":1,"confidence_rate":1},{"cnt":[[627,2460],[1762,2460],[1762,2501],[627,2501]],"region":{"top_left_x":627,"top_left_y":2459,"width":1135,"height":42},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10837c46d3084653ad5e162607fee949","type":"text","conversion_output":true,"text":"local regulations apply and will be described in the Informed Consent Form (ICF).","text_display":" local regulations apply and will be described in the Informed Consent Form (ICF).","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-017","page":17,"lines":[{"cnt":[[284,202],[889,202],[889,299],[284,299]],"region":{"top_left_x":283,"top_left_y":201,"width":607,"height":98},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a8be304c2c342f599c4ab0f56ebf8c2","type":"section_header","conversion_output":false,"children_ids":["a3d0b533553c49eb96845cf60774d070","7ed0d9c1d6a248399d2834b73ce1b5d2"],"text":"","text_display":""},{"cnt":[[292,206],[425,206],[425,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":134,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3d0b533553c49eb96845cf60774d070","type":"text","conversion_output":true,"parent_id":"7a8be304c2c342f599c4ab0f56ebf8c2","text":"Novartis","text_display":"\n\n\\section*{Novartis","confidence":1,"confidence_rate":1},{"cnt":[[288,249],[883,249],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":249,"width":597,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ed0d9c1d6a248399d2834b73ce1b5d2","type":"text","conversion_output":true,"parent_id":"7a8be304c2c342f599c4ab0f56ebf8c2","text":"Amended Protocol Version 03 (Clean)","text_display":" \\\\ Amended Protocol Version 03 (Clean)}","confidence":1,"confidence_rate":1},{"cnt":[[984,202],[1182,202],[1182,247],[984,247]],"region":{"top_left_x":983,"top_left_y":201,"width":199,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fa07cd6d1a3466da312864143546bf2","type":"section_header","conversion_output":false,"children_ids":["78f9eb147b3a4eaca4331ccaa0c69879"],"text":"","text_display":""},{"cnt":[[988,206],[1179,206],[1179,247],[988,247]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78f9eb147b3a4eaca4331ccaa0c69879","type":"text","conversion_output":true,"parent_id":"0fa07cd6d1a3466da312864143546bf2","text":"Confidential","text_display":"\n\n\\section*{Confidential}","confidence":1,"confidence_rate":1},{"cnt":[[1629,202],[1876,202],[1876,251],[1629,251]],"region":{"top_left_x":1628,"top_left_y":201,"width":248,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d95775ffe724239a9d1885373b32a7c","type":"text","conversion_output":true,"text":"Page 17 of 144","text_display":"\n\nPage 17 of 144","confidence":1,"confidence_rate":1},{"cnt":[[1414,249],[1876,249],[1876,290],[1414,290]],"region":{"top_left_x":1413,"top_left_y":249,"width":463,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"263aed4cc50f45269e7e40cbf555d960","type":"text","conversion_output":true,"text":"Protocol No. CACZ885T2301","text_display":"\nProtocol No. CACZ885T2301","confidence":0.99658203125,"confidence_rate":0.999885879067304},{"cnt":[[288,335],[1880,335],[1880,2539],[288,2539]],"region":{"top_left_x":287,"top_left_y":335,"width":1593,"height":2205},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df469819d98640e384b7788603840fa3","type":"table","conversion_output":true,"children_ids":["122f651ef5f04393876040549b5c4fc3","716ecc5f23264910a30cb5b407a38493","06fa1619f4624879afdd9aa859b3e694","6b4fafa5fbd94ee1a8a1783fe6b30508","449876ce5e1f41a98994519c6e3787fd","90eab9ba38eb4ba68e57f68b796a68d3","e37e508d32b54e11b3268ebe866fef22","e86b9adde6584446bd062fa5569fcae3","6f1abd43780c48eab484bd81973adca9","6e16f11ae45c43ff9fa2877b3cf5d413","bbe0fa300c2a431aa36c343e6192d922","e6412b49c1d345f483a7df0116356de5","d13a65895e6646d9bd5e7ae72c654e18","3ffd1db7a5e94b5bbd0a3bb7b6bf488c","500ce4d3ff8c46c28c31ab9881014f54","b144c21840ee41b09b7bd5a8ec47e207","4f06a59f23ee40ad92c00754bb066302","5bed1c3377d242cf8f58d4d52f36a771","fb6dd1f911c44fb2a4fdcdf5cce32095"],"text":"\\begin{tabular}{|l|l|}\n\\hline & No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects. \\\\\n\\hline Investigational and reference therapy & All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles. \\\\\n\\hline Efficacy assessments & Detection of first disease NSCLC recurrence will be done by clinical evaluation that includes physical examination, and radiological tumor measurements as determined by the investigator. In case of non-conclusive radiological evidence, a biopsy should be performed to confirm recurrence. The following assessments are required at screening/baseline: Chest, abdomen and pelvis CT or MRI, brain MRI and whole body bone scan, if clinically indicated. Subsequent imaging assessments will be done every 12 weeks for the first year (treatment phase) following Cycle 1 Day 1, then every 26 weeks during years two and three, and annually during years four and five (post-treatment surveillance phase). The intervals between imaging assessments across all study phases should be respected as described above regardless of whether study treatment is temporarily withheld or permanently discontinued before the last scheduled dose administration on Cycle 18 Day 1, or if unscheduled assessments are performed. If a subject discontinues study treatment for reasons other than recurrence, recurrence assessments should continue as per the scheduled visits until disease recurrence, withdrawal of consent by the subject, subject is lost to follow up, death, or the sponsor terminates the study. \\\\\n\\hline Safety assessments & \\begin{tabular}{l}\n- Adverse Events (AEs) including Serious AEs (SAEs) \\\\\n- Hematology \\\\\n- Biochemistry \\\\\n- Urinalysis \\\\\n- Coagulation \\\\\n- Pregnancy test (females) \\\\\n- Physical examination \\\\\n- Vital signs \\\\\n- Electrocardiograms (ECG) \\\\\n- Eastern Cooperative Oncology Group (ECOG) performance status\n\\end{tabular} \\\\\n\\hline Other assessments & \\begin{tabular}{l}\n- Blood pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) sampling![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-017.jpg?height=53\\&width=558\\&top_left_y=1677\\&top_left_x=624) \\\\\n- Patient reported outcomes\n\\end{tabular} \\\\\n\\hline Data analysis & \\begin{tabular}{l}\nThe primary efficacy variable of the study is disease free survival (DFS), defined as the time from the date of randomization to the date of the first documented disease recurrence of NSCLC as assessed by local investigator radiologically or death due to any cause. In case of non-conclusive radiological evidence, a biopsy will be performed to confirm NSCLC recurrence will be used as DFS event and radiological assessment date will be used as DFS event date. DFS events will be assessed locally. \\\\\nThe key secondary objective is to determine whether treatment with canakinumab prolongs overall survival (OS) compared with placebo arm. OS is defined as the time from the date of randomization to the date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date). \\\\\nDFS and OS will also be compared between canakinumab and placebo arms in subgroups defined respectively by PD-L1 and CD8 expression levels. \\\\\nPharmacokinetics objectives: \\\\\nThe Pharmacokinetic Analysis Set (PAS) will be used in the pharmacokinetic data analysis. Descriptive statistics (n, m (number of non-zero concentrations), mean, CV\\%, SD, median, geometric mean, geometric CV\\%, minimum and maximum) for canakinumab concentrations will be presented at each scheduled timepoint.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects. \\\\\n\\hline Investigational and reference therapy & All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles. \\\\\n\\hline Efficacy assessments & Detection of first disease NSCLC recurrence will be done by clinical evaluation that includes physical examination, and radiological tumor measurements as determined by the investigator. In case of non-conclusive radiological evidence, a biopsy should be performed to confirm recurrence. The following assessments are required at screening/baseline: Chest, abdomen and pelvis CT or MRI, brain MRI and whole body bone scan, if clinically indicated. Subsequent imaging assessments will be done every 12 weeks for the first year (treatment phase) following Cycle 1 Day 1, then every 26 weeks during years two and three, and annually during years four and five (post-treatment surveillance phase). The intervals between imaging assessments across all study phases should be respected as described above regardless of whether study treatment is temporarily withheld or permanently discontinued before the last scheduled dose administration on Cycle 18 Day 1, or if unscheduled assessments are performed. If a subject discontinues study treatment for reasons other than recurrence, recurrence assessments should continue as per the scheduled visits until disease recurrence, withdrawal of consent by the subject, subject is lost to follow up, death, or the sponsor terminates the study. \\\\\n\\hline Safety assessments & \\begin{tabular}{l}\n- Adverse Events (AEs) including Serious AEs (SAEs) \\\\\n- Hematology \\\\\n- Biochemistry \\\\\n- Urinalysis \\\\\n- Coagulation \\\\\n- Pregnancy test (females) \\\\\n- Physical examination \\\\\n- Vital signs \\\\\n- Electrocardiograms (ECG) \\\\\n- Eastern Cooperative Oncology Group (ECOG) performance status\n\\end{tabular} \\\\\n\\hline Other assessments & \\begin{tabular}{l}\n- Blood pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) sampling![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-017.jpg?height=53\\&width=558\\&top_left_y=1677\\&top_left_x=624) \\\\\n- Patient reported outcomes\n\\end{tabular} \\\\\n\\hline Data analysis & \\begin{tabular}{l}\nThe primary efficacy variable of the study is disease free survival (DFS), defined as the time from the date of randomization to the date of the first documented disease recurrence of NSCLC as assessed by local investigator radiologically or death due to any cause. In case of non-conclusive radiological evidence, a biopsy will be performed to confirm NSCLC recurrence will be used as DFS event and radiological assessment date will be used as DFS event date. DFS events will be assessed locally. \\\\\nThe key secondary objective is to determine whether treatment with canakinumab prolongs overall survival (OS) compared with placebo arm. OS is defined as the time from the date of randomization to the date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date). \\\\\nDFS and OS will also be compared between canakinumab and placebo arms in subgroups defined respectively by PD-L1 and CD8 expression levels. \\\\\nPharmacokinetics objectives: \\\\\nThe Pharmacokinetic Analysis Set (PAS) will be used in the pharmacokinetic data analysis. Descriptive statistics (n, m (number of non-zero concentrations), mean, CV\\%, SD, median, geometric mean, geometric CV\\%, minimum and maximum) for canakinumab concentrations will be presented at each scheduled timepoint.\n\\end{tabular} 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treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles.","text_display":"All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9326171875,"confidence_rate":0.9997148245611502},{"cnt":[[629,432],[1859,432],[1859,471],[629,471]],"region":{"top_left_x":629,"top_left_y":432,"width":1231,"height":40},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5bb5bc493a14b7c975d429afa3e6be4","type":"text","conversion_output":false,"parent_id":"bbe0fa300c2a431aa36c343e6192d922","text":"All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment","text_display":"All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[629,469],[1857,469],[1857,510],[629,510]],"region":{"top_left_x":629,"top_left_y":469,"width":1228,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cde34ebee7642b185760c2657488ac4","type":"text","conversion_output":false,"parent_id":"bbe0fa300c2a431aa36c343e6192d922","text":"arms: canakinumab 200 mg or matching placebo. 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The intervals between imaging assessments across all study phases","text_display":" surveillance phase). 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primary efficacy variable of the study is disease free survival (DFS), defined as the time from the date of randomization to the date of the first documented disease recurrence of NSCLC as assessed by local investigator radiologically or death due to any cause. In case of non-conclusive radiological evidence, a biopsy will be performed to confirm NSCLC recurrence will be used as DFS event and radiological assessment date will be used as DFS event date. DFS events will be assessed locally. \\\\\nThe key secondary objective is to determine whether treatment with canakinumab prolongs overall survival (OS) compared with placebo arm. OS is defined as the time from the date of randomization to the date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date). \\\\\nDFS and OS will also be compared between canakinumab and placebo arms in subgroups defined respectively by PD-L1 and CD8 expression levels. \\\\\nPharmacokinetics objectives: \\\\\nThe Pharmacokinetic Analysis Set (PAS) will be used in the pharmacokinetic data analysis. 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In","confidence":1,"confidence_rate":1},{"cnt":[[629,1963],[1857,1963],[1857,2002],[629,2002]],"region":{"top_left_x":629,"top_left_y":1963,"width":1228,"height":40},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d1aa2f01415430c903c10033bc00155","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"case of non-conclusive radiological evidence, a biopsy will be performed to confirm","text_display":" case of non-conclusive radiological evidence, a biopsy will be performed to confirm","confidence":1,"confidence_rate":1},{"cnt":[[629,1998],[1857,1998],[1857,2039],[629,2039]],"region":{"top_left_x":629,"top_left_y":1998,"width":1228,"height":42},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9015198b72d949d08826f08e8c937601","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"NSCLC recurrence will be used as DFS event and radiological assessment date will be","text_display":" NSCLC recurrence will be used as DFS event and radiological assessment date will be","confidence":1,"confidence_rate":1},{"cnt":[[629,2035],[1493,2035],[1493,2074],[629,2074]],"region":{"top_left_x":629,"top_left_y":2034,"width":865,"height":40},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6630261a50e4976b9ba8837c991d7e0","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"used as DFS event date. DFS events will be assessed locally.","text_display":" used as DFS event date. DFS events will be assessed locally.","confidence":1,"confidence_rate":1},{"cnt":[[629,2076],[1857,2076],[1857,2117],[629,2117]],"region":{"top_left_x":629,"top_left_y":2076,"width":1228,"height":42},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"08248592443c47cbb298c71853bc2078","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"The key secondary objective is to determine whether treatment with canakinumab","text_display":"\nThe key secondary objective is to determine whether treatment with canakinumab","confidence":1,"confidence_rate":1},{"cnt":[[629,2113],[1857,2113],[1857,2152],[629,2152]],"region":{"top_left_x":629,"top_left_y":2112,"width":1228,"height":40},"line":79,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"326d98f709234a7298e57e6c7c919998","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"prolongs overall survival (OS) compared with placebo arm. OS is defined as the time from","text_display":" prolongs overall survival (OS) compared with placebo arm. OS is defined as the time from","confidence":0.99609375,"confidence_rate":0.9999579159466216},{"cnt":[[629,2150],[1857,2150],[1857,2191],[629,2191]],"region":{"top_left_x":629,"top_left_y":2149,"width":1228,"height":42},"line":80,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc7cf037a81a400fa202ab4b14712578","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"the date of randomization to the date of death due to any cause. If a subject is not known","text_display":" the date of randomization to the date of death due to any cause. If a subject is not known","confidence":1,"confidence_rate":1},{"cnt":[[629,2184],[1857,2184],[1857,2225],[629,2225]],"region":{"top_left_x":629,"top_left_y":2184,"width":1228,"height":42},"line":81,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e79debdad92246b6b5c564479f2002b1","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"to have died, then OS will be censored at the latest date the subject was known to be","text_display":" to have died, then OS will be censored at the latest date the subject was known to be","confidence":0.9970703125,"confidence_rate":0.9999674006709831},{"cnt":[[629,2223],[1125,2223],[1125,2264],[629,2264]],"region":{"top_left_x":629,"top_left_y":2223,"width":497,"height":42},"line":82,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91074eefc57d4398a7713758bcb43392","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"alive (on or before the cut-off date).","text_display":" alive (on or before the cut-off date).","confidence":1,"confidence_rate":1},{"cnt":[[629,2262],[1859,2262],[1859,2303],[629,2303]],"region":{"top_left_x":629,"top_left_y":2262,"width":1231,"height":42},"line":83,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c734d86a49d940cd9537114a1fa72746","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"DFS and OS will also be compared between canakinumab and placebo arms in","text_display":"\nDFS and OS will also be compared between canakinumab and placebo arms in","confidence":0.9990234375,"confidence_rate":0.9999873112539076},{"cnt":[[629,2301],[1597,2301],[1597,2340],[629,2340]],"region":{"top_left_x":629,"top_left_y":2301,"width":969,"height":40},"line":84,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e63ec732b9f34ab58c2bc91b485151bb","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"subgroups defined respectively by PD-L1 and CD8 expression levels.","text_display":" subgroups defined respectively by PD-L1 and CD8 expression levels.","confidence":1,"confidence_rate":1},{"cnt":[[629,2340],[1077,2340],[1077,2381],[629,2381]],"region":{"top_left_x":629,"top_left_y":2340,"width":449,"height":42},"line":85,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17201778f0de45928d028dce5bd1569b","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"Pharmacokinetics objectives:","text_display":"\nPharmacokinetics objectives:","confidence":1,"confidence_rate":1},{"cnt":[[629,2384],[1857,2384],[1857,2425],[629,2425]],"region":{"top_left_x":629,"top_left_y":2383,"width":1228,"height":42},"line":86,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7da174acfb148ba949537894bcacfcf","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"The Pharmacokinetic Analysis Set (PAS) will be used in the pharmacokinetic data","text_display":"\nThe Pharmacokinetic Analysis Set (PAS) will be used in the pharmacokinetic data","confidence":0.970703125,"confidence_rate":0.9996460793239552},{"cnt":[[629,2423],[1857,2423],[1857,2462],[629,2462]],"region":{"top_left_x":629,"top_left_y":2422,"width":1228,"height":40},"line":87,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16bda51455944e129e9236442dd811de","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"analysis. Descriptive statistics (n, m (number of non-zero concentrations), mean, CV\\%,","text_display":" analysis. Descriptive statistics (n, m (number of non-zero concentrations), mean, CV\\%,","confidence":0.7612574100494385,"confidence_rate":0.9970068650248678},{"cnt":[[629,2457],[1857,2457],[1857,2498],[629,2498]],"region":{"top_left_x":629,"top_left_y":2457,"width":1228,"height":42},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a899b4d9c3549dcb3cca85c6fccac73","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"SD, median, geometric mean, geometric CV\\%, minimum and maximum) for canakinumab","text_display":" SD, median, geometric mean, geometric CV\\%, minimum and maximum) for canakinumab","confidence":0.99853515625,"confidence_rate":0.9999825487512927},{"cnt":[[629,2496],[1491,2496],[1491,2533],[629,2533]],"region":{"top_left_x":629,"top_left_y":2496,"width":863,"height":37},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca76f59d0fbc44048ec7690b77fecb4b","type":"text","conversion_output":false,"parent_id":"fb6dd1f911c44fb2a4fdcdf5cce32095","text":"concentrations will be presented at each scheduled timepoint.","text_display":" concentrations will be presented at each scheduled timepoint.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-018","page":18,"lines":[{"cnt":[[284,202],[889,202],[889,299],[284,299]],"region":{"top_left_x":283,"top_left_y":201,"width":607,"height":98},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84bec1dc27d742dc83950dfbd8bc7420","type":"page_info","conversion_output":false,"text":"Novartis\nAmended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,247],[988,247]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e93c6da14f1744139b8abe5f554a398c","type":"text","conversion_output":true,"text":"Confidential","text_display":"\n\nConfidential","confidence":1,"confidence_rate":1},{"cnt":[[1629,202],[1876,202],[1876,251],[1629,251]],"region":{"top_left_x":1628,"top_left_y":201,"width":248,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72869a1fe98c4b6b95757a487b626991","type":"text","conversion_output":true,"text":"Page 18 of 144","text_display":"\nPage 18 of 144","confidence":1,"confidence_rate":1},{"cnt":[[1414,249],[1876,249],[1876,294],[1414,294]],"region":{"top_left_x":1413,"top_left_y":249,"width":463,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"341c3b4e6b884bd381262e1e1c005462","type":"text","conversion_output":true,"text":"Protocol No. CACZ885T2301","text_display":"\nProtocol No. CACZ885T2301","confidence":0.9985356330871582,"confidence_rate":0.9999511531881798},{"cnt":[[286,333],[1880,333],[1880,2454],[286,2454]],"region":{"top_left_x":285,"top_left_y":333,"width":1595,"height":2121},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8036dda496104c4ebc6e9ef34bf0ed85","type":"table","conversion_output":true,"children_ids":["8b1e80c0ba43481aaa828cc321ad991a","1c696f3ef6a14c6cbd4570a391c09b96","f3688ac311f045b7b73b6dc90e1e06d1","e97e970375f348c489035d929024aabb","cdcc92cb04224208b3ddaa164b0b0130","32e298595c7749b1b2f5cea2784ad38f","568c1610ceee429da41184127694e722"],"text":"\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nImmunogenicity objectives: \\\\\nImmunogenicity will be characterized descriptively by tabulating anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment. \\\\\nPharmacodynamics objectives \\\\\nDescriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\), median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\) concentrations will be presented at each scheduled timepoint. Concentration of total IL\\(1 \\beta vs\\). time profiles will be displayed graphically. \\\\\nBiomarker objectives \\\\\nThe analysis of biomarker data □ in the sub-study, will include basic descriptive statistics for all randomized subjects by treatment arm. If ontreatment and post-treatment biomarker data are collected, distribution of change from baseline data will be described. \\\\\nthe pre- and post-surgery levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All biomarker data will be listed. \\\\\nApplicable for the sub-study, the following analyses will be performed: \\\\\n- For all subjects participating into sub-study: to assess the levels of hs-CRP, other cytokines and additional biomarkers in blood at pre- and post-surgery. \\\\\n- For subjects who will also enroll into the main study: to determine whether there is an association between pre- and post-surgery biomarker levels with canakinumab efficacy (e.g. DFS, OS). \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC). \\\\\nPatient Reported Outcomes objectives: \\\\\nDescriptive statistics will be used to summarize the original scores, as well as change from baseline, of the QLQ-C30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point for each treatment group. Additionally, change from baseline in the scale and subscale values at the time of each assessment will be summarized together with time to first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in global health status/quality of life. Subjects with an evaluable baseline score and at least one evaluable post-baseline score during the treatment period will be included in the change from baseline analyses. \\\\\nInterim Analysis for Disease Free Survival (DFS) \\\\\nOne interim analysis is planned after approximately 196 of the approximately 392 targeted DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no intent to carry out an analysis to declare superior efficacy at the time of the interim analysis. \\\\\nInterim Analyses for Overall Survival (OS) \\\\\nA maximum of three analyses are planned for OS: the first IA for OS when the final analysis for DFS is performed (provided DFS is statistically significant), when approximately \\(318(63 \\%)\\) deaths are expected, the second IA for OS when approximately \\(418(83 \\%)\\) deaths are expected, and the final analysis for OS when approximately 504 deaths are expected.\n\\end{tabular} \\\\\n\\hline Key words & NSCLC, canakinumab, adjuvant \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & \\begin{tabular}{l}\nImmunogenicity objectives: \\\\\nImmunogenicity will be characterized descriptively by tabulating anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment. \\\\\nPharmacodynamics objectives \\\\\nDescriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\), median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\) concentrations will be presented at each scheduled timepoint. Concentration of total IL\\(1 \\beta vs\\). time profiles will be displayed graphically. \\\\\nBiomarker objectives \\\\\nThe analysis of biomarker data □ in the sub-study, will include basic descriptive statistics for all randomized subjects by treatment arm. If ontreatment and post-treatment biomarker data are collected, distribution of change from baseline data will be described. \\\\\nthe pre- and post-surgery levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All biomarker data will be listed. \\\\\nApplicable for the sub-study, the following analyses will be performed: \\\\\n- For all subjects participating into sub-study: to assess the levels of hs-CRP, other cytokines and additional biomarkers in blood at pre- and post-surgery. \\\\\n- For subjects who will also enroll into the main study: to determine whether there is an association between pre- and post-surgery biomarker levels with canakinumab efficacy (e.g. DFS, OS). \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC). \\\\\nPatient Reported Outcomes objectives: \\\\\nDescriptive statistics will be used to summarize the original scores, as well as change from baseline, of the QLQ-C30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point for each treatment group. Additionally, change from baseline in the scale and subscale values at the time of each assessment will be summarized together with time to first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in global health status/quality of life. Subjects with an evaluable baseline score and at least one evaluable post-baseline score during the treatment period will be included in the change from baseline analyses. \\\\\nInterim Analysis for Disease Free Survival (DFS) \\\\\nOne interim analysis is planned after approximately 196 of the approximately 392 targeted DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no intent to carry out an analysis to declare superior efficacy at the time of the interim analysis. \\\\\nInterim Analyses for Overall Survival (OS) \\\\\nA maximum of three analyses are planned for OS: the first IA for OS when the final analysis for DFS is performed (provided DFS is statistically significant), when approximately \\(318(63 \\%)\\) deaths are expected, the second IA for OS when approximately \\(418(83 \\%)\\) deaths are expected, and the final analysis for OS when approximately 504 deaths are expected.\n\\end{tabular} \\\\\n\\hline Key words & NSCLC, canakinumab, adjuvant \\\\\n\\hline\n\\end{tabular}","confidence":0.20987838938060271,"confidence_rate":0.9997817103917922},{"cnt":[[304,337],[482,337],[482,2451],[304,2451]],"region":{"top_left_x":304,"top_left_y":337,"width":179,"height":2114},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b1e80c0ba43481aaa828cc321ad991a","type":"table_column","conversion_output":false,"parent_id":"8036dda496104c4ebc6e9ef34bf0ed85","text":"","text_display":""},{"cnt":[[618,2451],[621,333],[1875,334],[1872,2452]],"region":{"top_left_x":618,"top_left_y":332,"width":1257,"height":2121},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c696f3ef6a14c6cbd4570a391c09b96","type":"table_column","conversion_output":false,"parent_id":"8036dda496104c4ebc6e9ef34bf0ed85","text":"","text_display":""},{"cnt":[[285,339],[1881,339],[1881,2403],[285,2403]],"region":{"top_left_x":285,"top_left_y":339,"width":1596,"height":2065},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3688ac311f045b7b73b6dc90e1e06d1","type":"table_row","conversion_output":false,"parent_id":"8036dda496104c4ebc6e9ef34bf0ed85","text":"","text_display":""},{"cnt":[[285,2403],[1881,2403],[1881,2449],[285,2449]],"region":{"top_left_x":285,"top_left_y":2403,"width":1596,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e97e970375f348c489035d929024aabb","type":"table_row","conversion_output":false,"parent_id":"8036dda496104c4ebc6e9ef34bf0ed85","text":"","text_display":""},{"cnt":[[625,342],[1868,342],[1868,2405],[625,2405]],"region":{"top_left_x":624,"top_left_y":341,"width":1244,"height":2065},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdcc92cb04224208b3ddaa164b0b0130","type":"complex_cell","conversion_output":false,"parent_id":"8036dda496104c4ebc6e9ef34bf0ed85","children_ids":["1f31fc040f22494d8efd8e7483ed290a","4d648de1325d47d086c5e80f7cdec128","a7d214d7c97d4a58854763e360e9ad7b","a489a9e9c20440f0a18ec6b069e56d26","0936a30840b44f03b77475641458e1ea","15f1692013b647c6bcd1e50293ecfead","e70642b63b7f46aba505c7819c9750d2","a783e3afb24b4f269bc4c435e8d4283b","38be788400e84a71a59a15fa7f0d3a70","e46a95da5a394802a1a04c890430c9b1","52a771dc021c4a6d851761ffe954fb49","7617dd31cb8a4df5842bbfcdc4313273","1c3fc65289054e20b6d6877a943e962e","eb3fed10b9d7480bb7ae7a8a60738d66","cb825de81afa41b29454ce5d928249a2","2a7c0043cbcd45dfb2035ce878e1f78c","4c6f879fed594fe49b2e2f4cf0d22a28","2504606d0c554fa8be510e5189aad71b","48a7923d6f47412684ecba6a5f07ed25","97606752bd224408ba07ff018d7d518c","d781e99c61af4c30a68ecc4bfc918395","8a35e16241694026b651cad25ec6ac1c","fb671c885fe641b1826ffafdf71bb75d","06ac00116f6d43cda2748f34842abd65","fd925f10dced416886a8be9a0e2b3ce2","6eb40dcb3c52448194812db376554f19","d72dbacdfe7c423296174ad4a66f22d1","04469228a8b44d24a12b8e2a0897a450","1e036d9bda324075ae5bf2c2c6e856ad","70ba98947d024ee3bc5fc3e902c7a3e6","a8974ae92a20482bbdb239ea7eaa3fbe","d5b069b2a1644d42be60682c01400356","0e22b422311c44b59ea67267271fe2ad","f959c1f5ee82434d8d8ff4765fba5473","074c1d6da3ab434eb79f1baa65a0e2cd","5b797d27a9604cbcad0cfe962986a618","a30d8127f2504ec391afddbb9e6c84dd","ba69c0a3d9824fe081957f1494460bb3","d742a42c216a4f588fc2f0aa3fcac1e9","b7a456ada9c74be783f628c34f7a7e48","f72a65e39cb145339face9e29ef7b772","dfd37de6b7a1470fb61a4163ca96f81d","9a095daad39b45d1abbf125d3befd392","b976bf3d9f2a499bba0c96a5a466dd14","2f32790e5cd2420291676bec5dec8b27","4438e36f69b1438f916c99b20c531065","001fd557f10e40e9b8717f642117366c"],"text":"\\begin{tabular}{l}\nImmunogenicity objectives: \\\\\nImmunogenicity will be characterized descriptively by tabulating anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment. \\\\\nPharmacodynamics objectives \\\\\nDescriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\), median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\) concentrations will be presented at each scheduled timepoint. Concentration of total IL\\(1 \\beta vs\\). time profiles will be displayed graphically. \\\\\nBiomarker objectives \\\\\nThe analysis of biomarker data □ in the sub-study, will include basic descriptive statistics for all randomized subjects by treatment arm. If ontreatment and post-treatment biomarker data are collected, distribution of change from baseline data will be described. \\\\\nthe pre- and post-surgery levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All biomarker data will be listed. \\\\\nApplicable for the sub-study, the following analyses will be performed: \\\\\n- For all subjects participating into sub-study: to assess the levels of hs-CRP, other cytokines and additional biomarkers in blood at pre- and post-surgery. \\\\\n- For subjects who will also enroll into the main study: to determine whether there is an association between pre- and post-surgery biomarker levels with canakinumab efficacy (e.g. DFS, OS). \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC). \\\\\nPatient Reported Outcomes objectives: \\\\\nDescriptive statistics will be used to summarize the original scores, as well as change from baseline, of the QLQ-C30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point for each treatment group. Additionally, change from baseline in the scale and subscale values at the time of each assessment will be summarized together with time to first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in global health status/quality of life. Subjects with an evaluable baseline score and at least one evaluable post-baseline score during the treatment period will be included in the change from baseline analyses. \\\\\nInterim Analysis for Disease Free Survival (DFS) \\\\\nOne interim analysis is planned after approximately 196 of the approximately 392 targeted DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no intent to carry out an analysis to declare superior efficacy at the time of the interim analysis. \\\\\nInterim Analyses for Overall Survival (OS) \\\\\nA maximum of three analyses are planned for OS: the first IA for OS when the final analysis for DFS is performed (provided DFS is statistically significant), when approximately \\(318(63 \\%)\\) deaths are expected, the second IA for OS when approximately \\(418(83 \\%)\\) deaths are expected, and the final analysis for OS when approximately 504 deaths are expected.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nImmunogenicity objectives: \\\\\nImmunogenicity will be characterized descriptively by tabulating anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment. \\\\\nPharmacodynamics objectives \\\\\nDescriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\), median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\) concentrations will be presented at each scheduled timepoint. Concentration of total IL\\(1 \\beta vs\\). time profiles will be displayed graphically. \\\\\nBiomarker objectives \\\\\nThe analysis of biomarker data □ in the sub-study, will include basic descriptive statistics for all randomized subjects by treatment arm. If ontreatment and post-treatment biomarker data are collected, distribution of change from baseline data will be described. \\\\\nthe pre- and post-surgery levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All biomarker data will be listed. \\\\\nApplicable for the sub-study, the following analyses will be performed: \\\\\n- For all subjects participating into sub-study: to assess the levels of hs-CRP, other cytokines and additional biomarkers in blood at pre- and post-surgery. \\\\\n- For subjects who will also enroll into the main study: to determine whether there is an association between pre- and post-surgery biomarker levels with canakinumab efficacy (e.g. DFS, OS). \\\\\n*For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC). \\\\\nPatient Reported Outcomes objectives: \\\\\nDescriptive statistics will be used to summarize the original scores, as well as change from baseline, of the QLQ-C30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point for each treatment group. Additionally, change from baseline in the scale and subscale values at the time of each assessment will be summarized together with time to first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in global health status/quality of life. Subjects with an evaluable baseline score and at least one evaluable post-baseline score during the treatment period will be included in the change from baseline analyses. \\\\\nInterim Analysis for Disease Free Survival (DFS) \\\\\nOne interim analysis is planned after approximately 196 of the approximately 392 targeted DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no intent to carry out an analysis to declare superior efficacy at the time of the interim analysis. \\\\\nInterim Analyses for Overall Survival (OS) \\\\\nA maximum of three analyses are planned for OS: the first IA for OS when the final analysis for DFS is performed (provided DFS is statistically significant), when approximately \\(318(63 \\%)\\) deaths are expected, the second IA for OS when approximately \\(418(83 \\%)\\) deaths are expected, and the final analysis for OS when approximately 504 deaths are expected.\n\\end{tabular}","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.20987838938060271,"confidence_rate":0.9993452741160341},{"cnt":[[631,346],[1049,346],[1049,383],[631,383]],"region":{"top_left_x":631,"top_left_y":345,"width":419,"height":38},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f31fc040f22494d8efd8e7483ed290a","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Immunogenicity objectives:","text_display":"Immunogenicity objectives:","confidence":1,"confidence_rate":1},{"cnt":[[631,381],[1857,381],[1857,422],[631,422]],"region":{"top_left_x":631,"top_left_y":380,"width":1227,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d648de1325d47d086c5e80f7cdec128","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Immunogenicity will be characterized descriptively by tabulating anti-drug antibodies","text_display":"\nImmunogenicity will be characterized descriptively by tabulating anti-drug antibodies","confidence":1,"confidence_rate":1},{"cnt":[[631,420],[1513,420],[1513,456],[631,456]],"region":{"top_left_x":631,"top_left_y":419,"width":882,"height":38},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7d214d7c97d4a58854763e360e9ad7b","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"(ADA) prevalence at baseline and ADA incidence on-treatment.","text_display":" (ADA) prevalence at baseline and ADA incidence on-treatment.","confidence":1,"confidence_rate":1},{"cnt":[[631,528],[1093,528],[1093,565],[631,565]],"region":{"top_left_x":631,"top_left_y":527,"width":462,"height":38},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a489a9e9c20440f0a18ec6b069e56d26","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Pharmacodynamics objectives","text_display":"\nPharmacodynamics objectives","confidence":1,"confidence_rate":1},{"cnt":[[631,563],[1857,563],[1857,599],[631,599]],"region":{"top_left_x":631,"top_left_y":562,"width":1227,"height":38},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0936a30840b44f03b77475641458e1ea","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Descriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\),","text_display":"\nDescriptive statistics ( n , m (number of non-zero concentrations), mean, \\(CV \\%, SD\\),","confidence":0.20987838938060271,"confidence_rate":0.9856481778139363},{"cnt":[[631,597],[1859,597],[1859,638],[631,638]],"region":{"top_left_x":631,"top_left_y":597,"width":1229,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15f1692013b647c6bcd1e50293ecfead","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\)","text_display":" median, geometric mean, geometric CV\\%, minimum and maximum) for total IL-1 \\(\\beta\\)","confidence":0.9926891326904297,"confidence_rate":0.9999082826729077},{"cnt":[[631,632],[1859,632],[1859,673],[631,673]],"region":{"top_left_x":631,"top_left_y":631,"width":1229,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e70642b63b7f46aba505c7819c9750d2","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"concentrations will be presented at each scheduled timepoint. Concentration of total IL-","text_display":" concentrations will be presented at each scheduled timepoint. Concentration of total IL","confidence":1,"confidence_rate":1},{"cnt":[[631,671],[1305,671],[1305,708],[631,708]],"region":{"top_left_x":631,"top_left_y":670,"width":674,"height":38},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a783e3afb24b4f269bc4c435e8d4283b","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"\\(1 \\beta vs\\). time profiles will be displayed graphically.","text_display":"\\(1 \\beta vs\\). time profiles will be displayed graphically.","confidence":0.5734059810638428,"confidence_rate":0.9904568399064907},{"cnt":[[631,818],[958,818],[958,851],[631,851]],"region":{"top_left_x":631,"top_left_y":818,"width":328,"height":33},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38be788400e84a71a59a15fa7f0d3a70","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Biomarker objectives","text_display":"\nBiomarker objectives","confidence":0.9781023623907004,"confidence_rate":0.9991147540854362},{"cnt":[[631,848],[1084,848],[1084,890],[631,890]],"region":{"top_left_x":631,"top_left_y":848,"width":454,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e46a95da5a394802a1a04c890430c9b1","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"The analysis of biomarker data","text_display":"\nThe analysis of biomarker data","confidence":1,"confidence_rate":1},{"cnt":[[1082,844],[1556,844],[1556,896],[1082,896]],"region":{"top_left_x":1081,"top_left_y":844,"width":476,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52a771dc021c4a6d851761ffe954fb49","type":"form_field","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"","text_display":" □","subtype":"box"},{"cnt":[[1558,848],[1857,848],[1857,890],[1558,890]],"region":{"top_left_x":1558,"top_left_y":848,"width":300,"height":42},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7617dd31cb8a4df5842bbfcdc4313273","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"in the sub-study, will","text_display":" in the sub-study, will","confidence":1,"confidence_rate":1},{"cnt":[[631,885],[1859,885],[1859,924],[631,924]],"region":{"top_left_x":631,"top_left_y":885,"width":1229,"height":40},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c3fc65289054e20b6d6877a943e962e","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"include basic descriptive statistics for all randomized subjects by treatment arm. If on-","text_display":" include basic descriptive statistics for all randomized subjects by treatment arm. If on","confidence":0.8869361877441406,"confidence_rate":0.9987244074423592},{"cnt":[[631,922],[1857,922],[1857,959],[631,959]],"region":{"top_left_x":631,"top_left_y":922,"width":1227,"height":37},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb3fed10b9d7480bb7ae7a8a60738d66","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"treatment and post-treatment biomarker data are collected, distribution of change from","text_display":"treatment and post-treatment biomarker data are collected, distribution of change from","confidence":1,"confidence_rate":1},{"cnt":[[631,959],[1101,959],[1101,993],[631,993]],"region":{"top_left_x":631,"top_left_y":958,"width":471,"height":36},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb825de81afa41b29454ce5d928249a2","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"baseline data will be described.","text_display":" baseline data will be described.","confidence":1,"confidence_rate":1},{"cnt":[[1493,1030],[1859,1030],[1859,1067],[1493,1067]],"region":{"top_left_x":1493,"top_left_y":1030,"width":367,"height":38},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a7c0043cbcd45dfb2035ce878e1f78c","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"the pre- and post-surgery","text_display":"\nthe pre- and post-surgery","confidence":0.998046875,"confidence_rate":0.9999348342955167},{"cnt":[[631,1065],[1857,1065],[1857,1102],[631,1102]],"region":{"top_left_x":631,"top_left_y":1064,"width":1227,"height":38},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c6f879fed594fe49b2e2f4cf0d22a28","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All","text_display":" levels of hs-CRP, other cytokines and additional biomarkers in blood from sub-study. All","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[631,1100],[1054,1100],[1054,1136],[631,1136]],"region":{"top_left_x":631,"top_left_y":1099,"width":423,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2504606d0c554fa8be510e5189aad71b","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"biomarker data will be listed.","text_display":" biomarker data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[631,1355],[1604,1355],[1604,1392],[631,1392]],"region":{"top_left_x":631,"top_left_y":1355,"width":973,"height":37},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48a7923d6f47412684ecba6a5f07ed25","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Applicable for the sub-study, the following analyses will be performed:","text_display":"\nApplicable for the sub-study, the following analyses will be performed:","confidence":0.99853515625,"confidence_rate":0.9999807117954607},{"cnt":[[631,1390],[1859,1390],[1859,1431],[631,1431]],"region":{"top_left_x":631,"top_left_y":1389,"width":1229,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97606752bd224408ba07ff018d7d518c","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"- For all subjects participating into sub-study: to assess the levels of hs-CRP, other","text_display":"\n- For all subjects participating into sub-study: to assess the levels of hs-CRP, other","confidence":0.99609375,"confidence_rate":0.9999569910422619},{"cnt":[[666,1429],[1638,1429],[1638,1466],[666,1466]],"region":{"top_left_x":666,"top_left_y":1428,"width":973,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d781e99c61af4c30a68ecc4bfc918395","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"cytokines and additional biomarkers in blood at pre- and post-surgery.","text_display":" cytokines and additional biomarkers in blood at pre- and post-surgery.","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[631,1463],[1857,1463],[1857,1505],[631,1505]],"region":{"top_left_x":631,"top_left_y":1463,"width":1227,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a35e16241694026b651cad25ec6ac1c","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"- For subjects who will also enroll into the main study: to determine whether there is an","text_display":"\n- For subjects who will also enroll into the main study: to determine whether there is an","confidence":1,"confidence_rate":1},{"cnt":[[666,1502],[1859,1502],[1859,1541],[666,1541]],"region":{"top_left_x":666,"top_left_y":1502,"width":1194,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb671c885fe641b1826ffafdf71bb75d","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"association between pre- and post-surgery biomarker levels with canakinumab efficacy","text_display":" association between pre- and post-surgery biomarker levels with canakinumab 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approval from HA, EC and","confidence":0.9960954189300537,"confidence_rate":0.9999550329208464},{"cnt":[[631,1611],[1125,1611],[1125,1647],[631,1647]],"region":{"top_left_x":631,"top_left_y":1610,"width":495,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6eb40dcb3c52448194812db376554f19","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"additional authorities (i.e. HGRAC).","text_display":" additional authorities (i.e. HGRAC).","confidence":1,"confidence_rate":1},{"cnt":[[631,1645],[1223,1645],[1223,1682],[631,1682]],"region":{"top_left_x":631,"top_left_y":1645,"width":592,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d72dbacdfe7c423296174ad4a66f22d1","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"Patient Reported Outcomes objectives:","text_display":"\nPatient Reported Outcomes 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Additionally, change from baseline in the scale and","text_display":" time point for each treatment group. Additionally, change from baseline in the scale and","confidence":1,"confidence_rate":1},{"cnt":[[631,1788],[1857,1788],[1857,1827],[631,1827]],"region":{"top_left_x":631,"top_left_y":1788,"width":1227,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8974ae92a20482bbdb239ea7eaa3fbe","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"subscale values at the time of each assessment will be summarized together with time to","text_display":" subscale values at the time of each assessment will be summarized together with time to","confidence":1,"confidence_rate":1},{"cnt":[[631,1825],[1859,1825],[1859,1864],[631,1864]],"region":{"top_left_x":631,"top_left_y":1825,"width":1229,"height":40},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5b069b2a1644d42be60682c01400356","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in","text_display":" first 10 point deterioration and time to 10 point definitive deterioration in symptoms and in","confidence":0.9907433850457892,"confidence_rate":0.9999105835781972},{"cnt":[[631,1860],[1859,1860],[1859,1899],[631,1899]],"region":{"top_left_x":631,"top_left_y":1859,"width":1229,"height":40},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e22b422311c44b59ea67267271fe2ad","type":"text","conversion_output":false,"parent_id":"cdcc92cb04224208b3ddaa164b0b0130","text":"global health status/quality of life. 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As such all the relevant wording in section 4 and","text_display":" assessment, which is required by the protocol. 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A total of 1382","text_display":" for the final DFS analysis the screening activities ended on December \\(7{ }^{\\text {th }}\\), 2021. 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In addition, canakinumab did not elicit adverse effects","text_display":" administered throughout organogenesis. In addition, canakinumab did not elicit adverse effects","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[1876,490],[1876,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1589,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b610f7c2b00541e996130e908f5d69ad","type":"text","conversion_output":true,"text":"on fetal or neonatal growth when administered throughout late gestation, delivery and","text_display":" on fetal or neonatal growth when administered throughout late gestation, delivery and","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1876,537],[1876,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a0ccde2450c4c6bb0dcb890ea4db82c","type":"text","conversion_output":true,"text":"nursing. Based on this data, the protocol is being updated to require basic contraception (from","text_display":" nursing. Based on this data, the protocol is being updated to require basic contraception (from","confidence":1,"confidence_rate":1},{"cnt":[[288,587],[1876,587],[1876,638],[288,638]],"region":{"top_left_x":287,"top_left_y":586,"width":1589,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8be013b6d3f4cf0941b4c7bb9c87276","type":"text","conversion_output":true,"text":"highly) for women of childbearing potential treated with canakinumab monotherapy as per the","text_display":" highly) for women of childbearing potential treated with canakinumab monotherapy as per the","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1876,632],[1876,683],[288,683]],"region":{"top_left_x":287,"top_left_y":631,"width":1589,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c58c018865ef4d9f8fd2a5363eb6f5a7","type":"text","conversion_output":true,"text":"Novartis standards. The duration of contraception after discontinuation of the study drug was","text_display":" Novartis standards. The duration of contraception after discontinuation of the study drug was","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,681],[1878,681],[1878,733],[288,733]],"region":{"top_left_x":287,"top_left_y":681,"width":1591,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48871f958749417b9ec81527d335361d","type":"text","conversion_output":true,"text":"amended from 130 days to 3 months after last dose in line with the canakinumab IB and","text_display":" amended from 130 days to 3 months after last dose in line with the canakinumab IB and","confidence":0.99609375,"confidence_rate":0.9999592310464812},{"cnt":[[288,730],[462,730],[462,776],[288,776]],"region":{"top_left_x":287,"top_left_y":730,"width":175,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e025239b614ae79d6691db88aff091","type":"text","conversion_output":true,"text":"EuSmPC.","text_display":" EuSmPC.","confidence":0.9970715045928955,"confidence_rate":0.9997556305430905},{"cnt":[[288,799],[1876,799],[1876,849],[288,849]],"region":{"top_left_x":287,"top_left_y":799,"width":1589,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8873f38ab43c4d8283086e53f922fa00","type":"text","conversion_output":true,"text":"Rationale for reducing PK samples at C1D2 and C1D3: The C1D2 and C1D3 PK time points","text_display":"\n\nRationale for reducing PK samples at C1D2 and C1D3: The C1D2 and C1D3 PK time points","confidence":1,"confidence_rate":1},{"cnt":[[288,846],[1876,846],[1876,896],[288,896]],"region":{"top_left_x":287,"top_left_y":846,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e9ba1ab522f48b3a47aea34acbacfcf","type":"text","conversion_output":true,"text":"will be reduced and only a subset of approximately 400 subjects will have these time points","text_display":" will be reduced and only a subset of approximately 400 subjects will have these time points","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,894],[1876,894],[1876,945],[288,945]],"region":{"top_left_x":287,"top_left_y":893,"width":1589,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ac40b65212d4b90b3b4ceb3504f5b47","type":"text","conversion_output":true,"text":"taken. 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This will be adequate to capture the","confidence":1,"confidence_rate":1},{"cnt":[[288,988],[1882,988],[1882,1042],[288,1042]],"region":{"top_left_x":287,"top_left_y":988,"width":1596,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd9408563e4c4bfda424e66af3c84cfc","type":"text","conversion_output":true,"text":"absorption profile and derive the associated absorption parameters after SC injection of","text_display":" absorption profile and derive the associated absorption parameters after SC injection of","confidence":1,"confidence_rate":1},{"cnt":[[288,1040],[531,1040],[531,1085],[288,1085]],"region":{"top_left_x":287,"top_left_y":1039,"width":244,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70c5a383d1c947699b9181c2d8ae911e","type":"text","conversion_output":true,"text":"canakinumab.","text_display":" 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Section & Brief description of the change and/or new text \\\\\n\\hline List of abbreviations & Updates made to list of abbreviations. \\\\\n\\hline Glossary of terms & Updated to include the updated definitions. \\\\\n\\hline Protocol summary & Protocol summary sections have been updated to match the body of the protocol. \\\\\n\\hline Section 1.3.1.2.1 & This section is to provide information on clinical experience. Therefore, texts providing instructions to Investigators has been moved to the Adverse event of special interest (AESI) Section 8.1.3. \\\\\n\\hline Section 2.2 & Table 2-2 was removed as it did not provide the full AJCC/UICC v 8 staging guidelines. Additionally, text was updated to include specifications for substudy. \\\\\n\\hline Section 3 & Minor changes have been made to Table 3-1 to clarify wording on endpoints. Table 3-2 containing sub-study objectives\" has been included. \\\\\n\\hline Section 4.1 & Updated to provide information on the sub-study study design, including Figure 4-2. \\\\\n\\hline Section 5.1 & Redundant text has been removed. Table 5-1 has been removed as it did not include the full scope of staging guidelines. Inclusion criteria has been revised to clarify what is the minimum requirement to enter study. Description on sub-study population was also added. \\\\\n\\hline Section 5.2 & Inclusion criteria 3, 4, 5, 6 (now 3a) have been revised into one to provide clarity. \\\\\n\\hline Section 5.2 & Inclusion criteria 5 (now 5a) has been updated to indicate CTCAE v 5.0 will be used and added clarification text. \\\\\n\\hline Section 5.2.1 & Inclusion criteria 1, 2, 3 for the sub-study has been created. \\\\\n\\hline Section 5.3 & Exclusion criteria \\(3,4,5,6,10,11\\), and 12 have been revised to provide more clarification. Revised criterions has letter \"a\" added. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Section & Brief description of the change and/or new text \\\\\n\\hline List of abbreviations & Updates made to list of abbreviations. \\\\\n\\hline Glossary of terms & Updated to include the updated definitions. \\\\\n\\hline Protocol summary & Protocol summary sections have been updated to match the body of the protocol. \\\\\n\\hline Section 1.3.1.2.1 & This section is to provide information on clinical experience. Therefore, texts providing instructions to Investigators has been moved to the Adverse event of special interest (AESI) Section 8.1.3. \\\\\n\\hline Section 2.2 & Table 2-2 was removed as it did not provide the full AJCC/UICC v 8 staging guidelines. Additionally, text was updated to include specifications for substudy. \\\\\n\\hline Section 3 & Minor changes have been made to Table 3-1 to clarify wording on endpoints. Table 3-2 containing sub-study objectives\" has been included. \\\\\n\\hline Section 4.1 & Updated to provide information on the sub-study study design, including Figure 4-2. \\\\\n\\hline Section 5.1 & Redundant text has been removed. Table 5-1 has been removed as it did not include the full scope of staging guidelines. Inclusion criteria has been revised to clarify what is the minimum requirement to enter study. Description on sub-study population was also added. \\\\\n\\hline Section 5.2 & Inclusion criteria 3, 4, 5, 6 (now 3a) have been revised into one to provide clarity. \\\\\n\\hline Section 5.2 & Inclusion criteria 5 (now 5a) has been updated to indicate CTCAE v 5.0 will be used and added clarification text. \\\\\n\\hline Section 5.2.1 & Inclusion criteria 1, 2, 3 for the sub-study has been created. \\\\\n\\hline Section 5.3 & Exclusion criteria \\(3,4,5,6,10,11\\), and 12 have been revised to provide more clarification. 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Add in language to clarify that it is bilateral tubal ligation. \\\\\n\\hline Section 6.1.5, Section 7.1, Section 7.1.3, Section 7.1.4, Section 7.1.6.1, Section 7.2.1, and Section 8.1.1 & These sections have been updated to include guidance on what must be done upon start of new antineoplastic therapy. \\\\\n\\hline Section 6.3.3.2 and Table 6-2 & Has been updated to include the new DILI language and the dose modification table for hepatotoxicity was updated based on the updated Novartis Hepatotoxicity Clinical Safety Guideline (2018). \\\\\n\\hline Section 6.4 & Text updated to provide clarity on types of virus excluded. Added 'supplements.Drug-drug Interaction language not applicable for adjuvant setting has been removed. \\\\\n\\hline Section 6.4.2.1 & Further information on examples for immune modulating agent in doses with systemic effects has been included. \\\\\n\\hline Section 6.4.2.2 & Other anticancer therapy section has been included to provide further clarity to the protocol. \\\\\n\\hline Section 6.5.1 & Updated to include subject number for sub-study. \\\\\n\\hline Section 6.6 and Section 14.1 & Study drug preparation has been revised to be in line with the latest instructions. \\\\\n\\hline Section 7.1 & \\begin{tabular}{l}\nTable 7-1 has been updated to include corrections including: Disease recurrence was clarified to specify that it is referring to NSCLC recurrence. Visit numbers have been corrected. Missing IG time points were added. PK time points revised. 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CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,339],[763,339],[763,408],[288,408]],"region":{"top_left_x":287,"top_left_y":339,"width":476,"height":70},"line":6,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"3cc984c547974b6bbfa822b3b7181bfa","type":"section_header","conversion_output":false,"children_ids":["666d19a16a784046ad62a4421636b5b9"],"text":"","text_display":""},{"cnt":[[292,344],[758,344],[758,402],[292,402]],"region":{"top_left_x":292,"top_left_y":343,"width":467,"height":59},"line":7,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"666d19a16a784046ad62a4421636b5b9","type":"text","conversion_output":true,"parent_id":"3cc984c547974b6bbfa822b3b7181bfa","text":"1 Background","text_display":"\n\n\\section*{1 Background}","confidence":1,"confidence_rate":1},{"cnt":[[286,436],[1863,436],[1863,556],[286,556]],"region":{"top_left_x":285,"top_left_y":436,"width":1578,"height":121},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae18ae51cfd846ab88755c3eb844e47f","type":"section_header","conversion_output":false,"children_ids":["dabee0226e5f4265a167a5b9ac763482","0a59e7ea234a486b800c1532bc21bb64"],"text":"","text_display":""},{"cnt":[[292,443],[1858,443],[1858,501],[292,501]],"region":{"top_left_x":292,"top_left_y":442,"width":1567,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dabee0226e5f4265a167a5b9ac763482","type":"text","conversion_output":true,"parent_id":"ae18ae51cfd846ab88755c3eb844e47f","text":"1.1 Clarification statement regarding staging system used to assess","text_display":"\n\n\\subsection*{1.1 Clarification statement regarding staging system used to assess","confidence":1,"confidence_rate":1},{"cnt":[[464,494],[1119,494],[1119,552],[464,552]],"region":{"top_left_x":464,"top_left_y":494,"width":656,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a59e7ea234a486b800c1532bc21bb64","type":"text","conversion_output":true,"parent_id":"ae18ae51cfd846ab88755c3eb844e47f","text":"subject eligibility in this study","text_display":" subject eligibility in this study}","confidence":1,"confidence_rate":1},{"cnt":[[288,567],[1878,567],[1878,617],[288,617]],"region":{"top_left_x":287,"top_left_y":567,"width":1591,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baa328d0a8254add82b371d1406b06b5","type":"text","conversion_output":true,"text":"Please note that, unlike publications referenced in this protocol, inclusion and exclusion criteria","text_display":"\n\nPlease note that, unlike publications referenced in this protocol, inclusion and exclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[288,614],[1880,614],[1880,666],[288,666]],"region":{"top_left_x":287,"top_left_y":614,"width":1593,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d099651b084434cb7bd52b098ebcb6e","type":"text","conversion_output":true,"text":"are based on the new IASLC staging system (AJCC v.8) (AJCC Cancer Staging Manual). The","text_display":" are based on the new IASLC staging system (AJCC v.8) (AJCC Cancer Staging Manual). The","confidence":1,"confidence_rate":1},{"cnt":[[288,662],[1880,662],[1880,715],[288,715]],"region":{"top_left_x":287,"top_left_y":661,"width":1593,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dbf3ca352534eb1b59b216653d06603","type":"text","conversion_output":true,"text":"complete list of changes from prior American Joint Committee on Cancer (AJCC) v. 7 to AJCC","text_display":" complete list of changes from prior American Joint Committee on Cancer (AJCC) v. 7 to AJCC","confidence":1,"confidence_rate":1},{"cnt":[[288,711],[1880,711],[1880,763],[288,763]],"region":{"top_left_x":287,"top_left_y":711,"width":1593,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34f3ee2d0a6f456fbde8391f3d2d8777","type":"text","conversion_output":true,"text":"v. 8 are summarized by Goldstraw et al (2016) and include the following, which are important","text_display":" v. 8 are summarized by Goldstraw et al (2016) and include the following, which are important","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,758],[1878,758],[1878,810],[288,810]],"region":{"top_left_x":287,"top_left_y":758,"width":1591,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae332eb1376447dabcd54ba14e2ed90a","type":"text","conversion_output":true,"text":"for eligibility purpose: Stage IB subjects with T>4-5 cm become Stage IIA; Stage IIIA subjects","text_display":" for eligibility purpose: Stage IB subjects with T>4-5 cm become Stage IIA; Stage IIIA subjects","confidence":0.5796434436370916,"confidence_rate":0.9945066377701474},{"cnt":[[288,808],[1880,808],[1880,862],[288,862]],"region":{"top_left_x":287,"top_left_y":807,"width":1593,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eab04af032204b559e627c0aeef1e6ff","type":"text","conversion_output":true,"text":"with T>5cm N2 become stage IIIB. Both groups are eligible for this study if completely","text_display":" with T>5cm N2 become stage IIIB. Both groups are eligible for this study if completely","confidence":0.5712228805235782,"confidence_rate":0.9938653141497503},{"cnt":[[288,855],[1876,855],[1876,907],[288,907]],"region":{"top_left_x":287,"top_left_y":855,"width":1589,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb877972354a4fb9904ebdec3fbec0ee","type":"text","conversion_output":true,"text":"resected with negative margins (see Section 5 for complete list of inclusion/exclusion criteria).","text_display":" resected with negative margins (see Section 5 for complete list of inclusion/exclusion criteria).","confidence":1,"confidence_rate":1},{"cnt":[[288,902],[1880,902],[1880,956],[288,956]],"region":{"top_left_x":287,"top_left_y":902,"width":1593,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3c701450b654170948b4fe1b12d1e34","type":"text","conversion_output":true,"text":"The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at","text_display":" The inclusion of these subjects is consistent with other adjuvant NSCLC studies as they are at","confidence":1,"confidence_rate":1},{"cnt":[[288,950],[1356,950],[1356,1003],[288,1003]],"region":{"top_left_x":287,"top_left_y":949,"width":1069,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba6b72dc83154b6bb047913b06587371","type":"text","conversion_output":true,"text":"a significant risk of relapse to merit inclusion in adjuvant trials.","text_display":" a significant risk of relapse to merit inclusion in adjuvant trials.","confidence":1,"confidence_rate":1},{"cnt":[[284,1033],[1798,1033],[1798,1147],[284,1147]],"region":{"top_left_x":283,"top_left_y":1033,"width":1516,"height":115},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a1a2a9113174e7f9486226f59d4c388","type":"section_header","conversion_output":false,"children_ids":["02c752af4c444e24b42b4ed339b67624","56894d403dfd424fb13ab1854fca4b31"],"text":"","text_display":""},{"cnt":[[292,1040],[1792,1040],[1792,1096],[292,1096]],"region":{"top_left_x":292,"top_left_y":1039,"width":1500,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02c752af4c444e24b42b4ed339b67624","type":"text","conversion_output":true,"parent_id":"8a1a2a9113174e7f9486226f59d4c388","text":"1.2 Overview of disease pathogenesis, epidemiology and current","text_display":"\n\n\\subsection*{1.2 Overview of disease pathogenesis, epidemiology and current","confidence":0.9990236759185791,"confidence_rate":0.9999854209869283},{"cnt":[[464,1094],[683,1094],[683,1141],[464,1141]],"region":{"top_left_x":464,"top_left_y":1093,"width":220,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56894d403dfd424fb13ab1854fca4b31","type":"text","conversion_output":true,"parent_id":"8a1a2a9113174e7f9486226f59d4c388","text":"treatment","text_display":" treatment}","confidence":1,"confidence_rate":1},{"cnt":[[288,1164],[1878,1164],[1878,1216],[288,1216]],"region":{"top_left_x":287,"top_left_y":1164,"width":1591,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"344a9c6e9077496986bf11a6a84638af","type":"text","conversion_output":true,"text":"An estimated 1.8 million people were diagnosed globally with lung cancer in 2012 and there","text_display":"\n\nAn estimated 1.8 million people were diagnosed globally with lung cancer in 2012 and there","confidence":1,"confidence_rate":1},{"cnt":[[288,1212],[1880,1212],[1880,1265],[288,1265]],"region":{"top_left_x":287,"top_left_y":1211,"width":1593,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91ca4570dd5e4000a405575bedeeb7b3","type":"text","conversion_output":true,"text":"were 1.6 million deaths from this disease (Globocan 2012). Non-small cell lung cancer","text_display":" were 1.6 million deaths from this disease (Globocan 2012). Non-small cell lung cancer","confidence":1,"confidence_rate":1},{"cnt":[[288,1259],[1878,1259],[1878,1313],[288,1313]],"region":{"top_left_x":287,"top_left_y":1258,"width":1591,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35420740c311446480fd3cbdc1e5ec95","type":"text","conversion_output":true,"text":"(NSCLC) accounts for \\(85 \\%\\) of the lung cancer diagnoses (Jemal 2011). The majority of subjects","text_display":" (NSCLC) accounts for \\(85 \\%\\) of the lung cancer diagnoses (Jemal 2011). The majority of subjects","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1308],[1880,1308],[1880,1360],[288,1360]],"region":{"top_left_x":287,"top_left_y":1308,"width":1593,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b182ac22a1f40ec8ace5c27317c3d8a","type":"text","conversion_output":true,"text":"present with advanced disease; only \\(25-30 \\%\\) of subjects have surgically resectable disease and","text_display":" present with advanced disease; only \\(25-30 \\%\\) of subjects have surgically resectable disease and","confidence":0.9975595474243164,"confidence_rate":0.9999758078635858},{"cnt":[[288,1354],[1878,1354],[1878,1407],[288,1407]],"region":{"top_left_x":287,"top_left_y":1353,"width":1591,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ad02f8d064445a081205286a685a70c","type":"text","conversion_output":true,"text":"only half of these resected subjects are disease-free at 5 years (ACS 2012-2013). Meta-analysis","text_display":" only half of these resected subjects are disease-free at 5 years (ACS 2012-2013). Meta-analysis","confidence":1,"confidence_rate":1},{"cnt":[[288,1403],[1880,1403],[1880,1454],[288,1454]],"region":{"top_left_x":287,"top_left_y":1402,"width":1593,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08f8a743cabc49ceb1ce756d23f70d12","type":"text","conversion_output":true,"text":"of five large adjuvant cisplatin based chemotherapy versus observation trials demonstrated an","text_display":" of five large adjuvant cisplatin based chemotherapy versus observation trials demonstrated an","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,1452],[1878,1452],[1878,1504],[288,1504]],"region":{"top_left_x":287,"top_left_y":1452,"width":1591,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e395ce3f2974341986563a1ac017fba","type":"text","conversion_output":true,"text":"absolute improvement in 5 -year survival of \\(5.4 \\%\\) in subjects with resected stages IB through","text_display":" absolute improvement in 5 -year survival of \\(5.4 \\%\\) in subjects with resected stages IB through","confidence":0.9340296203736216,"confidence_rate":0.9993376259928521},{"cnt":[[288,1500],[1880,1500],[1880,1553],[288,1553]],"region":{"top_left_x":287,"top_left_y":1499,"width":1593,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e3dd2e07ebc4b9388b195d89f417024","type":"text","conversion_output":true,"text":"IIIA (Pignon 2008). Subjects with stage IB disease and large tumors demonstrated a trend","text_display":" IIIA (Pignon 2008). Subjects with stage IB disease and large tumors demonstrated a trend","confidence":1,"confidence_rate":1},{"cnt":[[288,1549],[1878,1549],[1878,1601],[288,1601]],"region":{"top_left_x":287,"top_left_y":1549,"width":1591,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1954963189d041d19ae625618557ee99","type":"text","conversion_output":true,"text":"toward benefit from adjuvant chemotherapy with a survival \\(HR =0.93\\) (not statistically","text_display":" toward benefit from adjuvant chemotherapy with a survival \\(HR =0.93\\) (not statistically","confidence":0.9960975646972656,"confidence_rate":0.9999588422188825},{"cnt":[[288,1594],[1880,1594],[1880,1648],[288,1648]],"region":{"top_left_x":287,"top_left_y":1594,"width":1593,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbefacad4b9a4a11a9d2c15d16f3426b","type":"text","conversion_output":true,"text":"significant), whereas, subjects with stages II-III had a statistically significant improvement in","text_display":" significant), whereas, subjects with stages II-III had a statistically significant improvement in","confidence":1,"confidence_rate":1},{"cnt":[[288,1644],[1880,1644],[1880,1695],[288,1695]],"region":{"top_left_x":287,"top_left_y":1643,"width":1593,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5200dfb8803b473bbc4b751fb0ec557d","type":"text","conversion_output":true,"text":"survival with \\(HR =0.83\\) (Pignon 2008). The standard of care for stages IIA-IIIA is entire surgical","text_display":" survival with \\(HR =0.83\\) (Pignon 2008). The standard of care for stages IIA-IIIA is entire surgical","confidence":0.82666015625,"confidence_rate":0.9982225012140095},{"cnt":[[288,1693],[1880,1693],[1880,1745],[288,1745]],"region":{"top_left_x":287,"top_left_y":1692,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"854c2536203841f0963d3ca79cac2494","type":"text","conversion_output":true,"text":"resection (margins free of cancer), followed by 4 cycles of cisplatin based chemotherapy","text_display":" resection (margins free of cancer), followed by 4 cycles of cisplatin based chemotherapy","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[288,1740],[1880,1740],[1880,1794],[288,1794]],"region":{"top_left_x":287,"top_left_y":1740,"width":1593,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a463b0aee7402dac2ef24cfa61bef4","type":"text","conversion_output":true,"text":"(NCCN guideline July 2017). Radiation therapy is suggested in addition to chemotherapy for","text_display":" (NCCN guideline July 2017). Radiation therapy is suggested in addition to chemotherapy for","confidence":1,"confidence_rate":1},{"cnt":[[288,1788],[1876,1788],[1876,1841],[288,1841]],"region":{"top_left_x":287,"top_left_y":1787,"width":1589,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c55b4d208cf4f6a945f4af7c15c6f7c","type":"text","conversion_output":true,"text":"subjects with IIIA N2 disease (NCCN guideline July 2017). Despite adjuvant chemotherapy,","text_display":" subjects with IIIA N2 disease (NCCN guideline July 2017). Despite adjuvant chemotherapy,","confidence":1,"confidence_rate":1},{"cnt":[[288,1835],[1880,1835],[1880,1888],[288,1888]],"region":{"top_left_x":287,"top_left_y":1834,"width":1593,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5470d1b188f347fa9b7e9dd20875fd5c","type":"text","conversion_output":true,"text":"only approximately \\(60 \\%\\) of subjects with stage IB disease will be alive at 5 years, only","text_display":" only approximately \\(60 \\%\\) of subjects with stage IB disease will be alive at 5 years, only","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,1882],[1878,1882],[1878,1936],[288,1936]],"region":{"top_left_x":287,"top_left_y":1882,"width":1591,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c02c03d4a68949f88f8ddccd45622887","type":"text","conversion_output":true,"text":"approximately \\(50 \\%\\) of stage II subjects and only approximately \\(40 \\%\\) of subjects with stage IIIA","text_display":" approximately \\(50 \\%\\) of stage II subjects and only approximately \\(40 \\%\\) of subjects with stage IIIA","confidence":0.9990236759185791,"confidence_rate":0.9999906077268363},{"cnt":[[288,1929],[1880,1929],[1880,1983],[288,1983]],"region":{"top_left_x":287,"top_left_y":1929,"width":1593,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5284d7c345ba448daf0f12eef0b78034","type":"text","conversion_output":true,"text":"diseases will be alive at 5 years (Douillard et al 2006). Thus, new adjuvant therapies continue","text_display":" diseases will be alive at 5 years (Douillard et al 2006). Thus, new adjuvant therapies continue","confidence":1,"confidence_rate":1},{"cnt":[[288,1979],[1807,1979],[1807,2030],[288,2030]],"region":{"top_left_x":287,"top_left_y":1978,"width":1520,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82e13c9edb41450683d86e42bf4dd514","type":"text","conversion_output":true,"text":"to be urgently needed to improve the disease-free and overall survival of NSCLC subjects.","text_display":" to be urgently needed to improve the disease-free and overall survival of NSCLC subjects.","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[288,2047],[1880,2047],[1880,2099],[288,2099]],"region":{"top_left_x":287,"top_left_y":2047,"width":1593,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6256290ea9fa465d95993d4aef5ed5b3","type":"text","conversion_output":true,"text":"Recently, a new IASLC staging system has been published which harmonizes AJCC and UICC","text_display":"\nRecently, a new IASLC staging system has been published which harmonizes AJCC and UICC","confidence":1,"confidence_rate":1},{"cnt":[[288,2097],[1878,2097],[1878,2151],[288,2151]],"region":{"top_left_x":287,"top_left_y":2096,"width":1591,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dceacd28da8a4355b8c2c5141af8ed84","type":"text","conversion_output":true,"text":"staging systems to ensure subjects with similar prognosis are regrouped within the same stage","text_display":" staging systems to ensure subjects with similar prognosis are regrouped within the same stage","confidence":1,"confidence_rate":1},{"cnt":[[288,2144],[1880,2144],[1880,2196],[288,2196]],"region":{"top_left_x":287,"top_left_y":2144,"width":1593,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5e2c40cbfa448859566a2f835213011","type":"text","conversion_output":true,"text":"category. The changes are summarized by (Goldstraw 2016). As an example, subjects with","text_display":" category. The changes are summarized by (Goldstraw 2016). As an example, subjects with","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1878,2191],[1878,2245],[288,2245]],"region":{"top_left_x":287,"top_left_y":2191,"width":1591,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98ecdbc0a8fd4e5189f0477b2c4e0eea","type":"text","conversion_output":true,"text":"stage IB per AJCC v. 7 have a 5 year overall survival of \\(71 \\%\\) (Goldstraw 2016). Those subjects","text_display":" stage IB per AJCC v. 7 have a 5 year overall survival of \\(71 \\%\\) (Goldstraw 2016). Those subjects","confidence":1,"confidence_rate":1},{"cnt":[[288,2239],[1880,2239],[1880,2292],[288,2292]],"region":{"top_left_x":287,"top_left_y":2238,"width":1593,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3824f88b86c24e149f961a73b306c75d","type":"text","conversion_output":true,"text":"with stage IB with primary tumors of \\(>4-5 cm\\) have a 5 year survival of \\(66 \\%\\) are more similar","text_display":" with stage IB with primary tumors of \\(>4-5 cm\\) have a 5 year survival of \\(66 \\%\\) are more similar","confidence":0.994145393371582,"confidence_rate":0.9999451247578082},{"cnt":[[288,2288],[1878,2288],[1878,2340],[288,2340]],"region":{"top_left_x":287,"top_left_y":2288,"width":1591,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c307526d7324703adcbfc881c633994","type":"text","conversion_output":true,"text":"to the IIA N0 who have primary tumors of \\(>5-6 cm\\), who have a \\(63 \\% 5\\)-year survival; therefore","text_display":" to the IIA N0 who have primary tumors of \\(>5-6 cm\\), who have a \\(63 \\% 5\\)-year survival; therefore","confidence":0.7481046511362245,"confidence_rate":0.9972398884851061},{"cnt":[[288,2333],[1880,2333],[1880,2387],[288,2387]],"region":{"top_left_x":287,"top_left_y":2333,"width":1593,"height":54},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebd5038c029a47bc9338c15be9ac2668","type":"text","conversion_output":true,"text":"these prior IB subjects are now moved to stage IIA in the new AJCC and UICC harmonized","text_display":" these prior IB subjects are now moved to stage IIA in the new AJCC and UICC harmonized","confidence":1,"confidence_rate":1},{"cnt":[[288,2385],[1880,2385],[1880,2434],[288,2434]],"region":{"top_left_x":287,"top_left_y":2384,"width":1593,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cce23b5187f34a71965aea93a8133c64","type":"text","conversion_output":true,"text":"version 8 staging system. The AJCC v. 7 stage IB subjects have a 5 year OS of \\(71 \\%\\) now in","text_display":" version 8 staging system. The AJCC v. 7 stage IB subjects have a 5 year OS of \\(71 \\%\\) now in","confidence":1,"confidence_rate":1},{"cnt":[[288,2430],[1880,2430],[1880,2481],[288,2481]],"region":{"top_left_x":287,"top_left_y":2429,"width":1593,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"844453fbd5cf407c9a8430769fc12d7a","type":"text","conversion_output":true,"text":"AJCC v. 8 have a \\(73 \\% 5\\) year OS. Similarly, subjects with AJCC v. 7 Stage IIIA N2 disease","text_display":" AJCC v. 8 have a \\(73 \\% 5\\) year OS. Similarly, subjects with AJCC v. 7 Stage IIIA N2 disease","confidence":0.94970703125,"confidence_rate":0.9994892222725004},{"cnt":[[288,2479],[1474,2479],[1474,2529],[288,2529]],"region":{"top_left_x":287,"top_left_y":2479,"width":1187,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf038f3dbdd34f5f867953ea4b5f7eaf","type":"text","conversion_output":true,"text":"become stage IIIB with \\(T >5 cm N 2\\) disease in the new IASLC system.","text_display":" become stage IIIB with \\(T >5 cm N 2\\) disease in the new IASLC system.","confidence":0.537907799705863,"confidence_rate":0.9922791090233394}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-033","page":33,"lines":[{"cnt":[[292,208],[423,208],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":208,"width":132,"height":35},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99e2cb3bdff84995b9e246b0fba5316b","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9433345774049f99166132927a32086","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae5fb3cd5a6c439baad5c59bfc2dd18f","type":"page_info","conversion_output":false,"text":"Page 33 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aef01782df1642cd8fec4e0c39aaec40","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eed8c33c65ec4427929693443f1044d8","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1880,346],[1880,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1593,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a631f85589a44b9918990478d4832aa","type":"text","conversion_output":true,"text":"Chronic inflammation plays an important role in the development of non-small cell lung cancer","text_display":"\n\nChronic inflammation plays an important role in the development of non-small cell lung cancer","confidence":1,"confidence_rate":1},{"cnt":[[288,395],[1878,395],[1878,445],[288,445]],"region":{"top_left_x":287,"top_left_y":395,"width":1591,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe6d8dff10934d10b77e8876d3a81fc9","type":"text","conversion_output":true,"text":"(NSCLC). Key etiological risk factors such as smoking, second-hand smoke exposure, chronic","text_display":" (NSCLC). Key etiological risk factors such as smoking, second-hand smoke exposure, chronic","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[1878,443],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":1591,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89b26be0a8d43d484141fa9a97c6289","type":"text","conversion_output":true,"text":"infections such as tuberculosis, and exposure to environmental toxins such as asbestos, silica","text_display":" infections such as tuberculosis, and exposure to environmental toxins such as asbestos, silica","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,490],[1878,490],[1878,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6487ea49af1f42feaa6da6538855e6a2","type":"text","conversion_output":true,"text":"dust, and various metal dusts cause a chronic inflammatory milieu that plays a critical role in","text_display":" dust, and various metal dusts cause a chronic inflammatory milieu that plays a critical role in","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,537],[1878,537],[1878,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1591,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fae6f28ce814ff0b4667291f022753a","type":"text","conversion_output":true,"text":"carcinogenesis, particularly, in lung cancer (O'Callaghan 2010, Krysan 2008). Indeed, elevation","text_display":" carcinogenesis, particularly, in lung cancer (O'Callaghan 2010, Krysan 2008). Indeed, elevation","confidence":0.98583984375,"confidence_rate":0.9998573964903816},{"cnt":[[288,584],[1878,584],[1878,638],[288,638]],"region":{"top_left_x":287,"top_left_y":584,"width":1591,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d019936e2abf4d46a59ceac48d74c755","type":"text","conversion_output":true,"text":"of the general inflammatory marker high-sensitivity C-reactive protein (hs-CRP) is associated","text_display":" of the general inflammatory marker high-sensitivity C-reactive protein (hs-CRP) is associated","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1878,632],[1878,683],[288,683]],"region":{"top_left_x":287,"top_left_y":631,"width":1591,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad608ed1974141dc9346a80424d91557","type":"text","conversion_output":true,"text":"with an increased risk of developing lung cancer (Chaturvedi 2010). It is also well established","text_display":" with an increased risk of developing lung cancer (Chaturvedi 2010). It is also well established","confidence":1,"confidence_rate":1},{"cnt":[[288,681],[1876,681],[1876,733],[288,733]],"region":{"top_left_x":287,"top_left_y":681,"width":1589,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc349d9959604f8d86ed590e23b48bf8","type":"text","conversion_output":true,"text":"that smoking, a lung cancer risk factor, induces chronic pulmonary inflammation and this","text_display":" that smoking, a lung cancer risk factor, induces chronic pulmonary inflammation and this","confidence":1,"confidence_rate":1},{"cnt":[[288,726],[1876,726],[1876,780],[288,780]],"region":{"top_left_x":287,"top_left_y":726,"width":1589,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9001a9411e3a46fa85346d3372d53203","type":"text","conversion_output":true,"text":"inflammation is thought to be one of the mechanisms that drive tumor promotion (Bracke 2006).","text_display":" inflammation is thought to be one of the mechanisms that drive tumor promotion (Bracke 2006).","confidence":1,"confidence_rate":1},{"cnt":[[288,778],[1880,778],[1880,827],[288,827]],"region":{"top_left_x":287,"top_left_y":777,"width":1593,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3730aa53d1d4c9a8599e15d2863aecc","type":"text","conversion_output":true,"text":"Finally, there is also evidence that anti-inflammatory drugs can reduce the risk of lung cancer","text_display":" Finally, there is also evidence that anti-inflammatory drugs can reduce the risk of lung cancer","confidence":1,"confidence_rate":1},{"cnt":[[288,821],[1878,821],[1878,874],[288,874]],"region":{"top_left_x":287,"top_left_y":820,"width":1591,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa1fb8fc699140feb7a08e5f6bf5ed8e","type":"text","conversion_output":true,"text":"development. In a meta-analysis of lung cancer studies, Khuder et al. demonstrated a \\(21 \\%\\)","text_display":" development. In a meta-analysis of lung cancer studies, Khuder et al. demonstrated a \\(21 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[288,872],[1880,872],[1880,924],[288,924]],"region":{"top_left_x":287,"top_left_y":872,"width":1593,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"957fafac96e342b7b4bc48a1308ec997","type":"text","conversion_output":true,"text":"relative risk reduction in the development of lung cancer for those subjects reporting","text_display":" relative risk reduction in the development of lung cancer for those subjects reporting","confidence":1,"confidence_rate":1},{"cnt":[[288,920],[1880,920],[1880,971],[288,971]],"region":{"top_left_x":287,"top_left_y":919,"width":1593,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"442b5377359f42f6b817d8b45bed8a36","type":"text","conversion_output":true,"text":"nonsteroidal anti-inflammatory drug (NSAID) use (Khuder 2005). Taken together, these","text_display":" nonsteroidal anti-inflammatory drug (NSAID) use (Khuder 2005). Taken together, these","confidence":1,"confidence_rate":1},{"cnt":[[288,967],[1824,967],[1824,1021],[288,1021]],"region":{"top_left_x":287,"top_left_y":966,"width":1538,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ffe9d95dd6462e98239eecf13582b9","type":"text","conversion_output":true,"text":"observations suggest an important role for inflammation in the development of lung cancer.","text_display":" observations suggest an important role for inflammation in the development of lung cancer.","confidence":1,"confidence_rate":1},{"cnt":[[288,1057],[1878,1057],[1878,1111],[288,1111]],"region":{"top_left_x":287,"top_left_y":1057,"width":1591,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06411962bedc42d48d59a99fa8af8a08","type":"text","conversion_output":true,"text":"The cytokine interleukin- \\(1 \\beta\\) ( \\(IL -1 \\beta\\) ) is thought to be one of the mediators of pulmonary","text_display":"\n\nThe cytokine interleukin- \\(1 \\beta\\) ( \\(IL -1 \\beta\\) ) is thought to be one of the mediators of pulmonary","confidence":0.9525429069430515,"confidence_rate":0.9995280713318625},{"cnt":[[288,1104],[1876,1104],[1876,1158],[288,1158]],"region":{"top_left_x":287,"top_left_y":1104,"width":1589,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da9fb16b257745b995f1a8d91ef35c39","type":"text","conversion_output":true,"text":"inflammation that promotes lung cancer. Genetic evidence also links IL- \\(1 \\beta\\) to lung cancer risk.","text_display":" inflammation that promotes lung cancer. Genetic evidence also links IL- \\(1 \\beta\\) to lung cancer risk.","confidence":0.56982421875,"confidence_rate":0.9945544214655755},{"cnt":[[288,1154],[1878,1154],[1878,1205],[288,1205]],"region":{"top_left_x":287,"top_left_y":1153,"width":1591,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc7acffb02c04f77bec018e59df15fd8","type":"text","conversion_output":true,"text":"Polymorphisms in the promoter region of the IL-1 gene result in altered levels of IL-1 \\(\\beta\\)","text_display":" Polymorphisms in the promoter region of the IL-1 gene result in altered levels of IL-1 \\(\\beta\\)","confidence":0.9863748215138912,"confidence_rate":0.9998508931491346},{"cnt":[[288,1199],[1880,1199],[1880,1253],[288,1253]],"region":{"top_left_x":287,"top_left_y":1198,"width":1593,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b411e91e03bd481a816117072952b30f","type":"text","conversion_output":true,"text":"expression and are associated with an increase in lung cancer risk (Li 2013). In addition to this","text_display":" expression and are associated with an increase in lung cancer risk (Li 2013). In addition to this","confidence":1,"confidence_rate":1},{"cnt":[[288,1248],[1880,1248],[1880,1300],[288,1300]],"region":{"top_left_x":287,"top_left_y":1248,"width":1593,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f40efccd5e2640fd9911f7e45c7fe29a","type":"text","conversion_output":true,"text":"clinical data, there is extensive preclinical data to support the role of IL- \\(1 \\beta\\) in several distinct","text_display":" clinical data, there is extensive preclinical data to support the role of IL- \\(1 \\beta\\) in several distinct","confidence":0.9121520519256592,"confidence_rate":0.9991489865841383},{"cnt":[[288,1298],[1880,1298],[1880,1347],[288,1347]],"region":{"top_left_x":287,"top_left_y":1297,"width":1593,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a55916afbe54abb9121b404f40c00b9","type":"text","conversion_output":true,"text":"steps in carcinogenesis. These steps include tumor initiation, promotion, angiogenesis, and","text_display":" steps in carcinogenesis. These steps include tumor initiation, promotion, angiogenesis, and","confidence":1,"confidence_rate":1},{"cnt":[[288,1345],[1880,1345],[1880,1396],[288,1396]],"region":{"top_left_x":287,"top_left_y":1344,"width":1593,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0202a8fa855f4bd79db0615022782cdd","type":"text","conversion_output":true,"text":"metastasis (Dalgleish 2006, Mantovani 2008, O'Byrne 2000, O'Byrne 2001). Tumor initiation","text_display":" metastasis (Dalgleish 2006, Mantovani 2008, O'Byrne 2000, O'Byrne 2001). Tumor initiation","confidence":1,"confidence_rate":1},{"cnt":[[288,1392],[1880,1392],[1880,1446],[288,1446]],"region":{"top_left_x":287,"top_left_y":1392,"width":1593,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cbbad77de0c4fc7ac8247a9759f1301","type":"text","conversion_output":true,"text":"is the first step in carcinogenesis and involves the acquisition of mutations in normal cells that","text_display":" is the first step in carcinogenesis and involves the acquisition of mutations in normal cells that","confidence":1,"confidence_rate":1},{"cnt":[[288,1439],[1880,1439],[1880,1493],[288,1493]],"region":{"top_left_x":287,"top_left_y":1439,"width":1593,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc0dd3e3b53b4d488fd1cd26b09b5a67","type":"text","conversion_output":true,"text":"allow a selective growth advantage. IL-1 \\(\\beta\\) is thought to create a microenvironment that","text_display":" allow a selective growth advantage. IL-1 \\(\\beta\\) is thought to create a microenvironment that","confidence":0.488949082448471,"confidence_rate":0.9924967444922382},{"cnt":[[288,1489],[1882,1489],[1882,1540],[288,1540]],"region":{"top_left_x":287,"top_left_y":1488,"width":1596,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3310fa631c64629a615ae6395ff7375","type":"text","conversion_output":true,"text":"promotes tumor initiation ( Wu 2016). In a mouse model of tumor initiation, the genetic loss of","text_display":" promotes tumor initiation ( Wu 2016). In a mouse model of tumor initiation, the genetic loss of","confidence":0.7322755856023377,"confidence_rate":0.997064709312424},{"cnt":[[288,1538],[1878,1538],[1878,1588],[288,1588]],"region":{"top_left_x":287,"top_left_y":1538,"width":1591,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93c58cd45304428b89d17598d1b02f6e","type":"text","conversion_output":true,"text":"IL-1 \\(\\beta\\) resulted in an attenuation of 3-MCA-induced tumor formation (Krelin 2007,","text_display":" IL-1 \\(\\beta\\) resulted in an attenuation of 3-MCA-induced tumor formation (Krelin 2007,","confidence":0.9858589111827314,"confidence_rate":0.9998381718827994},{"cnt":[[288,1586],[1880,1586],[1880,1635],[288,1635]],"region":{"top_left_x":287,"top_left_y":1585,"width":1593,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"925b446b78bd4dba8d9592fe8c0af368","type":"text","conversion_output":true,"text":"Voronov 2010). The ability of IL- \\(1 \\beta\\) to promote tumor initiation is thought to be mediated","text_display":" Voronov 2010). The ability of IL- \\(1 \\beta\\) to promote tumor initiation is thought to be mediated","confidence":0.7057099342346191,"confidence_rate":0.9964496746686184},{"cnt":[[288,1633],[1878,1633],[1878,1687],[288,1687]],"region":{"top_left_x":287,"top_left_y":1632,"width":1591,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e3d842adbf241e1856ab6bb3f051626","type":"text","conversion_output":true,"text":"through the induction of NF-кB expression (Kasza 2013). The second step in carcinogenesis is","text_display":" through the induction of NF-кB expression (Kasza 2013). The second step in carcinogenesis is","confidence":0.59912109375,"confidence_rate":0.9947325657441896},{"cnt":[[288,1680],[1880,1680],[1880,1734],[288,1734]],"region":{"top_left_x":287,"top_left_y":1680,"width":1593,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d49fad5ed384c16b79d5a12d11715c3","type":"text","conversion_output":true,"text":"tumor promotion. This step is characterized by the growth of a primary tumor from a single","text_display":" tumor promotion. This step is characterized by the growth of a primary tumor from a single","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,1729],[1880,1729],[1880,1781],[288,1781]],"region":{"top_left_x":287,"top_left_y":1729,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8d82c318bd5444fa72f2d3dab738417","type":"text","conversion_output":true,"text":"transformed cell. 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The third","confidence":0.9985356330871582,"confidence_rate":0.9999857725269791},{"cnt":[[288,1824],[1878,1824],[1878,1876],[288,1876]],"region":{"top_left_x":287,"top_left_y":1824,"width":1591,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ab85e53907341308967de5c8c97cdcf","type":"text","conversion_output":true,"text":"step in carcinogenesis is angiogenesis, in which blood vessel formation is induced to generate","text_display":" step in carcinogenesis is angiogenesis, in which blood vessel formation is induced to generate","confidence":1,"confidence_rate":1},{"cnt":[[288,1869],[1880,1869],[1880,1923],[288,1923]],"region":{"top_left_x":287,"top_left_y":1869,"width":1593,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61f7f7a803db4c12a95da20678d20c14","type":"text","conversion_output":true,"text":"a vascular network for the primary tumor. In this process, IL- \\(1 \\beta\\) is thought to play a critical","text_display":" a vascular network for the primary tumor. 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The final step in carcinogenesis is","text_display":" (VEGF) expression and tumor angiogenesis (Apte 2006). The final step in carcinogenesis is","confidence":1,"confidence_rate":1},{"cnt":[[288,2015],[1882,2015],[1882,2069],[288,2069]],"region":{"top_left_x":287,"top_left_y":2015,"width":1596,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59fa970e37d24b08ba6afd6862ccdb95","type":"text","conversion_output":true,"text":"metastasis. IL- \\(1 \\beta\\) is thought to play an important role in this step as well via the induction of","text_display":" metastasis. IL- \\(1 \\beta\\) is thought to play an important role in this step as well via the induction of","confidence":0.6513671875,"confidence_rate":0.9959256393960819},{"cnt":[[288,2065],[1878,2065],[1878,2116],[288,2116]],"region":{"top_left_x":287,"top_left_y":2064,"width":1591,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3754c0b97c33406a852eab599649c274","type":"text","conversion_output":true,"text":"genes critical for invasion and cell adhesion. Using a mouse model of lung cancer metastasis,","text_display":" genes critical for invasion and cell adhesion. Using a mouse model of lung cancer metastasis,","confidence":1,"confidence_rate":1},{"cnt":[[288,2110],[1882,2110],[1882,2163],[288,2163]],"region":{"top_left_x":287,"top_left_y":2109,"width":1596,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb24ece557f446cdb7da7507bfc3c24f","type":"text","conversion_output":true,"text":"Yano and colleagues demonstrated that tumors genetically programed to express high levels of","text_display":" Yano and colleagues demonstrated that tumors genetically programed to express high levels of","confidence":1,"confidence_rate":1},{"cnt":[[288,2159],[1880,2159],[1880,2211],[288,2211]],"region":{"top_left_x":287,"top_left_y":2159,"width":1593,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9ff64b36aba4ff5a9683f7792d11f79","type":"text","conversion_output":true,"text":"IL-1 \\(\\beta\\) developed lung metastasis more rapidly than controls, while treatment with an anti-IL-","text_display":" IL-1 \\(\\beta\\) developed lung metastasis more rapidly than controls, while treatment with an anti-IL","confidence":0.85791015625,"confidence_rate":0.9984837655183104},{"cnt":[[288,2209],[1878,2209],[1878,2258],[288,2258]],"region":{"top_left_x":287,"top_left_y":2208,"width":1591,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"475116ac0bde4d3dba62a2179138aa3e","type":"text","conversion_output":true,"text":"\\(1 \\beta\\) antibody inhibited formation of lung metastasis (Yano 2003). Taken together, these results","text_display":"\\(1 \\beta\\) antibody inhibited formation of lung metastasis (Yano 2003). Taken together, these results","confidence":1,"confidence_rate":1},{"cnt":[[288,2256],[1485,2256],[1485,2310],[288,2310]],"region":{"top_left_x":287,"top_left_y":2255,"width":1198,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"337ba159d9cb44819ff1371851ed1ecb","type":"text","conversion_output":true,"text":"suggest an important role for IL-1β in multiple steps of carcinogenesis.","text_display":" suggest an important role for IL-1β in multiple steps of carcinogenesis.","confidence":0.5064525604248047,"confidence_rate":0.9912035326192108},{"cnt":[[288,2325],[1878,2325],[1878,2374],[288,2374]],"region":{"top_left_x":287,"top_left_y":2324,"width":1591,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77762d218c1b4066a42f2b2e5db10143","type":"text","conversion_output":true,"text":"Given the evidence for the importance of IL-1 \\(\\beta\\) signaling in carcinogenesis, some in the","text_display":"\nGiven the evidence for the importance of IL-1 \\(\\beta\\) signaling in carcinogenesis, some in the","confidence":0.6189318224787712,"confidence_rate":0.9950149651333605},{"cnt":[[288,2372],[1880,2372],[1880,2426],[288,2426]],"region":{"top_left_x":287,"top_left_y":2371,"width":1593,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dda92f918d145bd852ee3ca2a9d8a64","type":"text","conversion_output":true,"text":"scientific community have already proposed to treat cancer with IL-1 \\(\\beta\\) blockade (Jenkins 2017,","text_display":" scientific community have already proposed to treat cancer with IL-1 \\(\\beta\\) blockade (Jenkins 2017,","confidence":0.6625354290008545,"confidence_rate":0.9959720434314158},{"cnt":[[288,2419],[1880,2419],[1880,2473],[288,2473]],"region":{"top_left_x":287,"top_left_y":2419,"width":1593,"height":54},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"144e8f73d8e448198b300ab9dd76e6ba","type":"text","conversion_output":true,"text":"Wu 2016). Lung cancer is the largest cause of cancer deaths on the globe. In 2015, lung cancer","text_display":" Wu 2016). Lung cancer is the largest cause of cancer deaths on the globe. In 2015, lung cancer","confidence":1,"confidence_rate":1},{"cnt":[[288,2469],[1880,2469],[1880,2520],[288,2520]],"region":{"top_left_x":287,"top_left_y":2468,"width":1593,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d564befc4b4fe3ace3121fb1b58fb6","type":"text","conversion_output":true,"text":"was responsible for 1.68 million deaths (WHO Cancer FACT Sheet Feb 2017). Despite adjuvant","text_display":" was responsible for 1.68 million deaths (WHO Cancer FACT Sheet Feb 2017). Despite adjuvant","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-034","page":34,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50fff189d762462b9f980bb49e7b5f9d","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e940a40325641ffb0c39ee55b232fe7","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4de5e549f8a24d0490fd1f51dc3b9535","type":"page_info","conversion_output":false,"text":"Page 34 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c554fd431664db88cff34bb904ad083","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad1a9e44a07a4b7fac17130b6a146506","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[292,346],[1876,346],[1876,397],[292,397]],"region":{"top_left_x":292,"top_left_y":345,"width":1584,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e66a8794ec4f91a3ef8eccca2e524f","type":"text","conversion_output":true,"text":"chemotherapy, only approximately \\(60 \\%\\) of subjects with stage IB disease will be alive at 5","text_display":"\nchemotherapy, only approximately \\(60 \\%\\) of subjects with stage IB disease will be alive at 5","confidence":0.99267578125,"confidence_rate":0.9999234282179035},{"cnt":[[288,395],[1876,395],[1876,445],[288,445]],"region":{"top_left_x":287,"top_left_y":395,"width":1589,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"061ae27bceeb412f95c2ab75bbca94e4","type":"text","conversion_output":true,"text":"years, only approximately \\(50 \\%\\) of stage II subjects and only approximately \\(40 \\%\\) of subjects","text_display":" years, only approximately \\(50 \\%\\) of stage II subjects and only approximately \\(40 \\%\\) of subjects","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[1876,443],[1876,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":1589,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f49f0049e2484a849a9b3bdd4c15a535","type":"text","conversion_output":true,"text":"with stage IIIA diseases will be alive at 5 years (Douillard et al 2006). Thus, treatments to","text_display":" with stage IIIA diseases will be alive at 5 years (Douillard et al 2006). Thus, treatments to","confidence":0.9985356330871582,"confidence_rate":0.9999854907968839},{"cnt":[[288,490],[1470,490],[1470,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1183,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b695d1bb0f849288e1402f1b88bbdc1","type":"text","conversion_output":true,"text":"improve the survival of subjects resected for cure are urgently needed.","text_display":" improve the survival of subjects resected for cure are urgently needed.","confidence":1,"confidence_rate":1},{"cnt":[[286,571],[1751,571],[1751,692],[286,692]],"region":{"top_left_x":285,"top_left_y":571,"width":1466,"height":121},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb85fa0845564c03b32d0bd49566a926","type":"section_header","conversion_output":false,"children_ids":["500ea470fc674ae5a2926e21b299a287","10d1acba58e64449853f27bda9d45eae"],"text":"","text_display":""},{"cnt":[[292,578],[1747,578],[1747,634],[292,634]],"region":{"top_left_x":292,"top_left_y":577,"width":1455,"height":57},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"500ea470fc674ae5a2926e21b299a287","type":"text","conversion_output":true,"parent_id":"fb85fa0845564c03b32d0bd49566a926","text":"1.3 Introduction to investigational treatment(s) and other study","text_display":"\n\n\\subsection*{1.3 Introduction to investigational treatment(s) and other study","confidence":0.9892628192901611,"confidence_rate":0.9998435594814927},{"cnt":[[464,632],[733,632],[733,685],[464,685]],"region":{"top_left_x":464,"top_left_y":631,"width":269,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10d1acba58e64449853f27bda9d45eae","type":"text","conversion_output":true,"parent_id":"fb85fa0845564c03b32d0bd49566a926","text":"treatment(s)","text_display":" treatment(s)}","confidence":1,"confidence_rate":1},{"cnt":[[286,718],[993,718],[993,776],[286,776]],"region":{"top_left_x":285,"top_left_y":717,"width":708,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dffc21b48e774e2bb8a37d113755eee6","type":"section_header","conversion_output":false,"children_ids":["c14b384fd3b441fbaf58b07e6922b99c"],"text":"","text_display":""},{"cnt":[[292,724],[986,724],[986,771],[292,771]],"region":{"top_left_x":292,"top_left_y":724,"width":695,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c14b384fd3b441fbaf58b07e6922b99c","type":"text","conversion_output":true,"parent_id":"dffc21b48e774e2bb8a37d113755eee6","text":"1.3.1 Overview of canakinumab","text_display":"\n\n\\subsection*{1.3.1 Overview of canakinumab}","confidence":1,"confidence_rate":1},{"cnt":[[288,793],[1878,793],[1878,844],[288,844]],"region":{"top_left_x":287,"top_left_y":792,"width":1591,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a1765509ce4e60b11718a4f4c0521b","type":"text","conversion_output":true,"text":"Canakinumab is a high-affinity human anti-Interleukin-1 \\(\\beta\\) (IL-1 \\(\\beta\\) ) monoclonal antibody that","text_display":"\n\nCanakinumab is a high-affinity human anti-Interleukin-1 \\(\\beta\\) (IL-1 \\(\\beta\\) ) monoclonal antibody that","confidence":0.8102137895766646,"confidence_rate":0.9979588129702373},{"cnt":[[288,842],[1876,842],[1876,892],[288,892]],"region":{"top_left_x":287,"top_left_y":842,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc334a44012f4d56a4b1ceb4864f9ff9","type":"text","conversion_output":true,"text":"belongs to the \\(IgG 1 / k\\) isotype subclass. The relative molecular mass of canakinumab based on","text_display":" belongs to the \\(IgG 1 / k\\) isotype subclass. The relative molecular mass of canakinumab based on","confidence":0.31217248165148703,"confidence_rate":0.9889736275327732},{"cnt":[[288,889],[1878,889],[1878,939],[288,939]],"region":{"top_left_x":287,"top_left_y":889,"width":1591,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14b60ff7c32140e0853c68d3a7602606","type":"text","conversion_output":true,"text":"the amino acid sequence without post-translational modification (e.g., glycosylation), but","text_display":" the amino acid sequence without post-translational modification (e.g., glycosylation), but","confidence":1,"confidence_rate":1},{"cnt":[[288,937],[1878,937],[1878,986],[288,986]],"region":{"top_left_x":287,"top_left_y":936,"width":1591,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c9823d7dbd842138dcda83eb5928298","type":"text","conversion_output":true,"text":"including N-terminal pyroglutamate formation and the C-terminal lysine residues at the heavy","text_display":" including N-terminal pyroglutamate formation and the C-terminal lysine residues at the heavy","confidence":1,"confidence_rate":1},{"cnt":[[288,984],[1764,984],[1764,1033],[288,1033]],"region":{"top_left_x":287,"top_left_y":983,"width":1477,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9267d66c22db400bae1fc195baab71ca","type":"text","conversion_output":true,"text":"chains, is \\(MW =145157\\) Da. Canakinumab is manufactured in a murine SP2/0 cell line.","text_display":" chains, is \\(MW =145157\\) Da. Canakinumab is manufactured in a murine SP2/0 cell line.","confidence":0.9843823909759521,"confidence_rate":0.9998289184545593},{"cnt":[[288,1072],[1119,1072],[1119,1115],[288,1115]],"region":{"top_left_x":287,"top_left_y":1072,"width":833,"height":44},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2430bdaf76e74cbc93e7f0e4d8a3bc43","type":"figure_label","conversion_output":false,"text":"Table 1-1 Canakinumab 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Chemical name: & Recombinant human monoclonal antibody ACZ885 \\\\\n\\hline INN: & Canakinumab \\\\\n\\hline Proprietary name: & ILARIS \\({ }^{\\circledR}\\) \\\\\n\\hline Drug class: & Anti-inflammatory \\\\\n\\hline Laboratory code: & ACZ885 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1-1 Canakinumab characteristics}\n\\begin{tabular}{|l|l|}\n\\hline Chemical name: & Recombinant human monoclonal antibody ACZ885 \\\\\n\\hline INN: & Canakinumab \\\\\n\\hline Proprietary name: & ILARIS \\({ }^{\\circledR}\\) \\\\\n\\hline Drug class: & Anti-inflammatory \\\\\n\\hline Laboratory code: & ACZ885 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For further details, please refer to the current","confidence":0.8700306108221412,"confidence_rate":0.9986749083949815},{"cnt":[[288,2454],[965,2454],[965,2503],[288,2503]],"region":{"top_left_x":287,"top_left_y":2453,"width":678,"height":50},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"074aca2de6af42d580b3e39842e55e07","type":"text","conversion_output":true,"text":"[canakinumab Investigator's Brochure].","text_display":" [canakinumab Investigator's Brochure].","confidence":0.900390625,"confidence_rate":0.9975628216826304}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-035","page":35,"lines":[{"cnt":[[292,208],[423,208],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":208,"width":132,"height":35},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c7ac20a447e4f7ba5fc5e50796fb126","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43666d5d5dd24a7ba1908ea2e4cbd12c","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebde13b1b9bf4b6d954f1ac3a17cd5f5","type":"page_info","conversion_output":false,"text":"Page 35 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d445bbaa1a68488e991e4b9055615723","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,254],[1871,254],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":253,"width":457,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a11b7350fe6a4979bb50a8bf9c222f95","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,339],[737,339],[737,402],[288,402]],"region":{"top_left_x":287,"top_left_y":339,"width":450,"height":63},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a256f6e4f4d407aacfe09307398018b","type":"section_header","conversion_output":false,"children_ids":["c1f15786f5304c838fa9e335d088db38"],"text":"","text_display":""},{"cnt":[[292,344],[733,344],[733,397],[292,397]],"region":{"top_left_x":292,"top_left_y":343,"width":441,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f15786f5304c838fa9e335d088db38","type":"text","conversion_output":true,"parent_id":"1a256f6e4f4d407aacfe09307398018b","text":"1.3.1.1.3 Toxicology","text_display":"\n\n\\subsection*{1.3.1.1.3 Toxicology}","confidence":1,"confidence_rate":1},{"cnt":[[288,415],[1876,415],[1876,466],[288,466]],"region":{"top_left_x":287,"top_left_y":414,"width":1589,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7ad48555b3c4eeb9cead0590e12a48e","type":"text","conversion_output":true,"text":"An extensive program of toxicology studies was performed. The marmoset monkey was","text_display":"\n\nAn extensive program of toxicology studies was performed. The marmoset monkey was","confidence":1,"confidence_rate":1},{"cnt":[[288,464],[1876,464],[1876,513],[288,513]],"region":{"top_left_x":287,"top_left_y":464,"width":1589,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3111f61879f4d209bb391eb7edb0fab","type":"text","conversion_output":true,"text":"characterized as an appropriate model to predict human safety. Regarding toxicokinetics,","text_display":" characterized as an appropriate model to predict human safety. Regarding toxicokinetics,","confidence":1,"confidence_rate":1},{"cnt":[[288,511],[1876,511],[1876,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40fabc572ae24d72b32301e5d1a8b3a4","type":"text","conversion_output":true,"text":"exposure to canakinumab was demonstrated. Following i.v. or s.c. administration, canakinumab","text_display":" exposure to canakinumab was demonstrated. Following i.v. or s.c. administration, canakinumab","confidence":1,"confidence_rate":1},{"cnt":[[288,559],[1878,559],[1878,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1591,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a29963e55bdd4311b6171e7b3da788a1","type":"text","conversion_output":true,"text":"was well tolerated in marmosets at all dose levels investigated without any relevant adverse","text_display":" was well tolerated in marmosets at all dose levels investigated without any relevant adverse","confidence":1,"confidence_rate":1},{"cnt":[[288,606],[1878,606],[1878,655],[288,655]],"region":{"top_left_x":287,"top_left_y":605,"width":1591,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cba8076cfdc48718e713a80ae237d11","type":"text","conversion_output":true,"text":"findings. No anti-drug antibodies were detected. Long-term animal studies have not been","text_display":" findings. No anti-drug antibodies were detected. Long-term animal studies have not been","confidence":1,"confidence_rate":1},{"cnt":[[288,653],[1880,653],[1880,707],[288,707]],"region":{"top_left_x":287,"top_left_y":653,"width":1593,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5039059ebcae4ecf815ff8d8fb9a7928","type":"text","conversion_output":true,"text":"performed to evaluate the carcinogenic potential of canakinumab. The mutagenic potential of","text_display":" performed to evaluate the carcinogenic potential of canakinumab. The mutagenic potential of","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1880,700],[1880,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1593,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9479a08189a40938b6eb71275e1bab0","type":"text","conversion_output":true,"text":"canakinumab was not evaluated. No significant treatment-related effects were observed with","text_display":" canakinumab was not evaluated. No significant treatment-related effects were observed with","confidence":1,"confidence_rate":1},{"cnt":[[288,748],[1880,748],[1880,801],[288,801]],"region":{"top_left_x":287,"top_left_y":747,"width":1593,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0aa0969af7c4a798a8f76cf4be2b119","type":"text","conversion_output":true,"text":"respect to male or female fertility in a mouse model using a murine analog of canakinumab. For","text_display":" respect to male or female fertility in a mouse model using a murine analog of canakinumab. For","confidence":1,"confidence_rate":1},{"cnt":[[288,797],[1652,797],[1652,849],[288,849]],"region":{"top_left_x":287,"top_left_y":797,"width":1366,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d35c2e43454346719a673e70a135b268","type":"text","conversion_output":true,"text":"further details, please refer to the current [canakinumab Investigator's Brochure].","text_display":" further details, please refer to the current [canakinumab Investigator's Brochure].","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[288,881],[917,881],[917,943],[288,943]],"region":{"top_left_x":287,"top_left_y":880,"width":631,"height":64},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3553e7b0de364b77a54d2c6773367e26","type":"section_header","conversion_output":false,"children_ids":["0f97b5ef745947a28f87bf6082bb2bb0"],"text":"","text_display":""},{"cnt":[[292,885],[913,885],[913,939],[292,939]],"region":{"top_left_x":292,"top_left_y":885,"width":622,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f97b5ef745947a28f87bf6082bb2bb0","type":"text","conversion_output":true,"parent_id":"3553e7b0de364b77a54d2c6773367e26","text":"1.3.1.2 Clinical experience","text_display":"\n\n\\subsection*{1.3.1.2 Clinical experience}","confidence":0.998046875,"confidence_rate":0.9999389070276328},{"cnt":[[288,954],[1876,954],[1876,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":953,"width":1589,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8bee09f161f4df986046f728d617a5b","type":"text","conversion_output":true,"text":"Seventy-four (74) Novartis-sponsored canakinumab studies (66 interventional studies, 5","text_display":"\n\nSeventy-four (74) Novartis-sponsored canakinumab studies (66 interventional studies, 5","confidence":0.7490234375,"confidence_rate":0.9967942050776601},{"cnt":[[288,1005],[1878,1005],[1878,1055],[288,1055]],"region":{"top_left_x":287,"top_left_y":1005,"width":1591,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a615cf9980d540a795958bd18f5c65f4","type":"text","conversion_output":true,"text":"integrated managed subject access programs, and 3 post-authorization safety studies) and 16","text_display":" integrated managed subject access programs, and 3 post-authorization safety studies) and 16","confidence":1,"confidence_rate":1},{"cnt":[[288,1053],[1876,1053],[1876,1102],[288,1102]],"region":{"top_left_x":287,"top_left_y":1052,"width":1589,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5509a7f40ac4711a15405b0ffed0028","type":"text","conversion_output":true,"text":"Third Party (Investigator Initiated) trials had been initiated by 30 -Jun-2017. A total of 15,902","text_display":" Third Party (Investigator Initiated) trials had been initiated by 30 -Jun-2017. A total of 15,902","confidence":0.8331727953627706,"confidence_rate":0.998246594582657},{"cnt":[[288,1100],[1878,1100],[1878,1149],[288,1149]],"region":{"top_left_x":287,"top_left_y":1100,"width":1591,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"498bf2dec1cc4cf69c4fca913770751d","type":"text","conversion_output":true,"text":"subjects had been enrolled in the Novartis-sponsored, interventional canakinumab studies. It is","text_display":" subjects had been enrolled in the Novartis-sponsored, interventional canakinumab studies. It is","confidence":1,"confidence_rate":1},{"cnt":[[288,1147],[1878,1147],[1878,1197],[288,1197]],"region":{"top_left_x":287,"top_left_y":1147,"width":1591,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c1604c86b6043db9901c7b5314642be","type":"text","conversion_output":true,"text":"estimated that 10,939 subjects were exposed to canakinumab treatment in these trials, with the","text_display":" estimated that 10,939 subjects were exposed to canakinumab treatment in these trials, with the","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[288,1195],[1878,1195],[1878,1246],[288,1246]],"region":{"top_left_x":287,"top_left_y":1194,"width":1591,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9761e8c91554ce39192d4b23a3e9b3a","type":"text","conversion_output":true,"text":"majority of subjects \\((6,717)\\) being enrolled in the pivotal CACZ885M2301 study (Canakinumab","text_display":" majority of subjects \\((6,717)\\) being enrolled in the pivotal CACZ885M2301 study (Canakinumab","confidence":0.9941503966692835,"confidence_rate":0.9999401366972395},{"cnt":[[288,1242],[1880,1242],[1880,1296],[288,1296]],"region":{"top_left_x":287,"top_left_y":1241,"width":1593,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e9a7519d03e43169608eb65037284d7","type":"text","conversion_output":true,"text":"ANti-inflammatory Thrombosis Outcomes Study, CANTOS) investigating the prevention of","text_display":" ANti-inflammatory Thrombosis Outcomes Study, CANTOS) investigating the prevention of","confidence":1,"confidence_rate":1},{"cnt":[[288,1293],[1878,1293],[1878,1343],[288,1343]],"region":{"top_left_x":287,"top_left_y":1293,"width":1591,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b26f8686214ae4a7917127cd0739ad","type":"text","conversion_output":true,"text":"recurrent cardiovascular events in subjects with a prior myocardial infarction (MI) and an","text_display":" recurrent cardiovascular events in subjects with a prior myocardial infarction (MI) and an","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,1336],[1878,1336],[1878,1390],[288,1390]],"region":{"top_left_x":287,"top_left_y":1336,"width":1591,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfc7710054734bdeacfac1af8e26da01","type":"text","conversion_output":true,"text":"elevated hs-CRP. It is additionally estimated that 528 unique pediatric subjects aged \\(<1\\) to 17","text_display":" elevated hs-CRP. It is additionally estimated that 528 unique pediatric subjects aged \\(<1\\) to 17","confidence":0.9990236759185791,"confidence_rate":0.9999906077268363},{"cnt":[[288,1388],[1878,1388],[1878,1437],[288,1437]],"region":{"top_left_x":287,"top_left_y":1387,"width":1591,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2a5939cd19848b1bf7dae204ad8a867","type":"text","conversion_output":true,"text":"years were exposed to canakinumab treatment in Novartis-sponsored interventional studies","text_display":" years were exposed to canakinumab treatment in Novartis-sponsored interventional studies","confidence":1,"confidence_rate":1},{"cnt":[[288,1435],[965,1435],[965,1487],[288,1487]],"region":{"top_left_x":287,"top_left_y":1435,"width":678,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e685af2f410f4e079d521272c5e58c4d","type":"text","conversion_output":true,"text":"[canakinumab Investigator's Brochure].","text_display":" [canakinumab Investigator's Brochure].","confidence":0.98974609375,"confidence_rate":0.9997603347776153},{"cnt":[[288,1504],[1878,1504],[1878,1555],[288,1555]],"region":{"top_left_x":287,"top_left_y":1503,"width":1591,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e0243075e464c5ba0118a8c82864060","type":"text","conversion_output":true,"text":"The safety, tolerability and efficacy data of canakinumab in completed Novartis-sponsored","text_display":"\nThe safety, tolerability and efficacy data of canakinumab in completed Novartis-sponsored","confidence":1,"confidence_rate":1},{"cnt":[[288,1551],[1878,1551],[1878,1601],[288,1601]],"region":{"top_left_x":287,"top_left_y":1551,"width":1591,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"122c13055f214e57933997331898316f","type":"text","conversion_output":true,"text":"interventional studies (studies with a clinical study report as of 30-Jun-2017) are available from","text_display":" interventional studies (studies with a clinical study report as of 30-Jun-2017) are available from","confidence":0.94482421875,"confidence_rate":0.9994491189684173},{"cnt":[[288,1598],[1878,1598],[1878,1652],[288,1652]],"region":{"top_left_x":287,"top_left_y":1598,"width":1591,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0d9c226cc6146f19ec560eb5f57f512","type":"text","conversion_output":true,"text":"3,861 male or female subjects exposed to the drug; these include 326 healthy subjects, 458","text_display":" 3,861 male or female subjects exposed to the drug; these include 326 healthy subjects, 458","confidence":0.9985356330871582,"confidence_rate":0.9999847351149894},{"cnt":[[288,1646],[1878,1646],[1878,1697],[288,1697]],"region":{"top_left_x":287,"top_left_y":1645,"width":1591,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3389b91233a74df1a8d8dbdf735299d3","type":"text","conversion_output":true,"text":"subjects with Cryopyrin-Associated Periodic Syndromes (CAPS), 324 with Systemic Juvenile","text_display":" subjects with Cryopyrin-Associated Periodic Syndromes (CAPS), 324 with Systemic Juvenile","confidence":1,"confidence_rate":1},{"cnt":[[288,1695],[1876,1695],[1876,1747],[288,1747]],"region":{"top_left_x":287,"top_left_y":1695,"width":1589,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f353ef59deb4324a96453b8471e82db","type":"text","conversion_output":true,"text":"Idiopathic Arthritis (SJIA), 441 with Rheumatoid Arthritis (RA), 1,179 with gouty arthritis, 95","text_display":" Idiopathic Arthritis (SJIA), 441 with Rheumatoid Arthritis (RA), 1,179 with gouty arthritis, 95","confidence":0.87744140625,"confidence_rate":0.998755583506534},{"cnt":[[288,1745],[1878,1745],[1878,1794],[288,1794]],"region":{"top_left_x":287,"top_left_y":1744,"width":1591,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdf86dff8f954d96b37ad94fa10026a0","type":"text","conversion_output":true,"text":"with respiratory indications, 673 with Type 2 Diabetes Mellitus (T2DM), 144 with","text_display":" with respiratory indications, 673 with Type 2 Diabetes Mellitus (T2DM), 144 with","confidence":1,"confidence_rate":1},{"cnt":[[288,1792],[1878,1792],[1878,1841],[288,1841]],"region":{"top_left_x":287,"top_left_y":1791,"width":1591,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c2a74ff7db74f5da4f579758ac35575","type":"text","conversion_output":true,"text":"cardiovascular indications, e.g. atherosclerosis and periphery artery disease, 64 with","text_display":" cardiovascular indications, e.g. atherosclerosis and periphery artery disease, 64 with","confidence":1,"confidence_rate":1},{"cnt":[[288,1839],[1878,1839],[1878,1893],[288,1893]],"region":{"top_left_x":287,"top_left_y":1839,"width":1591,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68ff44567add464b8132009ab3aa6f65","type":"text","conversion_output":true,"text":"osteoarthritis and 157 with other indications. The doses administered ranged from \\(0.5 mg / kg\\) to","text_display":" osteoarthritis and 157 with other indications. The doses administered ranged from \\(0.5 mg / kg\\) to","confidence":1,"confidence_rate":1},{"cnt":[[288,1886],[1878,1886],[1878,1938],[288,1938]],"region":{"top_left_x":287,"top_left_y":1886,"width":1591,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30fbc8643faa402580b6fe70d5c7a339","type":"text","conversion_output":true,"text":"\\(9 mg / kg\\) s.c., \\(0.03 mg / kg\\) to \\(10 mg / kg\\) i.v., and fixed doses of 5 mg to 600 mg s.c. and 150 mg","text_display":" \\(9 mg / kg\\) s.c., \\(0.03 mg / kg\\) to \\(10 mg / kg\\) i.v., and fixed doses of 5 mg to 600 mg s.c. and 150 mg","confidence":0.99951171875,"confidence_rate":0.999996184378388},{"cnt":[[288,1936],[1880,1936],[1880,1987],[288,1987]],"region":{"top_left_x":287,"top_left_y":1935,"width":1593,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67a0bc3073e3471ba188488ea77e19cb","type":"text","conversion_output":true,"text":"to 600 mg i.v. The frequency of dosing ranged from a single dose to quarterly repeated","text_display":" to 600 mg i.v. The frequency of dosing ranged from a single dose to quarterly repeated","confidence":1,"confidence_rate":1},{"cnt":[[288,1983],[1878,1983],[1878,2035],[288,2035]],"region":{"top_left_x":287,"top_left_y":1983,"width":1591,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0865ab7b06f4c3d85f6a3c99570bc22","type":"text","conversion_output":true,"text":"administration or treatment upon flare (in gouty arthritis) [canakinumab Investigator's","text_display":" administration or treatment upon flare (in gouty arthritis) [canakinumab Investigator's","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[288,2032],[477,2032],[477,2082],[288,2082]],"region":{"top_left_x":287,"top_left_y":2032,"width":190,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22367fd2524544b5bddea2f032c347a4","type":"text","conversion_output":true,"text":"Brochure].","text_display":" Brochure].","confidence":1,"confidence_rate":1},{"cnt":[[288,2114],[788,2114],[788,2176],[288,2176]],"region":{"top_left_x":287,"top_left_y":2114,"width":502,"height":63},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcc1602928a646a8ad824d0471334028","type":"section_header","conversion_output":false,"children_ids":["ff8f0cd26e8243638869ffa16adc07df"],"text":"","text_display":""},{"cnt":[[292,2118],[784,2118],[784,2172],[292,2172]],"region":{"top_left_x":292,"top_left_y":2118,"width":493,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff8f0cd26e8243638869ffa16adc07df","type":"text","conversion_output":true,"parent_id":"bcc1602928a646a8ad824d0471334028","text":"1.3.1.2.1 Clinical Safety","text_display":"\n\n\\subsection*{1.3.1.2.1 Clinical Safety}","confidence":1,"confidence_rate":1},{"cnt":[[288,2187],[1878,2187],[1878,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2187,"width":1591,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c31fb41a6494e0f8b5379f7d1ae4aef","type":"text","conversion_output":true,"text":"Due to the mode of action of all inhibitors of the IL-1 pathway, infections, predominately of the","text_display":"\n\nDue to the mode of action of all inhibitors of the IL-1 pathway, infections, predominately of the","confidence":1,"confidence_rate":1},{"cnt":[[288,2239],[1876,2239],[1876,2288],[288,2288]],"region":{"top_left_x":287,"top_left_y":2238,"width":1589,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2deb6133fee4e8d8bba670adb9d6273","type":"text","conversion_output":true,"text":"upper respiratory system, are the main risk in subjects treated with canakinumab. Canakinumab","text_display":" upper respiratory system, are the main risk in subjects treated with canakinumab. Canakinumab","confidence":1,"confidence_rate":1},{"cnt":[[288,2286],[1876,2286],[1876,2335],[288,2335]],"region":{"top_left_x":287,"top_left_y":2285,"width":1589,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de011f6c729247d99811b386415cf00b","type":"text","conversion_output":true,"text":"is associated with an increased incidence of serious infections during and after treatment.","text_display":" is associated with an increased incidence of serious infections during and after treatment.","confidence":1,"confidence_rate":1},{"cnt":[[288,2333],[1876,2333],[1876,2385],[288,2385]],"region":{"top_left_x":287,"top_left_y":2333,"width":1589,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e13f4792daaa472480496140e4bc40d2","type":"text","conversion_output":true,"text":"Although the majority of reports of infection resolved spontaneously or with standard therapy,","text_display":" Although the majority of reports of infection resolved spontaneously or with standard therapy,","confidence":1,"confidence_rate":1},{"cnt":[[288,2380],[1880,2380],[1880,2432],[288,2432]],"region":{"top_left_x":287,"top_left_y":2380,"width":1593,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48c67da389684385892d5be6dd63caa0","type":"text","conversion_output":true,"text":"severe, serious and fatal infections have been reported, including reports of fatal complicated","text_display":" severe, serious and fatal infections have been reported, including reports of fatal complicated","confidence":1,"confidence_rate":1},{"cnt":[[288,2430],[1772,2430],[1772,2481],[288,2481]],"region":{"top_left_x":287,"top_left_y":2429,"width":1486,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187e47650e2d47f7a6046a801455c169","type":"text","conversion_output":true,"text":"perforated diverticulitis and sepsis. Opportunistic infections have also been reported.","text_display":" perforated diverticulitis and sepsis. Opportunistic infections have also been reported.","confidence":0.99951171875,"confidence_rate":0.9999946913130248}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-036","page":36,"lines":[{"cnt":[[292,208],[423,208],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":208,"width":132,"height":35},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f3579463b5a4ba0b76c86eb69de249a","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57dbc36388f848e2a93b411c70e612b6","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed0eb4609d9049259a822bc81f6c3bce","type":"page_info","conversion_output":false,"text":"Page 36 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdad0403aa5b4e68940942c532697a81","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"410f9cac3bd449869dc78c636a9fdbda","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd87b17f526141969cde2caef2781ba2","type":"text","conversion_output":true,"text":"Neutropenia has been observed with medicinal products that inhibit IL-1, including","text_display":"\n\nNeutropenia has been observed with medicinal products that inhibit IL-1, including","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1880,391],[1880,445],[288,445]],"region":{"top_left_x":287,"top_left_y":391,"width":1593,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e24f4c8b5a9418c8385560cb210615c","type":"text","conversion_output":true,"text":"canakinumab. Other than neutropenia, thrombocytopenia, and uric acid increase specific for","text_display":" canakinumab. Other than neutropenia, thrombocytopenia, and uric acid increase specific for","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1880,440],[1880,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1593,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f934aca1554abea9b57ab7a44cdb53","type":"text","conversion_output":true,"text":"active gouty arthritis, there was no evidence of other clinically relevant drug-related changes in","text_display":" active gouty arthritis, there was no evidence of other clinically relevant drug-related changes in","confidence":1,"confidence_rate":1},{"cnt":[[288,486],[1721,486],[1721,539],[288,539]],"region":{"top_left_x":287,"top_left_y":485,"width":1434,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5a23781c0ad428b97c4bb4c85346d10","type":"text","conversion_output":true,"text":"vital signs, electrocardiogram (ECG) or laboratory values (see local label for Ilaris \\({ }^{\\circledR}\\) ).","text_display":" vital signs, electrocardiogram (ECG) or laboratory values (see local label for Ilaris \\({ }^{\\circledR}\\) ).","confidence":0.6142578125,"confidence_rate":0.9953694158062227},{"cnt":[[288,559],[1882,559],[1882,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1596,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5f1fee0338e4b6291496b064071fa6a","type":"text","conversion_output":true,"text":"Both i.v. and s.c. injections of canakinumab are well tolerated as evidenced by a low rate of","text_display":"\n\nBoth i.v. and s.c. injections of canakinumab are well tolerated as evidenced by a low rate of","confidence":0.9975600242614746,"confidence_rate":0.9999750721746797},{"cnt":[[288,606],[1876,606],[1876,655],[288,655]],"region":{"top_left_x":287,"top_left_y":605,"width":1589,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13cbff6b60194650979ba48a77085fc2","type":"text","conversion_output":true,"text":"injection-site events and discontinuations. Low treatment-related immunogenicity ( \\(<3 \\%\\) ) has","text_display":" injection-site events and discontinuations. Low treatment-related immunogenicity ( \\(<3 \\%\\) ) has","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,653],[1876,653],[1876,703],[288,703]],"region":{"top_left_x":287,"top_left_y":653,"width":1589,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c028f36fb1d43449cb712b0642c0692","type":"text","conversion_output":true,"text":"been detected, and no clinical consequences to detected anti-drug antibodies were evident. No","text_display":" been detected, and no clinical consequences to detected anti-drug antibodies were evident. No","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1878,700],[1878,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1591,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adcf16d7ee4d4f4f864ca3cdaec7b26f","type":"text","conversion_output":true,"text":"apparent impact on canakinumab pharmacokinetics or on total IL-1 \\(\\beta\\) concentration","text_display":" apparent impact on canakinumab pharmacokinetics or on total IL-1 \\(\\beta\\) concentration","confidence":0.9302767843556126,"confidence_rate":0.99917905171341},{"cnt":[[288,748],[1876,748],[1876,801],[288,801]],"region":{"top_left_x":287,"top_left_y":747,"width":1589,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51685fd7f4b44e818604a06c11926f05","type":"text","conversion_output":true,"text":"(pharmacodynamics) were evident; or any evidence of immune-related loss of efficacy.","text_display":" (pharmacodynamics) were evident; or any evidence of immune-related loss of efficacy.","confidence":1,"confidence_rate":1},{"cnt":[[288,795],[1721,795],[1721,849],[288,849]],"region":{"top_left_x":287,"top_left_y":794,"width":1434,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"789256caed3b48a8870159d12657ba21","type":"text","conversion_output":true,"text":"Overall, the immunogenicity profile is entirely consistent across all disease areas.","text_display":" Overall, the immunogenicity profile is entirely consistent across all disease areas.","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[286,879],[836,879],[836,947],[286,947]],"region":{"top_left_x":285,"top_left_y":878,"width":551,"height":70},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97cef81d578f40e48a4c7e93b7e2c5b1","type":"section_header","conversion_output":false,"children_ids":["fec985d2c0904603a7ada7b0426dcc9b"],"text":"","text_display":""},{"cnt":[[292,885],[827,885],[827,939],[292,939]],"region":{"top_left_x":292,"top_left_y":885,"width":536,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fec985d2c0904603a7ada7b0426dcc9b","type":"text","conversion_output":true,"parent_id":"97cef81d578f40e48a4c7e93b7e2c5b1","text":"1.3.1.2.2 Clinical Efficacy","text_display":"\n\n\\subsection*{1.3.1.2.2 Clinical Efficacy}","confidence":1,"confidence_rate":1},{"cnt":[[288,954],[1674,954],[1674,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":953,"width":1387,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4624d8ec8c7b47a09f2a2d9cc8c06b0e","type":"text","conversion_output":true,"text":"Canakinumab has demonstrated efficacy in a variety of non-oncologic indications.","text_display":"\n\nCanakinumab has demonstrated efficacy in a variety of non-oncologic indications.","confidence":1,"confidence_rate":1},{"cnt":[[288,1023],[1878,1023],[1878,1076],[288,1076]],"region":{"top_left_x":287,"top_left_y":1022,"width":1591,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39d1db3b8cd24e3c9f0122f6b495617b","type":"text","conversion_output":true,"text":"In CAPS subjects, the first approved indication of canakinumab, canakinumab treatment (150","text_display":"\nIn CAPS subjects, the first approved indication of canakinumab, canakinumab treatment (150","confidence":0.935546875,"confidence_rate":0.9992989403032778},{"cnt":[[288,1072],[1880,1072],[1880,1124],[288,1124]],"region":{"top_left_x":287,"top_left_y":1072,"width":1593,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e839a1c8e3c44f4aac5daa50faa1f69","type":"text","conversion_output":true,"text":"mg or \\(2 mg / kg\\) s.c. every 8 weeks) produces a rapid and complete resolution of signs and","text_display":" mg or \\(2 mg / kg\\) s.c. every 8 weeks) produces a rapid and complete resolution of signs and","confidence":0.9936552047729492,"confidence_rate":0.9999393827040921},{"cnt":[[288,1121],[1878,1121],[1878,1171],[288,1171]],"region":{"top_left_x":287,"top_left_y":1121,"width":1591,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d041e04b83e14ccf97fe81bb63bd815a","type":"text","conversion_output":true,"text":"symptoms in almost all subjects, starting within 1 day of treatment, along with an immediate","text_display":" symptoms in almost all subjects, starting within 1 day of treatment, along with an immediate","confidence":1,"confidence_rate":1},{"cnt":[[288,1169],[1876,1169],[1876,1218],[288,1218]],"region":{"top_left_x":287,"top_left_y":1168,"width":1589,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dfab159349142c6b58650168b9d6c2a","type":"text","conversion_output":true,"text":"and sustained normalization of serological and hematological parameters of inflammation.","text_display":" and sustained normalization of serological and hematological parameters of inflammation.","confidence":1,"confidence_rate":1},{"cnt":[[288,1216],[1878,1216],[1878,1268],[288,1268]],"region":{"top_left_x":287,"top_left_y":1216,"width":1591,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a868cda6e8b4ba38cfc0e2fae2d8f96","type":"text","conversion_output":true,"text":"Pediatric subjects and those with a severe CAPS phenotype may require higher than usual doses","text_display":" Pediatric subjects and those with a severe CAPS phenotype may require higher than usual doses","confidence":0.90478515625,"confidence_rate":0.998979523490921},{"cnt":[[288,1263],[1876,1263],[1876,1315],[288,1315]],"region":{"top_left_x":287,"top_left_y":1263,"width":1589,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74916c6dda0c4b01b01008425663465d","type":"text","conversion_output":true,"text":"to attain full clinical response and current labeling for Ilaris allows for dose escalation to 8","text_display":" to attain full clinical response and current labeling for Ilaris allows for dose escalation to 8","confidence":1,"confidence_rate":1},{"cnt":[[288,1311],[1349,1311],[1349,1364],[288,1364]],"region":{"top_left_x":287,"top_left_y":1310,"width":1063,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7d0014979494492a60d88b12d7716f0","type":"text","conversion_output":true,"text":"\\(mg / kg\\) for subjects \\(\\leq 40 kg\\) and to 600 mg for subjects \\(>40 kg\\).","text_display":" \\(mg / kg\\) for subjects \\(\\leq 40 kg\\) and to 600 mg for subjects \\(>40 kg\\).","confidence":1,"confidence_rate":1},{"cnt":[[288,1379],[1880,1379],[1880,1433],[288,1433]],"region":{"top_left_x":287,"top_left_y":1379,"width":1593,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e67ec4728c14771bff83bba46d123ff","type":"text","conversion_output":true,"text":"Significant improvement in disease activity was demonstrated in subjects with period fever","text_display":"\nSignificant improvement in disease activity was demonstrated in subjects with period fever","confidence":1,"confidence_rate":1},{"cnt":[[288,1431],[1880,1431],[1880,1480],[288,1480]],"region":{"top_left_x":287,"top_left_y":1430,"width":1593,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e079c15de28a4a848ceebbc110d05fa3","type":"text","conversion_output":true,"text":"syndromes including Familial Mediterranean Fever (FMF), Tumor Necrosis Factor Receptor","text_display":" syndromes including Familial Mediterranean Fever (FMF), Tumor Necrosis Factor Receptor","confidence":1,"confidence_rate":1},{"cnt":[[288,1474],[1880,1474],[1880,1528],[288,1528]],"region":{"top_left_x":287,"top_left_y":1473,"width":1593,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd08e8dd7f064563b2394d1e083a7d10","type":"text","conversion_output":true,"text":"Associated Periodic Syndrome (TRAPS) and Hyperimmunoglobulin D Syndrome (HIDS)/","text_display":" Associated Periodic Syndrome (TRAPS) and Hyperimmunoglobulin D Syndrome (HIDS)/","confidence":1,"confidence_rate":1},{"cnt":[[288,1523],[1880,1523],[1880,1575],[288,1575]],"region":{"top_left_x":287,"top_left_y":1523,"width":1593,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1154b7440d6a4a6498079aaab1db017d","type":"text","conversion_output":true,"text":"Mevalonate Kinase Deficiency (MKD) who had received canakinumab treatment ( 150 mg","text_display":" Mevalonate Kinase Deficiency (MKD) who had received canakinumab treatment ( 150 mg","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[288,1573],[1880,1573],[1880,1622],[288,1622]],"region":{"top_left_x":287,"top_left_y":1572,"width":1593,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e08c812ec2d44e948e9fa24b6000f0f2","type":"text","conversion_output":true,"text":"every 4 weeks). Canakinumab treatment showed resolution of index disease flare and","text_display":" every 4 weeks). Canakinumab treatment showed resolution of index disease flare and","confidence":1,"confidence_rate":1},{"cnt":[[288,1620],[1880,1620],[1880,1671],[288,1671]],"region":{"top_left_x":287,"top_left_y":1619,"width":1593,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebb2389d51d2435da8269666b3bb173a","type":"text","conversion_output":true,"text":"prevention of new flares. Canakinumab also demonstrated normalization of serological and","text_display":" prevention of new flares. Canakinumab also demonstrated normalization of serological and","confidence":1,"confidence_rate":1},{"cnt":[[288,1667],[1878,1667],[1878,1721],[288,1721]],"region":{"top_left_x":287,"top_left_y":1667,"width":1591,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"738e3aaaf5d84c88a5b28e0a0ae98660","type":"text","conversion_output":true,"text":"hematological parameters of inflammation. Subjects with HIDS/MKD may require higher than","text_display":" hematological parameters of inflammation. Subjects with HIDS/MKD may require higher than","confidence":1,"confidence_rate":1},{"cnt":[[288,1714],[1880,1714],[1880,1768],[288,1768]],"region":{"top_left_x":287,"top_left_y":1714,"width":1593,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c579634bfa74f2d961a143391fe6916","type":"text","conversion_output":true,"text":"usual doses to attain full clinical response. The response to treatment was long-lasting and","text_display":" usual doses to attain full clinical response. The response to treatment was long-lasting and","confidence":1,"confidence_rate":1},{"cnt":[[288,1764],[1635,1764],[1635,1815],[288,1815]],"region":{"top_left_x":287,"top_left_y":1763,"width":1348,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b118020b2c704a0f8b4742824d65218e","type":"text","conversion_output":true,"text":"sustained in all evaluated age-groups, both genders, and between all indications.","text_display":" sustained in all evaluated age-groups, both genders, and between all indications.","confidence":1,"confidence_rate":1},{"cnt":[[288,1833],[1880,1833],[1880,1884],[288,1884]],"region":{"top_left_x":287,"top_left_y":1832,"width":1593,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f612e2b6726f490da5e5ba2fc53c4307","type":"text","conversion_output":true,"text":"In SJIA, subjects treated with a single dose of canakinumab ( 300 mg or \\(4 mg / kg\\) ), \\(83 \\%\\) of all","text_display":"\nIn SJIA, subjects treated with a single dose of canakinumab ( 300 mg or \\(4 mg / kg\\) ), \\(83 \\%\\) of all","confidence":0.8740234375,"confidence_rate":0.998819573678884},{"cnt":[[288,1882],[1882,1882],[1882,1931],[288,1931]],"region":{"top_left_x":287,"top_left_y":1882,"width":1596,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"649514c4bda2412b97f4737c7c6da3aa","type":"text","conversion_output":true,"text":"children were classified responders and achieved at least an adapted American College of","text_display":" children were classified responders and achieved at least an adapted American College of","confidence":1,"confidence_rate":1},{"cnt":[[288,1929],[1880,1929],[1880,1979],[288,1979]],"region":{"top_left_x":287,"top_left_y":1929,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b9764477d264424ab01fca9da6d9426","type":"text","conversion_output":true,"text":"Rheumatology Pediatric Response Criteria score of ACRped30 at Day 15 of a 4 -week","text_display":" Rheumatology Pediatric Response Criteria score of ACRped30 at Day 15 of a 4 -week","confidence":0.99169921875,"confidence_rate":0.999909401663201},{"cnt":[[288,1977],[1626,1977],[1626,2030],[288,2030]],"region":{"top_left_x":287,"top_left_y":1976,"width":1340,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efa3441a91204d38a0c9aa0d6125e367","type":"text","conversion_output":true,"text":"randomized double-blind study. One third of subjects achieved an ACRped100.","text_display":" randomized double-blind study. One third of subjects achieved an ACRped100.","confidence":1,"confidence_rate":1},{"cnt":[[288,2045],[1880,2045],[1880,2099],[288,2099]],"region":{"top_left_x":287,"top_left_y":2045,"width":1593,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95f8ed721a4d4acd91aaf707fa2e093f","type":"text","conversion_output":true,"text":"In subjects with gouty arthritis who had an acute gout attack and who are refractory or","text_display":"\nIn subjects with gouty arthritis who had an acute gout attack and who are refractory or","confidence":1,"confidence_rate":1},{"cnt":[[288,2093],[1878,2093],[1878,2144],[288,2144]],"region":{"top_left_x":287,"top_left_y":2092,"width":1591,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be8e7bc550fe4cc2bf0af7f9e3f92bce","type":"text","conversion_output":true,"text":"contraindicated to NSAIDs and/or colchicine, treatment with canakinumab ( 150 mg s.c.),","text_display":" contraindicated to NSAIDs and/or colchicine, treatment with canakinumab ( 150 mg s.c.),","confidence":0.998535871389322,"confidence_rate":0.9999848949440379},{"cnt":[[288,2140],[1882,2140],[1882,2194],[288,2194]],"region":{"top_left_x":287,"top_left_y":2139,"width":1596,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9def49e33724624bf83428ec12d268b","type":"text","conversion_output":true,"text":"showed statistically significant efficacy, both in terms of pain relief and preventing the onset of","text_display":" showed statistically significant efficacy, both in terms of pain relief and preventing the onset of","confidence":1,"confidence_rate":1},{"cnt":[[288,2189],[1880,2189],[1880,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2189,"width":1593,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0223bce68daa473b9a2f55e72f4095cd","type":"text","conversion_output":true,"text":"a new flare, compared to triamcinolone acetonide 40 mg intramuscularly (i.m.). In confirmatory","text_display":" a new flare, compared to triamcinolone acetonide 40 mg intramuscularly (i.m.). In confirmatory","confidence":0.969755404163152,"confidence_rate":0.9997047416748298},{"cnt":[[288,2237],[1880,2237],[1880,2288],[288,2288]],"region":{"top_left_x":287,"top_left_y":2236,"width":1593,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9939026d50cc49048bdeeaffa967820b","type":"text","conversion_output":true,"text":"gout studies, canakinumab has showed sustained efficacy with a consistent safety profile over","text_display":" gout studies, canakinumab has showed sustained efficacy with a consistent safety profile over","confidence":1,"confidence_rate":1},{"cnt":[[288,2286],[617,2286],[617,2340],[288,2340]],"region":{"top_left_x":287,"top_left_y":2285,"width":330,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20915cbf015947efbed144c0ed8f72ac","type":"text","conversion_output":true,"text":"repeated treatment.","text_display":" repeated treatment.","confidence":1,"confidence_rate":1},{"cnt":[[288,2355],[1876,2355],[1876,2408],[288,2408]],"region":{"top_left_x":287,"top_left_y":2354,"width":1589,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32454d0ed3344ed1b9d235b62b430cfb","type":"text","conversion_output":true,"text":"In subjects with atherosclerosis and Type II Diabetes Mellitus or Impaired Glucose Tolerance,","text_display":"\nIn subjects with atherosclerosis and Type II Diabetes Mellitus or Impaired Glucose Tolerance,","confidence":1,"confidence_rate":1},{"cnt":[[288,2402],[1880,2402],[1880,2454],[288,2454]],"region":{"top_left_x":287,"top_left_y":2401,"width":1593,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cc489415ab7420ebc1f4cfeb718c51e","type":"text","conversion_output":true,"text":"the rate of progression of atherosclerotic plaque burden (as measured by vessel wall area) in","text_display":" the rate of progression of atherosclerotic plaque burden (as measured by vessel wall area) in","confidence":1,"confidence_rate":1},{"cnt":[[288,2449],[1880,2449],[1880,2501],[288,2501]],"region":{"top_left_x":287,"top_left_y":2449,"width":1593,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43a5e8dac1a2475aa74bfc478e53c0df","type":"text","conversion_output":true,"text":"three vascular beds (proximal ascending aorta, left carotid, right carotid) was attenuated after","text_display":" three vascular beds (proximal ascending aorta, left carotid, right carotid) was attenuated after","confidence":1,"confidence_rate":1},{"cnt":[[292,2496],[1016,2496],[1016,2546],[292,2546]],"region":{"top_left_x":292,"top_left_y":2496,"width":725,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25cf5dbb2cf14e03aee235cc0af6fb6d","type":"text","conversion_output":true,"text":"12 months of treatment with canakinumab.","text_display":" 12 months of treatment with canakinumab.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-037","page":37,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a03d4ad5300d4169a7a0a74024123e21","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30a99c8c1a19401a87be6f5e4138e2b7","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb5772e8c0614407820a22783bb63691","type":"page_info","conversion_output":false,"text":"Page 37 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d52c716e59c4422da5b2641b1b257a03","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c8bc6f41a3345ff9ac25599e7e8e5ac","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54b3846db4b0489baf91787add4acdbe","type":"text","conversion_output":true,"text":"In subjects with intermittent claudication, an improvement in maximum and pain-free walk","text_display":"\n\nIn subjects with intermittent claudication, an improvement in maximum and pain-free walk","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1880,391],[1880,445],[288,445]],"region":{"top_left_x":287,"top_left_y":391,"width":1593,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c54c657298462883c2c69db5c79593","type":"text","conversion_output":true,"text":"distance in the canakinumab-treated group was observed, but no statistically significant","text_display":" distance in the canakinumab-treated group was observed, but no statistically significant","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1878,440],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1591,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76204ba942a34342ba81437465eba44a","type":"text","conversion_output":true,"text":"between-treatment difference in mean vessel wall area ratio was determined as compared to","text_display":" between-treatment difference in mean vessel wall area ratio was determined as compared to","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[445,490],[445,535],[288,535]],"region":{"top_left_x":287,"top_left_y":489,"width":158,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc23456f03344342bfe17635d39f7dea","type":"text","conversion_output":true,"text":"baseline.","text_display":" baseline.","confidence":1,"confidence_rate":1},{"cnt":[[288,559],[1592,559],[1592,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1305,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eb1f97f587f42a796785dbcf9565d18","type":"text","conversion_output":true,"text":"For further details, please refer to the [canakinumab Investigator's Brochure].","text_display":"\n\nFor further details, please refer to the [canakinumab Investigator's Brochure].","confidence":1,"confidence_rate":1},{"cnt":[[288,642],[896,642],[896,703],[288,703]],"region":{"top_left_x":287,"top_left_y":642,"width":609,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cab1d8366444030a0d5baa6218ed9a4","type":"section_header","conversion_output":false,"children_ids":["cc3f8b427e014eeb8f47031c03b908ac"],"text":"","text_display":""},{"cnt":[[292,649],[892,649],[892,698],[292,698]],"region":{"top_left_x":292,"top_left_y":648,"width":600,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc3f8b427e014eeb8f47031c03b908ac","type":"text","conversion_output":true,"parent_id":"4cab1d8366444030a0d5baa6218ed9a4","text":"Efficacy in the CANTOS study","text_display":"\n\n\\section*{Efficacy in the CANTOS study}","confidence":0.9843893051147461,"confidence_rate":0.9995233310702136},{"cnt":[[288,715],[1880,715],[1880,767],[288,767]],"region":{"top_left_x":287,"top_left_y":715,"width":1593,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43c9776dcb894e13b5ab71c9a1972c23","type":"text","conversion_output":true,"text":"The CANTOS study has demonstrated a clinically and statistically significant effect of","text_display":"\n\nThe CANTOS study has demonstrated a clinically and statistically significant effect of","confidence":1,"confidence_rate":1},{"cnt":[[288,765],[1878,765],[1878,814],[288,814]],"region":{"top_left_x":287,"top_left_y":764,"width":1591,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b31cecb57c345ff9d8cb4cbaeb3e2f7","type":"text","conversion_output":true,"text":"canakinumab 150 mg and 300 mg every 3 months over matching placebo in reducing the risk","text_display":" canakinumab 150 mg and 300 mg every 3 months over matching placebo in reducing the risk","confidence":1,"confidence_rate":1},{"cnt":[[288,812],[1876,812],[1876,862],[288,862]],"region":{"top_left_x":287,"top_left_y":812,"width":1589,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e504e5b5fcdb4fae9d98d8ef3994a8d7","type":"text","conversion_output":true,"text":"of major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular death,","text_display":" of major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular death,","confidence":1,"confidence_rate":1},{"cnt":[[288,862],[1876,862],[1876,913],[288,913]],"region":{"top_left_x":287,"top_left_y":861,"width":1589,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e345ff5946574bf89d5907f134a01e5a","type":"text","conversion_output":true,"text":"non-fatal MI and non-fatal stroke in subjects with a history of MI and inflammatory","text_display":" non-fatal MI and non-fatal stroke in subjects with a history of MI and inflammatory","confidence":0.9990236759185791,"confidence_rate":0.9999889000502842},{"cnt":[[288,907],[1878,907],[1878,958],[288,958]],"region":{"top_left_x":287,"top_left_y":906,"width":1591,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e44a97df9a49437c8edcaec509d0b00f","type":"text","conversion_output":true,"text":"atherosclerosis. With the positive results of the CANTOS study, canakinumab is the first","text_display":" atherosclerosis. With the positive results of the CANTOS study, canakinumab is the first","confidence":1,"confidence_rate":1},{"cnt":[[288,956],[1878,956],[1878,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":956,"width":1591,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1bf452dc6a24ee3963932f76df0735f","type":"text","conversion_output":true,"text":"treatment to significantly reduce cardiovascular risk by directly targeting inflammation. The","text_display":" treatment to significantly reduce cardiovascular risk by directly targeting inflammation. The","confidence":1,"confidence_rate":1},{"cnt":[[288,1005],[1878,1005],[1878,1055],[288,1055]],"region":{"top_left_x":287,"top_left_y":1005,"width":1591,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f273d778d36a403bb9fdc5c56bff2845","type":"text","conversion_output":true,"text":"results of the CANTOS study also recently reported that inhibition of IL-1 \\(\\beta\\) dose dependently","text_display":" results of the CANTOS study also recently reported that inhibition of IL-1 \\(\\beta\\) dose dependently","confidence":0.9902429580688477,"confidence_rate":0.9999029259617775},{"cnt":[[288,1053],[1876,1053],[1876,1102],[288,1102]],"region":{"top_left_x":287,"top_left_y":1052,"width":1589,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15dd045c08d7421cafc1fb1d7d1dc2b7","type":"text","conversion_output":true,"text":"reduced the occurrence of lung cancers in post myocardial infarction (atherosclerotic) subjects","text_display":" reduced the occurrence of lung cancers in post myocardial infarction (atherosclerotic) subjects","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1100],[1523,1100],[1523,1149],[288,1149]],"region":{"top_left_x":287,"top_left_y":1100,"width":1237,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c291703a75fc4b38a22337fe6c6ed94a","type":"text","conversion_output":true,"text":"with elevated hs-CRP, who were previously cancer free (see Section 2.1).","text_display":" with elevated hs-CRP, who were previously cancer free (see Section 2.1).","confidence":1,"confidence_rate":1},{"cnt":[[288,1186],[1635,1186],[1635,1244],[288,1244]],"region":{"top_left_x":287,"top_left_y":1185,"width":1348,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b3a47fbf2c649b1bd211016bde73b52","type":"section_header","conversion_output":false,"children_ids":["454f1e1018b44ab3851d029685f25f89"],"text":"","text_display":""},{"cnt":[[292,1190],[1629,1190],[1629,1240],[292,1240]],"region":{"top_left_x":292,"top_left_y":1190,"width":1337,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"454f1e1018b44ab3851d029685f25f89","type":"text","conversion_output":true,"parent_id":"1b3a47fbf2c649b1bd211016bde73b52","text":"1.3.1.2.3 Clinical Pharmacokinetics, Pharmacodynamics and Immunogenicity","text_display":"\n\n\\subsection*{1.3.1.2.3 Clinical Pharmacokinetics, Pharmacodynamics and Immunogenicity}","confidence":1,"confidence_rate":1},{"cnt":[[288,1259],[1878,1259],[1878,1308],[288,1308]],"region":{"top_left_x":287,"top_left_y":1258,"width":1591,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2921576d71f47679ddf43eb50e9cfe9","type":"text","conversion_output":true,"text":"Canakinumab is a human anti-human IL-1 \\(\\beta\\) monoclonal IgG1/ \\(\\kappa\\) antibody which was derived","text_display":"\n\nCanakinumab is a human anti-human IL-1 \\(\\beta\\) monoclonal IgG1/ \\(\\kappa\\) antibody which was derived","confidence":0.5056754577980598,"confidence_rate":0.9929951624194461},{"cnt":[[288,1306],[1878,1304],[1878,1358],[288,1360]],"region":{"top_left_x":287,"top_left_y":1304,"width":1591,"height":56},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c064594c475243eab27bf7845a5e7247","type":"text","conversion_output":true,"text":"from a genetically engineered mouse carrying the human immunoglobulin repertoire. During","text_display":" from a genetically engineered mouse carrying the human immunoglobulin repertoire. During","confidence":1,"confidence_rate":1},{"cnt":[[288,1354],[1880,1354],[1880,1405],[288,1405]],"region":{"top_left_x":287,"top_left_y":1353,"width":1593,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"460e78c8e6ea485c8928788ed2817c6e","type":"text","conversion_output":true,"text":"the development of canakinumab, three changes relevant to drug substance manufacturing","text_display":" the development of canakinumab, three changes relevant to drug substance manufacturing","confidence":1,"confidence_rate":1},{"cnt":[[288,1401],[1876,1401],[1876,1452],[288,1452]],"region":{"top_left_x":287,"top_left_y":1400,"width":1589,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26532af90cab43b79c3fc22edb21a432","type":"text","conversion_output":true,"text":"process were introduced. The four drug forms were termed as Product Types A, B, C and D.","text_display":" process were introduced. The four drug forms were termed as Product Types A, B, C and D.","confidence":1,"confidence_rate":1},{"cnt":[[288,1448],[1878,1448],[1878,1500],[288,1500]],"region":{"top_left_x":287,"top_left_y":1448,"width":1591,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0db5612f681b43fbb38c84b0843402b1","type":"text","conversion_output":true,"text":"The rate and extent of absorption following s.c. administration were independently estimated","text_display":" The rate and extent of absorption following s.c. administration were independently estimated","confidence":1,"confidence_rate":1},{"cnt":[[288,1497],[1878,1497],[1878,1549],[288,1549]],"region":{"top_left_x":287,"top_left_y":1497,"width":1591,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ece0883642b446529160006c4dea1d5e","type":"text","conversion_output":true,"text":"for the four product types for the CAPS extension registration dossier. Bioavailabilities and","text_display":" for the four product types for the CAPS extension registration dossier. Bioavailabilities and","confidence":1,"confidence_rate":1},{"cnt":[[288,1543],[1876,1543],[1876,1594],[288,1594]],"region":{"top_left_x":287,"top_left_y":1542,"width":1589,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc2571561ab3419ebae41d75500d9e97","type":"text","conversion_output":true,"text":"absorption rate constants of the product types were similar, ranging from 63 to \\(76 \\%\\) and 0.28","text_display":" absorption rate constants of the product types were similar, ranging from 63 to \\(76 \\%\\) and 0.28","confidence":0.9970703125,"confidence_rate":0.9999712358310027},{"cnt":[[288,1590],[1878,1590],[1878,1644],[288,1644]],"region":{"top_left_x":287,"top_left_y":1589,"width":1591,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb74ae0e970b46e98aed7db54a47e742","type":"text","conversion_output":true,"text":"to 0.38 day \\(^{-1}\\), respectively. The bioavailability assessments of product types C and D (marketed","text_display":" to 0.38 day \\(^{-1}\\), respectively. The bioavailability assessments of product types C and D (marketed","confidence":0.9892932940410901,"confidence_rate":0.9999064005966568},{"cnt":[[288,1641],[1878,1641],[1878,1691],[288,1691]],"region":{"top_left_x":287,"top_left_y":1641,"width":1591,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f417b29e02ea4045b149886cabe9c95c","type":"text","conversion_output":true,"text":"product) were \\(76 \\%\\) and \\(66 \\%\\), respectively. Based on the relative bioavailability of D/C of 0.87","text_display":" product) were \\(76 \\%\\) and \\(66 \\%\\), respectively. Based on the relative bioavailability of D/C of 0.87","confidence":0.98974609375,"confidence_rate":0.999900900682706},{"cnt":[[288,1689],[1880,1689],[1880,1740],[288,1740]],"region":{"top_left_x":287,"top_left_y":1688,"width":1593,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de8647c2c3234488b89008981ddaf495","type":"text","conversion_output":true,"text":"\\(\\pm 0.11\\) (mean ± SEM), it was concluded that there was no apparent difference in the two product","text_display":" \\(\\pm 0.11\\) (mean ± SEM), it was concluded that there was no apparent difference in the two product","confidence":0.9936552047729492,"confidence_rate":0.9999343835035049},{"cnt":[[288,1738],[1878,1738],[1878,1790],[288,1790]],"region":{"top_left_x":287,"top_left_y":1738,"width":1591,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"883400cba05340f9a7e98753c4bd390d","type":"text","conversion_output":true,"text":"types. Two different formulations of canakinumab have been administered during its","text_display":" types. Two different formulations of canakinumab have been administered during its","confidence":1,"confidence_rate":1},{"cnt":[[288,1783],[1880,1783],[1880,1837],[288,1837]],"region":{"top_left_x":287,"top_left_y":1783,"width":1593,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99a12f43e5334c7ab5e1ae2f575efdcc","type":"text","conversion_output":true,"text":"development: a lyophilized powder form and a solution for injection formulation. A","text_display":" development: a lyophilized powder form and a solution for injection formulation. A","confidence":0.99853515625,"confidence_rate":0.9999831505134198},{"cnt":[[288,1833],[1880,1833],[1880,1884],[288,1884]],"region":{"top_left_x":287,"top_left_y":1832,"width":1593,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe763acb658a4871ba0c43fcb6d88cb3","type":"text","conversion_output":true,"text":"bioequivalence study, CACZ885A2104, demonstrated the bioequivalence of the lyophilized","text_display":" bioequivalence study, CACZ885A2104, demonstrated the bioequivalence of the lyophilized","confidence":1,"confidence_rate":1},{"cnt":[[288,1882],[1880,1882],[1880,1931],[288,1931]],"region":{"top_left_x":287,"top_left_y":1882,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b40f34918d444267be325ea8cca83e16","type":"text","conversion_output":true,"text":"form of canakinumab and the canakinumab solution for injection in a pre-filled syringe, one of","text_display":" form of canakinumab and the canakinumab solution for injection in a pre-filled syringe, one of","confidence":1,"confidence_rate":1},{"cnt":[[288,1929],[1878,1929],[1878,1979],[288,1979]],"region":{"top_left_x":287,"top_left_y":1929,"width":1591,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac22bbdd6ad49e18c79468f640f98c0","type":"text","conversion_output":true,"text":"the presentations of the liquid formulation. Other presentations of the liquid formulation include","text_display":" the presentations of the liquid formulation. Other presentations of the liquid formulation include","confidence":1,"confidence_rate":1},{"cnt":[[288,1977],[1876,1977],[1876,2026],[288,2026]],"region":{"top_left_x":287,"top_left_y":1976,"width":1589,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f29125da3eb1426fa5a0564d4618e637","type":"text","conversion_output":true,"text":"an auto-injector and the liquid in a vial. Study CACZ885M2101 demonstrated bioequivalence","text_display":" an auto-injector and the liquid in a vial. Study CACZ885M2101 demonstrated bioequivalence","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[288,2024],[1878,2024],[1878,2073],[288,2073]],"region":{"top_left_x":287,"top_left_y":2023,"width":1591,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e4c0365bb5e45bb8861e48644662e54","type":"text","conversion_output":true,"text":"of canakinumab in a liquid formulation administered via auto-injector or pre-filled syringe. No","text_display":" of canakinumab in a liquid formulation administered via auto-injector or pre-filled syringe. No","confidence":1,"confidence_rate":1},{"cnt":[[288,2071],[1880,2071],[1880,2123],[288,2123]],"region":{"top_left_x":287,"top_left_y":2071,"width":1593,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b215ddea81042fd80442ef81acf418f","type":"text","conversion_output":true,"text":"difference in bioavailability of the solution in a vial compared to powder for solution for","text_display":" difference in bioavailability of the solution in a vial compared to powder for solution for","confidence":1,"confidence_rate":1},{"cnt":[[288,2118],[1833,2118],[1833,2172],[288,2172]],"region":{"top_left_x":287,"top_left_y":2118,"width":1546,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9991f8aba9841869be37505542e1f66","type":"text","conversion_output":true,"text":"injection was detected in a population PK analysis of PK data from Study CACZ885N2301.","text_display":" injection was detected in a population PK analysis of PK data from Study CACZ885N2301.","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1878,2191],[1878,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2191,"width":1591,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a4667cab3054b4f87a74e66ba145095","type":"text","conversion_output":true,"text":"The peak serum canakinumab concentration ( \\(C _{\\max }\\) ) occurred approximately 7 days following","text_display":"\n\nThe peak serum canakinumab concentration ( \\(C _{\\max }\\) ) occurred approximately 7 days following","confidence":0.7104278176668686,"confidence_rate":0.9969790154793168},{"cnt":[[288,2239],[1878,2239],[1878,2288],[288,2288]],"region":{"top_left_x":287,"top_left_y":2238,"width":1591,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0875905b0db74750bb0b6a29ba197db3","type":"text","conversion_output":true,"text":"single s.c. administration of 150 mg in adult CAPS subjects. Based on a population PK analysis","text_display":" single s.c. administration of 150 mg in adult CAPS subjects. Based on a population PK analysis","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[288,2286],[1880,2286],[1880,2335],[288,2335]],"region":{"top_left_x":287,"top_left_y":2285,"width":1593,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"884f184c634c40768a0b3500dd84b141","type":"text","conversion_output":true,"text":"in the CAPS population including children from 2 years of age, the absolute bioavailability of","text_display":" in the CAPS population including children from 2 years of age, the absolute bioavailability of","confidence":1,"confidence_rate":1},{"cnt":[[288,2333],[1878,2333],[1878,2383],[288,2383]],"region":{"top_left_x":287,"top_left_y":2333,"width":1591,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35aecb56462e476b8379d081bba61875","type":"text","conversion_output":true,"text":"s.c. administration of canakinumab was estimated to be \\(66 \\%\\). Exposure parameters (such as","text_display":" s.c. administration of canakinumab was estimated to be \\(66 \\%\\). Exposure parameters (such as","confidence":0.9897551536560059,"confidence_rate":0.9998938439238065},{"cnt":[[288,2380],[1880,2380],[1880,2432],[288,2432]],"region":{"top_left_x":287,"top_left_y":2380,"width":1593,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"159eb5dee9964da7945991aa09e194f7","type":"text","conversion_output":true,"text":"AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to \\(10.0 mg / kg\\) given","text_display":" AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to \\(10.0 mg / kg\\) given","confidence":0.794647216796875,"confidence_rate":0.9978934419577132},{"cnt":[[288,2428],[1210,2428],[1210,2481],[288,2481]],"region":{"top_left_x":287,"top_left_y":2427,"width":923,"height":55},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be68dccc3014afba0a7872aa252d42a","type":"text","conversion_output":true,"text":"as i.v. infusion or from 150 to 600 mg as s.c. injection.","text_display":" as i.v. infusion or from 150 to 600 mg as s.c. injection.","confidence":0.99951171875,"confidence_rate":0.9999930228743673}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-038","page":38,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f90e6384bdb4c25a4a66032ab398790","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f4cd54549074d319befbea816ce004e","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e22263fbe7145a2acc9b63a905476b4","type":"page_info","conversion_output":false,"text":"Page 38 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f777aff81ffd4d2ca6e9f7a47790816b","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7752995208b94edc882a0e854361ba16","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fd23753a3864867bc65349c29129c44","type":"text","conversion_output":true,"text":"The serum clearance (CL) and volume of distribution of canakinumab varied according to body","text_display":"\n\nThe serum clearance (CL) and volume of distribution of canakinumab varied according to body","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1878,391],[1878,443],[288,443]],"region":{"top_left_x":287,"top_left_y":391,"width":1591,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"050793a2bbf64c71b9d89b6312cbb75b","type":"text","conversion_output":true,"text":"weight ( 6.01 L and \\(0.174 L /\\) day in a typical CAPS subject weighting 70 kg ). The mean terminal","text_display":" weight ( 6.01 L and \\(0.174 L /\\) day in a typical CAPS subject weighting 70 kg ). The mean terminal","confidence":0.7890800580207724,"confidence_rate":0.9979422288541394},{"cnt":[[288,440],[1878,440],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1591,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ef73574fd8e4f35aac2bd846fd18eba","type":"text","conversion_output":true,"text":"half-life was 26 days. After accounting for body weight differences, no clinically significant","text_display":" half-life was 26 days. After accounting for body weight differences, no clinically significant","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[1876,490],[1876,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1589,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89943844ce9d4f53b7517a6b334da924","type":"text","conversion_output":true,"text":"differences in the PK properties of canakinumab were observed between CAPS, TRAPS,","text_display":" differences in the PK properties of canakinumab were observed between CAPS, TRAPS,","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1878,537],[1878,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1591,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05d584cdfa4b4bb3bf98564be4533670","type":"text","conversion_output":true,"text":"HIDS/MKD, FMF, SJIA and gouty arthritis subjects. There was no indication of accelerated","text_display":" HIDS/MKD, FMF, SJIA and gouty arthritis subjects. There was no indication of accelerated","confidence":1,"confidence_rate":1},{"cnt":[[288,584],[1878,584],[1878,638],[288,638]],"region":{"top_left_x":287,"top_left_y":584,"width":1591,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7429cc7a761145f38ccb6700d0450e48","type":"text","conversion_output":true,"text":"clearance or time-dependent change in the PK properties of canakinumab following repeated","text_display":" clearance or time-dependent change in the PK properties of canakinumab following repeated","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[552,632],[552,679],[288,679]],"region":{"top_left_x":287,"top_left_y":631,"width":266,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dba321dcecec4fae9c72abf8e663e1da","type":"text","conversion_output":true,"text":"administration.","text_display":" administration.","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1878,700],[1878,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1591,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4356fa25efd43e29dcdab2abe147df9","type":"text","conversion_output":true,"text":"Canakinumab binds to human IL-1 \\(\\beta\\), and blocks the interaction of this cytokine with its","text_display":"\n\nCanakinumab binds to human IL-1 \\(\\beta\\), and blocks the interaction of this cytokine with its","confidence":0.931706428527832,"confidence_rate":0.9992634223985795},{"cnt":[[288,748],[1882,748],[1882,801],[288,801]],"region":{"top_left_x":287,"top_left_y":747,"width":1596,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"574acb6bce094c23b5a7c46624cba6a3","type":"text","conversion_output":true,"text":"receptors, thereby functionally neutralizing its bioactivity. The resulting complex of","text_display":" receptors, thereby functionally neutralizing its bioactivity. The resulting complex of","confidence":1,"confidence_rate":1},{"cnt":[[288,795],[1880,795],[1880,849],[288,849]],"region":{"top_left_x":287,"top_left_y":794,"width":1593,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e0ec1aef8134444a6e37e89f4b032ba","type":"text","conversion_output":true,"text":"canakinumab and IL- \\(1 \\beta\\) is eliminated at a much slower rate than the free IL- \\(1 \\beta\\), resulting in","text_display":" canakinumab and IL- \\(1 \\beta\\) is eliminated at a much slower rate than the free IL- \\(1 \\beta\\), resulting in","confidence":0.9076901949742013,"confidence_rate":0.9990780238189502},{"cnt":[[288,846],[1876,846],[1876,896],[288,896]],"region":{"top_left_x":287,"top_left_y":846,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f08fbaba3ec4cfb860b1ad0662e430b","type":"text","conversion_output":true,"text":"elevation of total IL-1β (free plus complex) following canakinumab administration. Thus,","text_display":" elevation of total IL-1β (free plus complex) following canakinumab administration. Thus,","confidence":0.5442523956298828,"confidence_rate":0.993480034086723},{"cnt":[[288,889],[1880,889],[1880,943],[288,943]],"region":{"top_left_x":287,"top_left_y":889,"width":1593,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd8c2d08f70c413c8db4d8e34a8dcde4","type":"text","conversion_output":true,"text":"measurement of free plus complexed IL-1 \\(\\beta\\), i.e. total IL-1 \\(\\beta\\), is a relevant PD biomarker for","text_display":" measurement of free plus complexed IL-1 \\(\\beta\\), i.e. total IL-1 \\(\\beta\\), is a relevant PD biomarker for","confidence":0.5262343798276561,"confidence_rate":0.99390428730949},{"cnt":[[288,941],[1878,941],[1878,993],[288,993]],"region":{"top_left_x":287,"top_left_y":941,"width":1591,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7807ece84b44ac7af4e03069873e948","type":"text","conversion_output":true,"text":"canakinumab indicative of binding of IL- \\(1 \\beta\\) by the antibody. An increase in total IL- \\(1 \\beta\\) was","text_display":" canakinumab indicative of binding of IL- \\(1 \\beta\\) by the antibody. An increase in total IL- \\(1 \\beta\\) was","confidence":0.5303764343261719,"confidence_rate":0.9938619418152543},{"cnt":[[288,988],[1876,988],[1876,1042],[288,1042]],"region":{"top_left_x":287,"top_left_y":988,"width":1589,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4ef5d71c2c344e79d51386f026ab413","type":"text","conversion_output":true,"text":"observed in both healthy subjects as well as subject populations, after canakinumab dosing.","text_display":" observed in both healthy subjects as well as subject populations, after canakinumab dosing.","confidence":1,"confidence_rate":1},{"cnt":[[288,1036],[1878,1036],[1878,1089],[288,1089]],"region":{"top_left_x":287,"top_left_y":1035,"width":1591,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22143802d165447ca014756b98b272ba","type":"text","conversion_output":true,"text":"Canakinumab treatment was associated with a decrease of IL-1 \\(\\beta\\)-induced downstream","text_display":" Canakinumab treatment was associated with a decrease of IL-1 \\(\\beta\\)-induced downstream","confidence":0.8624394773505628,"confidence_rate":0.9983570144728324},{"cnt":[[288,1085],[1878,1085],[1878,1137],[288,1137]],"region":{"top_left_x":287,"top_left_y":1084,"width":1591,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b606a4043da4dd3977f7fc51f71f9b5","type":"text","conversion_output":true,"text":"mediators including IL-1 \\(\\beta\\) itself, IL-1 \\(\\beta\\) pathway related genes, acute phase proteins such as","text_display":" mediators including IL-1 \\(\\beta\\) itself, IL-1 \\(\\beta\\) pathway related genes, acute phase proteins such as","confidence":0.8025169372558594,"confidence_rate":0.9978868289868283},{"cnt":[[288,1130],[1880,1130],[1880,1184],[288,1184]],"region":{"top_left_x":287,"top_left_y":1130,"width":1593,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a630e4d8bfdc4950ae5f07ed4e4b38ad","type":"text","conversion_output":true,"text":"serum amyloid (SAA) and C-reactive protein (CRP). This adds to the evidence that","text_display":" serum amyloid (SAA) and C-reactive protein (CRP). This adds to the evidence that","confidence":1,"confidence_rate":1},{"cnt":[[288,1179],[1790,1179],[1790,1233],[288,1233]],"region":{"top_left_x":287,"top_left_y":1179,"width":1503,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2433aaf99f764b7683dd0eb8e3267f57","type":"text","conversion_output":true,"text":"canakinumab neutralizes the activity and down-regulates the production of IL-1 \\(\\beta\\) in vivo.","text_display":" canakinumab neutralizes the activity and down-regulates the production of IL-1 \\(\\beta\\) in vivo.","confidence":0.8475933902586803,"confidence_rate":0.9982967691488249},{"cnt":[[288,1248],[1880,1248],[1880,1300],[288,1300]],"region":{"top_left_x":287,"top_left_y":1248,"width":1593,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"438dfb7c12c3440d9bbaa92711ab7001","type":"text","conversion_output":true,"text":"Overall, the immunogenicity profile of canakinumab is entirely consistent across all disease","text_display":"\nOverall, the immunogenicity profile of canakinumab is entirely consistent across all disease","confidence":1,"confidence_rate":1},{"cnt":[[288,1298],[1880,1298],[1880,1347],[288,1347]],"region":{"top_left_x":287,"top_left_y":1297,"width":1593,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6dd33ed60774ad8be168989206f5928","type":"text","conversion_output":true,"text":"areas. The incidence of treatment-emergent anti-drug antibodies (ADAs) remains very low, in","text_display":" areas. The incidence of treatment-emergent anti-drug antibodies (ADAs) remains very low, in","confidence":1,"confidence_rate":1},{"cnt":[[288,1345],[1876,1345],[1876,1396],[288,1396]],"region":{"top_left_x":287,"top_left_y":1344,"width":1589,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"450884c5b3e44e008903c84db6cd855e","type":"text","conversion_output":true,"text":"the range of \\(0.5 \\%\\) to \\(2.9 \\%\\) and no clinical consequences to these detected antibodies are evident.","text_display":" the range of \\(0.5 \\%\\) to \\(2.9 \\%\\) and no clinical consequences to these detected antibodies are evident.","confidence":1,"confidence_rate":1},{"cnt":[[288,1392],[1437,1392],[1437,1446],[288,1446]],"region":{"top_left_x":287,"top_left_y":1392,"width":1151,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69f487dbf29d4ae08ddc44ff1272874e","type":"text","conversion_output":true,"text":"No neutralizing antibodies were detected post-baseline in any study.","text_display":" No neutralizing antibodies were detected post-baseline in any study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1461],[1592,1461],[1592,1515],[288,1515]],"region":{"top_left_x":287,"top_left_y":1460,"width":1305,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2c701b88d464e0685a840d5c1cc6fd2","type":"text","conversion_output":true,"text":"For further details, please refer to the [canakinumab Investigator's Brochure].","text_display":"\nFor further details, please refer to the [canakinumab Investigator's Brochure].","confidence":1,"confidence_rate":1},{"cnt":[[286,1568],[698,1568],[698,1629],[286,1629]],"region":{"top_left_x":285,"top_left_y":1568,"width":414,"height":61},"line":29,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"e0a4adf9c075495db7173be533d21314","type":"section_header","conversion_output":false,"children_ids":["b0f852422a154ed2bfaafd859835e3ea"],"text":"","text_display":""},{"cnt":[[288,1573],[694,1573],[694,1622],[288,1622]],"region":{"top_left_x":287,"top_left_y":1572,"width":407,"height":51},"line":30,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"b0f852422a154ed2bfaafd859835e3ea","type":"text","conversion_output":true,"parent_id":"e0a4adf9c075495db7173be533d21314","text":"2 Rationale","text_display":"\n\n\\section*{2 Rationale}","confidence":0.9985356330871582,"confidence_rate":0.9999023087623707},{"cnt":[[284,1663],[1089,1663],[1089,1729],[284,1729]],"region":{"top_left_x":283,"top_left_y":1662,"width":807,"height":68},"line":31,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"b11e0b8453c749a79aa7a3caed11b29b","type":"section_header","conversion_output":false,"children_ids":["70f1ade516694c1dbea0a09253fe85f1"],"text":"","text_display":""},{"cnt":[[288,1669],[1085,1669],[1085,1725],[288,1725]],"region":{"top_left_x":287,"top_left_y":1669,"width":798,"height":57},"line":32,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"70f1ade516694c1dbea0a09253fe85f1","type":"text","conversion_output":true,"parent_id":"b11e0b8453c749a79aa7a3caed11b29b","text":"2.1 Study rationale and purpose","text_display":"\n\n\\subsection*{2.1 Study rationale and purpose}","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[288,1740],[1878,1740],[1878,1794],[288,1794]],"region":{"top_left_x":287,"top_left_y":1740,"width":1591,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abc84ccdb38242819ed05ea7d287f7b4","type":"text","conversion_output":true,"text":"As described in Section 1.2, inflammation (as measured through hs-CRP levels for example)","text_display":"\n\nAs described in Section 1.2, inflammation (as measured through hs-CRP levels for example)","confidence":1,"confidence_rate":1},{"cnt":[[288,1790],[1880,1790],[1880,1841],[288,1841]],"region":{"top_left_x":287,"top_left_y":1789,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfad79be32a8430a9fd92b250aadd345","type":"text","conversion_output":true,"text":"plays an important role in the development of lung cancer. Prior publications examining hs-","text_display":" plays an important role in the development of lung cancer. Prior publications examining hs","confidence":1,"confidence_rate":1},{"cnt":[[288,1835],[1880,1835],[1880,1888],[288,1888]],"region":{"top_left_x":287,"top_left_y":1834,"width":1593,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a24f1603e4044f6485f934fb0a20ae5f","type":"text","conversion_output":true,"text":"CRP levels in Stage I through Stage III NSCLC subjects show that higher stage is correlated","text_display":"CRP levels in Stage I through Stage III NSCLC subjects show that higher stage is correlated","confidence":1,"confidence_rate":1},{"cnt":[[288,1886],[1878,1886],[1878,1936],[288,1936]],"region":{"top_left_x":287,"top_left_y":1886,"width":1591,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb0b478673eb46f699547d400e57bcca","type":"text","conversion_output":true,"text":"with higher hs-CRP levels and poorer prognosis (Alifano et al 2011, Hara et al 2010,","text_display":" with higher hs-CRP levels and poorer prognosis (Alifano et al 2011, Hara et al 2010,","confidence":1,"confidence_rate":1},{"cnt":[[288,1934],[1878,1934],[1878,1985],[288,1985]],"region":{"top_left_x":287,"top_left_y":1933,"width":1591,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59c02622125548109b07d0f8aff7d29b","type":"text","conversion_output":true,"text":"Vaguliene et al 2011). The cytokine interleukin- \\(1 \\beta\\) ( \\(IL -1 \\beta\\) ) is thought to be one of the mediators","text_display":" Vaguliene et al 2011). The cytokine interleukin- \\(1 \\beta\\) ( \\(IL -1 \\beta\\) ) is thought to be one of the mediators","confidence":0.9350732455376939,"confidence_rate":0.9994061019557232},{"cnt":[[288,1981],[1878,1981],[1878,2035],[288,2035]],"region":{"top_left_x":287,"top_left_y":1980,"width":1591,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d63290cdcbd84b25858fec874f5e857e","type":"text","conversion_output":true,"text":"of pulmonary inflammation that promotes lung cancer and is critical in multiple steps of the","text_display":" of pulmonary inflammation that promotes lung cancer and is critical in multiple steps of the","confidence":1,"confidence_rate":1},{"cnt":[[288,2030],[1878,2030],[1878,2082],[288,2082]],"region":{"top_left_x":287,"top_left_y":2030,"width":1591,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc0e79a9dc814d13beaed8ffe3a2a5b6","type":"text","conversion_output":true,"text":"carcinogenesis process. Canakinumab is a high-affinity human anti-interleukin-1 \\(\\beta\\) (IL-1 \\(\\beta\\) )","text_display":" carcinogenesis process. Canakinumab is a high-affinity human anti-interleukin-1 \\(\\beta\\) (IL-1 \\(\\beta\\) )","confidence":0.67529296875,"confidence_rate":0.9961582938513964},{"cnt":[[288,2080],[1876,2080],[1876,2129],[288,2129]],"region":{"top_left_x":287,"top_left_y":2079,"width":1589,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e9b3d95919442c8ef4d50f5b3e8e16","type":"text","conversion_output":true,"text":"monoclonal antibody approved for the treatment of subjects with various IL- \\(1 \\beta\\) driven auto-","text_display":" monoclonal antibody approved for the treatment of subjects with various IL- \\(1 \\beta\\) driven auto","confidence":0.73095703125,"confidence_rate":0.9968393427829273},{"cnt":[[288,2127],[1878,2127],[1878,2176],[288,2176]],"region":{"top_left_x":287,"top_left_y":2126,"width":1591,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08a295d9dd5549f985d50a9fc8cc21a8","type":"text","conversion_output":true,"text":"inflammatory diseases. Results from the CANTOS study indicated that canakinumab was","text_display":"inflammatory diseases. Results from the CANTOS study indicated that canakinumab was","confidence":1,"confidence_rate":1},{"cnt":[[288,2174],[1880,2174],[1880,2224],[288,2224]],"region":{"top_left_x":287,"top_left_y":2174,"width":1593,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30fac4f202444c26976da4aa4fe1fa2d","type":"text","conversion_output":true,"text":"associated with dose-dependent reductions in the risks of lung cancer occurrence and lung","text_display":" associated with dose-dependent reductions in the risks of lung cancer occurrence and lung","confidence":1,"confidence_rate":1},{"cnt":[[288,2221],[1880,2221],[1880,2271],[288,2271]],"region":{"top_left_x":287,"top_left_y":2221,"width":1593,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2568f180434d4a6392feab965bba79ce","type":"text","conversion_output":true,"text":"cancer mortality among study participants (Ridker 2017b). The maximal reduction in lung","text_display":" cancer mortality among study participants (Ridker 2017b). The maximal reduction in lung","confidence":1,"confidence_rate":1},{"cnt":[[288,2269],[1878,2269],[1878,2322],[288,2322]],"region":{"top_left_x":287,"top_left_y":2268,"width":1591,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aa5d334ca0a4542a9dde77709feb705","type":"text","conversion_output":true,"text":"cancer occurrence and mortality was seen in subjects who received 300 mg s.c. every 3 months","text_display":" cancer occurrence and mortality was seen in subjects who received 300 mg s.c. every 3 months","confidence":0.9873106479644775,"confidence_rate":0.9998783831150782},{"cnt":[[288,2316],[651,2316],[651,2370],[288,2370]],"region":{"top_left_x":287,"top_left_y":2316,"width":364,"height":54},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bfc837814a146d589290e85046a5977","type":"text","conversion_output":true,"text":"(highest dose group).","text_display":" (highest dose group).","confidence":1,"confidence_rate":1},{"cnt":[[288,2385],[1882,2385],[1882,2436],[288,2436]],"region":{"top_left_x":287,"top_left_y":2384,"width":1596,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dd8b38f1a73450a85fea134e13e54b4","type":"text","conversion_output":true,"text":"CANTOS (Study CACZ885M2301) is a double-blind, placebo-controlled, Phase-III trial of","text_display":"\nCANTOS (Study CACZ885M2301) is a double-blind, placebo-controlled, Phase-III trial of","confidence":1,"confidence_rate":1},{"cnt":[[288,2432],[1880,2432],[1880,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":2432,"width":1593,"height":54},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87364b6ed02248378e846d03e8cf0f55","type":"text","conversion_output":true,"text":"10,061 randomized subjects who were in stable condition after a prior myocardial infarction","text_display":" 10,061 randomized subjects who were in stable condition after a prior myocardial infarction","confidence":1,"confidence_rate":1},{"cnt":[[288,2481],[1880,2481],[1880,2533],[288,2533]],"region":{"top_left_x":287,"top_left_y":2481,"width":1593,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f916578f90bf4fdeaeb095d6ed31838d","type":"text","conversion_output":true,"text":"(MI). It was designed to evaluate the efficacy, safety, and tolerability of canakinumab in","text_display":" (MI). It was designed to evaluate the efficacy, safety, and tolerability of canakinumab in","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-039","page":39,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d038c4ca3e4341d1a1b287dca96df24c","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc3f6eb4aa28426eb8f485ee6aeeb8dd","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68aab1cdcfeb4591bb3973245ab0381e","type":"page_info","conversion_output":false,"text":"Page 39 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adac9b310b15447fb08d2e87e17cce57","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,249],[1871,249],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":249,"width":457,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe1f4a5fcd404e93886c969470a1901e","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"489bb74280e94b0aa1136ba3e1538781","type":"text","conversion_output":true,"text":"combination with standard of care in the prevention of recurrent cardiovascular (CV) events in","text_display":"\ncombination with standard of care in the prevention of recurrent cardiovascular (CV) events in","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1878,391],[1878,443],[288,443]],"region":{"top_left_x":287,"top_left_y":391,"width":1591,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad353ec83a5f4211aa7c7fccaf64bfee","type":"text","conversion_output":true,"text":"subjects with inflammatory atherosclerosis, as defined by the presence of hs-CRP, a known","text_display":" subjects with inflammatory atherosclerosis, as defined by the presence of hs-CRP, a known","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1878,440],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1591,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"564734fc96284b00bf5acea15b53c59f","type":"text","conversion_output":true,"text":"marker of inflammation, at levels of \\(\\geq 2 mg / L\\). Subjects were ineligible if they had a pre-existing","text_display":" marker of inflammation, at levels of \\(\\geq 2 mg / L\\). Subjects were ineligible if they had a pre-existing","confidence":0.9975595474243164,"confidence_rate":0.9999779873113466},{"cnt":[[288,490],[1878,490],[1878,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"132902f027be440093a33156bf902203","type":"text","conversion_output":true,"text":"malignancy (other than basal cell skin carcinoma). Trial participants were randomized to","text_display":" malignancy (other than basal cell skin carcinoma). Trial participants were randomized to","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1878,537],[1878,589],[288,589]],"region":{"top_left_x":287,"top_left_y":537,"width":1591,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dd22bcffa0f4f6f9f9f314e2ab02bb8","type":"text","conversion_output":true,"text":"receive treatment with one of three doses of canakinumab ( \\(300 mg , 150 mg\\), or 50 mg ) or","text_display":" receive treatment with one of three doses of canakinumab ( \\(300 mg , 150 mg\\), or 50 mg ) or","confidence":0.99853515625,"confidence_rate":0.9999860389766703},{"cnt":[[288,584],[1880,584],[1880,638],[288,638]],"region":{"top_left_x":287,"top_left_y":584,"width":1593,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d3146861c484ca3a158da1d7adc8f08","type":"text","conversion_output":true,"text":"placebo administered subcutaneously every 3 months. Treatment was to be administered for a","text_display":" placebo administered subcutaneously every 3 months. Treatment was to be administered for a","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1882,632],[1882,685],[288,685]],"region":{"top_left_x":287,"top_left_y":631,"width":1596,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c40f3ccf4e54412b6bf1a2463a84f7c","type":"text","conversion_output":true,"text":"period of 6 years but was to be discontinued if any malignancy developed. The median age of","text_display":" period of 6 years but was to be discontinued if any malignancy developed. The median age of","confidence":1,"confidence_rate":1},{"cnt":[[288,681],[1878,681],[1878,733],[288,733]],"region":{"top_left_x":287,"top_left_y":681,"width":1591,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdc4f4e0b6da42c89c95b4f7d65b1ecf","type":"text","conversion_output":true,"text":"subjects enrolled in CANTOS was 61.1 years, \\(25.7 \\%\\) of the subjects were female, and the \\(23.5 \\%\\)","text_display":" subjects enrolled in CANTOS was 61.1 years, \\(25.7 \\%\\) of the subjects were female, and the \\(23.5 \\%\\)","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[288,728],[1876,728],[1876,780],[288,780]],"region":{"top_left_x":287,"top_left_y":728,"width":1589,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a76bec35145d4f4887c4727e23dc16ba","type":"text","conversion_output":true,"text":"of subjects were current smokers with an additional \\(47.3 \\%\\) of subjects were former smokers.","text_display":" of subjects were current smokers with an additional \\(47.3 \\%\\) of subjects were former smokers.","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,778],[1876,778],[1876,827],[288,827]],"region":{"top_left_x":287,"top_left_y":777,"width":1589,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3992327bba6648699d0ffc32b1b370b6","type":"text","conversion_output":true,"text":"All subjects had a hs-CRP greater than \\(2 mg / L\\) at entry and the median hs-CRP at entry was 4.2","text_display":" All subjects had a hs-CRP greater than \\(2 mg / L\\) at entry and the median hs-CRP at entry was 4.2","confidence":0.998046875,"confidence_rate":0.9999813807939509},{"cnt":[[288,825],[1876,825],[1876,874],[288,874]],"region":{"top_left_x":287,"top_left_y":825,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94464e6de8ba41eea1132058eb43e97a","type":"text","conversion_output":true,"text":"\\(mg / L\\) for all subjects enrolled. The median hs-CRP at entry in CANTOS subjects who were","text_display":" \\(mg / L\\) for all subjects enrolled. The median hs-CRP at entry in CANTOS subjects who were","confidence":1,"confidence_rate":1},{"cnt":[[288,872],[1147,872],[1147,922],[288,922]],"region":{"top_left_x":287,"top_left_y":872,"width":861,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"474ffcfe6dd14d1f8c11829b47226cc1","type":"text","conversion_output":true,"text":"subsequently diagnosed with cancer was \\(6.0 mg / L\\).","text_display":" subsequently diagnosed with cancer was \\(6.0 mg / L\\).","confidence":1,"confidence_rate":1},{"cnt":[[288,941],[1876,941],[1876,990],[288,990]],"region":{"top_left_x":287,"top_left_y":941,"width":1589,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"967f428c56b04f0c8968543a70aff004","type":"text","conversion_output":true,"text":"Data on cancer occurrence, as reported by the investigator, were collected as adverse events","text_display":"\n\nData on cancer occurrence, as reported by the investigator, were collected as adverse events","confidence":1,"confidence_rate":1},{"cnt":[[288,988],[1878,988],[1878,1042],[288,1042]],"region":{"top_left_x":287,"top_left_y":988,"width":1591,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dc81d986f7b40e3823978e453d186b7","type":"text","conversion_output":true,"text":"(AEs) and serious adverse events (SAEs). These events were adjudicated by an 8 -member panel","text_display":" (AEs) and serious adverse events (SAEs). These events were adjudicated by an 8 -member panel","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1038],[1878,1038],[1878,1089],[288,1089]],"region":{"top_left_x":287,"top_left_y":1037,"width":1591,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1b99acbf05740c2b76b8749d5a066fb","type":"text","conversion_output":true,"text":"of external oncologists (the Malignancy Adjudication Committee (MAC)) blinded to treatment","text_display":" of external oncologists (the Malignancy Adjudication Committee (MAC)) blinded to treatment","confidence":1,"confidence_rate":1},{"cnt":[[288,1087],[1876,1087],[1876,1137],[288,1137]],"region":{"top_left_x":287,"top_left_y":1087,"width":1589,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e1b9da7d47046d08c3ef12b45f5beda","type":"text","conversion_output":true,"text":"allocation. All malignancies that coded to a Medical Dictionary for Regulatory Activities","text_display":" allocation. All malignancies that coded to a Medical Dictionary for Regulatory Activities","confidence":1,"confidence_rate":1},{"cnt":[[288,1130],[1878,1130],[1878,1184],[288,1184]],"region":{"top_left_x":287,"top_left_y":1130,"width":1591,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95d43b23b8ba45409f363d7316e2cb99","type":"text","conversion_output":true,"text":"(MedDRA (version 20.0)) preferred term (PT) of 'malignant or unspecified tumors' were","text_display":" (MedDRA (version 20.0)) preferred term (PT) of 'malignant or unspecified tumors' were","confidence":1,"confidence_rate":1},{"cnt":[[288,1182],[1878,1182],[1878,1231],[288,1231]],"region":{"top_left_x":287,"top_left_y":1181,"width":1591,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21ae5aded69f476cab2026681aff3376","type":"text","conversion_output":true,"text":"forwarded to the MAC for assessment; the remit of the MAC was to categorize and evaluate","text_display":" forwarded to the MAC for assessment; the remit of the MAC was to categorize and evaluate","confidence":1,"confidence_rate":1},{"cnt":[[288,1229],[1878,1229],[1878,1280],[288,1280]],"region":{"top_left_x":287,"top_left_y":1228,"width":1591,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"868762c24af94698b7caeb730ecc0cc6","type":"text","conversion_output":true,"text":"whether investigator-reported malignancy AEs and SAEs occurred (or not). Any fatalities","text_display":" whether investigator-reported malignancy AEs and SAEs occurred (or not). Any fatalities","confidence":1,"confidence_rate":1},{"cnt":[[288,1276],[1878,1276],[1878,1326],[288,1326]],"region":{"top_left_x":287,"top_left_y":1276,"width":1591,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75bbd90fcba54088948f222efd77ce38","type":"text","conversion_output":true,"text":"occurring during the trial were reviewed and categorized by the Clinical Endpoint Committee","text_display":" occurring during the trial were reviewed and categorized by the Clinical Endpoint Committee","confidence":1,"confidence_rate":1},{"cnt":[[288,1323],[1876,1323],[1876,1377],[288,1377]],"region":{"top_left_x":287,"top_left_y":1323,"width":1589,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a0cb15d919147a6b6863ab0055a52be","type":"text","conversion_output":true,"text":"(CEC) for cause(s) of death. Deaths were adjudicated to be one of three major subtypes: (1) CV;","text_display":" (CEC) for cause(s) of death. Deaths were adjudicated to be one of three major subtypes: (1) CV;","confidence":1,"confidence_rate":1},{"cnt":[[288,1371],[1880,1371],[1880,1424],[288,1424]],"region":{"top_left_x":287,"top_left_y":1370,"width":1593,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be0d324f97824722bc802234955d2709","type":"text","conversion_output":true,"text":"(2) non-CV; and (3) unknown (presumed CV). Use of both the MAC and CEC was predefined","text_display":" (2) non-CV; and (3) unknown (presumed CV). Use of both the MAC and CEC was predefined","confidence":0.9985356330871582,"confidence_rate":0.9999837174642737},{"cnt":[[288,1420],[651,1420],[651,1472],[288,1472]],"region":{"top_left_x":287,"top_left_y":1420,"width":364,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0d5c1f2f3c445b4a1b8fbd916edc05e","type":"text","conversion_output":true,"text":"in the study protocol.","text_display":" in the study protocol.","confidence":1,"confidence_rate":1},{"cnt":[[288,1489],[1876,1489],[1876,1540],[288,1540]],"region":{"top_left_x":287,"top_left_y":1488,"width":1589,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdb24eb6ff9949f6be1959bc3ac51b22","type":"text","conversion_output":true,"text":"Canakinumab treatment resulted in dose-dependent decreases in hs-CRP of 26-41\\% and IL-6","text_display":"\nCanakinumab treatment resulted in dose-dependent decreases in hs-CRP of 26-41\\% and IL-6","confidence":0.93603515625,"confidence_rate":0.9992817554186733},{"cnt":[[288,1538],[1876,1538],[1876,1588],[288,1588]],"region":{"top_left_x":287,"top_left_y":1538,"width":1589,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f83cb11d6444f17a783d6dac052c495","type":"text","conversion_output":true,"text":"decreases of \\(25-43 \\%\\) (Ridker 2017b). As shown in Table 2-1, lung cancer incidence was less","text_display":" decreases of \\(25-43 \\%\\) (Ridker 2017b). As shown in Table 2-1, lung cancer incidence was less","confidence":0.9560546875,"confidence_rate":0.9995368066569785},{"cnt":[[288,1586],[1876,1586],[1876,1635],[288,1635]],"region":{"top_left_x":287,"top_left_y":1585,"width":1589,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dd97c65f25e403db049debe01e6982b","type":"text","conversion_output":true,"text":"frequent in the 150 and 300 mg treated groups, with HR of \\(0.61(95 \\% CI 0.39-0.97)\\) and 0.33","text_display":" frequent in the 150 and 300 mg treated groups, with HR of \\(0.61(95 \\% CI 0.39-0.97)\\) and 0.33","confidence":0.7317385841855639,"confidence_rate":0.9970298296692612},{"cnt":[[288,1633],[1876,1633],[1876,1687],[288,1687]],"region":{"top_left_x":287,"top_left_y":1632,"width":1589,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90a6bf4d96ca466a9376ecf292de6eb2","type":"text","conversion_output":true,"text":"( \\(95 \\% CI 0.18-0.59\\) ), respectively (Ridker 2017b). Lung cancer mortality was significantly less","text_display":" ( \\(95 \\% CI 0.18-0.59\\) ), respectively (Ridker 2017b). Lung cancer mortality was significantly less","confidence":0.6188598761556086,"confidence_rate":0.9953964328637697},{"cnt":[[288,1680],[1878,1680],[1878,1734],[288,1734]],"region":{"top_left_x":287,"top_left_y":1680,"width":1591,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52480aa08189494ca87ebede07f6d834","type":"text","conversion_output":true,"text":"in the canakinumab 300 mg treated group ( \\(HR =0.23[95 \\% CI 0.10-0.54)]\\) and in the pooled","text_display":" in the canakinumab 300 mg treated group ( \\(HR =0.23[95 \\% CI 0.10-0.54)]\\) and in the pooled","confidence":0.5689819931844753,"confidence_rate":0.9945401392074802},{"cnt":[[288,1729],[1878,1729],[1878,1781],[288,1781]],"region":{"top_left_x":287,"top_left_y":1729,"width":1591,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bc9b489a3d34480bc275404f0c7f617","type":"text","conversion_output":true,"text":"canakinumab subjects (Ridker 2017b). Total cancer mortality was significantly lower in the","text_display":" canakinumab subjects (Ridker 2017b). Total cancer mortality was significantly lower in the","confidence":1,"confidence_rate":1},{"cnt":[[288,1779],[1880,1779],[1880,1828],[288,1828]],"region":{"top_left_x":287,"top_left_y":1778,"width":1593,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bdbde6502b244d8b1fef2b5ae819278","type":"text","conversion_output":true,"text":"pooled canakinumab groups versus the placebo group ( \\(p =0.0007\\) ), but only the 300 mg","text_display":" pooled canakinumab groups versus the placebo group ( \\(p =0.0007\\) ), but only the 300 mg","confidence":0.9990236759185791,"confidence_rate":0.999989825041388},{"cnt":[[288,1824],[1876,1824],[1876,1876],[288,1876]],"region":{"top_left_x":287,"top_left_y":1824,"width":1589,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e79de247942140d29078af68e5ab197c","type":"text","conversion_output":true,"text":"canakinumab group had statistically significant lowering ( \\(HR =0.49,95 \\% CI 0.31,0.75\\),","text_display":" canakinumab group had statistically significant lowering ( \\(HR =0.49,95 \\% CI 0.31,0.75\\),","confidence":0.5402587428311522,"confidence_rate":0.993672606910941},{"cnt":[[288,1873],[746,1873],[746,1927],[288,1927]],"region":{"top_left_x":287,"top_left_y":1873,"width":459,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4878bb7f75d1476fa5ae19adebcfa608","type":"text","conversion_output":true,"text":"\\(p =0.0009\\) ) (Ridker 2017b).","text_display":" \\(p =0.0009\\) ) (Ridker 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Event & Placebo \\(n =3344\\) & Can* 50 mg s.c. quarterly \\(n =2170\\) & Can 150 mg s.c. quarterly \\(n =2284\\) & Can 300 mg s.c. quarterly \\(n =2263\\) & All Doses Can \\(n =6717\\) & p value (trend across doses) \\\\\n\\hline Any Cancer & & & & & & \\\\\n\\hline Incidence rate(n) & 1.88 (231) & 1.85 (144) & 1.69 (143) & 1.72 (144) & 1.75 (431) & 0.31 \\\\\n\\hline HR (95\\% CI) & 1 (ref) & 0.99 (0.80-1.22) & 0.90 (0.73-1.11) & 0.91 (0.74-1.12) & 0.93 (0.79-1.09) & \\\\\n\\hline P & Ref & 0.91 & 0.31 & 0.38 & 0.38 & \\\\\n\\hline Any Cancer (fatal) & & & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2-1 Incidence rate per 100 subject years and hazard ratios for any cancer, fatal cancer, lung cancer and fatal lung cancer (Ridker 2017b)}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline Event & Placebo \\(n =3344\\) & Can* 50 mg s.c. quarterly \\(n =2170\\) & Can 150 mg s.c. quarterly \\(n =2284\\) & Can 300 mg 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Goldstraw, 2016)}","confidence":1,"confidence_rate":1},{"cnt":[[288,498],[1772,498],[1772,544],[288,544]],"region":{"top_left_x":287,"top_left_y":498,"width":1486,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26149c13053e4f0184161c97decd0fe8","type":"text","conversion_output":true,"text":"Table 2-2 is removed. Refer to Section 5.1 for details on the inclusion/exclusion criteria.","text_display":"\n\nTable 2-2 is removed. Refer to Section 5.1 for details on the inclusion/exclusion criteria.","confidence":1,"confidence_rate":1},{"cnt":[[288,567],[1351,567],[1351,617],[288,617]],"region":{"top_left_x":287,"top_left_y":567,"width":1065,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ce7c3b0ca8c469787ebc8ac6424523d","type":"text","conversion_output":true,"text":"Randomization will be stratified by the three following factors:","text_display":"\nRandomization will be stratified by the three following factors:","confidence":0.998046875,"confidence_rate":0.9999716665631994},{"cnt":[[288,625],[1820,625],[1820,675],[288,675]],"region":{"top_left_x":287,"top_left_y":625,"width":1533,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ffcded0b70943a280414d0ef2bf678a","type":"text","conversion_output":true,"text":"- AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease","text_display":"\n- AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus IIIB with T>5cm, N2 disease","confidence":0.9878253727219999,"confidence_rate":0.9998682952855139},{"cnt":[[288,683],[1085,683],[1085,733],[288,733]],"region":{"top_left_x":287,"top_left_y":683,"width":798,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"886742d0413f4c00b4cb65b075514991","type":"text","conversion_output":true,"text":"- Histology: squamous versus non-squamous","text_display":"\n- Histology: squamous versus non-squamous","confidence":1,"confidence_rate":1},{"cnt":[[288,752],[1330,752],[1330,801],[288,801]],"region":{"top_left_x":287,"top_left_y":751,"width":1043,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccca2ca173c549898c4075e014a33bad","type":"text","conversion_output":true,"text":"Both staging and histology are key determinants of prognosis.","text_display":"\n\nBoth staging and histology are key determinants of prognosis.","confidence":1,"confidence_rate":1},{"cnt":[[288,810],[1871,810],[1871,862],[288,862]],"region":{"top_left_x":287,"top_left_y":809,"width":1585,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b323372212a480b86543e0ec9cbd837","type":"text","conversion_output":true,"text":"- Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW),","text_display":"\n- Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW),","confidence":1,"confidence_rate":1},{"cnt":[[352,859],[1257,859],[1257,907],[352,907]],"region":{"top_left_x":352,"top_left_y":859,"width":905,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"530227d6955747569f1da711beb515f8","type":"text","conversion_output":true,"text":"to account for possible differences in standard of care","text_display":" to account for possible differences in standard of care","confidence":1,"confidence_rate":1},{"cnt":[[288,928],[1880,928],[1880,978],[288,978]],"region":{"top_left_x":287,"top_left_y":928,"width":1593,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69ee127a8e5447e7a70d681237e1c464","type":"text","conversion_output":true,"text":"The primary endpoint is disease-free survival (DFS) determined by local investigator","text_display":"\n\nThe primary endpoint is disease-free survival (DFS) determined by local investigator","confidence":1,"confidence_rate":1},{"cnt":[[288,975],[1880,975],[1880,1023],[288,1023]],"region":{"top_left_x":287,"top_left_y":975,"width":1593,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5894822cf4544866a2a476c74cab2b25","type":"text","conversion_output":true,"text":"assessment to reflect a reduced risk of lung cancer recurrence, with overall survival (OS) as a","text_display":" assessment to reflect a reduced risk of lung cancer recurrence, with overall survival (OS) as a","confidence":1,"confidence_rate":1},{"cnt":[[288,1023],[1876,1023],[1876,1072],[288,1072]],"region":{"top_left_x":287,"top_left_y":1022,"width":1589,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a858c62b35a443f28653d0b3fa17f52d","type":"text","conversion_output":true,"text":"key secondary endpoint. Tumor assessments and follow-up visits for assessment of recurrence","text_display":" key secondary endpoint. Tumor assessments and follow-up visits for assessment of recurrence","confidence":1,"confidence_rate":1},{"cnt":[[288,1070],[1876,1070],[1876,1119],[288,1119]],"region":{"top_left_x":287,"top_left_y":1069,"width":1589,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f72f2248ff284be884c62191fbf7a68a","type":"text","conversion_output":true,"text":"will be performed as per the NCCN guidelines for NSCLC version 8, 14 July 2017. It is","text_display":" will be performed as per the NCCN guidelines for NSCLC version 8, 14 July 2017. It is","confidence":1,"confidence_rate":1},{"cnt":[[288,1117],[1878,1117],[1878,1167],[288,1167]],"region":{"top_left_x":287,"top_left_y":1117,"width":1591,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f653b646b354ca7afd37bddbcf4bce0","type":"text","conversion_output":true,"text":"postulated that 18 cycles (approximately one year) of adjuvant treatment will provide an","text_display":" postulated that 18 cycles (approximately one year) of adjuvant treatment will provide an","confidence":1,"confidence_rate":1},{"cnt":[[288,1164],[1880,1164],[1880,1216],[288,1216]],"region":{"top_left_x":287,"top_left_y":1164,"width":1593,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e4d40abbedf45d9890d2985401bbd6f","type":"text","conversion_output":true,"text":"acceptable benefit to risk ratio in subjects who have intermediate or high risk of developing","text_display":" acceptable benefit to risk ratio in subjects who have intermediate or high risk of developing","confidence":1,"confidence_rate":1},{"cnt":[[288,1216],[614,1216],[614,1257],[288,1257]],"region":{"top_left_x":287,"top_left_y":1216,"width":328,"height":41},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48b57cd2421d4906a961b390f565b3f2","type":"text","conversion_output":true,"text":"disease recurrence.","text_display":" disease recurrence.","confidence":1,"confidence_rate":1},{"cnt":[[288,1283],[1878,1283],[1878,1334],[288,1334]],"region":{"top_left_x":287,"top_left_y":1282,"width":1591,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cedb282ccdd49f693942a9c5a4349fc","type":"text","conversion_output":true,"text":"Applicable for the sub-study*: Rationale to include the biomarker sub-study is to understand","text_display":"\n\nApplicable for the sub-study*: Rationale to include the biomarker sub-study is to understand","confidence":1,"confidence_rate":1},{"cnt":[[288,1332],[1878,1332],[1878,1381],[288,1381]],"region":{"top_left_x":287,"top_left_y":1332,"width":1591,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57c5b4e50ae4966987aac13bdfc6e4f","type":"text","conversion_output":true,"text":"how resection surgery may impact the levels of hsCRP, other cytokines and biomarkers in","text_display":" how resection surgery may impact the levels of hsCRP, other cytokines and biomarkers in","confidence":1,"confidence_rate":1},{"cnt":[[288,1379],[1876,1379],[1876,1429],[288,1429]],"region":{"top_left_x":287,"top_left_y":1379,"width":1589,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac5caf365ef4e33a9a524ac5a1a01aa","type":"text","conversion_output":true,"text":"blood. Adult subjects with NSCLC Stage IIA-IIIA, IIIB (T>5cm, N2 disease only) who are","text_display":" blood. Adult subjects with NSCLC Stage IIA-IIIA, IIIB (T>5cm, N2 disease only) who are","confidence":0.9858684539794922,"confidence_rate":0.9998436128111381},{"cnt":[[288,1427],[1878,1427],[1878,1476],[288,1476]],"region":{"top_left_x":287,"top_left_y":1426,"width":1591,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a1ccb8af1c24b15a0ddaa298b308370","type":"text","conversion_output":true,"text":"candidates for complete resection surgery (and therefore prospective candidates for the main","text_display":" candidates for complete resection surgery (and therefore prospective candidates for the main","confidence":1,"confidence_rate":1},{"cnt":[[288,1474],[1265,1474],[1265,1523],[288,1523]],"region":{"top_left_x":287,"top_left_y":1473,"width":979,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8170779ae64646f5a0252fcd849d48fd","type":"text","conversion_output":true,"text":"study, CACZ885T2301) will be enrolled in the sub-study.","text_display":" study, CACZ885T2301) will be enrolled in the sub-study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1543],[1878,1543],[1878,1592],[288,1592]],"region":{"top_left_x":287,"top_left_y":1542,"width":1591,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eacbd9c23ba744c98e3762b5b26b599b","type":"text","conversion_output":true,"text":"*For China only: biomarker collection is conditional upon approval from HA, EC and","text_display":"\n*For China only: biomarker collection is conditional upon approval from HA, EC and","confidence":0.9795112609863281,"confidence_rate":0.9997620795145158},{"cnt":[[288,1590],[907,1590],[907,1639],[288,1639]],"region":{"top_left_x":287,"top_left_y":1589,"width":620,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38a1caf84c5642d1919da2294f477b30","type":"text","conversion_output":true,"text":"additional authorities (i.e. HGRAC).","text_display":" additional authorities (i.e. HGRAC).","confidence":0.998046875,"confidence_rate":0.9999523173603702},{"cnt":[[286,1676],[1360,1676],[1360,1738],[286,1738]],"region":{"top_left_x":285,"top_left_y":1675,"width":1075,"height":64},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b898080cd7f48fe83c6ef995cfa57b2","type":"section_header","conversion_output":false,"children_ids":["9547a677ffb44aad881151f65336fe5c"],"text":"","text_display":""},{"cnt":[[288,1680],[1356,1680],[1356,1734],[288,1734]],"region":{"top_left_x":287,"top_left_y":1680,"width":1069,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9547a677ffb44aad881151f65336fe5c","type":"text","conversion_output":true,"parent_id":"8b898080cd7f48fe83c6ef995cfa57b2","text":"2.3 Rationale for dose and regimen selection","text_display":"\n\n\\subsection*{2.3 Rationale for dose and regimen selection}","confidence":0.9853708744049072,"confidence_rate":0.9996992863165226},{"cnt":[[288,1753],[1880,1753],[1880,1803],[288,1803]],"region":{"top_left_x":287,"top_left_y":1753,"width":1593,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6feb7a3c87c4e06a59c7fcc3b940145","type":"text","conversion_output":true,"text":"The 200 mg s.c. every 3 weeks (q 3 w ) dosing regimen of canakinumab is selected as the dosing","text_display":"\n\nThe 200 mg s.c. every 3 weeks (q 3 w ) dosing regimen of canakinumab is selected as the dosing","confidence":0.37532094544086547,"confidence_rate":0.9912884020446944},{"cnt":[[288,1800],[1141,1800],[1141,1850],[288,1850]],"region":{"top_left_x":287,"top_left_y":1800,"width":854,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a54fcd65ef644ee08aab1c51143e55bd","type":"text","conversion_output":true,"text":"schedule for the development program in NSCLC.","text_display":" schedule for the development program in NSCLC.","confidence":1,"confidence_rate":1},{"cnt":[[288,1869],[1878,1869],[1878,1919],[288,1919]],"region":{"top_left_x":287,"top_left_y":1869,"width":1591,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70949c9f186b4b13b5c64d28b65ad9d6","type":"text","conversion_output":true,"text":"The every three week dosing regimen is feasible for canakinumab, based on its \\(>3\\) weeks half-","text_display":"\n\nThe every three week dosing regimen is feasible for canakinumab, based on its \\(>3\\) weeks half","confidence":0.98583984375,"confidence_rate":0.9998573964903816},{"cnt":[[288,1916],[1878,1916],[1878,1966],[288,1966]],"region":{"top_left_x":287,"top_left_y":1916,"width":1591,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"affafc63047245f7ab3938ae29f4431d","type":"text","conversion_output":true,"text":"life, and has proven its ability to neutralize IL- \\(1 \\beta\\) and suppress hs-CRP for at least 1 month","text_display":"life, and has proven its ability to neutralize IL- \\(1 \\beta\\) and suppress hs-CRP for at least 1 month","confidence":0.92626953125,"confidence_rate":0.9992708372425143},{"cnt":[[288,1966],[1878,1966],[1878,2015],[288,2015]],"region":{"top_left_x":287,"top_left_y":1965,"width":1591,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e298f5cafa044bbeb40ea6a7318128c3","type":"text","conversion_output":true,"text":"across a wide range of doses. More importantly, given the evidence of the efficacy profile from","text_display":" across a wide range of doses. More importantly, given the evidence of the efficacy profile from","confidence":1,"confidence_rate":1},{"cnt":[[288,2015],[1880,2015],[1880,2065],[288,2065]],"region":{"top_left_x":287,"top_left_y":2015,"width":1593,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb2c049b20d6415ea21f65b4a928555b","type":"text","conversion_output":true,"text":"the CANTOS study in which canakinumab shows no plateau effect in lung cancer risk reduction","text_display":" the CANTOS study in which canakinumab shows no plateau effect in lung cancer risk reduction","confidence":1,"confidence_rate":1},{"cnt":[[288,2062],[1880,2062],[1880,2112],[288,2112]],"region":{"top_left_x":287,"top_left_y":2062,"width":1593,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1af4a89dc6064ff8831862c00e1eacd5","type":"text","conversion_output":true,"text":"at 300 mg s.c. quarterly (q12w), and the comprehensive and well-established safety profile of","text_display":" at 300 mg s.c. quarterly (q12w), and the comprehensive and well-established safety profile of","confidence":1,"confidence_rate":1},{"cnt":[[288,2110],[1878,2110],[1878,2159],[288,2159]],"region":{"top_left_x":287,"top_left_y":2109,"width":1591,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4c5820eb522493783bfaf0efc53bb87","type":"text","conversion_output":true,"text":"canakinumab across a wide range of doses and dosing intervals studied in interventional trials,","text_display":" canakinumab across a wide range of doses and dosing intervals studied in interventional trials,","confidence":1,"confidence_rate":1},{"cnt":[[288,2157],[1878,2157],[1878,2206],[288,2206]],"region":{"top_left_x":287,"top_left_y":2157,"width":1591,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4ff99d8cdc844b1aabc9cf90e29e6d1","type":"text","conversion_output":true,"text":"a 200 mg s.c q3w dosing schedule for canakinumab, which has an approximately equivalent","text_display":" a 200 mg s.c q3w dosing schedule for canakinumab, which has an approximately equivalent","confidence":0.46965415170416236,"confidence_rate":0.992238946880973},{"cnt":[[288,2204],[1878,2204],[1878,2254],[288,2254]],"region":{"top_left_x":287,"top_left_y":2204,"width":1591,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"712dac913ea94a92acc1ed2ce8c0d911","type":"text","conversion_output":true,"text":"total dose amount and similar predicted PK range as 300 mg s.c. q4w (a regimen already used","text_display":" total dose amount and similar predicted PK range as 300 mg s.c. q4w (a regimen already used","confidence":0.9970703125,"confidence_rate":0.9999709510413867},{"cnt":[[288,2254],[1878,2254],[1878,2303],[288,2303]],"region":{"top_left_x":287,"top_left_y":2253,"width":1591,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd6b51c8f8434b3ea2bfb32599cfee0a","type":"text","conversion_output":true,"text":"in certain approved indications), is selected for the NSCLC development program to ensure a","text_display":" in certain approved indications), is selected for the NSCLC development program to ensure a","confidence":1,"confidence_rate":1},{"cnt":[[288,2299],[1880,2299],[1880,2350],[288,2350]],"region":{"top_left_x":287,"top_left_y":2298,"width":1593,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd63bcfe41b04252ad200aadd5c2d819","type":"text","conversion_output":true,"text":"positive benefit/risk ratio. Every three weeks is preferred over every four weeks as the dosing","text_display":" positive benefit/risk ratio. Every three weeks is preferred over every four weeks as the dosing","confidence":1,"confidence_rate":1},{"cnt":[[288,2350],[1878,2350],[1878,2400],[288,2400]],"region":{"top_left_x":287,"top_left_y":2350,"width":1591,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c66cc1a674a24792b815a2a4053d72f2","type":"text","conversion_output":true,"text":"regimens of combination partners (checkpoint inhibitors, chemotherapy) for future planned","text_display":" regimens of combination partners (checkpoint inhibitors, chemotherapy) for future planned","confidence":1,"confidence_rate":1},{"cnt":[[288,2398],[1265,2398],[1265,2447],[288,2447]],"region":{"top_left_x":287,"top_left_y":2397,"width":979,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"480ad7a729c2422db3168a1bd414192c","type":"text","conversion_output":true,"text":"NSCLC trials often follow the every three week schedule.","text_display":" NSCLC trials often follow the every three week 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42 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"811605b1301a481e8a97dc90fecfc4f4","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50f593f9e84746ec858e19ec826f4eda","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[292,346],[1878,346],[1878,397],[292,397]],"region":{"top_left_x":292,"top_left_y":345,"width":1586,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a53cefef3d4f16a7c5dec50ecdfe06","type":"text","conversion_output":true,"text":"Sub-sections below provide further details for the various considerations for dose and regimen","text_display":"\n\nSub-sections below provide further details for the various considerations for dose and regimen","confidence":1,"confidence_rate":1},{"cnt":[[292,395],[458,395],[458,436],[292,436]],"region":{"top_left_x":292,"top_left_y":395,"width":166,"height":42},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5fe3fb9defd4710bc77643edd483350","type":"text","conversion_output":true,"text":"selection:","text_display":" selection:","confidence":1,"confidence_rate":1},{"cnt":[[286,460],[754,460],[754,511],[286,511]],"region":{"top_left_x":285,"top_left_y":459,"width":470,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55ed5eb803ed4cfabf105e9c4e8026f5","type":"section_header","conversion_output":false,"children_ids":["fc8764ffd71c4b61ab716beb00d85fd5"],"text":"","text_display":""},{"cnt":[[288,464],[750,464],[750,507],[288,507]],"region":{"top_left_x":287,"top_left_y":464,"width":463,"height":44},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8764ffd71c4b61ab716beb00d85fd5","type":"text","conversion_output":true,"parent_id":"55ed5eb803ed4cfabf105e9c4e8026f5","text":"PK and PD consideration:","text_display":"\n\n\\section*{PK and PD consideration:}","confidence":1,"confidence_rate":1},{"cnt":[[288,529],[1876,529],[1876,580],[288,580]],"region":{"top_left_x":287,"top_left_y":528,"width":1589,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e0ef9689ccd45f395f0f42767fca41e","type":"text","conversion_output":true,"text":"Canakinumab displays PK properties typical of an IgG1 antibody, with a mean terminal half-","text_display":"\n\nCanakinumab displays PK properties typical of an IgG1 antibody, with a mean terminal half","confidence":1,"confidence_rate":1},{"cnt":[[288,580],[1876,580],[1876,629],[288,629]],"region":{"top_left_x":287,"top_left_y":580,"width":1589,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66e947cbd3f34c0ba2eee20b5ebfb6d8","type":"text","conversion_output":true,"text":"life of 26 days. Every 3 weeks dosing schedule of canakinumab is feasible based on its half-life","text_display":"life of 26 days. Every 3 weeks dosing schedule of canakinumab is feasible based on its half-life","confidence":1,"confidence_rate":1},{"cnt":[[288,627],[1878,627],[1878,677],[288,677]],"region":{"top_left_x":287,"top_left_y":627,"width":1591,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e7f14b7e1754c0bb56d12cd6bf39e5d","type":"text","conversion_output":true,"text":"of 26 days, and its ability to suppress hs-CRP for at least 1 month as previously demonstrated","text_display":" of 26 days, and its ability to suppress hs-CRP for at least 1 month as previously demonstrated","confidence":1,"confidence_rate":1},{"cnt":[[288,675],[1878,675],[1878,724],[288,724]],"region":{"top_left_x":287,"top_left_y":674,"width":1591,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e0036f0a90343e190ee5745d1ec145f","type":"text","conversion_output":true,"text":"in two single-dose phase 2 studies with dose ranges of 0.03 to \\(10 mg / kg\\) i.v. and 25 to 300 mg","text_display":" in two single-dose phase 2 studies with dose ranges of 0.03 to \\(10 mg / kg\\) i.v. and 25 to 300 mg","confidence":0.8129945215769112,"confidence_rate":0.99821684251102},{"cnt":[[288,722],[1807,722],[1807,776],[288,776]],"region":{"top_left_x":287,"top_left_y":721,"width":1520,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc23b19863f9402baf540b7b6146a124","type":"text","conversion_output":true,"text":"s.c. ([Study CACZ885A2213] in diabetes and [Study CACZ885H2251] in gouty arthritis).","text_display":" s.c. ([Study CACZ885A2213] in diabetes and [Study CACZ885H2251] in gouty arthritis).","confidence":1,"confidence_rate":1},{"cnt":[[284,791],[707,791],[707,849],[284,849]],"region":{"top_left_x":283,"top_left_y":790,"width":424,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab76222b66e441b6ad884dc5060bf6a4","type":"section_header","conversion_output":false,"children_ids":["a0206ef259d748b4b47f7314038c0fa2"],"text":"","text_display":""},{"cnt":[[288,795],[700,795],[700,844],[288,844]],"region":{"top_left_x":287,"top_left_y":794,"width":414,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0206ef259d748b4b47f7314038c0fa2","type":"text","conversion_output":true,"parent_id":"ab76222b66e441b6ad884dc5060bf6a4","text":"Efficacy consideration:","text_display":"\n\n\\section*{Efficacy consideration:}","confidence":0.99853515625,"confidence_rate":0.9999476471675111},{"cnt":[[288,859],[1880,859],[1880,913],[288,913]],"region":{"top_left_x":287,"top_left_y":859,"width":1593,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe58ea74f1a549bd88d36a5542b9d205","type":"text","conversion_output":true,"text":"Canakinumab has demonstrated clinical benefit and is approved in 68 countries, including EU","text_display":"\n\nCanakinumab has demonstrated clinical benefit and is approved in 68 countries, including EU","confidence":1,"confidence_rate":1},{"cnt":[[288,907],[1880,907],[1880,958],[288,958]],"region":{"top_left_x":287,"top_left_y":906,"width":1593,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30e10818e95b49d7980ed254cc77234b","type":"text","conversion_output":true,"text":"and US for the treatment of subjects with various IL- \\(1 \\beta\\)-driven auto-inflammatory diseases. For","text_display":" and US for the treatment of subjects with various IL- \\(1 \\beta\\)-driven auto-inflammatory diseases. For","confidence":0.51953125,"confidence_rate":0.993723354834855},{"cnt":[[288,956],[1878,956],[1878,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":956,"width":1591,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f1e34861ac4319bacf7826a085cdf0","type":"text","conversion_output":true,"text":"CAPS, the approved dosing regimen in US is 150 mg s.c. every 8 weeks (q8w) in adults (up-","text_display":" CAPS, the approved dosing regimen in US is 150 mg s.c. every 8 weeks (q8w) in adults (up","confidence":0.52294921875,"confidence_rate":0.9936645568754134},{"cnt":[[288,1005],[1876,1005],[1876,1055],[288,1055]],"region":{"top_left_x":287,"top_left_y":1005,"width":1589,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3eba48b5868f4af0840503a00885e007","type":"text","conversion_output":true,"text":"titration up to 600 mg s.c. q8w is allowed in EU). In other approved indications such as SJIA,","text_display":"titration up to 600 mg s.c. q8w is allowed in EU). In other approved indications such as SJIA,","confidence":0.9980475902557373,"confidence_rate":0.9999812086555921},{"cnt":[[288,1053],[1876,1053],[1876,1102],[288,1102]],"region":{"top_left_x":287,"top_left_y":1052,"width":1589,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28dd4170aad34c369162d2fe3b73f434","type":"text","conversion_output":true,"text":"TRAPS, HIDS/ MKD, and FMF, a starting dose at \\(4 mg / kg\\) (max. 300 mg ) every 4 weeks (q4w)","text_display":" TRAPS, HIDS/ MKD, and FMF, a starting dose at \\(4 mg / kg\\) (max. 300 mg ) every 4 weeks (q4w)","confidence":0.9349453449249268,"confidence_rate":0.9993830600552265},{"cnt":[[288,1100],[1878,1100],[1878,1149],[288,1149]],"region":{"top_left_x":287,"top_left_y":1100,"width":1591,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55893c4d009c45a49e34b5f64274f110","type":"text","conversion_output":true,"text":"or up-titration to \\(4 mg / kg\\) or 300 mg q4w is required to achieve adequate efficacy in adults and","text_display":" or up-titration to \\(4 mg / kg\\) or 300 mg q4w is required to achieve adequate efficacy in adults and","confidence":0.8879452511064301,"confidence_rate":0.9989488255081079},{"cnt":[[288,1147],[1878,1147],[1878,1197],[288,1197]],"region":{"top_left_x":287,"top_left_y":1147,"width":1591,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36de22fcd6a942f188f80bd2fb71c158","type":"text","conversion_output":true,"text":"children. If a full treatment response is subsequently achieved, the intensified dosing regimen","text_display":" children. If a full treatment response is subsequently achieved, the intensified dosing regimen","confidence":1,"confidence_rate":1},{"cnt":[[288,1195],[1878,1195],[1878,1246],[288,1246]],"region":{"top_left_x":287,"top_left_y":1194,"width":1591,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2719e5c1ebc242e38c2ca58e5d9c9336","type":"text","conversion_output":true,"text":"of 300 mg q4w should be maintained. The different dosing regimens across indications could","text_display":" of 300 mg q4w should be maintained. The different dosing regimens across indications could","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[288,1242],[1878,1242],[1878,1293],[288,1293]],"region":{"top_left_x":287,"top_left_y":1241,"width":1591,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb72d0a39b1b41368c3fd03cd26f8f42","type":"text","conversion_output":true,"text":"be due to differences in drug sensitivity across diseases likely caused by different clinical","text_display":" be due to differences in drug sensitivity across diseases likely caused by different clinical","confidence":1,"confidence_rate":1},{"cnt":[[288,1291],[896,1291],[896,1343],[288,1343]],"region":{"top_left_x":287,"top_left_y":1291,"width":609,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"601890877e4d471588f349ef31443d30","type":"text","conversion_output":true,"text":"conditions and inflammatory status.","text_display":" conditions and inflammatory status.","confidence":1,"confidence_rate":1},{"cnt":[[288,1360],[1878,1360],[1878,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1359,"width":1591,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5288d0ecc1824c74b7c61c6f14454d99","type":"text","conversion_output":true,"text":"For the CANTOS study, the dose selection was primarily based on Study CACZ885I2202, a","text_display":"\nFor the CANTOS study, the dose selection was primarily based on Study CACZ885I2202, a","confidence":1,"confidence_rate":1},{"cnt":[[288,1409],[1878,1409],[1878,1459],[288,1459]],"region":{"top_left_x":287,"top_left_y":1409,"width":1591,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ac23e804e0f433ea7582b75d62b063e","type":"text","conversion_output":true,"text":"key dose finding study in subjects with diabetes, who were treated with 5, 15, 50 and 150 mg","text_display":" key dose finding study in subjects with diabetes, who were treated with 5, 15, 50 and 150 mg","confidence":0.9810520135144998,"confidence_rate":0.9998106139762876},{"cnt":[[288,1457],[1876,1457],[1876,1506],[288,1506]],"region":{"top_left_x":287,"top_left_y":1456,"width":1589,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7ed3649cbe94a24ba0b80d503d47b95","type":"text","conversion_output":true,"text":"s.c. monthly doses, with 4 -month treatment period (see [canakinumab Investigator's","text_display":" s.c. monthly doses, with 4 -month treatment period (see [canakinumab Investigator's","confidence":0.9727629216649103,"confidence_rate":0.9996965857804898},{"cnt":[[288,1504],[492,1504],[492,1553],[288,1553]],"region":{"top_left_x":287,"top_left_y":1503,"width":205,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8772d27ac234764bcf586a8df1bd717","type":"text","conversion_output":true,"text":"Brochure]).","text_display":" Brochure]).","confidence":1,"confidence_rate":1},{"cnt":[[288,1573],[1878,1573],[1878,1622],[288,1622]],"region":{"top_left_x":287,"top_left_y":1572,"width":1591,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2dcc18b017b42459624d7e78f9bfdf9","type":"text","conversion_output":true,"text":"As observed in Study CACZ885I2202, the largest observed reduction in hs-CRP at 4 -month","text_display":"\n\nAs observed in Study CACZ885I2202, the largest observed reduction in hs-CRP at 4 -month","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[288,1620],[1878,1620],[1878,1671],[288,1671]],"region":{"top_left_x":287,"top_left_y":1619,"width":1591,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3c10b8027a44a389a0f8060c779fec0","type":"text","conversion_output":true,"text":"was found at a dose of 50 mg s.c. monthly. However, PK/PD modeling has predicted maximal","text_display":" was found at a dose of 50 mg s.c. monthly. However, PK/PD modeling has predicted maximal","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[288,1669],[1878,1669],[1878,1721],[288,1721]],"region":{"top_left_x":287,"top_left_y":1669,"width":1591,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5caac6d0b10464db037d872392b6339","type":"text","conversion_output":true,"text":"hs-CRP reduction at doses between 75 and 100 mg s.c. monthly. Therefore, 50 mg s.c. monthly","text_display":" hs-CRP reduction at doses between 75 and 100 mg s.c. monthly. Therefore, 50 mg s.c. monthly","confidence":1,"confidence_rate":1},{"cnt":[[288,1714],[1880,1714],[1880,1766],[288,1766]],"region":{"top_left_x":287,"top_left_y":1714,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082f8ce81ea74278875a4b761dc81c62","type":"text","conversion_output":true,"text":"(or 150 mg s.c. quarterly) was considered as an efficacious dose while 15 mg s.c. monthly (or","text_display":" (or 150 mg s.c. quarterly) was considered as an efficacious dose while 15 mg s.c. monthly (or","confidence":0.9980478286743164,"confidence_rate":0.9999819068368716},{"cnt":[[288,1766],[1876,1766],[1876,1815],[288,1815]],"region":{"top_left_x":287,"top_left_y":1766,"width":1589,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430fded2829242699ffcd89a1d43815a","type":"text","conversion_output":true,"text":"50 mg s.c. quarterly) as a sub-optimal dose, and 100 mg s.c. monthly (or 300 mg s.c. quarterly)","text_display":" 50 mg s.c. quarterly) as a sub-optimal dose, and 100 mg s.c. monthly (or 300 mg s.c. quarterly)","confidence":0.9970715045928955,"confidence_rate":0.999973578800939},{"cnt":[[288,1813],[1878,1813],[1878,1863],[288,1863]],"region":{"top_left_x":287,"top_left_y":1813,"width":1591,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8261c5f54c6940c581a7e67665bb9b17","type":"text","conversion_output":true,"text":"as the dose predicted to achieve the maximal hs-CRP reduction (see [Study M2301, Section","text_display":" as the dose predicted to achieve the maximal hs-CRP reduction (see [Study M2301, Section","confidence":1,"confidence_rate":1},{"cnt":[[288,1861],[1545,1861],[1545,1912],[288,1912]],"region":{"top_left_x":287,"top_left_y":1860,"width":1258,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a102bd6cf994c49887f2a8def466847","type":"text","conversion_output":true,"text":"3.3] and [canakinumab Investigator's Brochure], [CACZ885I2202 study]).","text_display":" 3.3] and [canakinumab Investigator's Brochure], [CACZ885I2202 study]).","confidence":0.9990236759185791,"confidence_rate":0.9999869760715292},{"cnt":[[288,1929],[1876,1929],[1876,1979],[288,1979]],"region":{"top_left_x":287,"top_left_y":1929,"width":1589,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"006080143d16441cba0888851dc417d9","type":"text","conversion_output":true,"text":"Consistent with the modeling prediction, among the three dosing regimens tested in the","text_display":"\n\nConsistent with the modeling prediction, among the three dosing regimens tested in the","confidence":1,"confidence_rate":1},{"cnt":[[288,1977],[1876,1977],[1876,2026],[288,2026]],"region":{"top_left_x":287,"top_left_y":1976,"width":1589,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f3567c1d524127a9ccb573083f4dd3","type":"text","conversion_output":true,"text":"CANTOS study ( 50,150 , and 300 mg s.c. quarterly), maximal hs-CRP reduction at 48 months","text_display":" CANTOS study ( 50,150 , and 300 mg s.c. quarterly), maximal hs-CRP reduction at 48 months","confidence":0.9985356330871582,"confidence_rate":0.9999860435245741},{"cnt":[[288,2024],[1876,2024],[1876,2073],[288,2073]],"region":{"top_left_x":287,"top_left_y":2023,"width":1589,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31c400a8445f452180a9817011290b6f","type":"text","conversion_output":true,"text":"was observed in the 300 mg s.c. quarterly dose (median reduction from baseline is \\(26 \\%, 37 \\%\\),","text_display":" was observed in the 300 mg s.c. quarterly dose (median reduction from baseline is \\(26 \\%, 37 \\%\\),","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[288,2071],[1876,2071],[1876,2125],[288,2125]],"region":{"top_left_x":287,"top_left_y":2071,"width":1589,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b71e77cd0f5f43eea92b3de1d26a8757","type":"text","conversion_output":true,"text":"and \\(41 \\%\\) in the \\(50 mg , 150 mg\\), and 300 mg groups, respectively), as compared with placebo,","text_display":" and \\(41 \\%\\) in the \\(50 mg , 150 mg\\), and 300 mg groups, respectively), as compared with placebo,","confidence":1,"confidence_rate":1},{"cnt":[[288,2123],[1876,2123],[1876,2172],[288,2172]],"region":{"top_left_x":287,"top_left_y":2122,"width":1589,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ed69f1faeee44f39355a9f8996be3e6","type":"text","conversion_output":true,"text":"among atherosclerosis subject with elevated baseline hs-CRP who did not have a prior diagnosis","text_display":" among atherosclerosis subject with elevated baseline hs-CRP who did not have a prior diagnosis","confidence":1,"confidence_rate":1},{"cnt":[[288,2168],[1876,2168],[1876,2219],[288,2219]],"region":{"top_left_x":287,"top_left_y":2167,"width":1589,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"620486abe03d443a8f013a68f6c6081e","type":"text","conversion_output":true,"text":"of cancer (Ridker 2017a). 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In regards to clinical effects, 150 mg s.c. quarterly met the primary","confidence":0.9985356330871582,"confidence_rate":0.9999860435245741},{"cnt":[[288,2217],[1876,2217],[1876,2267],[288,2267]],"region":{"top_left_x":287,"top_left_y":2217,"width":1589,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d01b67eb65e84007a8ddc4aa96f7e8fd","type":"text","conversion_output":true,"text":"endpoint with \\(15 \\%\\) relative hazard reduction for MACE; 50 mg s.c. quarterly did not show","text_display":" endpoint with \\(15 \\%\\) relative hazard reduction for MACE; 50 mg s.c. quarterly did not 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Unlike the cardiovascular","text_display":"\ndependent risk reductions in lung cancer and lung cancer mortality. Unlike the cardiovascular","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1876,391],[1876,443],[288,443]],"region":{"top_left_x":287,"top_left_y":391,"width":1589,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12a203fb4127455eb699567c104125bc","type":"text","conversion_output":true,"text":"indication, there is a clear differentiation in clinical benefits across all three dosing regimens,","text_display":" indication, there is a clear differentiation in clinical benefits across all three dosing regimens,","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1880,440],[1880,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1593,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bda09871a2aa476ca62cf4f6a0f65a9c","type":"text","conversion_output":true,"text":"with the greatest risk reduction in lung cancer mortality achieved with the highest dose, 300 mg","text_display":" with the greatest risk reduction in lung cancer mortality achieved with the highest dose, 300 mg","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[1876,490],[1876,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1589,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4d3ad68e7294148aeeced99d67a8631","type":"text","conversion_output":true,"text":"s.c. quarterly. Hazard ratios ( \\(95 \\%\\) confidence interval, P -value) were \\(0.67(0.37-1.20, P =0.18)\\),","text_display":" s.c. quarterly. 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The dose-dependent","text_display":" s.c. quarterly dose groups, respectively as reported by (Ridker 2017b). 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The different median baseline hs-CRP levels among canakinumab-treated","text_display":" across diseases. 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This finding suggests that raising the dose and/or shortening the","text_display":" baseline hs-CRP (Figure 2-2). This finding suggests that raising the dose and/or shortening the","confidence":1,"confidence_rate":1},{"cnt":[[288,1276],[1876,1276],[1876,1326],[288,1326]],"region":{"top_left_x":287,"top_left_y":1276,"width":1589,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25d5c820268f4b5888ee5db887287246","type":"text","conversion_output":true,"text":"dosing interval may lead to better control of inflammation in subjects with higher baseline hs-","text_display":" dosing interval may lead to better control of inflammation in subjects with higher baseline hs","confidence":1,"confidence_rate":1},{"cnt":[[288,1323],[1878,1323],[1878,1377],[288,1377]],"region":{"top_left_x":287,"top_left_y":1323,"width":1591,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d91c57974f14827924d26134c786e1b","type":"text","conversion_output":true,"text":"CRP and deliver greater efficacy in subjects with higher baseline hs-CRP. Prior publications","text_display":"CRP and deliver greater efficacy in subjects with higher baseline hs-CRP. Prior publications","confidence":1,"confidence_rate":1},{"cnt":[[288,1371],[1880,1371],[1880,1422],[288,1422]],"region":{"top_left_x":287,"top_left_y":1370,"width":1593,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22aff4e753594b3290eccdd7a06e6eac","type":"text","conversion_output":true,"text":"examining hs-CRP levels in Stage I through Stage III NSCLC subjects have shown that higher","text_display":" examining hs-CRP levels in Stage I through Stage III NSCLC subjects have shown that higher","confidence":1,"confidence_rate":1},{"cnt":[[288,1420],[1878,1420],[1878,1472],[288,1472]],"region":{"top_left_x":287,"top_left_y":1420,"width":1591,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55aece414238451da9419bf62aefd2e8","type":"text","conversion_output":true,"text":"stage is correlated with higher hs-CRP levels and poorer prognosis (Alifano 2011, Hara 2010,","text_display":" stage is 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Of 52 subjects","text_display":" canakinumab was given at a dose of 600 mg i.v. q4w along with methotrexate. Of 52 subjects","confidence":0.9970715045928955,"confidence_rate":0.9999715266981888},{"cnt":[[288,490],[1880,490],[1880,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1593,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cedf7472ffe646b1b3be0dea43d14336","type":"text","conversion_output":true,"text":"randomized to canakinumab plus methotrexate, 47 subjects received all 8 i.v. infusions of","text_display":" randomized to canakinumab plus methotrexate, 47 subjects received all 8 i.v. infusions of","confidence":0.9980478286743164,"confidence_rate":0.9999804593979635},{"cnt":[[288,537],[1876,537],[1876,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"695b1f7a7b2f4a94869541aac529b4fc","type":"text","conversion_output":true,"text":"canakinumab, where the other 5 subjects received 2 to 7 i.v. infusions. This study reported no","text_display":" canakinumab, where the other 5 subjects received 2 to 7 i.v. infusions. This study reported no","confidence":0.9970703125,"confidence_rate":0.9999728338186853},{"cnt":[[288,587],[1876,587],[1876,638],[288,638]],"region":{"top_left_x":287,"top_left_y":586,"width":1589,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4b1258011644104aa4cee6da2fcd1b3","type":"text","conversion_output":true,"text":"patient deaths and only 4 serious adverse events (SAEs); 2 in each treatment group. The SAEs","text_display":" patient deaths and only 4 serious adverse events (SAEs); 2 in each treatment group. The SAEs","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1876,632],[1876,683],[288,683]],"region":{"top_left_x":287,"top_left_y":631,"width":1589,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b57e4828e9d14886b59c32991601b68b","type":"text","conversion_output":true,"text":"in the methotrexate + placebo group were non-cardiac chest pain and upper gastrointestinal","text_display":" in the methotrexate + placebo group were non-cardiac chest pain and upper gastrointestinal","confidence":0.78369140625,"confidence_rate":0.9974376048628594},{"cnt":[[288,681],[1880,681],[1880,733],[288,733]],"region":{"top_left_x":287,"top_left_y":681,"width":1593,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5757d4ab84de48ccb4478439e93b6a6d","type":"text","conversion_output":true,"text":"hemorrhage. The 2 SAEs in the methotrexate+ canakinumab group were elective cataract","text_display":" hemorrhage. The 2 SAEs in the methotrexate+ canakinumab group were elective cataract","confidence":1,"confidence_rate":1},{"cnt":[[288,728],[1878,728],[1878,780],[288,780]],"region":{"top_left_x":287,"top_left_y":728,"width":1591,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fcf0f1079e64648b24cac9456459968","type":"text","conversion_output":true,"text":"surgery, which was planned prior to study entry for pre-existing cataracts, and lip edema, which","text_display":" surgery, which was planned prior to study entry for pre-existing cataracts, and lip edema, which","confidence":1,"confidence_rate":1},{"cnt":[[288,778],[1876,778],[1876,827],[288,827]],"region":{"top_left_x":287,"top_left_y":777,"width":1589,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d70f20c04d1497d84f4e04c77c6fd64","type":"text","conversion_output":true,"text":"resulted in permanent discontinuation of canakinumab. The occurrence of infectious adverse","text_display":" resulted in permanent discontinuation of canakinumab. The occurrence of infectious adverse","confidence":1,"confidence_rate":1},{"cnt":[[288,825],[1876,825],[1876,874],[288,874]],"region":{"top_left_x":287,"top_left_y":825,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7a6ae60236b46b08da7cc2d9033ac7e","type":"text","conversion_output":true,"text":"events in the treatment groups was similar; \\(40.4 \\%\\) in the methotrexate + canakinumab group","text_display":" events in the treatment groups was similar; \\(40.4 \\%\\) in the methotrexate + canakinumab group","confidence":0.9456343391211703,"confidence_rate":0.9994411630240597},{"cnt":[[288,872],[1878,872],[1878,922],[288,922]],"region":{"top_left_x":287,"top_left_y":872,"width":1591,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14a42fc6d0174a05a1afb1126df25669","type":"text","conversion_output":true,"text":"and \\(42.3 \\%\\) in the methotrexate + placebo group. No infectious SAEs were reported. These","text_display":" and \\(42.3 \\%\\) in the methotrexate + placebo group. No infectious SAEs were reported. These","confidence":0.9458527565002441,"confidence_rate":0.9994262639220537},{"cnt":[[288,920],[1876,920],[1876,971],[288,971]],"region":{"top_left_x":287,"top_left_y":919,"width":1589,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40f08ffa7ea74c21a3d6f753130b6e05","type":"text","conversion_output":true,"text":"studies did not reveal clinically relevant differences in the types and severity of reported AEs","text_display":" studies did not reveal clinically relevant differences in the types and severity of reported AEs","confidence":1,"confidence_rate":1},{"cnt":[[288,969],[1878,969],[1878,1021],[288,1021]],"region":{"top_left_x":287,"top_left_y":968,"width":1591,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a006c3bf4a1547fda9735b9f3a8d45f8","type":"text","conversion_output":true,"text":"across different dose groups. The AEs observed were mostly mild and moderate in severity, and","text_display":" across different dose groups. The AEs observed were mostly mild and moderate in severity, and","confidence":1,"confidence_rate":1},{"cnt":[[288,1018],[1878,1018],[1878,1068],[288,1068]],"region":{"top_left_x":287,"top_left_y":1018,"width":1591,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a369d0d4a3dd4b70805fb39fc84101a7","type":"text","conversion_output":true,"text":"similar to that of the placebo group. In addition, the AEs appear to be independent from duration","text_display":" similar to that of the placebo group. In addition, the AEs appear to be independent from duration","confidence":1,"confidence_rate":1},{"cnt":[[288,1061],[1543,1061],[1543,1115],[288,1115]],"region":{"top_left_x":287,"top_left_y":1061,"width":1256,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"134d070352634db387b6a3c4568d0020","type":"text","conversion_output":true,"text":"of exposure and dose, and with consistent safety profile across indications.","text_display":" of exposure and dose, and with consistent safety profile across indications.","confidence":1,"confidence_rate":1},{"cnt":[[288,1134],[1880,1134],[1880,1184],[288,1184]],"region":{"top_left_x":287,"top_left_y":1134,"width":1593,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a40d6c84fcf46cc8ffcceab275a88c3","type":"text","conversion_output":true,"text":"In summary, with approval in many markets for use in multiple indications, the large body of","text_display":"\n\nIn summary, with approval in many markets for use in multiple indications, the large body of","confidence":1,"confidence_rate":1},{"cnt":[[288,1182],[1878,1182],[1878,1231],[288,1231]],"region":{"top_left_x":287,"top_left_y":1181,"width":1591,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"460a1243c29841b6a9853a00c3b0a8bf","type":"text","conversion_output":true,"text":"accumulated safety data of canakinumab provides sufficient safety margin to evaluate","text_display":" accumulated safety data of canakinumab provides sufficient safety margin to evaluate","confidence":1,"confidence_rate":1},{"cnt":[[288,1229],[1278,1229],[1278,1278],[288,1278]],"region":{"top_left_x":287,"top_left_y":1228,"width":992,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"692fb1f46466420489a356cf36a44fc2","type":"text","conversion_output":true,"text":"canakinumab s.c. at the dose of 200 mg every three weeks.","text_display":" canakinumab s.c. at the dose of 200 mg every three weeks.","confidence":0.9980478286743164,"confidence_rate":0.9999708350626834},{"cnt":[[284,1313],[1384,1313],[1384,1377],[284,1377]],"region":{"top_left_x":283,"top_left_y":1312,"width":1101,"height":66},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa2ad9ee5d4d420a835808f97406677d","type":"section_header","conversion_output":false,"children_ids":["499b2e97f17b400f994650ee060e9f37"],"text":"","text_display":""},{"cnt":[[288,1319],[1377,1319],[1377,1373],[288,1373]],"region":{"top_left_x":287,"top_left_y":1319,"width":1091,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"499b2e97f17b400f994650ee060e9f37","type":"text","conversion_output":true,"parent_id":"fa2ad9ee5d4d420a835808f97406677d","text":"2.4 Rationale for choice of combination drugs","text_display":"\n\n\\subsection*{2.4 Rationale for choice of combination drugs}","confidence":0.970757226459682,"confidence_rate":0.9994065988082594},{"cnt":[[288,1388],[561,1388],[561,1446],[288,1446]],"region":{"top_left_x":287,"top_left_y":1387,"width":274,"height":59},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c0efa66800f47fd906371fdb75b342a","type":"section_header","conversion_output":false,"children_ids":["17d988b9e7ba4417b56985cb3c9080c5"],"text":"","text_display":""},{"cnt":[[288,1392],[556,1392],[556,1442],[288,1442]],"region":{"top_left_x":287,"top_left_y":1392,"width":270,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17d988b9e7ba4417b56985cb3c9080c5","type":"text","conversion_output":true,"parent_id":"1c0efa66800f47fd906371fdb75b342a","text":"Not Applicable","text_display":"\n\n\\section*{Not Applicable}","confidence":1,"confidence_rate":1},{"cnt":[[284,1474],[1388,1474],[1388,1540],[284,1540]],"region":{"top_left_x":283,"top_left_y":1473,"width":1105,"height":68},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"578a7095950d4cfca4bcf25181db1d39","type":"section_header","conversion_output":false,"children_ids":["05b10bdf6564416d9a04fd2b46be2bec"],"text":"","text_display":""},{"cnt":[[288,1480],[1384,1480],[1384,1536],[288,1536]],"region":{"top_left_x":287,"top_left_y":1480,"width":1097,"height":57},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05b10bdf6564416d9a04fd2b46be2bec","type":"text","conversion_output":true,"parent_id":"578a7095950d4cfca4bcf25181db1d39","text":"2.5 Rationale for choice of comparators drugs","text_display":"\n\n\\subsection*{2.5 Rationale for choice of comparators drugs}","confidence":0.9282920191762969,"confidence_rate":0.9985129283911807},{"cnt":[[288,1555],[544,1555],[544,1605],[288,1605]],"region":{"top_left_x":287,"top_left_y":1555,"width":257,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55b9771afc5345b89586aeffe97fd201","type":"text","conversion_output":true,"text":"Not applicable","text_display":"\n\nNot applicable","confidence":1,"confidence_rate":1},{"cnt":[[284,1637],[879,1637],[879,1695],[284,1695]],"region":{"top_left_x":283,"top_left_y":1637,"width":596,"height":59},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d63c866add404c0a803490daba46b8de","type":"section_header","conversion_output":false,"children_ids":["e1721bca98ac4ec595252dce9aba3bc6"],"text":"","text_display":""},{"cnt":[[288,1641],[872,1641],[872,1691],[288,1691]],"region":{"top_left_x":287,"top_left_y":1641,"width":586,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1721bca98ac4ec595252dce9aba3bc6","type":"text","conversion_output":true,"parent_id":"d63c866add404c0a803490daba46b8de","text":"2.6 Risks and benefits","text_display":"\n\n\\subsection*{2.6 Risks and benefits}","confidence":0.998046875,"confidence_rate":0.9999275939238241},{"cnt":[[288,1714],[1880,1714],[1880,1766],[288,1766]],"region":{"top_left_x":287,"top_left_y":1714,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e0c360ddc774d6980b41e834614eaca","type":"text","conversion_output":true,"text":"Canakinumab is approved in several inflammatory disorders in many countries and is marketed","text_display":"\n\nCanakinumab is approved in several inflammatory disorders in many countries and is marketed","confidence":1,"confidence_rate":1},{"cnt":[[288,1764],[1880,1764],[1880,1813],[288,1813]],"region":{"top_left_x":287,"top_left_y":1763,"width":1593,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4228727ac42b453e9405d47bd14c052f","type":"text","conversion_output":true,"text":"under the trade name Ilaris. No dose limiting toxicities of canakinumab have been observed in","text_display":" under the trade name Ilaris. No dose limiting toxicities of canakinumab have been observed in","confidence":1,"confidence_rate":1},{"cnt":[[288,1811],[1880,1811],[1880,1863],[288,1863]],"region":{"top_left_x":287,"top_left_y":1811,"width":1593,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc4f80742fdb4289993088072cb1f0bb","type":"text","conversion_output":true,"text":"subjects receiving doses of up to 600 mg I.V. q 4 weeks for 26 weeks (CACZ885A2204) or","text_display":" subjects receiving doses of up to 600 mg I.V. q 4 weeks for 26 weeks (CACZ885A2204) or","confidence":0.99609375,"confidence_rate":0.9999616291742071},{"cnt":[[288,1861],[1880,1861],[1880,1910],[288,1910]],"region":{"top_left_x":287,"top_left_y":1860,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bb96bd027fb4873b149e3d55fb02179","type":"text","conversion_output":true,"text":"with chronic dosing of up to 300 mg s.c. every 4 weeks for over 2 years (CACZ885G2301, a","text_display":" with chronic dosing of up to 300 mg s.c. every 4 weeks for over 2 years (CACZ885G2301, a","confidence":0.9975595474243164,"confidence_rate":0.9999765057054769},{"cnt":[[288,1908],[565,1908],[565,1957],[288,1957]],"region":{"top_left_x":287,"top_left_y":1907,"width":279,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a97cde3400c4739b52dee164990dca1","type":"text","conversion_output":true,"text":"two-part study).","text_display":" two-part study).","confidence":1,"confidence_rate":1},{"cnt":[[288,1977],[1880,1977],[1880,2026],[288,2026]],"region":{"top_left_x":287,"top_left_y":1976,"width":1593,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"559f0047a5c5466db654756d92123efb","type":"text","conversion_output":true,"text":"The CANTOS study randomized 6717 subjects to canakinumab treatment. The most common","text_display":"\n\nThe CANTOS study randomized 6717 subjects to canakinumab treatment. The most common","confidence":1,"confidence_rate":1},{"cnt":[[288,2024],[1880,2024],[1880,2075],[288,2075]],"region":{"top_left_x":287,"top_left_y":2023,"width":1593,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c43e6fcfd4343b28fd495eb49a10622","type":"text","conversion_output":true,"text":"adverse events (AEs), experienced by \\(\\geq 10 \\%\\) of subjects, regardless of study drug relationship","text_display":" adverse events (AEs), experienced by \\(\\geq 10 \\%\\) of subjects, regardless of study drug relationship","confidence":1,"confidence_rate":1},{"cnt":[[288,2071],[1880,2071],[1880,2121],[288,2121]],"region":{"top_left_x":287,"top_left_y":2071,"width":1593,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04c9e16f03d440dbb139a13810b952e4","type":"text","conversion_output":true,"text":"were viral upper respiratory tract infection and hypertension, in \\(12.5-13.9 \\%\\) and \\(10.1-10.3 \\%\\) of","text_display":" were viral upper respiratory tract infection and hypertension, in \\(12.5-13.9 \\%\\) and \\(10.1-10.3 \\%\\) of","confidence":0.9141456878278404,"confidence_rate":0.9991454574785803},{"cnt":[[288,2118],[1878,2118],[1878,2170],[288,2170]],"region":{"top_left_x":287,"top_left_y":2118,"width":1591,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8479cee27bd7401d9e3b1eacb5123b9b","type":"text","conversion_output":true,"text":"canakinumab-treated subjects versus \\(12.3 \\%\\) and \\(10.1 \\%\\) in the placebo group, respectively","text_display":" canakinumab-treated subjects versus \\(12.3 \\%\\) and \\(10.1 \\%\\) in the placebo group, respectively","confidence":1,"confidence_rate":1},{"cnt":[[288,2168],[1876,2168],[1876,2219],[288,2219]],"region":{"top_left_x":287,"top_left_y":2167,"width":1589,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"215a9890943b45379111169b8dea7a24","type":"text","conversion_output":true,"text":"(Table 2-4). The most commonly reported serious adverse event (SAE) in \\(\\geq 1 \\%\\) of subjects was","text_display":" (Table 2-4). The most commonly reported serious adverse event (SAE) in \\(\\geq 1 \\%\\) of subjects was","confidence":0.9965834617614746,"confidence_rate":0.9999650782839314},{"cnt":[[288,2217],[1876,2217],[1876,2267],[288,2267]],"region":{"top_left_x":287,"top_left_y":2217,"width":1589,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfad6034b79744dbb529e2a856bf2730","type":"text","conversion_output":true,"text":"pneumonia, which occurred in \\(3.4-3.7 \\%\\) in canakinumab-treated subjects versus \\(3.3 \\%\\) in the","text_display":" pneumonia, which occurred in \\(3.4-3.7 \\%\\) in canakinumab-treated subjects versus \\(3.3 \\%\\) in the","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[288,2264],[1878,2264],[1878,2314],[288,2314]],"region":{"top_left_x":287,"top_left_y":2264,"width":1591,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71b6ca066839417990e85db787f14f4d","type":"text","conversion_output":true,"text":"placebo group. Additional infectious SAEs included cellulitis and sepsis in \\(0.9-1.5 \\%\\) and 1.0 -","text_display":" placebo group. Additional infectious SAEs included cellulitis and sepsis in \\(0.9-1.5 \\%\\) and 1.0 ","confidence":0.9833984375,"confidence_rate":0.999840575443913},{"cnt":[[292,2312],[1876,2312],[1876,2361],[292,2361]],"region":{"top_left_x":292,"top_left_y":2311,"width":1584,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50dfc76e67e74d04ba4857058b040bf7","type":"text","conversion_output":true,"text":"\\(1.4 \\%\\) of canakinumab-treated subjects versus \\(3.3 \\%\\) and \\(0.8 \\%\\) in the placebo group, respectively.","text_display":"\\(1.4 \\%\\) of canakinumab-treated subjects versus \\(3.3 \\%\\) and \\(0.8 \\%\\) in the placebo group, 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Preferred term & Can300mg \\(N =2263\\) n (\\%) & Can150mg \\(N =2285\\) n (\\%) & Can50mg \\(N =2170\\) n (\\%) & Placebo \\(N =3348\\) n (\\%) \\\\\n\\hline Subjects with at least one AE & 1987 ( 87.8) & 1970 ( 86.2) & 1872 ( 86.3) & 2914 ( 87.0) \\\\\n\\hline Viral upper respiratory tract infection & 282 ( 12.5) & 318 ( 13.9) & 278 ( 12.8) & 411 ( 12.3) \\\\\n\\hline Hypertension & 229 ( 10.1) & 235 ( 10.3) & 222 ( 10.2) & 339 ( 10.1) \\\\\n\\hline Angina pectoris & 191 ( 8.4) & 207 ( 9.1) & 169 ( 7.8) & 306 ( 9.1) \\\\\n\\hline Back pain & 189 ( 8.4) & 202 ( 8.8) & 171 ( 7.9) & 301 ( 9.0) \\\\\n\\hline Non-cardiac chest pain & 190 ( 8.4) & 196 ( 8.6) & 157 ( 7.2) & 304 ( 9.1) \\\\\n\\hline Arthralgia & 183 ( 8.1) & 201 ( 8.8) & 155 ( 7.1) & 273 ( 8.2) \\\\\n\\hline Upper respiratory tract infection & 166 ( 7.3) & 168 ( 7.4) & 148 ( 6.8) & 273 ( 8.2) \\\\\n\\hline Bronchitis & 153 ( 6.8) & 183 ( 8.0) & 135 ( 6.2) & 269 ( 8.0) \\\\\n\\hline Cough & 169 ( 7.5) & 169 ( 7.4) & 129 ( 5.9) & 252 ( 7.5) \\\\\n\\hline Diarrhea & 148 ( 6.5) & 168 ( 7.4) & 160 ( 7.4) & 233 ( 7.0) \\\\\n\\hline Dyspnea & 157 ( 6.9) & 147 ( 6.4) & 137 ( 6.3) & 236 ( 7.0) \\\\\n\\hline Urinary tract infection & 159 ( 7.0) & 164 ( 7.2) & 121 ( 5.6) & 224 ( 6.7) \\\\\n\\hline Influenza & 162 ( 7.2) & 162 ( 7.1) & 126 ( 5.8) & 205 ( 6.1) \\\\\n\\hline Pain in extremity & 160 ( 7.1) & 155 ( 6.8) & 110 ( 5.1) & 227 ( 6.8) \\\\\n\\hline Edema peripheral & 146 ( 6.5) & 153 ( 6.7) & 142 ( 6.5) & 197 ( 5.9) \\\\\n\\hline Dizziness & 128 ( 5.7) & 138 ( 6.0) & 145 ( 6.7) & 212 ( 6.3) \\\\\n\\hline Pneumonia & 132 ( 5.8) & 153 ( 6.7) & 128 ( 5.9) & 208 ( 6.2) \\\\\n\\hline Headache & 145 ( 6.4) & 120 ( 5.3) & 126 ( 5.8) & 196 ( 5.9) \\\\\n\\hline Fatigue & 125 ( 5.5) & 108 ( 4.7) & 93 ( 4.3) & 183 ( 5.5) \\\\\n\\hline Osteoarthritis & 109 ( 4.8) & 95 ( 4.2) & 94 ( 4.3) & 202 ( 6.0) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2-4 Summary of Adverse Events, regardless of relationship to study medication experienced by \\(1 0 \\%\\) of subjects in CANTOS}\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline Preferred term & Can300mg \\(N =2263\\) n (\\%) & Can150mg \\(N =2285\\) n (\\%) & Can50mg \\(N =2170\\) n (\\%) & Placebo \\(N =3348\\) n (\\%) \\\\\n\\hline Subjects with at least one AE & 1987 ( 87.8) & 1970 ( 86.2) & 1872 ( 86.3) & 2914 ( 87.0) \\\\\n\\hline Viral upper respiratory tract infection & 282 ( 12.5) & 318 ( 13.9) & 278 ( 12.8) & 411 ( 12.3) \\\\\n\\hline Hypertension & 229 ( 10.1) & 235 ( 10.3) & 222 ( 10.2) & 339 ( 10.1) \\\\\n\\hline Angina pectoris & 191 ( 8.4) & 207 ( 9.1) & 169 ( 7.8) & 306 ( 9.1) \\\\\n\\hline Back pain & 189 ( 8.4) & 202 ( 8.8) & 171 ( 7.9) & 301 ( 9.0) \\\\\n\\hline Non-cardiac chest pain & 190 ( 8.4) & 196 ( 8.6) & 157 ( 7.2) & 304 ( 9.1) \\\\\n\\hline Arthralgia & 183 ( 8.1) & 201 ( 8.8) & 155 ( 7.1) & 273 ( 8.2) \\\\\n\\hline Upper respiratory tract infection & 166 ( 7.3) & 168 ( 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CACZ885T2301","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[288,346],[1876,346],[1876,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ec687c26a1544feaeacad6d56a4c970","type":"text","conversion_output":true,"text":"The most common AE in CANTOS was upper respiratory infection and the most common SAE","text_display":"\n\nThe most common AE in CANTOS was upper respiratory infection and the most common SAE","confidence":1,"confidence_rate":1},{"cnt":[[288,395],[569,395],[569,445],[288,445]],"region":{"top_left_x":287,"top_left_y":395,"width":283,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9c6335bebac4c80b8a912519e4ec926","type":"text","conversion_output":true,"text":"was pneumonia.","text_display":" was pneumonia.","confidence":1,"confidence_rate":1},{"cnt":[[288,460],[1876,460],[1876,513],[288,513]],"region":{"top_left_x":287,"top_left_y":459,"width":1589,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46bf616af12849b4bed705eaa8488fdc","type":"text","conversion_output":true,"text":"The occurrence of sepsis was reported in a slightly higher percentage of subjects \\(1.0-1.4 \\%\\) in","text_display":"\nThe occurrence of sepsis was reported in a slightly higher percentage of subjects \\(1.0-1.4 \\%\\) in","confidence":0.9956116648390889,"confidence_rate":0.9999564564711546},{"cnt":[[288,511],[1412,511],[1412,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":1125,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2f134b68f0e4207a94fbe2a75807105","type":"text","conversion_output":true,"text":"the canakinumab-treated groups versus \\(0.8 \\%\\) in the placebo group.","text_display":" the canakinumab-treated groups versus \\(0.8 \\%\\) in the placebo group.","confidence":1,"confidence_rate":1},{"cnt":[[288,578],[1878,578],[1878,629],[288,629]],"region":{"top_left_x":287,"top_left_y":577,"width":1591,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1c5fc9470944549bbd6c1bc8a6c789f","type":"text","conversion_output":true,"text":"Due to the mode of action of all inhibitors of the IL-1 pathway, infection is an important","text_display":"\nDue to the mode of action of all inhibitors of the IL-1 pathway, infection is an important","confidence":1,"confidence_rate":1},{"cnt":[[288,627],[1878,627],[1878,677],[288,677]],"region":{"top_left_x":287,"top_left_y":627,"width":1591,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"317acad5330540e89c7cb08453cc3ac9","type":"text","conversion_output":true,"text":"concern. Subjects should be closely monitored for signs or symptoms of infection and","text_display":" concern. Subjects should be closely monitored for signs or symptoms of infection and","confidence":1,"confidence_rate":1},{"cnt":[[288,675],[1876,675],[1876,724],[288,724]],"region":{"top_left_x":287,"top_left_y":674,"width":1589,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03dacebc465646c3833c9bc757152daf","type":"text","conversion_output":true,"text":"appropriate treatment instituted in a timely manner (see Section 6.3.3). Reported infections are","text_display":" appropriate treatment instituted in a timely manner (see Section 6.3.3). Reported infections are","confidence":0.9970722198486328,"confidence_rate":0.9999709699809471},{"cnt":[[288,722],[1878,722],[1878,776],[288,776]],"region":{"top_left_x":287,"top_left_y":721,"width":1591,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b7ba132553a409193dbd2da854caf26","type":"text","conversion_output":true,"text":"usually mild to moderate in severity. Although the majority of reported infections resolved","text_display":" usually mild to moderate in severity. Although the majority of reported infections resolved","confidence":1,"confidence_rate":1},{"cnt":[[288,769],[1876,769],[1876,821],[288,821]],"region":{"top_left_x":287,"top_left_y":769,"width":1589,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03d00376b7924979a74d9aec9105d6a3","type":"text","conversion_output":true,"text":"spontaneously or with standard therapy, severe, serious and fatal infections have been reported.","text_display":" spontaneously or with standard therapy, severe, serious and fatal infections have been reported.","confidence":1,"confidence_rate":1},{"cnt":[[288,816],[1880,816],[1880,870],[288,870]],"region":{"top_left_x":287,"top_left_y":816,"width":1593,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b086cadd5864530a4553afbe5cd854b","type":"text","conversion_output":true,"text":"Relevant to increased infections, mild to moderate neutropenia has been reported. No CTC","text_display":" Relevant to increased infections, mild to moderate neutropenia has been reported. No CTC","confidence":1,"confidence_rate":1},{"cnt":[[288,866],[1878,866],[1878,917],[288,917]],"region":{"top_left_x":287,"top_left_y":865,"width":1591,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbbd04ce89cf4579bda96ec70adba4b9","type":"text","conversion_output":true,"text":"grade 3 or 4 episodes of neutropenia or thrombocytopenia have been reported in clinical trials","text_display":" grade 3 or 4 episodes of neutropenia or thrombocytopenia have been reported in clinical trials","confidence":1,"confidence_rate":1},{"cnt":[[288,915],[1880,915],[1880,965],[288,965]],"region":{"top_left_x":287,"top_left_y":915,"width":1593,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d58bf37d1739447aa4e8abb060fa945a","type":"text","conversion_output":true,"text":"with canakinumab. Inclusion/exclusion criteria (Section 5), on treatment visits and monitoring","text_display":" with canakinumab. Inclusion/exclusion criteria (Section 5), on treatment visits and monitoring","confidence":1,"confidence_rate":1},{"cnt":[[288,962],[1878,962],[1878,1016],[288,1016]],"region":{"top_left_x":287,"top_left_y":962,"width":1591,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be668826bd6f4079a2f65fb1bec1c413","type":"text","conversion_output":true,"text":"(Section 7) as well as dose adjustments (Section 6) have been included in the study protocol to","text_display":" (Section 7) as well as dose adjustments (Section 6) have been included in the study protocol to","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1010],[629,1010],[629,1059],[288,1059]],"region":{"top_left_x":287,"top_left_y":1009,"width":343,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9169c37167de4bd39c31f4bc78fc3b69","type":"text","conversion_output":true,"text":"mitigate these risks.","text_display":" mitigate these risks.","confidence":1,"confidence_rate":1},{"cnt":[[288,1079],[1876,1079],[1876,1130],[288,1130]],"region":{"top_left_x":287,"top_left_y":1078,"width":1589,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e551d9b013a946559e4982db3792e731","type":"text","conversion_output":true,"text":"Canakinumab showed a dose-related reduction in the occurrence of lung cancer in the CANTOS","text_display":"\n\nCanakinumab showed a dose-related reduction in the occurrence of lung cancer in the CANTOS","confidence":1,"confidence_rate":1},{"cnt":[[288,1126],[1878,1126],[1878,1177],[288,1177]],"region":{"top_left_x":287,"top_left_y":1125,"width":1591,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac7d8b9833f74f8ab603975a96f8c098","type":"text","conversion_output":true,"text":"study, as detailed in Section 2.1 and Section 2.3. Given an expected benefit of a \\(28.4 \\%\\) decrease","text_display":" study, as detailed in Section 2.1 and Section 2.3. Given an expected benefit of a \\(28.4 \\%\\) decrease","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[288,1173],[1878,1173],[1878,1227],[288,1227]],"region":{"top_left_x":287,"top_left_y":1173,"width":1591,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc9f941d6a8148a0bb916710519abb7a","type":"text","conversion_output":true,"text":"in the recurrence of NSCLC and a manageable risk of potential infections, canakinumab has a","text_display":" in the recurrence of NSCLC and a manageable risk of potential infections, canakinumab has a","confidence":1,"confidence_rate":1},{"cnt":[[288,1222],[1377,1222],[1377,1274],[288,1274]],"region":{"top_left_x":287,"top_left_y":1222,"width":1091,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85f7424b48d548cbb014e4f175b1d53d","type":"text","conversion_output":true,"text":"favorable risk-benefit ratio in the defined enrollment population.","text_display":" favorable risk-benefit ratio in the defined enrollment population.","confidence":1,"confidence_rate":1},{"cnt":[[284,1308],[1781,1308],[1781,1371],[284,1371]],"region":{"top_left_x":283,"top_left_y":1308,"width":1499,"height":63},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cf34f1075e740e8b5b6866dcb1b510b","type":"section_header","conversion_output":false,"children_ids":["5bd4ab1dd056497f952a87f97a1599c5"],"text":"","text_display":""},{"cnt":[[288,1313],[1777,1313],[1777,1369],[288,1369]],"region":{"top_left_x":287,"top_left_y":1312,"width":1490,"height":57},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bd4ab1dd056497f952a87f97a1599c5","type":"text","conversion_output":true,"parent_id":"1cf34f1075e740e8b5b6866dcb1b510b","text":"2.7 Rationale for public health emergency mitigation procedures","text_display":"\n\n\\subsection*{2.7 Rationale for public health emergency mitigation procedures}","confidence":0.9762253297851657,"confidence_rate":0.999646211884044},{"cnt":[[288,1384],[1876,1384],[1876,1435],[288,1435]],"region":{"top_left_x":287,"top_left_y":1383,"width":1589,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"458486191d1242ff9253781f1e86243a","type":"text","conversion_output":true,"text":"In the event of a public health emergency as declared by local or regional authorities (i.e.","text_display":"\n\nIn the event of a public health emergency as declared by local or regional authorities (i.e.","confidence":1,"confidence_rate":1},{"cnt":[[288,1433],[1876,1433],[1876,1485],[288,1485]],"region":{"top_left_x":287,"top_left_y":1433,"width":1589,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94b05340705e40b6b6dfe5ecd13991d1","type":"text","conversion_output":true,"text":"pandemic, epidemic or natural disaster,), mitigation procedures may be required to ensure","text_display":" pandemic, epidemic or natural disaster,), mitigation procedures may be required to ensure","confidence":0.99609375,"confidence_rate":0.9999583636399967},{"cnt":[[288,1482],[1876,1482],[1876,1532],[288,1532]],"region":{"top_left_x":287,"top_left_y":1482,"width":1589,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4329eb89f14486ab283611ee9ed14b8","type":"text","conversion_output":true,"text":"subject safety and trial integrity and are listed in relevant sections of the study protocol.","text_display":" subject safety and trial integrity and are listed in relevant sections of the study protocol.","confidence":1,"confidence_rate":1},{"cnt":[[288,1525],[1876,1525],[1876,1579],[288,1579]],"region":{"top_left_x":287,"top_left_y":1525,"width":1589,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2821378ebbd8433cb6e0e1b6a9b48b7f","type":"text","conversion_output":true,"text":"Notification of the public health emergency should be discussed with Novartis/Sponsor prior to","text_display":" Notification of the public health emergency should be discussed with Novartis/Sponsor prior to","confidence":1,"confidence_rate":1},{"cnt":[[288,1577],[1878,1577],[1878,1626],[288,1626]],"region":{"top_left_x":287,"top_left_y":1576,"width":1591,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f82639ade657485bac6278b3b2d9113c","type":"text","conversion_output":true,"text":"implementation of mitigation procedures and permitted/approved by local or regional health","text_display":" implementation of mitigation procedures and permitted/approved by local or regional health","confidence":1,"confidence_rate":1},{"cnt":[[288,1624],[1111,1624],[1111,1676],[288,1676]],"region":{"top_left_x":287,"top_left_y":1624,"width":824,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a061d509c8064831ab82998f356e227e","type":"text","conversion_output":true,"text":"authorities and ethics committees as appropriate.","text_display":" authorities and ethics committees as appropriate.","confidence":1,"confidence_rate":1},{"cnt":[[284,1729],[1070,1729],[1070,1798],[284,1798]],"region":{"top_left_x":283,"top_left_y":1729,"width":787,"height":70},"line":32,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"7cd78608e1dc4155875ab8a1941b99f1","type":"section_header","conversion_output":false,"children_ids":["d66b9f5247c04212aa18220757bf2fc7"],"text":"","text_display":""},{"cnt":[[288,1736],[1063,1736],[1063,1794],[288,1794]],"region":{"top_left_x":287,"top_left_y":1735,"width":777,"height":59},"line":33,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"d66b9f5247c04212aa18220757bf2fc7","type":"text","conversion_output":true,"parent_id":"7cd78608e1dc4155875ab8a1941b99f1","text":"3 Objectives and endpoints","text_display":"\n\n\\section*{3 Objectives and endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[288,1809],[1652,1809],[1652,1863],[288,1863]],"region":{"top_left_x":287,"top_left_y":1808,"width":1366,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c44255c6e3e4472a86f349dca08a124","type":"text","conversion_output":true,"text":"Objectives and related endpoints are described in Table 3-1 and Table 3-2 below.","text_display":"\n\nObjectives and related endpoints are described in Table 3-1 and Table 3-2 below.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-048","page":48,"lines":[{"cnt":[[198,305],[333,305],[333,337],[198,337]],"region":{"top_left_x":197,"top_left_y":305,"width":137,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d7601d951294de19cbb95645aca435e","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1285,305],[1472,305],[1472,337],[1285,337]],"region":{"top_left_x":1284,"top_left_y":305,"width":188,"height":33},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"529da9e6a15e4f85b26ad07c6a6c867d","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2314,305],[2554,305],[2554,346],[2314,346]],"region":{"top_left_x":2313,"top_left_y":305,"width":242,"height":41},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db3e34ed6ecf4931ae4e846ff1dd265f","type":"page_info","conversion_output":false,"text":"Page 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endpoints","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[193,529],[2557,529],[2557,1781],[193,1781]],"region":{"top_left_x":193,"top_left_y":528,"width":2364,"height":1254},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6afa96102e844899c55fa8b48cde774","type":"table","conversion_output":true,"children_ids":["b2bd0ad395324116aa37d9b5311eb472","05878318f3f5412296120d95069d5a8e","d542d325538a43e088eaa00fdbc1d5e6","543b8e3c6d7945f1b27cd798141e4374","5bf95192810b4650baf6a23c4248811a","b0a20d20d29043c385bb67b94ff1787a","c2430b07d80f456a8165f068f481156f","20a222ab46914cf7a2899c5e866167d5","1572cae459c345dab672cd3b981831b3","6793505498804d00bf8cba126472eaf8","38743bd5896a45bab07ad72991c22213","56c3e9f8d4754e4787849b913da284cd","b87a546748f74cdabe47c26cfe28cb40","3753f78a8031483da5d991dd6cb78fa5","83df35ede2214178b8f60fb6a4ef145e","5d34db45966c4500ad55377269f86fc1","960c6e949821487eb56057cf66baa7a5","7e1ef206c1d549caabe6404b8bfe0e00","fd259969f0ac4482a66239ed27dde6ff","aaaa895bd6ee4b26ae9c3afb716f1409","5c4d2a852ce74b5cab5ed38886c2799a","479ccb8b254a4aa9adfa465db9dc3c2a","b2080a89cd9a40dabdc53b090015a549","7b32a9259ad14270a169be0db0315be5","813b2a39c89b4c91953f14997ee65f8c","70bac8b9e7fc44eda603bb510eb68ed6","ae3ee281a7bf467bb272833e69387ccc","40f8acfb679241eabb4d73976935c656","7a3d9c0e8a874d6bba03d07ec3c50361","566f46e43a29412e9540d11fdc70d602","ea9b1c4c9ee743cd95ec5b8f7fbb4273","81ca9443fecf474fbd3df1984093d878","2f7a8ae88af944d29a53015b8b7e2891","7be1c6e4696c4fd7a40e38919bed2a58","8c6613add6cd4dc9902781aedcd811e4","ef04f731aefb4800a823dc17206a3e6e","2079119c86364266a65034a9bac1d9d9"],"selected_labels":["0db4d88ece3a4301a58e4a236ecbbe7a"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Objective & Endpoint & Analysis \\\\\n\\hline \\multicolumn{2}{|l|}{Primary} & Refer to Section 10.4. \\\\\n\\hline The primary objective is to compare the Disease-free survival (DFS) in the canakinumab versus placebo arms as determined by local investigator assessment. & DFS determined by local investigator assessment & \\\\\n\\hline Key secondary & & Refer to Section 10.5.1. \\\\\n\\hline To compare overall survival (OS) in the canakinumab arm versus placebo arm & OS & \\\\\n\\hline Other secondary & & \\begin{tabular}{l}\nRefer to Section 10.5.2, Section 10.5.3, \\\\\nSection 10.5.4, \\\\\nSection 10.5.6,\n\\end{tabular} \\\\\n\\hline 1. 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Subjects must not have had","confidence":1,"confidence_rate":1},{"cnt":[[288,868],[1665,868],[1665,917],[288,917]],"region":{"top_left_x":287,"top_left_y":867,"width":1379,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"383cf4becbf14e37b8d35863eef753ff","type":"text","conversion_output":true,"text":"preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status.","text_display":" preoperative neo-adjuvant chemotherapy or radiotherapy to achieve the R0 status.","confidence":1,"confidence_rate":1},{"cnt":[[288,935],[1878,935],[1878,986],[288,986]],"region":{"top_left_x":287,"top_left_y":934,"width":1591,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83615e4b570a4df0a9439ef7c213ba0b","type":"text","conversion_output":true,"text":"NSCLC subjects who are candidates for complete resection surgery (and therefore prospective","text_display":"\nNSCLC subjects who are candidates for complete resection surgery (and therefore prospective","confidence":1,"confidence_rate":1},{"cnt":[[288,984],[1878,984],[1878,1033],[288,1033]],"region":{"top_left_x":287,"top_left_y":983,"width":1591,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01c50f8d34ae4c6dbf5cea45e076538e","type":"text","conversion_output":true,"text":"candidates for the main study, CACZ885T2301) will be asked to participate in a biomarker sub-","text_display":" candidates for the main study, CACZ885T2301) will be asked to participate in a biomarker sub","confidence":1,"confidence_rate":1},{"cnt":[[288,1027],[1880,1027],[1880,1081],[288,1081]],"region":{"top_left_x":287,"top_left_y":1026,"width":1593,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6b8bb60fd554e089fd7d94e1bf8b6aa","type":"text","conversion_output":true,"text":"study (CACZ885T2301A). Unless otherwise noted that it is specific for the sub-study, the","text_display":"study (CACZ885T2301A). Unless otherwise noted that it is specific for the sub-study, the","confidence":1,"confidence_rate":1},{"cnt":[[288,1079],[1343,1079],[1343,1132],[288,1132]],"region":{"top_left_x":287,"top_left_y":1078,"width":1056,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6229472e86af4ed7b15586c9550fd831","type":"text","conversion_output":true,"text":"protocol will be referring to the conduct of the main study.","text_display":" protocol will be referring to the conduct of the main study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1147],[1880,1147],[1880,1197],[288,1197]],"region":{"top_left_x":287,"top_left_y":1147,"width":1593,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cecdc2de545e40ec9526bfc339718f7b","type":"text","conversion_output":true,"text":"In this sub-study, an additional consent will be obtained to collect pre- and post-surgery blood","text_display":"\nIn this sub-study, an additional consent will be obtained to collect pre- and post-surgery blood","confidence":1,"confidence_rate":1},{"cnt":[[288,1195],[1880,1195],[1880,1246],[288,1246]],"region":{"top_left_x":287,"top_left_y":1194,"width":1593,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c83513afd83542b9b9fcd354e484852e","type":"text","conversion_output":true,"text":"samples to understand how resection surgery may impact hs-CRP, other cytokines and","text_display":" samples to understand how resection surgery may impact hs-CRP, other cytokines and","confidence":1,"confidence_rate":1},{"cnt":[[288,1242],[1128,1242],[1128,1296],[288,1296]],"region":{"top_left_x":287,"top_left_y":1241,"width":841,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"768858fadbeb41e18dede0f123bda0eb","type":"text","conversion_output":true,"text":"additional biomarker levels in blood (Figure 4-2).","text_display":" additional biomarker levels in blood (Figure 4-2).","confidence":1,"confidence_rate":1},{"cnt":[[288,1311],[1880,1311],[1880,1364],[288,1364]],"region":{"top_left_x":287,"top_left_y":1310,"width":1593,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b974e464c2554661a800fe17cb1f4fe3","type":"text","conversion_output":true,"text":"These subjects may later be eligible for the main study after the completion of the post-surgery","text_display":"\nThese subjects may later be eligible for the main study after the completion of the post-surgery","confidence":1,"confidence_rate":1},{"cnt":[[288,1358],[1880,1358],[1880,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1357,"width":1593,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50604a2f0d744414b30df8a9df684e3e","type":"text","conversion_output":true,"text":"standard of care treatment (i.e. cisplatin based chemotherapy with or without radiation). Further","text_display":" standard of care treatment (i.e. cisplatin based chemotherapy with or without radiation). Further","confidence":0.9780378341674805,"confidence_rate":0.9997823087525637},{"cnt":[[288,1405],[941,1405],[941,1459],[288,1459]],"region":{"top_left_x":287,"top_left_y":1405,"width":655,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5d68d2a2d4e4db88c7850a038d31b60","type":"text","conversion_output":true,"text":"details are provided in Section 7.2.4.2.","text_display":" details are provided in Section 7.2.4.2.","confidence":1,"confidence_rate":1},{"cnt":[[288,1474],[1880,1474],[1880,1528],[288,1528]],"region":{"top_left_x":287,"top_left_y":1473,"width":1593,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd76b0109341493d995189dd8000ccdf","type":"text","conversion_output":true,"text":"In the main study, approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200","text_display":"\nIn the main study, approximately 1500 subjects will be randomized \\(1: 1\\) to canakinumab, 200","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,1523],[1876,1523],[1876,1575],[288,1575]],"region":{"top_left_x":287,"top_left_y":1523,"width":1589,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a82ae1b3c3d42759b64cb3c8b3c9308","type":"text","conversion_output":true,"text":"mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1).","text_display":" mg subcutaneously (s.c.) every 3 weeks or matching placebo, s.c., every 3 weeks (Figure 4-1).","confidence":0.9951193332672119,"confidence_rate":0.9999538443097061},{"cnt":[[288,1573],[1878,1573],[1878,1622],[288,1622]],"region":{"top_left_x":287,"top_left_y":1572,"width":1591,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94f4964d68c74cdfa3c9d0fabd637925","type":"text","conversion_output":true,"text":"Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus","text_display":" Randomization will be stratified by AJCC/UICC v. 8 stage: IIA versus IIB versus IIIA versus","confidence":1,"confidence_rate":1},{"cnt":[[288,1620],[1878,1620],[1878,1669],[288,1669]],"region":{"top_left_x":287,"top_left_y":1619,"width":1591,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4229e6c532a4dbd8b8a2737fd8a0919","type":"text","conversion_output":true,"text":"IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region:","text_display":" IIIB with T>5cm, N2 disease; Histology: squamous versus non-squamous; and Region:","confidence":0.5245607446349823,"confidence_rate":0.9925258153611598},{"cnt":[[288,1663],[1880,1663],[1880,1721],[288,1721]],"region":{"top_left_x":287,"top_left_y":1662,"width":1593,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"448c98f7c14a48278e351c3aa00179a5","type":"text","conversion_output":true,"text":"Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW). 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It is postulated that the one year duration of adjuvant treatment will provide an acceptable","text_display":" first. It is postulated that the one year duration of adjuvant treatment will provide an acceptable","confidence":1,"confidence_rate":1},{"cnt":[[288,1955],[1884,1955],[1884,2007],[288,2007]],"region":{"top_left_x":287,"top_left_y":1955,"width":1598,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33be8bb6c8e247baa171ef2654d99dfb","type":"text","conversion_output":true,"text":"benefit in subjects who have intermediate or high risk of developing disease recurrence. If","text_display":" benefit in subjects who have intermediate or high risk of developing disease recurrence. If","confidence":1,"confidence_rate":1},{"cnt":[[288,2002],[1880,2002],[1880,2056],[288,2056]],"region":{"top_left_x":287,"top_left_y":2002,"width":1593,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830c6b6f289b42908183c2c379826910","type":"text","conversion_output":true,"text":"NSCLC disease recurrence is not observed during the treatment phase, subjects will be followed","text_display":" NSCLC disease recurrence is not observed during the treatment phase, subjects will be followed","confidence":0.998046875,"confidence_rate":0.9999802523683627},{"cnt":[[288,2050],[1880,2050],[1880,2103],[288,2103]],"region":{"top_left_x":287,"top_left_y":2049,"width":1593,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b474850db4c481c8d2fad2f04e5faa1","type":"text","conversion_output":true,"text":"until NSCLC disease recurrence, withdrawal of consent by the subject, subject is lost to follow","text_display":" until NSCLC disease recurrence, withdrawal of consent by the subject, subject is lost to follow","confidence":1,"confidence_rate":1},{"cnt":[[288,2099],[1880,2099],[1880,2151],[288,2151]],"region":{"top_left_x":287,"top_left_y":2099,"width":1593,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f336c44d189f452a9f6fdf59aac48638","type":"text","conversion_output":true,"text":"up, death or the sponsor terminates the study for up to five years. All subjects who discontinue","text_display":" up, death or the sponsor terminates the study for up to five years. All subjects who discontinue","confidence":1,"confidence_rate":1},{"cnt":[[288,2144],[1880,2144],[1880,2198],[288,2198]],"region":{"top_left_x":287,"top_left_y":2144,"width":1593,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb1543eab51c4d45aad26194f9b8a439","type":"text","conversion_output":true,"text":"from the study treatment will be followed up every 12 weeks for survival until the final overall","text_display":" from the study treatment will be followed up every 12 weeks for survival until the final overall","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1880,2191],[1880,2245],[288,2245]],"region":{"top_left_x":287,"top_left_y":2191,"width":1593,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8091f029542543d68db1c8c73e4850a0","type":"text","conversion_output":true,"text":"survival (OS) analysis or death, lost to follow-up or withdrawal of consent for survival follow-","text_display":" survival (OS) analysis or death, lost to follow-up or withdrawal of consent for survival follow","confidence":1,"confidence_rate":1},{"cnt":[[277,2247],[350,2247],[350,2299],[277,2299]],"region":{"top_left_x":277,"top_left_y":2247,"width":74,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28f7212b88c1475f98403a8ae75d0430","type":"text","conversion_output":true,"text":"up.","text_display":"up.","confidence":1,"confidence_rate":1},{"cnt":[[288,2310],[1880,2310],[1880,2361],[288,2361]],"region":{"top_left_x":287,"top_left_y":2309,"width":1593,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a50559931fdf46ac9e7709e17b59e58e","type":"text","conversion_output":true,"text":"The purpose of this prospective, multicenter, randomized, double blind, placebo-controlled","text_display":"\nThe purpose of this prospective, multicenter, randomized, double blind, placebo-controlled","confidence":1,"confidence_rate":1},{"cnt":[[288,2359],[1878,2359],[1878,2413],[288,2413]],"region":{"top_left_x":287,"top_left_y":2358,"width":1591,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b6321bb0202405fafa8871d47be9da2","type":"text","conversion_output":true,"text":"phase III study is to evaluate the efficacy and safety of canakinumab as adjuvant therapy,","text_display":" phase III study is to evaluate the efficacy and safety of canakinumab as adjuvant therapy,","confidence":1,"confidence_rate":1},{"cnt":[[288,2406],[1880,2406],[1880,2460],[288,2460]],"region":{"top_left_x":287,"top_left_y":2406,"width":1593,"height":54},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ecf3a5127ce48cc9f9bb01fbc2c6b36","type":"text","conversion_output":true,"text":"following standard of care for completely resected (R0) AJCC/UICC v. 8 stages II-IIIA and","text_display":" following standard of care for completely resected (R0) AJCC/UICC v. 8 stages II-IIIA and","confidence":1,"confidence_rate":1},{"cnt":[[288,2454],[984,2454],[984,2507],[288,2507]],"region":{"top_left_x":287,"top_left_y":2453,"width":697,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a40d8097febc4199809b25479fc01d63","type":"text","conversion_output":true,"text":"stage IIIB ( \\(T >5 cm\\) N2) NSCLC subjects.","text_display":" stage IIIB ( \\(T >5 cm\\) N2) NSCLC subjects.","confidence":0.8333243134193863,"confidence_rate":0.9964997482759622}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-052","page":52,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4f810da877e4d58a5b15d26034c0a5d","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0db6ab58ae945588006efdc457b6baf","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f63899a2b03b4212a8e3ce2a6f0e5a92","type":"page_info","conversion_output":false,"text":"Page 52 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,249],[883,249],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":249,"width":597,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8078bac3d5c4785b555fcf2300d7613","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,249],[1871,249],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":249,"width":457,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c11da3d89aed409a95ed529f9b2778d0","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.9970703125,"confidence_rate":0.9999022052010635},{"cnt":[[290,346],[1878,346],[1878,397],[290,397]],"region":{"top_left_x":290,"top_left_y":345,"width":1588,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f8f8875e56847998894fbe0e88d1246","type":"text","conversion_output":true,"text":"Standard of care includes complete resection of the NSCLC with margins free of cancer. At a","text_display":"\n\nStandard of care includes complete resection of the NSCLC with margins free of cancer. At a","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1876,391],[1876,443],[288,443]],"region":{"top_left_x":287,"top_left_y":391,"width":1589,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd1abaa931a947518f2f1fa2ed9e7eae","type":"text","conversion_output":true,"text":"minimum, two cycles of cisplatin-based doublet chemotherapy are required for all stage IIB-","text_display":" minimum, two cycles of cisplatin-based doublet chemotherapy are required for all stage IIB","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1878,440],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1591,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5217012f5c1e4a25b2a512c44084902c","type":"text","conversion_output":true,"text":"IIIA and IIIB ( \\(T >5 cm N 2\\) ) disease subjects; chemotherapy is recommended but not mandatory","text_display":"IIIA and IIIB ( \\(T >5 cm N 2\\) ) disease subjects; chemotherapy is recommended but not mandatory","confidence":0.6663099186042452,"confidence_rate":0.9961037603707514},{"cnt":[[288,490],[1878,490],[1878,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a86dd7a725f34d7b822adba2e21e6112","type":"text","conversion_output":true,"text":"for stage IIA with no nodal involvement. Radiation therapy is allowed if indicated as per local","text_display":" for stage IIA with no nodal involvement. Radiation therapy is allowed if indicated as per local","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1876,537],[1876,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2be1dabbd9fc4a78b4e39e5fb033720f","type":"text","conversion_output":true,"text":"guidelines or practice. All subjects must have had complete surgical resection of their NSCLC","text_display":" guidelines or practice. 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adaptations}","confidence":0.99365234375,"confidence_rate":0.9998902148495428},{"cnt":[[288,417],[1878,417],[1878,471],[288,471]],"region":{"top_left_x":287,"top_left_y":416,"width":1591,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04340da6f14f4a6b8940403defdd545a","type":"text","conversion_output":true,"text":"One interim analysis (IA) will be performed for DFS for futility when approximately 196 (50\\%)","text_display":"\n\nOne interim analysis (IA) will be performed for DFS for futility when approximately 196 (50\\%)","confidence":0.8206819110782817,"confidence_rate":0.9980452824048431},{"cnt":[[288,468],[1880,468],[1880,518],[288,518]],"region":{"top_left_x":287,"top_left_y":468,"width":1593,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9737b88a7e349d0bafb10904030f79d","type":"text","conversion_output":true,"text":"of the 392 DFS events have been observed. The primary intent of this IA is to determine whether","text_display":" of the 392 DFS events have been observed. The primary intent of this IA is to determine whether","confidence":1,"confidence_rate":1},{"cnt":[[288,516],[1878,516],[1878,565],[288,565]],"region":{"top_left_x":287,"top_left_y":515,"width":1591,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cd8056393234b8aa00bfa829b3a287e","type":"text","conversion_output":true,"text":"there is a need to stop the study early for lack of efficacy (futility, there is no plan to stop the","text_display":" there is a need to stop the study early for lack of efficacy (futility, there is no plan to stop the","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[288,563],[782,563],[782,612],[288,612]],"region":{"top_left_x":287,"top_left_y":562,"width":496,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3af80d980da74dd48d0548d5f0f62c43","type":"text","conversion_output":true,"text":"study for efficacy at this IA).","text_display":" study for efficacy at this IA).","confidence":1,"confidence_rate":1},{"cnt":[[288,629],[1878,629],[1878,681],[288,681]],"region":{"top_left_x":287,"top_left_y":629,"width":1591,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08a9f9789e294503a02b2133e9b87254","type":"text","conversion_output":true,"text":"In addition, a hierarchical testing procedure will be adopted and the statistical tests for OS will","text_display":"\nIn addition, a hierarchical testing procedure will be adopted and the statistical tests for OS will","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[288,679],[1669,679],[1669,728],[288,728]],"region":{"top_left_x":287,"top_left_y":678,"width":1383,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09e5d8bc66cc4400be015626dc91d2ca","type":"text","conversion_output":true,"text":"be performed only if the primary efficacy endpoint DFS is statistically significant.","text_display":" be performed only if the primary efficacy endpoint DFS is statistically significant.","confidence":1,"confidence_rate":1},{"cnt":[[288,748],[1876,748],[1876,797],[288,797]],"region":{"top_left_x":287,"top_left_y":747,"width":1589,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e74093dd80a4ee29e494e5839c603cc","type":"text","conversion_output":true,"text":"A maximum of three analyses are planned for OS (OS will be statistically tested only if DFS","text_display":"\n\nA maximum of three analyses are planned for OS (OS will be statistically tested only if DFS","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[288,795],[1160,795],[1160,846],[288,846]],"region":{"top_left_x":287,"top_left_y":794,"width":874,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"015ae627c0ab42d9987bf21a7b2e433c","type":"text","conversion_output":true,"text":"meets statistical significance at final DFS analysis):","text_display":" meets statistical significance at final DFS analysis):","confidence":0.9975600242614746,"confidence_rate":0.9999585948007728},{"cnt":[[288,851],[1876,851],[1876,904],[288,904]],"region":{"top_left_x":287,"top_left_y":850,"width":1589,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b29de4b92d64dec9e97b76e069fa8a3","type":"text","conversion_output":true,"text":"- At the time of final DFS analysis (provided DFS is statistically significant at final DFS","text_display":"\n- At the time of final DFS analysis (provided DFS is statistically significant at final DFS","confidence":1,"confidence_rate":1},{"cnt":[[352,902],[1706,902],[1706,952],[352,952]],"region":{"top_left_x":352,"top_left_y":902,"width":1354,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"975ed3fae71c4a81a0eca56a354defd1","type":"text","conversion_output":true,"text":"analysis), at which point a total of approximately 318 ( \\(63 \\%\\) ) deaths are expected","text_display":" analysis), at which point a total of approximately 318 ( \\(63 \\%\\) ) deaths are expected","confidence":0.7228013500571251,"confidence_rate":0.9965155380760359},{"cnt":[[288,958],[1880,958],[1880,1010],[288,1010]],"region":{"top_left_x":287,"top_left_y":958,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e1736eb54db4395a2045d98072a6ee7","type":"text","conversion_output":true,"text":"- An additional IA for OS when a total of approximately 418 ( \\(83 \\%\\) ) deaths are expected","text_display":"\n- An additional IA for OS when a total of approximately 418 ( \\(83 \\%\\) ) deaths are expected","confidence":0.8531701216707006,"confidence_rate":0.9983809415595329},{"cnt":[[352,1005],[1579,1005],[1579,1059],[352,1059]],"region":{"top_left_x":352,"top_left_y":1005,"width":1228,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ea50780bc5740bc9ad908a73f98303d","type":"text","conversion_output":true,"text":"(expected 52 months from the date of the first subject being randomized)","text_display":" (expected 52 months from the date of the first subject being randomized)","confidence":1,"confidence_rate":1},{"cnt":[[288,1061],[1876,1061],[1876,1115],[288,1115]],"region":{"top_left_x":287,"top_left_y":1061,"width":1589,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1cd53c4c67044f99fb4617c59595148","type":"text","conversion_output":true,"text":"- A final analysis for OS when approximately 504 deaths are expected (expected 63 months","text_display":"\n- A final analysis for OS when approximately 504 deaths are expected (expected 63 months","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[352,1113],[1231,1113],[1231,1162],[352,1162]],"region":{"top_left_x":352,"top_left_y":1112,"width":880,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da96b3897cb946dea82d48b780d5b321","type":"text","conversion_output":true,"text":"from the date of the first subject being randomized).","text_display":" from the date of the first subject being randomized).","confidence":1,"confidence_rate":1},{"cnt":[[284,1197],[1025,1197],[1025,1261],[284,1261]],"region":{"top_left_x":283,"top_left_y":1196,"width":742,"height":66},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"debad76ea4d34302a05633b64d317863","type":"section_header","conversion_output":false,"children_ids":["9add77322c124d4c8f3c49ecac3f5f54"],"text":"","text_display":""},{"cnt":[[288,1203],[1021,1203],[1021,1257],[288,1257]],"region":{"top_left_x":287,"top_left_y":1203,"width":734,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9add77322c124d4c8f3c49ecac3f5f54","type":"text","conversion_output":true,"parent_id":"debad76ea4d34302a05633b64d317863","text":"4.3 Definition of end of study","text_display":"\n\n\\subsection*{4.3 Definition of end of study}","confidence":1,"confidence_rate":1},{"cnt":[[288,1276],[1880,1276],[1880,1326],[288,1326]],"region":{"top_left_x":287,"top_left_y":1276,"width":1593,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0470574cdb49427895312420e932edbb","type":"text","conversion_output":true,"text":"The primary analysis of DFS will occur when approximately 392 DFS events are reached, (refer","text_display":"\n\nThe primary analysis of DFS will occur when approximately 392 DFS events are reached, (refer","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[288,1323],[1757,1323],[1757,1373],[288,1373]],"region":{"top_left_x":287,"top_left_y":1323,"width":1471,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9dc80a633a644fa84be8db7836025c2","type":"text","conversion_output":true,"text":"to Section 10.4). At this time, the primary clinical study report (CSR) will be produced.","text_display":" to Section 10.4). At this time, the primary clinical study report (CSR) will be produced.","confidence":1,"confidence_rate":1},{"cnt":[[288,1392],[1878,1392],[1878,1442],[288,1442]],"region":{"top_left_x":287,"top_left_y":1392,"width":1591,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ceab1f1f7f04af9a126d0dd181a761b","type":"text","conversion_output":true,"text":"After the primary analysis of DFS, the study will remain open provided the DFS demonstrates","text_display":"\n\nAfter the primary analysis of DFS, the study will remain open provided the DFS demonstrates","confidence":1,"confidence_rate":1},{"cnt":[[288,1439],[1880,1439],[1880,1489],[288,1489]],"region":{"top_left_x":287,"top_left_y":1439,"width":1593,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"262f5da13c8a42afa5981af97112a2ad","type":"text","conversion_output":true,"text":"treatment benefit. Subjects still being followed on the study after the primary analysis time point","text_display":" treatment benefit. Subjects still being followed on the study after the primary analysis time point","confidence":1,"confidence_rate":1},{"cnt":[[288,1487],[1111,1487],[1111,1538],[288,1538]],"region":{"top_left_x":287,"top_left_y":1486,"width":824,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89004386c3ce419cacf234afe7c024b9","type":"text","conversion_output":true,"text":"will continue as per the schedule of assessments.","text_display":" will continue as per the schedule of assessments.","confidence":1,"confidence_rate":1},{"cnt":[[288,1555],[1878,1555],[1878,1605],[288,1605]],"region":{"top_left_x":287,"top_left_y":1555,"width":1591,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccf6ab70f5bb410e9ee7362ffc7f1ce1","type":"text","conversion_output":true,"text":"The study will end once the final OS analysis is performed when approximately 504 deaths are","text_display":"\nThe study will end once the final OS analysis is performed when approximately 504 deaths are","confidence":0.99462890625,"confidence_rate":0.9999461457508662},{"cnt":[[288,1603],[1878,1603],[1878,1652],[288,1652]],"region":{"top_left_x":287,"top_left_y":1602,"width":1591,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35abc5af030a4f8c9ab7111a5463eb7c","type":"text","conversion_output":true,"text":"observed or when statistical significance is reached for OS analysis at interim analysis (refer to","text_display":" observed or when statistical significance is reached for OS analysis at interim analysis (refer to","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[288,1650],[1878,1650],[1878,1704],[288,1704]],"region":{"top_left_x":287,"top_left_y":1650,"width":1591,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d60e2edfbd2e4b6ebcf62847c5d5d447","type":"text","conversion_output":true,"text":"Section 10.7) and the final analysis of study data is conducted. All available data from all","text_display":" Section 10.7) and the final analysis of study data is conducted. All available data from all","confidence":1,"confidence_rate":1},{"cnt":[[288,1697],[1081,1697],[1081,1751],[288,1751]],"region":{"top_left_x":287,"top_left_y":1697,"width":794,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"218a85408f87414fa72159ea5637647a","type":"text","conversion_output":true,"text":"subjects up to this cutoff date will be analyzed.","text_display":" subjects up to this cutoff date will be analyzed.","confidence":1,"confidence_rate":1},{"cnt":[[288,1766],[1876,1766],[1876,1820],[288,1820]],"region":{"top_left_x":287,"top_left_y":1766,"width":1589,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d136958dd5d44220be2332bdd0907639","type":"text","conversion_output":true,"text":"If the primary analysis of DFS does not demonstrate treatment benefit, the follow-up for OS","text_display":"\nIf the primary analysis of DFS does not demonstrate treatment benefit, the follow-up for OS","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[288,1818],[445,1818],[445,1863],[288,1863]],"region":{"top_left_x":287,"top_left_y":1817,"width":158,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35e65a6aaf5545de97f7bbc7f0474b8b","type":"text","conversion_output":true,"text":"will end.","text_display":" will end.","confidence":1,"confidence_rate":1},{"cnt":[[284,1899],[982,1899],[982,1966],[284,1966]],"region":{"top_left_x":283,"top_left_y":1899,"width":699,"height":67},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3731aae59eb24cc48eb4d6604788b890","type":"section_header","conversion_output":false,"children_ids":["90464ab617264efc9ef717e2281bcfba"],"text":"","text_display":""},{"cnt":[[288,1904],[975,1904],[975,1962],[288,1962]],"region":{"top_left_x":287,"top_left_y":1903,"width":689,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90464ab617264efc9ef717e2281bcfba","type":"text","conversion_output":true,"parent_id":"3731aae59eb24cc48eb4d6604788b890","text":"4.4 Early study termination","text_display":"\n\n\\subsection*{4.4 Early study termination}","confidence":0.99462890625,"confidence_rate":0.9998317151010989},{"cnt":[[288,1979],[1876,1979],[1876,2030],[288,2030]],"region":{"top_left_x":287,"top_left_y":1978,"width":1589,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c19433176924fa2a57da6930fbc1c0f","type":"text","conversion_output":true,"text":"The study can be terminated at any time for any reason by Novartis. 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CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,339],[728,339],[728,408],[288,408]],"region":{"top_left_x":287,"top_left_y":339,"width":442,"height":70},"line":6,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"21eefc855d7a4824842e2b2e2a8c11fd","type":"section_header","conversion_output":false,"children_ids":["c82d4137ba6641c6ac7fbbe59665c19a"],"text":"","text_display":""},{"cnt":[[292,346],[724,346],[724,404],[292,404]],"region":{"top_left_x":292,"top_left_y":345,"width":433,"height":59},"line":7,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"c82d4137ba6641c6ac7fbbe59665c19a","type":"text","conversion_output":true,"parent_id":"21eefc855d7a4824842e2b2e2a8c11fd","text":"5 Population","text_display":"\n\n\\section*{5 Population}","confidence":1,"confidence_rate":1},{"cnt":[[288,438],[883,438],[883,501],[288,501]],"region":{"top_left_x":287,"top_left_y":438,"width":597,"height":63},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0337c333b694a178204892c70026fd0","type":"section_header","conversion_output":false,"children_ids":["5cea957c345745eab0e0afe8582421d7"],"text":"","text_display":""},{"cnt":[[292,443],[879,443],[879,496],[292,496]],"region":{"top_left_x":292,"top_left_y":442,"width":587,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cea957c345745eab0e0afe8582421d7","type":"text","conversion_output":true,"parent_id":"f0337c333b694a178204892c70026fd0","text":"5.1 Subject population","text_display":"\n\n\\subsection*{5.1 Subject 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These groups have been","text_display":" NSCLC AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5 cm N2) disease. These groups have been","confidence":0.8535128561561578,"confidence_rate":0.9983514158893757},{"cnt":[[288,610],[1878,610],[1878,660],[288,660]],"region":{"top_left_x":287,"top_left_y":610,"width":1591,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f958167bc9be49adb9b54ce8e4c9dca2","type":"text","conversion_output":true,"text":"included to allow all subjects that are able to achieve complete resection of their cancer with","text_display":" included to allow all subjects that are able to achieve complete resection of their cancer with","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,660],[1880,660],[1880,711],[288,711]],"region":{"top_left_x":287,"top_left_y":659,"width":1593,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55d4bee694c34a7696a6f4080386bed5","type":"text","conversion_output":true,"text":"negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant","text_display":" negative margins (R0 status). The inclusion of these subjects is consistent with other adjuvant","confidence":1,"confidence_rate":1},{"cnt":[[288,709],[1854,709],[1854,758],[288,758]],"region":{"top_left_x":287,"top_left_y":708,"width":1568,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36612f9b5ab64ea5b0bf420093acb821","type":"text","conversion_output":true,"text":"NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials.","text_display":" NSCLC studies as they are at a significant risk of relapse to merit inclusion in adjuvant trials.","confidence":1,"confidence_rate":1},{"cnt":[[288,776],[1878,776],[1878,827],[288,827]],"region":{"top_left_x":287,"top_left_y":775,"width":1591,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7cb5ad01b2a439e884049acf15a6554","type":"text","conversion_output":true,"text":"See inclusion criteria (Section 5.2) for complete information on required adjuvant cisplatin-","text_display":"\nSee inclusion criteria (Section 5.2) for complete information on required adjuvant cisplatin","confidence":1,"confidence_rate":1},{"cnt":[[288,825],[1878,825],[1878,874],[288,874]],"region":{"top_left_x":287,"top_left_y":825,"width":1591,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2b3fc792e394d06bf85fb3aacb05cf9","type":"text","conversion_output":true,"text":"based doublet therapy. Subjects will be randomized after completing adjuvant cisplatin-doublet","text_display":"based doublet therapy. Subjects will be randomized after completing adjuvant cisplatin-doublet","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,872],[984,872],[984,922],[288,922]],"region":{"top_left_x":287,"top_left_y":872,"width":697,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66bcf0acc60444f0b9fd41930c63aa47","type":"text","conversion_output":true,"text":"chemotherapy and meeting entry criteria.","text_display":" chemotherapy and meeting entry criteria.","confidence":1,"confidence_rate":1},{"cnt":[[288,941],[1878,941],[1878,990],[288,990]],"region":{"top_left_x":287,"top_left_y":941,"width":1591,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56255727a6c64dd28b8fdba6f864f39d","type":"text","conversion_output":true,"text":"The investigator or designee must ensure that only subjects who meet all the following inclusion","text_display":"\n\nThe investigator or designee must ensure that only subjects who meet all the following inclusion","confidence":1,"confidence_rate":1},{"cnt":[[288,988],[1429,988],[1429,1040],[288,1040]],"region":{"top_left_x":287,"top_left_y":988,"width":1142,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d0a1aad891c4918aafbf049261e0243","type":"text","conversion_output":true,"text":"and none of the exclusion criteria are offered treatment in the study.","text_display":" and none of the exclusion criteria are offered treatment in the study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1057],[1876,1057],[1876,1106],[288,1106]],"region":{"top_left_x":287,"top_left_y":1057,"width":1589,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1abc9cd423074075a4bbea1838c4f89a","type":"text","conversion_output":true,"text":"Applicable for the sub-study: The sub-study, CACZ885T2301A, will enroll adult subjects","text_display":"\nApplicable for the sub-study: The sub-study, CACZ885T2301A, will enroll adult subjects","confidence":1,"confidence_rate":1},{"cnt":[[288,1104],[1876,1104],[1876,1156],[288,1156]],"region":{"top_left_x":287,"top_left_y":1104,"width":1589,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c3535791b8744f4aae317014a1d7b23","type":"text","conversion_output":true,"text":"with NSCLC Stage IIA-IIIA, IIIB (T>5cm, N2 disease only) who are candidates for complete","text_display":" with NSCLC Stage IIA-IIIA, IIIB (T>5cm, N2 disease only) who are candidates for complete","confidence":0.9513270854949951,"confidence_rate":0.9994636134004156},{"cnt":[[288,1154],[1876,1154],[1876,1205],[288,1205]],"region":{"top_left_x":287,"top_left_y":1153,"width":1589,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bc0eb737876492f976c3fa1c4254b72","type":"text","conversion_output":true,"text":"resection surgery (and therefore prospective candidates for the main study, CACZ885T2301).","text_display":" resection surgery (and therefore prospective candidates for the main study, CACZ885T2301).","confidence":1,"confidence_rate":1},{"cnt":[[288,1199],[1876,1199],[1876,1253],[288,1253]],"region":{"top_left_x":287,"top_left_y":1198,"width":1589,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95ba4edddeab4668bed4d0c89a8ead7f","type":"text","conversion_output":true,"text":"Biomarker samples pre- and post-surgery will be collected from these subjects.","text_display":" Biomarker samples pre- and post-surgery will be collected from these subjects.","confidence":1,"confidence_rate":1},{"cnt":[[288,1248],[1248,1248],[1248,1296],[288,1296]],"region":{"top_left_x":287,"top_left_y":1248,"width":962,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7851c8a945ee44fa90247f0e14ab05dd","type":"text","conversion_output":true,"text":"See Sections 5.2.1 and Section 7.2.4.2 for further details.","text_display":" See Sections 5.2.1 and Section 7.2.4.2 for further details.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[284,1332],[1429,1332],[1429,1399],[284,1399]],"region":{"top_left_x":283,"top_left_y":1332,"width":1146,"height":67},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1266193c21dd44c78702249d374b3e42","type":"section_header","conversion_output":false,"children_ids":["69c4305f1ead43f3bcde23d1207599b3"],"text":"","text_display":""},{"cnt":[[292,1336],[1422,1336],[1422,1394],[292,1394]],"region":{"top_left_x":292,"top_left_y":1336,"width":1131,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69c4305f1ead43f3bcde23d1207599b3","type":"text","conversion_output":true,"parent_id":"1266193c21dd44c78702249d374b3e42","text":"5.2 Inclusion criteria (applicable for main study)","text_display":"\n\n\\subsection*{5.2 Inclusion 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of screening:","confidence":1,"confidence_rate":1},{"cnt":[[292,1512],[1663,1512],[1663,1566],[292,1566]],"region":{"top_left_x":292,"top_left_y":1512,"width":1371,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"501112c3f1f94cbfb246d6f3fbfe3899","type":"text","conversion_output":true,"text":"1. Written informed consent must be obtained prior to any screening procedures.","text_display":"\n1. Written informed consent must be obtained prior to any screening procedures.","confidence":1,"confidence_rate":1},{"cnt":[[288,1568],[614,1568],[614,1620],[288,1620]],"region":{"top_left_x":287,"top_left_y":1568,"width":328,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74a4343ee8744353a489cc25e4dc118b","type":"text","conversion_output":true,"text":"2. Age \\(\\geq 18\\) years","text_display":"\n2. Age \\(\\geq 18\\) years","confidence":1,"confidence_rate":1},{"cnt":[[288,1624],[1878,1624],[1878,1674],[288,1674]],"region":{"top_left_x":287,"top_left_y":1624,"width":1591,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e10918952da4fdd8538ac97e90f284d","type":"text","conversion_output":true,"text":"3a. Completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (T>5cm, N2","text_display":"\n\n3a. Completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (T>5cm, N2","confidence":0.9975595474243164,"confidence_rate":0.9999734412729728},{"cnt":[[352,1671],[1777,1671],[1777,1721],[352,1721]],"region":{"top_left_x":352,"top_left_y":1671,"width":1425,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51aa8e422c6345c1ba9985a3858524d8","type":"text","conversion_output":true,"text":"disease only). Minimal treatments considered adequate prior to study enrollment are:","text_display":" disease only). Minimal treatments considered adequate prior to study enrollment are:","confidence":1,"confidence_rate":1},{"cnt":[[288,1732],[1878,1732],[1878,2262],[288,2262]],"region":{"top_left_x":287,"top_left_y":1731,"width":1591,"height":532},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b666de1c90944c6b10d7cfc4e7c3522","type":"table","conversion_output":true,"children_ids":["d0ff84477797440891168df0784140a4","9c6afd283da9466fb8cec3a1b4d93285","96a4c6a269c843a4bb409b1e6700ca93","5c65e5d854ba438f9da9de2e108fc379","0e5a421567c744d3b19f192ead8e830c","d13d8164a90a45239d0c640b98fdab59","28a4de0a927e4132b3b5452ad21305d2","8e91263e89c54c08bf7b62610822abd9","ac49e404559b45bcaeeaf1271f4c96a9","2f59a51c7043451395bcf9e65aa4f181","6a02330354d94df3bb8d53e46a0ae69a","1ecd3dc4aeed44aebb512666e6f86e36","c681dd368baf449386f40e0dfde230f8","49ea93346d414e1bae1716ea22c17846"],"text":"\\begin{tabular}{|l|l|}\n\\hline Treatment modality & - Minimum extent of treatment required prior to study entry \\\\\n\\hline Surgery & \\begin{tabular}{l}\n- Complete surgical resection (R0) is mandatory for all subjects. \\\\\n- R0 is considered when in microscopic pathology evaluation there are no cancer cells in the surgical margin or within 1 mm of the margin.\n\\end{tabular} \\\\\n\\hline Chemotherapy & \\begin{tabular}{l}\n- Cisplatin-based chemotherapy is mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy can be administered if recommended by the treating physician). \\\\\n- When required, a minimum of two cycles of cisplatin-based chemotherapy is mandatory, after which additional therapies can be given based upon local clinical practice and/or guidelines. \\\\\n- Typically, chemotherapy is initiated within 60 days of surgery.\n\\end{tabular} \\\\\n\\hline Radiation therapy & - Radiation therapy is allowed if indicated as per local guidelines or practice. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Treatment modality & - Minimum extent of treatment required prior to study entry \\\\\n\\hline Surgery & \\begin{tabular}{l}\n- Complete surgical resection (R0) is mandatory for all subjects. \\\\\n- R0 is considered when in microscopic pathology evaluation there are no cancer cells in the surgical margin or within 1 mm of the margin.\n\\end{tabular} \\\\\n\\hline Chemotherapy & \\begin{tabular}{l}\n- Cisplatin-based chemotherapy is mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy can be administered if recommended by the treating physician). \\\\\n- When required, a minimum of two cycles of cisplatin-based chemotherapy is mandatory, after which additional therapies can be given based upon local clinical practice and/or guidelines. \\\\\n- Typically, chemotherapy is initiated within 60 days of surgery.\n\\end{tabular} 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Thoracic radiotherapy to lung fields \\(\\leq 4\\) weeks prior to starting cycle 1 day 1 or subjects who","confidence":0.5998046398162842,"confidence_rate":0.9954056201412176},{"cnt":[[352,982],[1291,982],[1291,1033],[352,1033]],"region":{"top_left_x":352,"top_left_y":981,"width":940,"height":53},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66c88d76e76e4f4a988448ccc174c14c","type":"text","conversion_output":true,"text":"have not recovered from radiotherapy-related toxicities.","text_display":" have not recovered from radiotherapy-related toxicities.","confidence":1,"confidence_rate":1},{"cnt":[[292,1036],[1876,1036],[1876,1085],[292,1085]],"region":{"top_left_x":292,"top_left_y":1035,"width":1584,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26e302c89d5e417b901396b6c7e080fa","type":"text","conversion_output":true,"text":"7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to","text_display":"\n7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to","confidence":1,"confidence_rate":1},{"cnt":[[337,1083],[1876,1083],[1876,1132],[337,1132]],"region":{"top_left_x":337,"top_left_y":1082,"width":1539,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc552fcff72f4723bb740eca57936489","type":"text","conversion_output":true,"text":"randomization or who have not recovered from side effects of such procedure. Video-assisted","text_display":" randomization or who have not recovered from side effects of such procedure. 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Uncontrolled diabetes as defined by the investigator.","text_display":"\n8. Uncontrolled diabetes as defined by the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[288,1289],[1878,1289],[1878,1338],[288,1338]],"region":{"top_left_x":287,"top_left_y":1289,"width":1591,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffdf9cf01fef43dbb93860961c4dcbf2","type":"text","conversion_output":true,"text":"9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or","text_display":"\n9. 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Note: Daily glucocorticoid-replacement for conditions such as adrenal or pituitary","text_display":"\niv. Note: Daily glucocorticoid-replacement for conditions such as adrenal or pituitary","confidence":1,"confidence_rate":1},{"cnt":[[490,2415],[1876,2415],[1876,2464],[490,2464]],"region":{"top_left_x":489,"top_left_y":2414,"width":1387,"height":51},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e67cceda1d284920aa3d5559eaa70d5a","type":"text","conversion_output":true,"text":"insufficiency is allowed. Topical, inhaled or local steroid use in doses that are not","text_display":" insufficiency is allowed. 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Live or attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR,","text_display":"\n12a. Live or attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR,","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[370,498],[1072,498],[1072,546],[370,546]],"region":{"top_left_x":369,"top_left_y":498,"width":704,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a8c037b818841618e8c6550b131c105","type":"text","conversion_output":true,"text":"Yellow Fever, Rotavirus, Smallpox, etc.).","text_display":" Yellow Fever, Rotavirus, Smallpox, etc.).","confidence":1,"confidence_rate":1},{"cnt":[[294,550],[1878,550],[1878,604],[294,604]],"region":{"top_left_x":294,"top_left_y":550,"width":1584,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c25f9a5e24ef490c9a4fbb9e7a147fcb","type":"text","conversion_output":true,"text":"13. 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All eligible subjects will be randomized to one of the following two","text_display":"\n\nThe study is double-blind. All eligible subjects will be randomized to one of the following two","confidence":1,"confidence_rate":1},{"cnt":[[288,1444],[780,1444],[780,1489],[288,1489]],"region":{"top_left_x":287,"top_left_y":1443,"width":493,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31cb6d4bf8c442e08bff09b2c6293e98","type":"text","conversion_output":true,"text":"treatment arms in a 1:1 ratio:","text_display":" treatment arms in a 1:1 ratio:","confidence":0.9248411655426025,"confidence_rate":0.9977701107868016},{"cnt":[[288,1500],[1549,1500],[1549,1551],[288,1551]],"region":{"top_left_x":287,"top_left_y":1499,"width":1263,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d579954b66544bea6276ff0571440a9","type":"text","conversion_output":true,"text":"- Canakinumab 200 mg s.c. on day 1 of every 21 -day cycle for 18 cycles","text_display":"\n- Canakinumab 200 mg s.c. on day 1 of every 21 -day cycle for 18 cycles","confidence":0.8853096961975098,"confidence_rate":0.998647384987397},{"cnt":[[288,1555],[1313,1555],[1313,1609],[288,1609]],"region":{"top_left_x":287,"top_left_y":1555,"width":1026,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cab843c093b4c4e889b421fd5503042","type":"text","conversion_output":true,"text":"- Placebo s.c. on day 1 of every 21 -day cycle for 18 cycles","text_display":"\n- Placebo s.c. on day 1 of every 21 -day cycle for 18 cycles","confidence":0.9033203125,"confidence_rate":0.9986269155970763},{"cnt":[[288,1626],[1876,1626],[1876,1678],[288,1678]],"region":{"top_left_x":287,"top_left_y":1626,"width":1589,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0b31516dc11464f9ed57a69ac063a0d","type":"text","conversion_output":true,"text":"The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21","text_display":"\n\nThe study drug will be given as subcutaneous injections on C1D1 and then every cycle (21","confidence":0.85205078125,"confidence_rate":0.9982798773298882},{"cnt":[[288,1676],[1876,1676],[1876,1725],[288,1725]],"region":{"top_left_x":287,"top_left_y":1675,"width":1589,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d731d7d66835484ba2d974727a35c9d7","type":"text","conversion_output":true,"text":"days) for 18 cycles. 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recommended or mandated in order to allow subjects to continue the study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[288,1989],[1201,1989],[1201,2039],[288,2039]],"region":{"top_left_x":287,"top_left_y":1989,"width":914,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13746c468e094a8a875fd688b74cb3a0","type":"text","conversion_output":true,"text":"There are no dose reductions allowed in this study.","text_display":" There are no dose reductions allowed in this study.","confidence":1,"confidence_rate":1},{"cnt":[[288,2058],[1878,2058],[1878,2108],[288,2108]],"region":{"top_left_x":287,"top_left_y":2058,"width":1591,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0d23d2bd9d2440e9ce46df9b9a8c31a","type":"text","conversion_output":true,"text":"These dose modifications are summarized in Table 6-2. If mandatory dose interruptions are not","text_display":"\n\nThese dose modifications are summarized in Table 6-2. If mandatory dose interruptions are not","confidence":1,"confidence_rate":1},{"cnt":[[288,2105],[1878,2105],[1878,2155],[288,2155]],"region":{"top_left_x":287,"top_left_y":2105,"width":1591,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8453a2ef81c4a4caaf2dca106344bba","type":"text","conversion_output":true,"text":"performed, deviations will be noted. Permanent treatment discontinuation is mandatory for","text_display":" performed, deviations will be noted. Permanent treatment discontinuation is mandatory for","confidence":1,"confidence_rate":1},{"cnt":[[288,2153],[1480,2153],[1480,2202],[288,2202]],"region":{"top_left_x":287,"top_left_y":2152,"width":1194,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87fe7d77bc7c4abdb9b5a6beb27f48d5","type":"text","conversion_output":true,"text":"specific events indicated as such in Table 6-2 or listed in Section 7.1.4.","text_display":" specific events indicated as such in Table 6-2 or listed in Section 7.1.4.","confidence":1,"confidence_rate":1},{"cnt":[[288,2221],[1876,2221],[1876,2275],[288,2275]],"region":{"top_left_x":287,"top_left_y":2221,"width":1589,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4af16f101c5b40b6b8549cb9a53dec2d","type":"text","conversion_output":true,"text":"Scheduled dosing of study drug may, at the discretion of the Investigator, be delayed by up to","text_display":"\n\nScheduled dosing of study drug may, at the discretion of the Investigator, be delayed by up to","confidence":1,"confidence_rate":1},{"cnt":[[288,2271],[1876,2271],[1876,2322],[288,2322]],"region":{"top_left_x":287,"top_left_y":2270,"width":1589,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"406fd805ec7649af88ab506c07a1ed42","type":"text","conversion_output":true,"text":"7 days if subjects present with conditions that require withholding of study drug, e.g., presence","text_display":" 7 days if subjects present with conditions that require withholding of study drug, e.g., presence","confidence":1,"confidence_rate":1},{"cnt":[[288,2316],[1878,2316],[1878,2370],[288,2370]],"region":{"top_left_x":287,"top_left_y":2316,"width":1591,"height":54},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53fd7fa9f5f849149355aa968003edfd","type":"text","conversion_output":true,"text":"of skin ulcer or evidence for active infection (treated or untreated). Outside of this 7 day","text_display":" of skin ulcer or evidence for active infection (treated or untreated). Outside of this 7 day","confidence":1,"confidence_rate":1},{"cnt":[[288,2368],[1876,2368],[1876,2417],[288,2417]],"region":{"top_left_x":287,"top_left_y":2367,"width":1589,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e69bec29b66a4a70bc01d34b26513b66","type":"text","conversion_output":true,"text":"window, the dose will be considered missed. After a dose is missed, the subject should resume","text_display":" window, the dose will be considered missed. After a dose is missed, the subject should resume","confidence":1,"confidence_rate":1},{"cnt":[[288,2415],[1876,2415],[1876,2464],[288,2464]],"region":{"top_left_x":287,"top_left_y":2414,"width":1589,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48a8ec80931d4cfb9b3f2d7e7253c604","type":"text","conversion_output":true,"text":"treatment on the original schedule of study drug administration per C1D1. If a subject requires","text_display":" treatment on the original schedule of study drug administration per C1D1. If a subject requires","confidence":1,"confidence_rate":1},{"cnt":[[288,2462],[1876,2462],[1876,2512],[288,2512]],"region":{"top_left_x":287,"top_left_y":2462,"width":1589,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4daf969abbb94a23bb4dfe1d0b155323","type":"text","conversion_output":true,"text":"a dose interruption of greater than 42 days from the intended day of the next scheduled dose,","text_display":" a dose interruption of greater than 42 days from the intended day of the next scheduled dose,","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-060","page":60,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0b3daaa3041478889e7df9643366c31","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"286d0b12addb424aad88978a89157fc2","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"584b42469d5b48748bf6095bfb5859e6","type":"page_info","conversion_output":false,"text":"Page 60 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4e092f756f4499e964bf66cdcabb8f1","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,251],[1871,251],[1871,290],[1414,290]],"region":{"top_left_x":1413,"top_left_y":251,"width":459,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b32ce017e664523803049a09b79817f","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1876,346],[1876,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ef5b12de5f149859467527a0cb61daf","type":"text","conversion_output":true,"text":"then the subject must be discontinued from the study. Subjects who discontinue the study for a","text_display":"\nthen the subject must be discontinued from the study. Subjects who discontinue the study for a","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[288,391],[1878,391],[1878,443],[288,443]],"region":{"top_left_x":287,"top_left_y":391,"width":1591,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"177ec0de49ac4b4eb86bc7c84ff89502","type":"text","conversion_output":true,"text":"study related adverse event or an abnormal laboratory value must be followed as described in","text_display":" study related adverse event or an abnormal laboratory value must be followed as described in","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[526,443],[526,488],[288,488]],"region":{"top_left_x":287,"top_left_y":442,"width":240,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c2d0619124044cc8c48ce631e821a8c","type":"text","conversion_output":true,"text":"Section 7.1.4.","text_display":" Section 7.1.4.","confidence":0.99951171875,"confidence_rate":0.999974295041004},{"cnt":[[286,507],[479,507],[479,556],[286,556]],"region":{"top_left_x":285,"top_left_y":507,"width":195,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78c1379595e14a1c9f6f758aa64e8dc3","type":"section_header","conversion_output":false,"children_ids":["74092bc0f7d04014bc3e5640282da3ea"],"text":"","text_display":""},{"cnt":[[288,511],[475,511],[475,556],[288,556]],"region":{"top_left_x":287,"top_left_y":511,"width":188,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74092bc0f7d04014bc3e5640282da3ea","type":"text","conversion_output":true,"parent_id":"78c1379595e14a1c9f6f758aa64e8dc3","text":"Infections","text_display":"\n\n\\section*{Infections}","confidence":1,"confidence_rate":1},{"cnt":[[288,576],[1876,576],[1876,629],[288,629]],"region":{"top_left_x":287,"top_left_y":575,"width":1589,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b149f429e6d942ccbd2169c8d5708a63","type":"text","conversion_output":true,"text":"Infections are the most common adverse event and may be related to study medication. Subjects","text_display":"\n\nInfections are the most common adverse event and may be related to study medication. Subjects","confidence":1,"confidence_rate":1},{"cnt":[[288,627],[1878,627],[1878,677],[288,677]],"region":{"top_left_x":287,"top_left_y":627,"width":1591,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2708af22bb7d447696a71d68041a7d16","type":"text","conversion_output":true,"text":"should be followed closely for any signs or symptoms of infection and receive prompt","text_display":" should be followed closely for any signs or symptoms of infection and receive prompt","confidence":1,"confidence_rate":1},{"cnt":[[288,675],[1878,675],[1878,724],[288,724]],"region":{"top_left_x":287,"top_left_y":674,"width":1591,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"135e27b54f1a42dda0eaa6f6faa8fbfd","type":"text","conversion_output":true,"text":"appropriate treatment for any suspected infection. Respiratory infections are common in","text_display":" appropriate treatment for any suspected infection. Respiratory infections are common in","confidence":0.9970703125,"confidence_rate":0.9999681093407484},{"cnt":[[288,722],[1876,722],[1876,776],[288,776]],"region":{"top_left_x":287,"top_left_y":721,"width":1589,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"487e0b984931403ea07c3c7d352d7db6","type":"text","conversion_output":true,"text":"subjects who have had lung cancer, in part due to underlying lung diseases such as chronic","text_display":" subjects who have had lung cancer, in part due to underlying lung diseases such as chronic","confidence":1,"confidence_rate":1},{"cnt":[[288,769],[1876,769],[1876,821],[288,821]],"region":{"top_left_x":287,"top_left_y":769,"width":1589,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfdf2f6ab4d242fabcb65d28536654af","type":"text","conversion_output":true,"text":"obstructive pulmonary disease and other smoking or second-hand smoke related lung diseases.","text_display":" obstructive pulmonary disease and other smoking or second-hand smoke related lung diseases.","confidence":1,"confidence_rate":1},{"cnt":[[288,816],[1878,816],[1878,870],[288,870]],"region":{"top_left_x":287,"top_left_y":816,"width":1591,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26c62f784fe1421fa2029739a8a7c788","type":"text","conversion_output":true,"text":"Subjects will have a urinalysis performed at every study visit (screening and throughout the","text_display":" Subjects will have a urinalysis performed at every study visit (screening and throughout the","confidence":1,"confidence_rate":1},{"cnt":[[288,868],[1876,868],[1876,917],[288,917]],"region":{"top_left_x":287,"top_left_y":867,"width":1589,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f22011000a1a4655bdadd6417a387e82","type":"text","conversion_output":true,"text":"study treatment); occult urinary tract infections, if not promptly treated may result in urosepsis.","text_display":" study treatment); occult urinary tract infections, if not promptly treated may result in urosepsis.","confidence":1,"confidence_rate":1},{"cnt":[[288,915],[1882,915],[1882,965],[288,965]],"region":{"top_left_x":287,"top_left_y":915,"width":1596,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"112a5794b09d4844bfd190c723ded90d","type":"text","conversion_output":true,"text":"Site personnel should be aware of this concern and review urinalysis results and take action if","text_display":" Site personnel should be aware of this concern and review urinalysis results and take action if","confidence":1,"confidence_rate":1},{"cnt":[[288,962],[1351,962],[1351,1016],[288,1016]],"region":{"top_left_x":287,"top_left_y":962,"width":1065,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"183a2324b52443c3b7b47a3e6fac7a0a","type":"text","conversion_output":true,"text":"treatment of the subject for a urinary tract infection is required.","text_display":" treatment of the subject for a urinary tract infection is required.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-061","page":61,"lines":[{"cnt":[[198,305],[333,305],[333,339],[198,339]],"region":{"top_left_x":197,"top_left_y":305,"width":137,"height":35},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce06b2e72ecd43639fbafeb5290461cc","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1283,305],[1472,305],[1472,337],[1283,337]],"region":{"top_left_x":1282,"top_left_y":305,"width":190,"height":33},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1826b2ee570944deafd194f2e18ea0c9","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2312,305],[2554,305],[2554,346],[2312,346]],"region":{"top_left_x":2311,"top_left_y":305,"width":244,"height":41},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b273e0470a4a476692ef6bc929a765c9","type":"page_info","conversion_output":false,"text":"Page 61 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,350],[793,350],[793,393],[196,393]],"region":{"top_left_x":195,"top_left_y":350,"width":598,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"001271a80b1c4a3ebc4a8dd4737ed5f3","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2097,352],[2552,352],[2552,389],[2097,389]],"region":{"top_left_x":2096,"top_left_y":352,"width":457,"height":37},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e90d93457fb547a88713f596f38588e1","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[198,481],[2041,481],[2041,529],[198,529]],"region":{"top_left_x":197,"top_left_y":481,"width":1845,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f7b8b8eb3cd4617a7012ec562341c3e","type":"figure_label","conversion_output":false,"text":"Table 6-2 Criteria for dose interruption and re-initiation of treatment for adverse drug reactions","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[198,533],[2557,533],[2557,1611],[198,1611]],"region":{"top_left_x":197,"top_left_y":532,"width":2360,"height":1080},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6876f7c91ac49fabd799827e919a480","type":"table","conversion_output":true,"children_ids":["e6a7dab092dc4c809bfaf1a7b2ef0190","9c2c0acc7c224aedb4634591dfa97e27","4d0351b1d9e34238a3566cffb27456be","7fc76fc1fb3c4fe7a99bf49c6b3d4f18","46c488788a614ba68569d9bcd62a30dc","3826f2975ed9483fa1b61944616cad43","28f715d294f24fa48da98c5a4cffcdcd","3905932d668645639b83a76a463484c8","d871c49a0273422980c60536b24ab87b","54afa5fc23044c42b524363a3551d109","9d06f0751bb642f58586b05d4cc101e7","10527806813b4badbd96d280efb29eb5","557e8a73439b4abf90c08c8cf1607628","9ae22a3d03bc4a9b87b8503186d2bf6a","8a137054888e4208b52a926aeac02053","63fe3d85b5b14c5388087934a154d99f","9ff6490ce74e4831828da04fdf9846e1","10d9cb23bbbe435d8eac1e2c8d52a1ca","7c87303989524c5a8507117e7168e063","9d109d0fe6c64e71be25e2da012f4095","e2be896f0b49435993611b7ef741275e","0e17594676eb42eb937e66edd2404eb4","e52d35342c1f42ecb893e73aa0ad9e5b","3d2fd0819a514c6b99177d746ea338f6"],"selected_labels":["4f7b8b8eb3cd4617a7012ec562341c3e"],"text":"\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|l|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline \\begin{tabular}{l}\nInfections fall under many CTC terms \\\\\nGrade 1 \\\\\nGrade 2 \\\\\nGrade 3 \\\\\nGrade 4\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: maintain dose level \\\\\nRecommendation: maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 2, then maintain dose level \\\\\nMandatory: Permanently discontinue study medication\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|l|}{Investigations (Hematologic)} \\\\\n\\hline \\multicolumn{2}{|l|}{Neutropenia (ANC)} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (ANC < LLN - 1500/mm3) \\\\\nGrade 2 (ANC < 1500-1000/mm3) \\\\\nGrade 3 (ANC < 1000-500/mm3) \\\\\nGrade 4 (ANC < 500/mm3)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nMandatory: Omit dose until resolved to \\(\\leq\\) Grade 2, then maintain dose level \\\\\nMandatory: Permanently Discontinue study medication\n\\end{tabular} \\\\\n\\hline Febrile neutropenia (ANC \\(< 1 . 0 \\times 1 0 9 / L\\), fever \\(\\geq 38.5^{\\circ} C\\) ) & Mandatory: Permanently Discontinue study medication \\\\\n\\hline \\multicolumn{2}{|l|}{Thrombocytopenia} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (PLT < LLN - 75,000/mm3) \\\\\nGrade 2 (PLT < 75,000-50,000/mm3) \\\\\nGrade 3 (PLT < 50,000-25,000/mm3) \\\\\nGrade 4 (PLT < 25,000/mm3)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 1, then: \\\\\nIf resolved in \\(\\leq 7\\) days, then maintain dose level If resolved in \\(>7\\) days, permanently discontinue study medication (mandatory) \\\\\nMandatory: permanently discontinue study medication\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6-2 Criteria for dose interruption and re-initiation of treatment for adverse drug reactions}\n\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|l|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline \\begin{tabular}{l}\nInfections fall under many CTC terms \\\\\nGrade 1 \\\\\nGrade 2 \\\\\nGrade 3 \\\\\nGrade 4\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: maintain dose level \\\\\nRecommendation: maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 2, then maintain dose level \\\\\nMandatory: Permanently discontinue study medication\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|l|}{Investigations (Hematologic)} \\\\\n\\hline \\multicolumn{2}{|l|}{Neutropenia (ANC)} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (ANC < LLN - 1500/mm3) \\\\\nGrade 2 (ANC < 1500-1000/mm3) \\\\\nGrade 3 (ANC < 1000-500/mm3) \\\\\nGrade 4 (ANC < 500/mm3)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nMandatory: Omit dose until resolved to \\(\\leq\\) Grade 2, then maintain dose level \\\\\nMandatory: Permanently Discontinue study medication\n\\end{tabular} \\\\\n\\hline Febrile neutropenia (ANC \\(< 1 . 0 \\times 1 0 9 / L\\), fever \\(\\geq 38.5^{\\circ} C\\) ) & Mandatory: Permanently Discontinue study medication \\\\\n\\hline \\multicolumn{2}{|l|}{Thrombocytopenia} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (PLT < LLN - 75,000/mm3) \\\\\nGrade 2 (PLT < 75,000-50,000/mm3) \\\\\nGrade 3 (PLT < 50,000-25,000/mm3) \\\\\nGrade 4 (PLT < 25,000/mm3)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 1, then: \\\\\nIf resolved in \\(\\leq 7\\) days, then maintain dose level If resolved in \\(>7\\) days, permanently discontinue study medication (mandatory) \\\\\nMandatory: permanently discontinue study medication\n\\end{tabular} 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1 (PLT < LLN - 75,000/mm3) \\\\\nGrade 2 (PLT < 75,000-50,000/mm3) \\\\\nGrade 3 (PLT < 50,000-25,000/mm3) \\\\\nGrade 4 (PLT < 25,000/mm3)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nGrade 1 (PLT < LLN - 75,000/mm3) \\\\\nGrade 2 (PLT < 75,000-50,000/mm3) \\\\\nGrade 3 (PLT < 50,000-25,000/mm3) \\\\\nGrade 4 (PLT < 25,000/mm3)\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.6925642490386963,"confidence_rate":0.997239665692608},{"cnt":[[221,1320],[719,1320],[719,1359],[221,1359]],"region":{"top_left_x":220,"top_left_y":1320,"width":499,"height":40},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"135d8fe59c87444b84b909fbc790d992","type":"text","conversion_output":false,"parent_id":"e52d35342c1f42ecb893e73aa0ad9e5b","text":"Grade 1 (PLT < LLN - 75,000/mm3)","text_display":"Grade 1 (PLT < LLN - 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discontinue study medication\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 1, then: \\\\\nIf resolved in \\(\\leq 7\\) days, then maintain dose level If resolved in \\(>7\\) days, permanently discontinue study medication (mandatory) \\\\\nMandatory: permanently discontinue study medication\n\\end{tabular}","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970722198486328,"confidence_rate":0.9999941824088198},{"cnt":[[1050,1320],[1390,1320],[1390,1359],[1050,1359]],"region":{"top_left_x":1050,"top_left_y":1320,"width":341,"height":40},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48801a7dd6e54c809d6ca0d3f274b6aa","type":"text","conversion_output":false,"parent_id":"3d2fd0819a514c6b99177d746ea338f6","text":"May maintain dose level","text_display":"May maintain dose 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\\begin{tabular}{l}\nNovartis \\\\\nAmended Protocol Version 03 (Clean)\n\\end{tabular} & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline \\multicolumn{2}{|c|}{Investigations (Renal)} \\\\\n\\hline \\multicolumn{2}{|c|}{Serum creatinine} \\\\\n\\hline Grade 1 (> ULN - 1.5 x ULN) & May maintain dose level \\\\\n\\hline \\begin{tabular}{l}\nGrade 2 (> 1.5-3.0 x ULN) \\\\\nGrade 3 (> 3.0-6.0 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: May maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 2 or baseline. \\\\\nIf not resolved within 14 days, then permanently discontinue subject from study drug treatment\n\\end{tabular} \\\\\n\\hline Grade 4 (> 6.0 x ULN) & Mandatory: Discontinue subject from study drug treatment \\\\\n\\hline \\multicolumn{2}{|c|}{Investigations (Hepatic)} \\\\\n\\hline \\multicolumn{2}{|c|}{Isolated total Bilirubin elevation} \\\\\n\\hline \\begin{tabular}{l}\nAny elevation > ULN: \\\\\nGrade 2 (> 1.5-3.0x ULN) \\\\\nGrade 3 (> 3.0-10.0x ULN)* \\\\\nGrade 4 (> 10.0 x ULN)*\n\\end{tabular} & \\begin{tabular}{l}\n- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to local institutional guidelines. \\\\\n- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- See footnote** - otherwise discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|l|}{*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.} \\\\\n\\hline \\multicolumn{2}{|c|}{**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should therefore, be ruled out before basing dose modification decisions on bilirubin values alone.} \\\\\n\\hline \\multicolumn{2}{|c|}{Isolated AST or ALT elevation} \\\\\n\\hline \\begin{tabular}{l}\nWith normal baseline AST/ALT: \\\\\n> ULN - 3.0 x ULN\n\\end{tabular} & Recommendation: Maintain dose level \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\begin{tabular}{l}\nNovartis \\\\\nAmended Protocol Version 03 (Clean)\n\\end{tabular} & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline \\multicolumn{2}{|c|}{Investigations (Renal)} \\\\\n\\hline \\multicolumn{2}{|c|}{Serum creatinine} \\\\\n\\hline Grade 1 (> ULN - 1.5 x ULN) & May maintain dose level \\\\\n\\hline \\begin{tabular}{l}\nGrade 2 (> 1.5-3.0 x ULN) \\\\\nGrade 3 (> 3.0-6.0 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: May maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 2 or baseline. \\\\\nIf not resolved within 14 days, then permanently discontinue subject from study drug treatment\n\\end{tabular} \\\\\n\\hline Grade 4 (> 6.0 x ULN) & Mandatory: Discontinue subject from study drug treatment \\\\\n\\hline \\multicolumn{2}{|c|}{Investigations (Hepatic)} \\\\\n\\hline \\multicolumn{2}{|c|}{Isolated total Bilirubin elevation} \\\\\n\\hline \\begin{tabular}{l}\nAny elevation > ULN: \\\\\nGrade 2 (> 1.5-3.0x ULN) \\\\\nGrade 3 (> 3.0-10.0x ULN)* \\\\\nGrade 4 (> 10.0 x ULN)*\n\\end{tabular} & \\begin{tabular}{l}\n- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to local institutional guidelines. \\\\\n- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- See footnote** - otherwise discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|l|}{*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.} \\\\\n\\hline \\multicolumn{2}{|c|}{**An isolated bilirubin elevation is not typical for drug-induced liver injury. 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level","confidence":1,"confidence_rate":1},{"cnt":[[1051,792],[2006,792],[2006,826],[1051,826]],"region":{"top_left_x":1050,"top_left_y":791,"width":956,"height":36},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"751367479d194e74993ea6201762e21d","type":"text","conversion_output":false,"parent_id":"c530012e772b41eda1d46cd675988b2a","text":"Recommendation: Omit dose until resolved to \\(\\leq\\) Grade 2 or baseline.","text_display":"\nRecommendation: Omit dose until resolved to \\(\\leq\\) Grade 2 or baseline.","confidence":1,"confidence_rate":1},{"cnt":[[1051,835],[2361,835],[2361,872],[1051,872]],"region":{"top_left_x":1050,"top_left_y":835,"width":1311,"height":37},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"166d2bdd1a4b4795b658a2c9006f76bb","type":"text","conversion_output":false,"parent_id":"c530012e772b41eda1d46cd675988b2a","text":"If not resolved within 14 days, then permanently discontinue subject from study drug treatment","text_display":"\nIf not resolved within 14 days, then permanently discontinue subject from study drug treatment","confidence":1,"confidence_rate":1},{"cnt":[[219,883],[531,883],[531,919],[219,919]],"region":{"top_left_x":218,"top_left_y":882,"width":313,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c803bad54634ad9bdde7d23f25885ca","type":"simple_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","text":"Grade 4 (> 6.0 x ULN)","text_display":"Grade 4 (> 6.0 x ULN)","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1051,883],[1863,883],[1863,919],[1051,919]],"region":{"top_left_x":1050,"top_left_y":882,"width":813,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2203d90fb84c4fb7be6b6840750b9e2b","type":"simple_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","text":"Mandatory: Discontinue subject from study drug treatment","text_display":"Mandatory: Discontinue subject from study drug treatment","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[215,928],[2556,928],[2556,969],[215,969]],"region":{"top_left_x":214,"top_left_y":928,"width":2342,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec33fa4274874d0aa2c8ae18f30fa16f","type":"table_spanning_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["1a41a3215cad4b01a7fd6967fc7c5483"],"text":"","text_display":"Investigations (Hepatic)","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[219,930],[576,930],[576,967],[219,967]],"region":{"top_left_x":218,"top_left_y":930,"width":359,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a41a3215cad4b01a7fd6967fc7c5483","type":"simple_cell","conversion_output":false,"parent_id":"ec33fa4274874d0aa2c8ae18f30fa16f","text":"Investigations (Hepatic)","text_display":"Investigations (Hepatic)","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[215,978],[2556,978],[2556,1013],[215,1013]],"region":{"top_left_x":214,"top_left_y":977,"width":2342,"height":36},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce1ab79ed743438fb65f491e4b4c0ceb","type":"table_spanning_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["8b732afb5da24c6cab65b4cf17340e2a"],"text":"","text_display":"Isolated total Bilirubin elevation","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[219,978],[698,978],[698,1010],[219,1010]],"region":{"top_left_x":218,"top_left_y":977,"width":480,"height":34},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b732afb5da24c6cab65b4cf17340e2a","type":"simple_cell","conversion_output":false,"parent_id":"ce1ab79ed743438fb65f491e4b4c0ceb","text":"Isolated total Bilirubin elevation","text_display":"Isolated total Bilirubin elevation","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[212,1026],[639,1026],[639,1409],[212,1409]],"region":{"top_left_x":212,"top_left_y":1025,"width":428,"height":384},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01037d07f16146b7a9281c479b9a6ef9","type":"complex_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["74d4e297edf14a5f9a0ce3d07619ced6","cf1e4d6d50a6459f89fdeb890116de1b","6b6a47b972284260bca39b300897d119","e3218f379c9c478d835ba996dc6541cf"],"text":"\\begin{tabular}{l}\nAny elevation > ULN: \\\\\nGrade 2 (> 1.5-3.0x ULN) \\\\\nGrade 3 (> 3.0-10.0x ULN)* \\\\\nGrade 4 (> 10.0 x ULN)*\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAny elevation > ULN: \\\\\nGrade 2 (> 1.5-3.0x ULN) \\\\\nGrade 3 (> 3.0-10.0x ULN)* \\\\\nGrade 4 (> 10.0 x ULN)*\n\\end{tabular}","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.5609144415939227,"confidence_rate":0.9936915501283762},{"cnt":[[219,1026],[520,1026],[520,1065],[219,1065]],"region":{"top_left_x":218,"top_left_y":1025,"width":302,"height":40},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74d4e297edf14a5f9a0ce3d07619ced6","type":"text","conversion_output":false,"parent_id":"01037d07f16146b7a9281c479b9a6ef9","text":"Any elevation > ULN:","text_display":"Any elevation > ULN:","confidence":0.9638671875,"confidence_rate":0.9985290123178903},{"cnt":[[219,1147],[602,1147],[602,1188],[219,1188]],"region":{"top_left_x":218,"top_left_y":1146,"width":385,"height":43},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf1e4d6d50a6459f89fdeb890116de1b","type":"text","conversion_output":false,"parent_id":"01037d07f16146b7a9281c479b9a6ef9","text":"Grade 2 (> 1.5-3.0x ULN)","text_display":"\nGrade 2 (> 1.5-3.0x ULN)","confidence":0.8833857944506462,"confidence_rate":0.9961327079194922},{"cnt":[[219,1285],[637,1285],[637,1322],[219,1322]],"region":{"top_left_x":218,"top_left_y":1285,"width":419,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b6a47b972284260bca39b300897d119","type":"text","conversion_output":false,"parent_id":"01037d07f16146b7a9281c479b9a6ef9","text":"Grade 3 (> 3.0-10.0x ULN)*","text_display":"\nGrade 3 (> 3.0-10.0x ULN)*","confidence":0.5609144415939227,"confidence_rate":0.983138280377803},{"cnt":[[219,1368],[563,1368],[563,1409],[219,1409]],"region":{"top_left_x":218,"top_left_y":1367,"width":346,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3218f379c9c478d835ba996dc6541cf","type":"text","conversion_output":false,"parent_id":"01037d07f16146b7a9281c479b9a6ef9","text":"Grade 4 (> 10.0 x ULN)*","text_display":"\nGrade 4 (> 10.0 x ULN)*","confidence":0.9042163286358118,"confidence_rate":0.9970430086063689},{"cnt":[[1046,1028],[2540,1028],[2540,1411],[1046,1411]],"region":{"top_left_x":1046,"top_left_y":1027,"width":1495,"height":385},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b4411fc52684319b5a0f09a93b3b08b","type":"complex_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["bafb0844f2564e2190b38560c39f3ce8","70998cd10b5a439fa15bfc319fe7d131","9e4c9315587e42c1b06a1d910c974663","cb045f3e6c684cb989ec3f46e0647ebe","caa38a3ca4fa457d99ab7b7268e34796","489c8bc85e604119b68bb10c488d4e09","5eb2bfba407e49d9b35aa2e00d3b606f","c4f762d4d31645028777746e82506fb0"],"text":"\\begin{tabular}{l}\n- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to local institutional guidelines. \\\\\n- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- See footnote** - otherwise discontinue study treatment.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation (e.g. disease progression [imaging]). Treat alternative causes according to local institutional guidelines. \\\\\n- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\) Grade 1 or to baseline. \\\\\n- See footnote** - otherwise discontinue study treatment.\n\\end{tabular}","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.95607590675354,"confidence_rate":0.9999480927034023},{"cnt":[[1051,1030],[2534,1030],[2534,1067],[1051,1067]],"region":{"top_left_x":1050,"top_left_y":1029,"width":1484,"height":38},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bafb0844f2564e2190b38560c39f3ce8","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation","text_display":"- Fractionate bilirubin, evaluate for cholestatic liver injury (ALP) or alternative causes of bilirubin elevation","confidence":1,"confidence_rate":1},{"cnt":[[1113,1065],[2382,1065],[2382,1106],[1113,1106]],"region":{"top_left_x":1113,"top_left_y":1064,"width":1270,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70998cd10b5a439fa15bfc319fe7d131","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"(e.g. disease progression [imaging]). Treat alternative causes according to local institutional","text_display":" (e.g. disease progression [imaging]). Treat alternative causes according to local institutional","confidence":1,"confidence_rate":1},{"cnt":[[1111,1104],[1269,1104],[1269,1140],[1111,1140]],"region":{"top_left_x":1111,"top_left_y":1103,"width":159,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e4c9315587e42c1b06a1d910c974663","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"guidelines.","text_display":" guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[1051,1149],[2486,1149],[2486,1188],[1051,1188]],"region":{"top_left_x":1050,"top_left_y":1149,"width":1437,"height":40},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb045f3e6c684cb989ec3f46e0647ebe","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\)","text_display":"\n- Maintain treatment. Repeat LFTs \\({ }^{\\text {b }}\\) within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\)","confidence":0.95607590675354,"confidence_rate":0.9996288460127634},{"cnt":[[1113,1186],[1434,1186],[1434,1218],[1113,1218]],"region":{"top_left_x":1113,"top_left_y":1185,"width":321,"height":34},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"caa38a3ca4fa457d99ab7b7268e34796","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"Grade 1 or to baseline.","text_display":" Grade 1 or to baseline.","confidence":0.9990234375,"confidence_rate":0.9999684830886739},{"cnt":[[1051,1290],[2482,1290],[2482,1327],[1051,1327]],"region":{"top_left_x":1050,"top_left_y":1289,"width":1432,"height":38},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"489c8bc85e604119b68bb10c488d4e09","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\)","text_display":"\n- Interrupt treatment. Repeat LFTs within 48-72 hours, then monitor LFTs weekly until resolution to \\(\\leq\\)","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[1113,1324],[1434,1324],[1434,1357],[1113,1357]],"region":{"top_left_x":1113,"top_left_y":1324,"width":321,"height":33},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5eb2bfba407e49d9b35aa2e00d3b606f","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"Grade 1 or to baseline.","text_display":" Grade 1 or to baseline.","confidence":1,"confidence_rate":1},{"cnt":[[1051,1372],[1867,1372],[1867,1409],[1051,1409]],"region":{"top_left_x":1050,"top_left_y":1372,"width":817,"height":37},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4f762d4d31645028777746e82506fb0","type":"text","conversion_output":false,"parent_id":"9b4411fc52684319b5a0f09a93b3b08b","text":"- See footnote** - otherwise discontinue study treatment.","text_display":"\n- See footnote** - otherwise discontinue study treatment.","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[212,1415],[2556,1415],[2556,1498],[212,1498]],"region":{"top_left_x":212,"top_left_y":1415,"width":2344,"height":83},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19f26e77b1864901a5c53d81d2fa3885","type":"table_spanning_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["f9ce991d01784875a6d0c27441736555"],"text":"","text_display":"*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[215,1418],[2421,1418],[2421,1496],[215,1496]],"region":{"top_left_x":214,"top_left_y":1417,"width":2208,"height":79},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9ce991d01784875a6d0c27441736555","type":"complex_cell","conversion_output":false,"parent_id":"19f26e77b1864901a5c53d81d2fa3885","children_ids":["49e0bbec838a477e8546360a5f9a6f13","52eb3fe2de034436a741e638bb727f8b"],"text":"*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.","text_display":"*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.4772115661751286,"confidence_rate":0.9978264968054962},{"cnt":[[219,1420],[2417,1420],[2417,1457],[219,1457]],"region":{"top_left_x":218,"top_left_y":1419,"width":2199,"height":38},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49e0bbec838a477e8546360a5f9a6f13","type":"text","conversion_output":false,"parent_id":"f9ce991d01784875a6d0c27441736555","text":"*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional","text_display":"*Note: If total bilirubin > \\(3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional","confidence":0.4772115661751286,"confidence_rate":0.995657717727129},{"cnt":[[219,1454],[2114,1454],[2114,1496],[219,1496]],"region":{"top_left_x":218,"top_left_y":1454,"width":1896,"height":42},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52eb3fe2de034436a741e638bb727f8b","type":"text","conversion_output":false,"parent_id":"f9ce991d01784875a6d0c27441736555","text":"guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.","text_display":" guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[199,1500],[2543,1500],[2543,1651],[199,1651]],"region":{"top_left_x":199,"top_left_y":1499,"width":2344,"height":153},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"caa00fc49aa0443184868e50d5086b52","type":"table_spanning_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["9a5eef3fadcc4e7ab476eaa7bbcedd00"],"text":"","text_display":"**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should therefore, be ruled out before basing dose modification decisions on bilirubin values alone.","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[204,1502],[2540,1502],[2540,1651],[204,1651]],"region":{"top_left_x":203,"top_left_y":1502,"width":2338,"height":150},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a5eef3fadcc4e7ab476eaa7bbcedd00","type":"complex_cell","conversion_output":false,"parent_id":"caa00fc49aa0443184868e50d5086b52","children_ids":["969f5f1cd2974ac7bb391c35722cb949","012791b00bac49d59dcead30e93a63db","be1ee20ddbab4ca994d51f23023655bd","6436058c1bb24484b4bd2cfc26eb373b"],"text":"**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should therefore, be ruled out before basing dose modification decisions on bilirubin values alone.","text_display":"**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should therefore, be ruled out before basing dose modification decisions on bilirubin values alone.","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.91064453125,"confidence_rate":0.9998606873023657},{"cnt":[[219,1504],[2530,1504],[2530,1543],[219,1543]],"region":{"top_left_x":218,"top_left_y":1504,"width":2312,"height":40},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"969f5f1cd2974ac7bb391c35722cb949","type":"text","conversion_output":false,"parent_id":"9a5eef3fadcc4e7ab476eaa7bbcedd00","text":"**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation","text_display":"**An isolated bilirubin elevation is not typical for drug-induced liver injury. Bilirubin can be elevated either as part of a \"Hy's law\" constellation with a preceding elevation","confidence":0.91064453125,"confidence_rate":0.9994858319325772},{"cnt":[[219,1541],[2499,1541],[2499,1578],[219,1578]],"region":{"top_left_x":218,"top_left_y":1540,"width":2282,"height":38},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"012791b00bac49d59dcead30e93a63db","type":"text","conversion_output":false,"parent_id":"9a5eef3fadcc4e7ab476eaa7bbcedd00","text":"of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction","text_display":" of ALT/AST, or as part of a cholestatic reaction with simultaneous elevation of other cholestatic parameters (ALP, GGT). Isolated bilirubin can be seen in conjunction","confidence":0.99267578125,"confidence_rate":0.9999570116109802},{"cnt":[[219,1576],[2417,1576],[2417,1615],[219,1615]],"region":{"top_left_x":218,"top_left_y":1575,"width":2199,"height":40},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be1ee20ddbab4ca994d51f23023655bd","type":"text","conversion_output":false,"parent_id":"9a5eef3fadcc4e7ab476eaa7bbcedd00","text":"with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should","text_display":" with drugs that inhibit bilirubin conjugation or excretion, but both scenarios do not typically represent liver injury. Alternative causes of bilirubin elevation should","confidence":1,"confidence_rate":1},{"cnt":[[219,1610],[1473,1610],[1473,1647],[219,1647]],"region":{"top_left_x":218,"top_left_y":1610,"width":1255,"height":38},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6436058c1bb24484b4bd2cfc26eb373b","type":"text","conversion_output":false,"parent_id":"9a5eef3fadcc4e7ab476eaa7bbcedd00","text":"therefore, be ruled out before basing dose modification decisions on bilirubin values alone.","text_display":" therefore, be ruled out before basing dose modification decisions on bilirubin values alone.","confidence":1,"confidence_rate":1},{"cnt":[[215,1658],[2556,1658],[2556,1695],[215,1695]],"region":{"top_left_x":214,"top_left_y":1657,"width":2342,"height":38},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"092ff9bbd97048efaf4fc2a83a39ebf4","type":"table_spanning_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["3d829a75f47344abbdd34e2c3dd7a166"],"text":"","text_display":"Isolated AST or ALT elevation","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[219,1660],[667,1660],[667,1693],[219,1693]],"region":{"top_left_x":218,"top_left_y":1660,"width":450,"height":33},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d829a75f47344abbdd34e2c3dd7a166","type":"simple_cell","conversion_output":false,"parent_id":"092ff9bbd97048efaf4fc2a83a39ebf4","text":"Isolated AST or ALT elevation","text_display":"Isolated AST or ALT elevation","cell_row":13,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[215,1706],[691,1706],[691,1786],[215,1786]],"region":{"top_left_x":214,"top_left_y":1705,"width":478,"height":81},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df957326997445ed8fa5eed8a8ffc27a","type":"complex_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","children_ids":["05f40ec8a9c74e43bb2a0c26b194f7d7","e0a75d48480645749705050689c93162"],"text":"\\begin{tabular}{l}\nWith normal baseline AST/ALT: \\\\\n> ULN - 3.0 x ULN\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nWith normal baseline AST/ALT: \\\\\n> ULN - 3.0 x ULN\n\\end{tabular}","cell_row":14,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.691289265244973,"confidence_rate":0.9926432558087481},{"cnt":[[219,1710],[689,1710],[689,1742],[219,1742]],"region":{"top_left_x":218,"top_left_y":1709,"width":471,"height":34},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05f40ec8a9c74e43bb2a0c26b194f7d7","type":"text","conversion_output":false,"parent_id":"df957326997445ed8fa5eed8a8ffc27a","text":"With normal baseline AST/ALT:","text_display":"With normal baseline AST/ALT:","confidence":1,"confidence_rate":1},{"cnt":[[219,1749],[483,1749],[483,1786],[219,1786]],"region":{"top_left_x":218,"top_left_y":1748,"width":266,"height":38},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0a75d48480645749705050689c93162","type":"text","conversion_output":false,"parent_id":"df957326997445ed8fa5eed8a8ffc27a","text":"> ULN - 3.0 x ULN","text_display":"\n> ULN - 3.0 x ULN","confidence":0.691289265244973,"confidence_rate":0.9853406333025918},{"cnt":[[1051,1749],[1590,1749],[1590,1786],[1051,1786]],"region":{"top_left_x":1050,"top_left_y":1748,"width":540,"height":38},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8af417e03e0148558af440dc1a67d8d9","type":"simple_cell","conversion_output":false,"parent_id":"3be191ab40d942458e4c50f645357e00","text":"Recommendation: Maintain dose level","text_display":"Recommendation: Maintain dose level","cell_row":14,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9912109375,"confidence_rate":0.9997793264988906}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-063","page":63,"lines":[{"cnt":[[193,299],[2559,299],[2559,1807],[193,1807]],"region":{"top_left_x":193,"top_left_y":298,"width":2366,"height":1509},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33709bf9274b4afa82b57b67f1ac2d8a","type":"table","conversion_output":true,"children_ids":["221f6c6ec1ae447da38a684acb4b8c9b","d2f0ae0661214429bbb6a6a2a0784ad7","413e565f28034e71af31263b5cfa5036","a801dbf652a54297babd1f02267f8120","d76f592ad95a4af0b01a500ace310fd6","270bc827ade34f2ca801ea218d3d1be0","455b6e13caf545e4b59e44d3b8712eca","5a61a64060ef45fea9e47c63e1dabb49","baecff6dfdd2476ca3ad3b9b10271ac7","3527b1a5cc9b463cbd7e04b64e275df7","8c6bf0c0354749ee9f27b4e5259f7aa7","becf6ccaa1064e448c0eb1e6317fe58f","9cb5291c0b694cc3a1f88379545ebea3","53824774502f40b88c3ef4ff02189bf2","09177f13e27f4ca1926ca43fc016f096","704b3e18bac0439584860115678e9a6e","b8be5335d6e643ecadd45d9dc5529f49","1097665869604fcda149403112adb7d6","d9e5e9afb9f64b938f00907450b98962","515779fb581d4614bdb86b89ce1975cf","e061d9c57e0a48a096c24be7e35baabf","e54097d19afa445dadd2842bf7038f13","2c0afef2461e4085893fd616e7ca20d9","51ab306505724b7ab84882d32ae523ec","f3e145c5b08d464f98f1455f884d734e"],"text":"\\begin{tabular}{|l|l|}\n\\hline \\begin{tabular}{l}\nNovartis \\\\\nAmended Protocol Version 03 (Clean)\n\\end{tabular} & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline > 3.0-5.0 x ULN & \\begin{tabular}{l}\nRecommendation: Maintain dose level. Repeat LFTs \\({ }^{\\text {b }}\\) as soon as possible, preferably within 48-72 hours from awareness of the abnormal results; if abnormal lab values are confirmed upon the repeat test, then monitor LFTs \\({ }^{\\text {b }}\\) weekly, or more frequently if clinically indicated, until resolved to \\\\\n\\(\\leq 3.0 \\times\\) ULN \\\\\nMaintain dose level\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\n- Grade 3: AST or ALT (>5.0 - 20.0) x ULN \\\\\nIf AST or ALT > 5.0-10.0 x ULN \\\\\nIf AST or ALT > 10.0-20.0 x ULN \\\\\n- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)\n\\end{tabular} & \\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption > 42 days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{With abnormal baseline ALT/AST (up to Grade 1: \\(\\leq 3.0\\) ULN):} \\\\\n\\hline \\begin{tabular}{l}\n- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN \\\\\n- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN \\\\\n- Grade 4: AST or ALT (>20 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Concomitant elevations of AST or ALT and total bilirubin \\({ }^{c}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWith normal baseline LFTs: \\\\\nGrade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\) ULN without evidence of cholestasis \\({ }^{ d }\\) (unless Gilbert's syndrome)\n\\end{tabular} & \\begin{tabular}{l}\nInterrupt study treatment. Assess if case is true DILI \\\\\n(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.) \\\\\nIf DILI confirmed - Permanently discontinue \\\\\nIf Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\begin{tabular}{l}\nNovartis \\\\\nAmended Protocol Version 03 (Clean)\n\\end{tabular} & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline > 3.0-5.0 x ULN & \\begin{tabular}{l}\nRecommendation: Maintain dose level. Repeat LFTs \\({ }^{\\text {b }}\\) as soon as possible, preferably within 48-72 hours from awareness of the abnormal results; if abnormal lab values are confirmed upon the repeat test, then monitor LFTs \\({ }^{\\text {b }}\\) weekly, or more frequently if clinically indicated, until resolved to \\\\\n\\(\\leq 3.0 \\times\\) ULN \\\\\nMaintain dose level\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\n- Grade 3: AST or ALT (>5.0 - 20.0) x ULN \\\\\nIf AST or ALT > 5.0-10.0 x ULN \\\\\nIf AST or ALT > 10.0-20.0 x ULN \\\\\n- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)\n\\end{tabular} & \\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption > 42 days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{With abnormal baseline ALT/AST (up to Grade 1: \\(\\leq 3.0\\) ULN):} \\\\\n\\hline \\begin{tabular}{l}\n- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN \\\\\n- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN \\\\\n- Grade 4: AST or ALT (>20 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Concomitant elevations of AST or ALT and total bilirubin \\({ }^{c}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWith normal baseline LFTs: \\\\\nGrade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\) ULN without evidence of cholestasis \\({ }^{ d }\\) (unless Gilbert's syndrome)\n\\end{tabular} & \\begin{tabular}{l}\nInterrupt study treatment. Assess if case is true DILI \\\\\n(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.) \\\\\nIf DILI confirmed - Permanently discontinue \\\\\nIf Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.\n\\end{tabular} 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Repeat LFTs \\({ }^{\\text {b }}\\) as soon as possible, preferably within 48-72 hours from awareness of the abnormal results; if abnormal lab values are confirmed upon the repeat test, then monitor LFTs \\({ }^{\\text {b }}\\) weekly, or more frequently if clinically indicated, until resolved to \\\\\n\\(\\leq 3.0 \\times\\) ULN \\\\\nMaintain dose level\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98388671875,"confidence_rate":0.9999731499277777},{"cnt":[[1051,588],[2499,588],[2499,629],[1051,629]],"region":{"top_left_x":1050,"top_left_y":588,"width":1450,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3309809fc0e2458baa57ff9c80530be9","type":"text","conversion_output":false,"parent_id":"b8be5335d6e643ecadd45d9dc5529f49","text":"Recommendation: Maintain dose level. 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20.0) x ULN \\\\\nIf AST or ALT > 5.0-10.0 x ULN \\\\\nIf AST or ALT > 10.0-20.0 x ULN \\\\\n- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Grade 3: AST or ALT (>5.0 - 20.0) x ULN \\\\\nIf AST or ALT > 5.0-10.0 x ULN \\\\\nIf AST or ALT > 10.0-20.0 x ULN \\\\\n- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)\n\\end{tabular}","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.6034247850561503,"confidence_rate":0.9971072584650131},{"cnt":[[219,805],[858,805],[858,842],[219,842]],"region":{"top_left_x":218,"top_left_y":804,"width":640,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2b896456e7e48a6a4028ae9cd7d346c","type":"text","conversion_output":false,"parent_id":"1097665869604fcda149403112adb7d6","text":"- Grade 3: AST or ALT (>5.0 - 20.0) x ULN","text_display":"- Grade 3: AST or ALT (>5.0 - 20.0) x ULN","confidence":0.6034247850561503,"confidence_rate":0.9890789017207928},{"cnt":[[219,848],[676,848],[676,881],[219,881]],"region":{"top_left_x":218,"top_left_y":848,"width":458,"height":33},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"834ec90ba2754b8ba1263059062329cd","type":"text","conversion_output":false,"parent_id":"1097665869604fcda149403112adb7d6","text":"If AST or ALT > 5.0-10.0 x ULN","text_display":"\nIf AST or ALT > 5.0-10.0 x ULN","confidence":0.99853515625,"confidence_rate":0.9999581175147387},{"cnt":[[219,930],[693,930],[693,967],[219,967]],"region":{"top_left_x":218,"top_left_y":930,"width":476,"height":38},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6a0c8d03a9547b39384a808d14bcf48","type":"text","conversion_output":false,"parent_id":"1097665869604fcda149403112adb7d6","text":"If AST or ALT > 10.0-20.0 x ULN","text_display":"\nIf AST or ALT > 10.0-20.0 x ULN","confidence":0.9960968487430364,"confidence_rate":0.9998913728883796},{"cnt":[[219,1060],[780,1060],[780,1101],[219,1101]],"region":{"top_left_x":218,"top_left_y":1060,"width":562,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab3eee72b1c04e2bbd7a6aefcb3682c1","type":"text","conversion_output":false,"parent_id":"1097665869604fcda149403112adb7d6","text":"- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)","text_display":"\n- Grade 4: AST or ALT (> \\(20.0 \\times\\) ULN)","confidence":0.9805810144710354,"confidence_rate":0.9995440572040469},{"cnt":[[1046,803],[2458,803],[2458,1101],[1046,1101]],"region":{"top_left_x":1046,"top_left_y":802,"width":1413,"height":300},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9e5e9afb9f64b938f00907450b98962","type":"complex_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["7f562e645c2c4e94a13a54e6921bae1f","4efb7d31013b4961a361ed88b1b5bb4d","c70558b8949540b882985c77b686f6e1","7cf9b6a275b74591be635eae1143b54b","55eb837470214f73a38ebddb951a46b1","376498faf7c24c78b1c5be8613482834","f9cf5b1cb1244bcbb3d60621605e181c"],"text":"\\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption > 42 days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption > 42 days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to Grade \\(\\leq 1\\) or to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.54638671875,"confidence_rate":0.997694763147941},{"cnt":[[1051,805],[2456,805],[2456,844],[1051,844]],"region":{"top_left_x":1050,"top_left_y":804,"width":1406,"height":40},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f562e645c2c4e94a13a54e6921bae1f","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","text_display":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","confidence":1,"confidence_rate":1},{"cnt":[[1090,844],[1776,844],[1776,881],[1090,881]],"region":{"top_left_x":1089,"top_left_y":843,"width":687,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4efb7d31013b4961a361ed88b1b5bb4d","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"Grade \\(\\leq 1\\) or to baseline, then resume study drug.","text_display":" Grade \\(\\leq 1\\) or to baseline, then resume study drug.","confidence":1,"confidence_rate":1},{"cnt":[[1051,887],[1912,887],[1912,924],[1051,924]],"region":{"top_left_x":1050,"top_left_y":887,"width":863,"height":37},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c70558b8949540b882985c77b686f6e1","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"- If interruption > 42 days then subject must be discontinued.","text_display":"\n- If interruption > 42 days then subject must be discontinued.","confidence":0.595900297164917,"confidence_rate":0.992631823201872},{"cnt":[[1051,935],[2454,935],[2454,971],[1051,971]],"region":{"top_left_x":1050,"top_left_y":934,"width":1404,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cf9b6a275b74591be635eae1143b54b","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","text_display":"\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","confidence":1,"confidence_rate":1},{"cnt":[[1090,969],[1776,969],[1776,1010],[1090,1010]],"region":{"top_left_x":1089,"top_left_y":969,"width":687,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55eb837470214f73a38ebddb951a46b1","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"Grade \\(\\leq 1\\) or to baseline, then resume study drug.","text_display":" Grade \\(\\leq 1\\) or to baseline, then resume study drug.","confidence":1,"confidence_rate":1},{"cnt":[[1051,1017],[1912,1017],[1912,1054],[1051,1054]],"region":{"top_left_x":1050,"top_left_y":1016,"width":863,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"376498faf7c24c78b1c5be8613482834","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"- If interruption \\(>42\\) days then subject must be discontinued.","text_display":"\n- If interruption \\(>42\\) days then subject must be discontinued.","confidence":0.54638671875,"confidence_rate":0.991278425412614},{"cnt":[[1051,1062],[1629,1062],[1629,1099],[1051,1099]],"region":{"top_left_x":1050,"top_left_y":1062,"width":579,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9cf5b1cb1244bcbb3d60621605e181c","type":"text","conversion_output":false,"parent_id":"d9e5e9afb9f64b938f00907450b98962","text":"Permanently discontinue study treatment.","text_display":"\nPermanently discontinue study 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\\(\\leq 3.0\\) ULN):","text_display":"With abnormal baseline ALT/AST (up to Grade 1: \\(\\leq 3.0\\) ULN):","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.7063016587067068,"confidence_rate":0.9946648541883045},{"cnt":[[215,1177],[871,1177],[871,1314],[215,1314]],"region":{"top_left_x":214,"top_left_y":1177,"width":657,"height":137},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e061d9c57e0a48a096c24be7e35baabf","type":"complex_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["f6f9c3b4a4be408fbe04822f9b9d9dd4","da5c4ddd3df74601903d0e8a80c0a6c2","44d034930c78456ca24ddd5542a0353f"],"text":"\\begin{tabular}{l}\n- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN \\\\\n- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN \\\\\n- Grade 4: AST or ALT (>20 x ULN)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN \\\\\n- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN \\\\\n- Grade 4: AST or ALT (>20 x ULN)\n\\end{tabular}","cell_row":6,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.7761154174804688,"confidence_rate":0.9977810817721803},{"cnt":[[219,1182],[866,1182],[866,1214],[219,1214]],"region":{"top_left_x":218,"top_left_y":1181,"width":649,"height":34},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6f9c3b4a4be408fbe04822f9b9d9dd4","type":"text","conversion_output":false,"parent_id":"e061d9c57e0a48a096c24be7e35baabf","text":"- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN","text_display":"- ALT/AST > \\(2.0 \\times\\) baseline AND > \\(5.0 \\times\\) ULN","confidence":0.7761154174804688,"confidence_rate":0.9950426414827807},{"cnt":[[219,1225],[849,1225],[849,1257],[219,1257]],"region":{"top_left_x":218,"top_left_y":1224,"width":632,"height":34},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da5c4ddd3df74601903d0e8a80c0a6c2","type":"text","conversion_output":false,"parent_id":"e061d9c57e0a48a096c24be7e35baabf","text":"- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN","text_display":"\n- ALT/AST \\(>3.0 \\times\\) baseline AND \\(>10 \\times\\) ULN","confidence":0.9546947479248047,"confidence_rate":0.9990345574798741},{"cnt":[[219,1272],[737,1272],[737,1314],[219,1314]],"region":{"top_left_x":218,"top_left_y":1272,"width":519,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44d034930c78456ca24ddd5542a0353f","type":"text","conversion_output":false,"parent_id":"e061d9c57e0a48a096c24be7e35baabf","text":"- Grade 4: AST or ALT (>20 x ULN)","text_display":"\n- Grade 4: AST or ALT (>20 x ULN)","confidence":0.9726946230512112,"confidence_rate":0.9992717101481674},{"cnt":[[1046,1177],[2458,1177],[2458,1470],[1046,1470]],"region":{"top_left_x":1046,"top_left_y":1177,"width":1413,"height":293},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e54097d19afa445dadd2842bf7038f13","type":"complex_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["92eb1a2f01814d57be342c5c2f9217d8","5e4584e5dac44f24ab12409b64332a52","f942e2d7a1014d4a9dad211bfa6c42a5","aaf32245edfc4fb59bf93e36fddcda7b","7aaf2ff387cf4ccdb116847a230d80a3","2f186c92b0ce4bd9bec82133822b367e","4575800962d14eabb2ee1512d5c47bd6"],"text":"\\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to baseline, then resume study drug. \\\\\n- If interruption \\(>42\\) days then subject must be discontinued. \\\\\nPermanently discontinue study treatment.\n\\end{tabular}","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8681640625,"confidence_rate":0.999513623031514},{"cnt":[[1051,1182],[2454,1182],[2454,1218],[1051,1218]],"region":{"top_left_x":1050,"top_left_y":1181,"width":1404,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92eb1a2f01814d57be342c5c2f9217d8","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","text_display":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","confidence":1,"confidence_rate":1},{"cnt":[[1090,1216],[1564,1216],[1564,1253],[1090,1253]],"region":{"top_left_x":1089,"top_left_y":1216,"width":475,"height":37},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e4584e5dac44f24ab12409b64332a52","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"baseline, then resume study drug.","text_display":" baseline, then resume study drug.","confidence":1,"confidence_rate":1},{"cnt":[[1050,1260],[1912,1257],[1912,1298],[1051,1301]],"region":{"top_left_x":1050,"top_left_y":1257,"width":863,"height":44},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f942e2d7a1014d4a9dad211bfa6c42a5","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"- If interruption \\(>42\\) days then subject must be discontinued.","text_display":"\n- If interruption \\(>42\\) days then subject must be discontinued.","confidence":0.8681640625,"confidence_rate":0.9979531907639054},{"cnt":[[1051,1307],[2456,1307],[2456,1344],[1051,1344]],"region":{"top_left_x":1050,"top_left_y":1307,"width":1406,"height":37},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aaf32245edfc4fb59bf93e36fddcda7b","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","text_display":"\n- Interrupt treatment. Repeat LFTsb within 48-72 hours, then monitor LFTsb weekly until recovery to","confidence":1,"confidence_rate":1},{"cnt":[[1090,1344],[1566,1344],[1566,1381],[1090,1381]],"region":{"top_left_x":1089,"top_left_y":1343,"width":477,"height":38},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7aaf2ff387cf4ccdb116847a230d80a3","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"baseline, then resume study drug.","text_display":" baseline, then resume study drug.","confidence":1,"confidence_rate":1},{"cnt":[[1051,1385],[1912,1385],[1912,1426],[1051,1426]],"region":{"top_left_x":1050,"top_left_y":1385,"width":863,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f186c92b0ce4bd9bec82133822b367e","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"- If interruption \\(>42\\) days then subject must be discontinued.","text_display":"\n- If interruption \\(>42\\) days then subject must be discontinued.","confidence":0.91064453125,"confidence_rate":0.9986443595077856},{"cnt":[[1051,1428],[1633,1428],[1633,1470],[1051,1470]],"region":{"top_left_x":1050,"top_left_y":1428,"width":584,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4575800962d14eabb2ee1512d5c47bd6","type":"text","conversion_output":false,"parent_id":"e54097d19afa445dadd2842bf7038f13","text":"Permanently discontinue study treatment.","text_display":"\nPermanently discontinue study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[215,1476],[2556,1476],[2556,1513],[215,1513]],"region":{"top_left_x":214,"top_left_y":1476,"width":2342,"height":37},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c0afef2461e4085893fd616e7ca20d9","type":"table_spanning_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["8e4e2793ffb74a38b12bd23bcf04331d"],"text":"","text_display":"Concomitant elevations of AST or ALT and total bilirubin \\({ }^{c}\\)","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[228,1478],[1092,1478],[1092,1513],[228,1513]],"region":{"top_left_x":227,"top_left_y":1478,"width":865,"height":35},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e4e2793ffb74a38b12bd23bcf04331d","type":"simple_cell","conversion_output":false,"parent_id":"2c0afef2461e4085893fd616e7ca20d9","text":"Concomitant elevations of AST or ALT and total bilirubin \\({ }^{c}\\)","text_display":"Concomitant elevations of AST or ALT and total bilirubin \\({ }^{c}\\)","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.5194915679749101,"confidence_rate":0.9905535284480295},{"cnt":[[215,1524],[966,1524],[966,1690],[215,1690]],"region":{"top_left_x":214,"top_left_y":1523,"width":753,"height":168},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51ab306505724b7ab84882d32ae523ec","type":"complex_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["3d27dffe20d4429dbe7b7ce65349255d","b63c5fd83a3940dda9b4d803f5515869","2bd41242080d45109a50c5b0e9dd6022","2caa8d2806434d7a802f18a29e94121b"],"text":"\\begin{tabular}{l}\nWith normal baseline LFTs: \\\\\nGrade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\) ULN without evidence of cholestasis \\({ }^{ d }\\) (unless Gilbert's syndrome)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nWith normal baseline LFTs: \\\\\nGrade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\) ULN without evidence of cholestasis \\({ }^{ d }\\) (unless Gilbert's syndrome)\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.5955197918256494,"confidence_rate":0.9958308281365396},{"cnt":[[217,1524],[633,1522],[633,1558],[217,1561]],"region":{"top_left_x":216,"top_left_y":1521,"width":417,"height":40},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d27dffe20d4429dbe7b7ce65349255d","type":"text","conversion_output":false,"parent_id":"51ab306505724b7ab84882d32ae523ec","text":"With normal baseline LFTs:","text_display":"With normal baseline LFTs:","confidence":1,"confidence_rate":1},{"cnt":[[219,1567],[962,1567],[962,1608],[219,1608]],"region":{"top_left_x":218,"top_left_y":1566,"width":744,"height":43},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b63c5fd83a3940dda9b4d803f5515869","type":"text","conversion_output":false,"parent_id":"51ab306505724b7ab84882d32ae523ec","text":"Grade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\)","text_display":"\nGrade 2 ALT/AST ( \\(>3.0 \\times\\) ULN) with bilirubin \\(>2.0 \\times\\)","confidence":0.5955197918256494,"confidence_rate":0.991253380350654},{"cnt":[[219,1606],[741,1606],[741,1638],[219,1638]],"region":{"top_left_x":218,"top_left_y":1605,"width":523,"height":34},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bd41242080d45109a50c5b0e9dd6022","type":"text","conversion_output":false,"parent_id":"51ab306505724b7ab84882d32ae523ec","text":"ULN without evidence of cholestasis \\({ }^{ d }\\)","text_display":" ULN without evidence of cholestasis \\({ }^{ d }\\)","confidence":0.6674778461456299,"confidence_rate":0.9921048789669569},{"cnt":[[219,1645],[604,1645],[604,1686],[219,1686]],"region":{"top_left_x":218,"top_left_y":1644,"width":387,"height":43},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2caa8d2806434d7a802f18a29e94121b","type":"text","conversion_output":false,"parent_id":"51ab306505724b7ab84882d32ae523ec","text":"(unless Gilbert's syndrome)","text_display":" (unless Gilbert's syndrome)","confidence":1,"confidence_rate":1},{"cnt":[[1046,1524],[2543,1524],[2543,1801],[1046,1801]],"region":{"top_left_x":1046,"top_left_y":1523,"width":1497,"height":278},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3e145c5b08d464f98f1455f884d734e","type":"complex_cell","conversion_output":false,"parent_id":"33709bf9274b4afa82b57b67f1ac2d8a","children_ids":["4cd96e49bc6f470480b6359c85969b9e","34ea28ce015f4d10a374f946ba89826e","a17e55e1d4a642cd95adc68421f6b8b4","6d28ffa2fb3a45bd9c8f74ffb721a32c","193b387325ab425d9ac03e67223bc271","dfa66a35e261442fa9bbd3224d5ee99d","327103f6dc584017ae2389147763be8a"],"text":"\\begin{tabular}{l}\nInterrupt study treatment. Assess if case is true DILI \\\\\n(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.) \\\\\nIf DILI confirmed - Permanently discontinue \\\\\nIf Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nInterrupt study treatment. Assess if case is true DILI \\\\\n(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear and haptoglobin determination), continue treatment at the discretion of the investigator.) \\\\\nIf DILI confirmed - Permanently discontinue \\\\\nIf Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.\n\\end{tabular}","cell_row":8,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5905318260192871,"confidence_rate":0.999321507799657},{"cnt":[[1051,1524],[1774,1524],[1774,1565],[1051,1565]],"region":{"top_left_x":1050,"top_left_y":1523,"width":724,"height":42},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4cd96e49bc6f470480b6359c85969b9e","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"Interrupt study treatment. Assess if case is true DILI","text_display":"Interrupt study treatment. Assess if case is true DILI","confidence":1,"confidence_rate":1},{"cnt":[[1051,1567],[2508,1567],[2508,1608],[1051,1608]],"region":{"top_left_x":1050,"top_left_y":1566,"width":1458,"height":43},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34ea28ce015f4d10a374f946ba89826e","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis","text_display":"\n(Note: If total bilirubin \\(>3.0 \\times\\) ULN is due to the indirect (non-conjugated) component only, and hemolysis","confidence":0.5905318260192871,"confidence_rate":0.9953495042948706},{"cnt":[[1051,1606],[2482,1606],[2482,1643],[1051,1643]],"region":{"top_left_x":1050,"top_left_y":1605,"width":1432,"height":38},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a17e55e1d4a642cd95adc68421f6b8b4","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear","text_display":" as the etiology has been ruled out as per institutional guidelines (e.g., review of peripheral blood smear","confidence":0.99267578125,"confidence_rate":0.9999337754133857},{"cnt":[[1051,1641],[2270,1641],[2270,1680],[1051,1680]],"region":{"top_left_x":1050,"top_left_y":1640,"width":1220,"height":40},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d28ffa2fb3a45bd9c8f74ffb721a32c","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"and haptoglobin determination), continue treatment at the discretion of the investigator.)","text_display":" and haptoglobin determination), continue treatment at the discretion of the investigator.)","confidence":1,"confidence_rate":1},{"cnt":[[1051,1680],[1672,1680],[1672,1721],[1051,1721]],"region":{"top_left_x":1050,"top_left_y":1679,"width":623,"height":42},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"193b387325ab425d9ac03e67223bc271","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"If DILI confirmed - Permanently discontinue","text_display":"\nIf DILI confirmed - Permanently discontinue","confidence":1,"confidence_rate":1},{"cnt":[[1051,1725],[2536,1725],[2536,1764],[1051,1764]],"region":{"top_left_x":1050,"top_left_y":1725,"width":1487,"height":40},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfa66a35e261442fa9bbd3224d5ee99d","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"If Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs","text_display":"\nIf Not DILI - interrupt treatment. Treat the identified cause according to institutional guidelines. Repeat LFTs","confidence":1,"confidence_rate":1},{"cnt":[[1051,1762],[2317,1762],[2317,1799],[1051,1799]],"region":{"top_left_x":1050,"top_left_y":1761,"width":1268,"height":38},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"327103f6dc584017ae2389147763be8a","type":"text","conversion_output":false,"parent_id":"f3e145c5b08d464f98f1455f884d734e","text":"within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.","text_display":" within 48-72 hours, then monitor weekly, till enzyme levels resolve to \\(\\leq\\) Grade 1 or Baseline.","confidence":0.9975602623308077,"confidence_rate":0.9999765125962303}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-064","page":64,"lines":[{"cnt":[[193,299],[2559,299],[2559,1854],[193,1854]],"region":{"top_left_x":193,"top_left_y":298,"width":2366,"height":1557},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e916f3b69934b6e9edcefb38100feb9","type":"table","conversion_output":true,"children_ids":["490dc1f1258e4e499a272ddc5f0dc1e0","90b2fcfe2af64ddaaadd77c40a602a45","c5244267b4e14861b5f00411c8cc1f96","110034f37883474bbaf9c35dcea7d0fb","5da6b0ecf5b844b4b93634aeccb9de05","7dc7413d96bd4354ab8424a68ff1479d","1205f332f61d4bdd9af357bee30b5c93","92c6a74f931041619a3ae420b8f6d0cd","aec71359042e43d5a3262a8447bc7ca0","00bc49c4e7554c52a5b968060cead50f","b781dbaecfff423f9f43a0c4afb8a74c","a6fdcc523b674b72bbced6cf9cdc5a26","6dfb6fc4a422405991885e9cf50e96c7","35aa2ff98353445a9f9d0b6f0545ef63","2d43834ae5604036a1daf826f5383a11","1148b92e696349699b2c0c932b90cfe7","ae918897bd624260a8e36401c0849dc2","8d649addc9a04654993788eb84c03b5c","ee6b942c2d7d433ebd1ec9448776f9e9","e4ca0a7653ef42b4967bb1abc089deb3","1c97378f2623469d90f2dd0ee1a9e43c","c39aa18b59bd4a68bb26937d0bc8aea7","0e01671719934da9b60a5f6fe141e7e6","d30c959f26514dc4a7f012707d2043cb","eace702e03bb4a8bb8fe104cf0d6cac4","12dedb0d3c3b4c0ba828e628d9b7e10c","72b38c8fa595400bad046cc871a48309","a16ac3b7cc1b4190850355596a5509e0","fdaa616329bc46eca60af555f1a796dc","c6bf2c6d84eb49b7b58844a05576379c","d2406ebf156c47fca2e2735221964cec","c8bf1f95d03048c18740f654de9a7bbf","6a93e2329fb246e4bdddc95a561e04ce","7e1a4f0bffa84e87b35e110ba62ce92f","9a6fe833ab8f4f2581783c9adcfbfaf3","8c19511962464551aba98a60e8bb9891","4ce29ea6ecc34b62bb53cc2bbc210b69","f363a5060412482891db65d3db49ce55","c2bb9c91550e43148b00b117aa8dc195","b4bba0dc4ca84ab59dedd160f23641da"],"text":"\\begin{tabular}{|l|l|}\n\\hline Novartis Amended Protocol Version 03 (Clean) & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline & Note: For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.3.3.2. \\\\\n\\hline \\begin{tabular}{l}\nWith abnormal baseline LFTs: \\\\\nALT or AST \\(>2 \\times\\) baseline OR ALT or AST \\(>8 \\times\\) ULN (whichever is lower) combined with total bilirubin >2.0x ULN\n\\end{tabular} & \\begin{tabular}{l}\nAfter recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. \\\\\nNote: For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.3.3.2.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Investigation (metabolic)} \\\\\n\\hline \\multicolumn{2}{|c|}{Asymptomatic amylase and/or lipase elevation} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (> ULN - 1.5 x ULN) \\\\\nGrade 2 (> 1.5-2.0 x ULN; > 2.0-5.0 X ULN and asymptomatic) \\\\\nGrade 3* (> 2.0-5.0 x ULN with signs or symptoms; > 5.0 ULN and asymptomatic)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nRecommendation: Omit dose : \\\\\nIf resolved to grade \\(\\leq 1\\) or baseline in \\(\\leq 7\\) days, then maintain dose level \\\\\nIf resolved to grade \\(\\leq 1\\) or baseline in \\(>7\\) days, then discontinue subject from study medication (mandatory)\n\\end{tabular} \\\\\n\\hline Grade 4* (> \\(5.0 \\times\\) ULN and with signs or symptoms) & Mandatory: Discontinue subject from study drug treatment. \\\\\n\\hline \\multicolumn{2}{|c|}{*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently from study treatment.} \\\\\n\\hline \\multicolumn{2}{|c|}{Vascular disorders} \\\\\n\\hline \\multicolumn{2}{|c|}{Hypertension} \\\\\n\\hline \\begin{tabular}{l}\nCTCAE Grade 3 \\\\\nCTCAE Grade 4\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: Omit dose until resolved \\(\\leq\\) Grade 1, then maintain level \\\\\nMandatory: Discontinue subject from study drug treatment\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Gastrointestinal} \\\\\n\\hline \\multicolumn{2}{|c|}{Pancreatitis} \\\\\n\\hline \\begin{tabular}{l}\nGrade 2 \\\\\nGrade \\(\\geq 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: Maintain dose level \\\\\nMandatory: Discontinue subject from study drug treatment\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Novartis Amended Protocol Version 03 (Clean) & Confidential \\\\\n\\hline \\multicolumn{2}{|c|}{Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)} \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} & \\\\\n\\hline & Note: For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.3.3.2. \\\\\n\\hline \\begin{tabular}{l}\nWith abnormal baseline LFTs: \\\\\nALT or AST \\(>2 \\times\\) baseline OR ALT or AST \\(>8 \\times\\) ULN (whichever is lower) combined with total bilirubin >2.0x ULN\n\\end{tabular} & \\begin{tabular}{l}\nAfter recovery, re-administration of study treatment could be considered only if Investigator assesses benefit to outweigh the risk. \\\\\nNote: For additional information on follow-up of potential drug induced liver injury cases, refer to Section 6.3.3.2.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Investigation (metabolic)} \\\\\n\\hline \\multicolumn{2}{|c|}{Asymptomatic amylase and/or lipase elevation} \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 (> ULN - 1.5 x ULN) \\\\\nGrade 2 (> 1.5-2.0 x ULN; > 2.0-5.0 X ULN and asymptomatic) \\\\\nGrade 3* (> 2.0-5.0 x ULN with signs or symptoms; > 5.0 ULN and asymptomatic)\n\\end{tabular} & \\begin{tabular}{l}\nMay maintain dose level \\\\\nMay maintain dose level \\\\\nRecommendation: Omit dose : \\\\\nIf resolved to grade \\(\\leq 1\\) or baseline in \\(\\leq 7\\) days, then maintain dose level \\\\\nIf resolved to grade \\(\\leq 1\\) or baseline in \\(>7\\) days, then discontinue subject from study medication (mandatory)\n\\end{tabular} \\\\\n\\hline Grade 4* (> \\(5.0 \\times\\) ULN and with signs or symptoms) & Mandatory: Discontinue subject from study drug treatment. \\\\\n\\hline \\multicolumn{2}{|c|}{*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently from study treatment.} \\\\\n\\hline \\multicolumn{2}{|c|}{Vascular disorders} \\\\\n\\hline \\multicolumn{2}{|c|}{Hypertension} \\\\\n\\hline \\begin{tabular}{l}\nCTCAE Grade 3 \\\\\nCTCAE Grade 4\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: Omit dose until resolved \\(\\leq\\) Grade 1, then maintain level \\\\\nMandatory: Discontinue subject from study drug treatment\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{Gastrointestinal} \\\\\n\\hline \\multicolumn{2}{|c|}{Pancreatitis} \\\\\n\\hline \\begin{tabular}{l}\nGrade 2 \\\\\nGrade \\(\\geq 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nRecommendation: Maintain dose level \\\\\nMandatory: Discontinue subject from study drug treatment\n\\end{tabular} 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If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently from study treatment.","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[215,1337],[2495,1337],[2495,1450],[215,1450]],"region":{"top_left_x":214,"top_left_y":1337,"width":2281,"height":114},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b910aa15bc34fe49fbd96e05712f2ad","type":"complex_cell","conversion_output":false,"parent_id":"c8bf1f95d03048c18740f654de9a7bbf","children_ids":["662551e0dddf433bb8302452b86fc1c1","f718b747b9714e81b5c39b95c7f9687c","b87b92ad528c4fc19699d643c466e4e0"],"text":"*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently from study treatment.","text_display":"*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently from study treatment.","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":0.9805114106275141,"confidence_rate":0.999961979052456},{"cnt":[[221,1337],[2493,1337],[2493,1374],[221,1374]],"region":{"top_left_x":221,"top_left_y":1337,"width":2272,"height":38},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"662551e0dddf433bb8302452b86fc1c1","type":"text","conversion_output":false,"parent_id":"7b910aa15bc34fe49fbd96e05712f2ad","text":"*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of","text_display":"*Note: A CT scan or other imaging study to assess the pancreas, liver, and gallbladder must be performed within 2 weeks of the first occurrence of any \\(\\geq\\) Grade 3 of","confidence":0.9805114106275141,"confidence_rate":0.9998888141146397},{"cnt":[[219,1374],[2473,1374],[2473,1411],[219,1411]],"region":{"top_left_x":218,"top_left_y":1374,"width":2256,"height":38},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f718b747b9714e81b5c39b95c7f9687c","type":"text","conversion_output":false,"parent_id":"7b910aa15bc34fe49fbd96e05712f2ad","text":"amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently","text_display":" amylase and/or lipase. If asymptomatic Grade 2 elevations of lipase and/or amylase occur again after restarting therapy, subjects will be discontinued permanently","confidence":0.99951171875,"confidence_rate":0.9999971270600203},{"cnt":[[219,1411],[518,1411],[518,1448],[219,1448]],"region":{"top_left_x":218,"top_left_y":1411,"width":300,"height":37},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b87b92ad528c4fc19699d643c466e4e0","type":"text","conversion_output":false,"parent_id":"7b910aa15bc34fe49fbd96e05712f2ad","text":"from study treatment.","text_display":" from study 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Grade 3 \\\\\nCTCAE Grade 4\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nCTCAE Grade 3 \\\\\nCTCAE Grade 4\n\\end{tabular}","cell_row":12,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[219,1554],[451,1554],[451,1586],[219,1586]],"region":{"top_left_x":218,"top_left_y":1553,"width":233,"height":34},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f871959410c4fc994c36541703de0b0","type":"text","conversion_output":false,"parent_id":"9a6fe833ab8f4f2581783c9adcfbfaf3","text":"CTCAE Grade 3","text_display":"CTCAE Grade 3","confidence":1,"confidence_rate":1},{"cnt":[[219,1610],[451,1610],[451,1643],[219,1643]],"region":{"top_left_x":218,"top_left_y":1610,"width":233,"height":33},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc55678ed54649efb21c2876740668e7","type":"text","conversion_output":false,"parent_id":"9a6fe833ab8f4f2581783c9adcfbfaf3","text":"CTCAE Grade 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until resolved to \\(\\leq\\) Grade 1, then maintain dose level. \\\\\nRecommendation: Discontinue subject from study drug treatment \\\\\nMandatory: Discontinue subject from study drug treatment\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999967625019388},{"cnt":[[1051,679],[1871,679],[1871,720],[1051,720]],"region":{"top_left_x":1050,"top_left_y":679,"width":822,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c0462116d81450e814d0768da3e113f","type":"text","conversion_output":false,"parent_id":"8100d5e5c08f41bf8c6a553586f6221d","text":"May maintain dose level but initiate anti-diarrhea treatment","text_display":"May maintain dose level but initiate anti-diarrhea 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Consider to initiate/institute appropriate skin toxicity therapy (such as antihistamines and/or topical corticosteroids)","text_display":"May maintain dose level. Consider to initiate/institute appropriate skin toxicity therapy (such as antihistamines and/or topical corticosteroids)","cell_row":7,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1051,1028],[2361,1028],[2361,1067],[1051,1067]],"region":{"top_left_x":1050,"top_left_y":1027,"width":1311,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18711a46443d4197a0bb34e73bf01379","type":"text","conversion_output":false,"parent_id":"369b08640b87483fb051ecd3257b770c","text":"May maintain dose level. Consider to initiate/institute appropriate skin toxicity therapy (such as","text_display":"May maintain dose level. Consider to initiate/institute appropriate skin toxicity therapy (such as","confidence":1,"confidence_rate":1},{"cnt":[[1051,1065],[1674,1065],[1674,1104],[1051,1104]],"region":{"top_left_x":1050,"top_left_y":1064,"width":625,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9940684a4664e6f994c24c3e3f9886a","type":"text","conversion_output":false,"parent_id":"369b08640b87483fb051ecd3257b770c","text":"antihistamines and/or topical corticosteroids)","text_display":" antihistamines and/or topical 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therapy\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[219,1112],[338,1112],[338,1149],[219,1149]],"region":{"top_left_x":218,"top_left_y":1112,"width":121,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0287c2d7d99c4b20b9365af8f9c6d5fb","type":"text","conversion_output":false,"parent_id":"d839449e48ff474d8812de234a7e2d22","text":"Grade 2","text_display":"Grade 2","confidence":1,"confidence_rate":1},{"cnt":[[219,1199],[739,1199],[739,1240],[219,1240]],"region":{"top_left_x":218,"top_left_y":1198,"width":521,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0537e1f21314b4d85ece5ca96a1e4d2","type":"text","conversion_output":false,"parent_id":"d839449e48ff474d8812de234a7e2d22","text":"Grade 3, despite skin toxicity therapy","text_display":"\nGrade 3, despite skin toxicity 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\\(>7\\) days (despite appropriate skin toxicity therapy), then discontinue subject from study drug treatment (mandatory) \\\\\nMandatory: Discontinue subject from study drug treament\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMay maintain dose level, but initiate/intensify appropriate skin toxicity therapy (such as antihistamines and/or topical corticosteroids). \\\\\nRecommendation: Omit dose until resolved to Grade \\(\\leq 1\\), then: \\\\\nIf resolved resolved in \\(\\leq 7\\) days, then maintain dose level \\\\\nIf resolved resolved in \\(>7\\) days (despite appropriate skin toxicity therapy), then discontinue subject from study drug treatment (mandatory) \\\\\nMandatory: Discontinue subject from study drug 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antihistamines","confidence":1,"confidence_rate":1},{"cnt":[[1051,1149],[1473,1149],[1473,1188],[1051,1188]],"region":{"top_left_x":1050,"top_left_y":1149,"width":423,"height":40},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cabfaa1bcf34e4c878d0ea586ad32cd","type":"text","conversion_output":false,"parent_id":"915252b8b06443238e68a6d89c6aeed9","text":"and/or topical corticosteroids).","text_display":" and/or topical corticosteroids).","confidence":1,"confidence_rate":1},{"cnt":[[1051,1199],[1923,1199],[1923,1236],[1051,1236]],"region":{"top_left_x":1050,"top_left_y":1198,"width":874,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89f7f082f4bf4d68abcc72c0d6452026","type":"text","conversion_output":false,"parent_id":"915252b8b06443238e68a6d89c6aeed9","text":"Recommendation: Omit dose until resolved to Grade \\(\\leq 1\\), then:","text_display":"\nRecommendation: Omit dose until resolved to Grade 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resolved in \\(\\leq 14\\) days, then maintain dose level \\\\\nIf resolved in \\(>14\\) days, then discontinue subject from study drug treatment (mandatory)\n\\end{tabular}","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.943516731262207,"confidence_rate":0.999784278792345},{"cnt":[[1051,1476],[1391,1476],[1391,1517],[1051,1517]],"region":{"top_left_x":1050,"top_left_y":1476,"width":341,"height":42},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55379ad535a24100b923715925763278","type":"text","conversion_output":false,"parent_id":"3f966169e26b498dab2b919d49153f85","text":"May maintain dose level","text_display":"May maintain dose 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maintain dose level","text_display":"\nIf resolved in \\(\\leq 14\\) days, then maintain dose level","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[1051,1623],[2274,1623],[2274,1664],[1051,1664]],"region":{"top_left_x":1050,"top_left_y":1623,"width":1225,"height":42},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d71c736d0c8047909457e9c03a12545a","type":"text","conversion_output":false,"parent_id":"3f966169e26b498dab2b919d49153f85","text":"If resolved in \\(>14\\) days, then discontinue subject from study drug treatment (mandatory)","text_display":"\nIf resolved in \\(>14\\) days, then discontinue subject from study drug treatment (mandatory)","confidence":0.943516731262207,"confidence_rate":0.99938817480832},{"cnt":[[212,1669],[2556,1669],[2556,1712],[212,1712]],"region":{"top_left_x":212,"top_left_y":1668,"width":2344,"height":45},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fd01158c2ca49829127d300cb0002b7","type":"table_spanning_cell","conversion_output":false,"parent_id":"a5eba2fe41284936b02417ba4ffa09a4","children_ids":["7ab1bcc1893a4b74b0f825b17ec26d24"],"text":"","text_display":"Other adverse events","cell_row":11,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[219,1671],[542,1671],[542,1708],[219,1708]],"region":{"top_left_x":218,"top_left_y":1670,"width":324,"height":38},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ab1bcc1893a4b74b0f825b17ec26d24","type":"simple_cell","conversion_output":false,"parent_id":"4fd01158c2ca49829127d300cb0002b7","text":"Other adverse events","text_display":"Other adverse 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\\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) grade 1, maintain dose level \\\\\nRecommendation: Discontinue from study drug treatment\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMay maintain dose level \\\\\nRecommendation: Omit dose until resolved to \\(\\leq\\) grade 1, maintain dose level \\\\\nRecommendation: Discontinue from study drug treatment\n\\end{tabular}","cell_row":12,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9951221942901611,"confidence_rate":0.99997169859016},{"cnt":[[1051,1723],[1393,1723],[1393,1760],[1051,1760]],"region":{"top_left_x":1050,"top_left_y":1722,"width":343,"height":38},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dc48592e0f94514bc44864fb3af1561","type":"text","conversion_output":false,"parent_id":"18b737db93a6457da14465017fc3f5c0","text":"May maintain dose level","text_display":"May maintain dose 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Discontinue from study drug treatment","text_display":"\nRecommendation: Discontinue from study drug 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CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[198,434],[2557,434],[2557,1106],[198,1106]],"region":{"top_left_x":197,"top_left_y":433,"width":2360,"height":674},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f9eba9a16504b73bde6158a69190def","type":"table","conversion_output":true,"children_ids":["76ae8e7a30064e7da3cdc4c4bbb138af","8c9f2fd72ae24068b163243167be9037","b22d2ab307cb49439bd7b8b94158cd82","36183696cf3a480e8ae7ea8340fbcc19","f510e38f8acc460c8dfa707bace49e6a","f908de3bf7e54fb9a367c9335a921bb1","e291fa6962bc49089257971c5ec02250"],"text":"\\begin{tabular}{|l|}\n\\hline Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\) \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nAll dose modifications should be based on the worst preceding toxicity. \\\\\n\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0) \\\\\n\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.) \\\\\nc \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold \\\\\nIf combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, restart the treatment at the same dose \\\\\n\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4 weeks. \\\\\nNote: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|}\n\\hline Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\) \\\\\n\\hline \\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nAll dose modifications should be based on the worst preceding toxicity. \\\\\n\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0) \\\\\n\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.) \\\\\nc \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold \\\\\nIf combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, restart the treatment at the same dose \\\\\n\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4 weeks. \\\\\nNote: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.51416015625,"confidence_rate":0.9995683964488267},{"cnt":[[201,433],[2551,433],[2551,1109],[201,1109]],"region":{"top_left_x":201,"top_left_y":433,"width":2350,"height":676},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76ae8e7a30064e7da3cdc4c4bbb138af","type":"table_column","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","text":"","text_display":""},{"cnt":[[197,442],[2557,442],[2557,489],[197,489]],"region":{"top_left_x":197,"top_left_y":441,"width":2361,"height":49},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c9f2fd72ae24068b163243167be9037","type":"table_row","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","text":"","text_display":""},{"cnt":[[197,489],[2555,489],[2555,585],[197,585]],"region":{"top_left_x":197,"top_left_y":489,"width":2359,"height":96},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b22d2ab307cb49439bd7b8b94158cd82","type":"table_row","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","text":"","text_display":""},{"cnt":[[197,580],[2557,580],[2557,1104],[197,1104]],"region":{"top_left_x":197,"top_left_y":580,"width":2361,"height":525},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36183696cf3a480e8ae7ea8340fbcc19","type":"table_row","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","text":"","text_display":""},{"cnt":[[219,446],[938,446],[938,483],[219,483]],"region":{"top_left_x":218,"top_left_y":445,"width":720,"height":38},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f510e38f8acc460c8dfa707bace49e6a","type":"simple_cell","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","text":"Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)","text_display":"Dose Schedule modifications for Canakinumab \\({ }^{\\text {a }}\\)","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970703125,"confidence_rate":0.9999519030020291},{"cnt":[[216,494],[851,494],[851,582],[216,582]],"region":{"top_left_x":216,"top_left_y":493,"width":635,"height":90},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f908de3bf7e54fb9a367c9335a921bb1","type":"complex_cell","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","children_ids":["c68545751c024f68b48b3f02d14dc056","575575b6b3544273877d004f78bb61a9"],"text":"\\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nWorst toxicity \\\\\nCTCAE Version 5.0 during a cycle of therapy\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[219,498],[411,498],[411,537],[219,537]],"region":{"top_left_x":218,"top_left_y":497,"width":194,"height":40},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c68545751c024f68b48b3f02d14dc056","type":"text","conversion_output":false,"parent_id":"f908de3bf7e54fb9a367c9335a921bb1","text":"Worst toxicity","text_display":"Worst toxicity","confidence":1,"confidence_rate":1},{"cnt":[[219,541],[849,541],[849,578],[219,578]],"region":{"top_left_x":218,"top_left_y":541,"width":631,"height":38},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"575575b6b3544273877d004f78bb61a9","type":"text","conversion_output":false,"parent_id":"f908de3bf7e54fb9a367c9335a921bb1","text":"CTCAE Version 5.0 during a cycle of therapy","text_display":"\nCTCAE Version 5.0 during a cycle of therapy","confidence":1,"confidence_rate":1},{"cnt":[[208,585],[2544,585],[2544,1102],[208,1102]],"region":{"top_left_x":207,"top_left_y":584,"width":2338,"height":519},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e291fa6962bc49089257971c5ec02250","type":"complex_cell","conversion_output":false,"parent_id":"5f9eba9a16504b73bde6158a69190def","children_ids":["43363feb5b434dc6b79e804c5f6504b2","13eb9e4f414f4661ba6cceb0c8a53094","bb9c483de6b74a659e68ac62defe6df7","dd1b2094fe7746cd9167e4b4500716e3","b0fe2fbe8fc8444e87c2d87f6102c222","d8dbf464b7064be5bbbac6e7ffc40676","09b0e45351d8432ab82bfe4585a5c646","098dee9317ee41b98c2c00b1c2383da4","df9c154108884c76bcdc7e6494eba9b7","392cf121eb2c4c0e9dba17078f06568f","4ae0188e9d4d4b5e8adec4a84ea0cc85","9ea8f1ee3b88456caf3fe244c744f3b6","90505e3601cc4ef9b2fa63e5df623af5"],"text":"\\begin{tabular}{l}\nAll dose modifications should be based on the worst preceding toxicity. \\\\\n\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0) \\\\\n\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.) \\\\\nc \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold \\\\\nIf combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, restart the treatment at the same dose \\\\\n\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4 weeks. \\\\\nNote: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAll dose modifications should be based on the worst preceding toxicity. \\\\\n\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0) \\\\\n\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.) \\\\\nc \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold \\\\\nIf combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, restart the treatment at the same dose \\\\\n\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4 weeks. \\\\\nNote: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.51416015625,"confidence_rate":0.9987537851697352},{"cnt":[[216,589],[1200,589],[1200,626],[216,626]],"region":{"top_left_x":216,"top_left_y":588,"width":984,"height":38},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43363feb5b434dc6b79e804c5f6504b2","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"All dose modifications should be based on the worst preceding toxicity.","text_display":"All dose modifications should be based on the worst preceding toxicity.","confidence":1,"confidence_rate":1},{"cnt":[[219,632],[1169,632],[1169,669],[219,669]],"region":{"top_left_x":218,"top_left_y":632,"width":952,"height":38},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13eb9e4f414f4661ba6cceb0c8a53094","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0)","text_display":"\n\\({ }^{a}\\) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0)","confidence":0.51416015625,"confidence_rate":0.9912852941431151},{"cnt":[[219,671],[2538,671],[2538,712],[219,712]],"region":{"top_left_x":218,"top_left_y":671,"width":2320,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb9c483de6b74a659e68ac62defe6df7","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification","text_display":"\n\\({ }^{b}\\) Core LFTs consist of ALT, AST, GGT, total bilirubin (fractionated [direct and indirect], if total bilirubin > \\(2.0 \\times\\) ULN), and alkaline phosphatase (fractionated [quantification","confidence":0.7296880480869277,"confidence_rate":0.9983514223494401},{"cnt":[[219,710],[914,710],[914,747],[219,747]],"region":{"top_left_x":218,"top_left_y":710,"width":696,"height":37},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd1b2094fe7746cd9167e4b4500716e3","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.)","text_display":" of isoforms], if alkaline phosphatase \\(>2.0 \\times\\) ULN.)","confidence":0.7736080424210927,"confidence_rate":0.995506792536937},{"cnt":[[219,753],[2083,753],[2083,790],[219,790]],"region":{"top_left_x":218,"top_left_y":753,"width":1866,"height":38},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0fe2fbe8fc8444e87c2d87f6102c222","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"c \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold","text_display":"\nc \"Concomitant\" defined as total bilirubin increase to the defined threshold concurrently with ALT/AST increase to the defined threshold","confidence":0.9248757362365723,"confidence_rate":0.9994462818003965},{"cnt":[[219,797],[2538,797],[2538,834],[219,834]],"region":{"top_left_x":218,"top_left_y":796,"width":2320,"height":38},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8dbf464b7064be5bbbac6e7ffc40676","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"If combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and","text_display":"\nIf combined elevations of AST or ALT and total bilirubin do not meet the defined thresholds, please follow the instructions for isolated elevation of total bilirubin and","confidence":0.9868283271789551,"confidence_rate":0.9999238006697562},{"cnt":[[219,831],[2538,831],[2538,868],[219,868]],"region":{"top_left_x":218,"top_left_y":831,"width":2320,"height":38},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09b0e45351d8432ab82bfe4585a5c646","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed","text_display":" isolated elevation of AST/ALT, and take a conservative action based on the degree of the elevations (e.g. discontinue treatment at the situation when omit dose is needed","confidence":0.9985356330871582,"confidence_rate":0.9999915779656613},{"cnt":[[219,868],[2538,868],[2538,905],[219,905]],"region":{"top_left_x":218,"top_left_y":868,"width":2320,"height":38},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"098dee9317ee41b98c2c00b1c2383da4","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, re-","text_display":" for one parameter and discontinue treatment is required for another parameter). After all elevations resolve to the defined thresholds that allow treatment re-initiation, re","confidence":1,"confidence_rate":1},{"cnt":[[219,905],[728,905],[728,938],[219,938]],"region":{"top_left_x":218,"top_left_y":905,"width":510,"height":33},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df9c154108884c76bcdc7e6494eba9b7","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"start the treatment at the same dose","text_display":"start the treatment at the same dose","confidence":1,"confidence_rate":1},{"cnt":[[219,946],[2538,946],[2538,985],[219,985]],"region":{"top_left_x":218,"top_left_y":946,"width":2320,"height":40},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"392cf121eb2c4c0e9dba17078f06568f","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4","text_display":"\n\\({ }^{d}\\) The subject should be monitored biweekly (including LFTs), or more frequently if clinically indicated, until total bilirubin have resolved to baseline or stabilization over 4","confidence":0.9732246398925781,"confidence_rate":0.9998540947851644},{"cnt":[[219,983],[320,983],[320,1016],[219,1016]],"region":{"top_left_x":218,"top_left_y":983,"width":103,"height":33},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ae0188e9d4d4b5e8adec4a84ea0cc85","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"weeks.","text_display":" weeks.","confidence":0.99951171875,"confidence_rate":0.9999556009403848},{"cnt":[[219,1024],[2538,1024],[2538,1063],[219,1063]],"region":{"top_left_x":218,"top_left_y":1024,"width":2320,"height":40},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ea8f1ee3b88456caf3fe244c744f3b6","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"Note: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP","text_display":"\nNote: The \\(R\\) value is calculated by dividing the ALT by the ALP, using multiples of the ULN for both values. It denotes whether the relative pattern of ALT and/or ALP","confidence":0.9785258769989014,"confidence_rate":0.9998745278323092},{"cnt":[[219,1061],[1561,1061],[1561,1102],[219,1102]],"region":{"top_left_x":218,"top_left_y":1060,"width":1344,"height":43},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90505e3601cc4ef9b2fa63e5df623af5","type":"text","conversion_output":false,"parent_id":"e291fa6962bc49089257971c5ec02250","text":"elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury","text_display":" elevation is due to cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R>2\\) and \\(<5\\) ) liver injury","confidence":0.9594922065734863,"confidence_rate":0.999649628462665}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-067","page":67,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25036638221049e78dec7bd086ddf217","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72d455f4f1c1413a95460c66a7b3ce62","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8606f5040d98454a9e143b472f93a28c","type":"page_info","conversion_output":false,"text":"Page 67 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2072e4d22b14693b2b617908809171c","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,254],[1871,254],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":253,"width":457,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04a8de021f90471dbede99ae8a0d49b0","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,382],[1287,382],[1287,440],[288,440]],"region":{"top_left_x":287,"top_left_y":382,"width":1000,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a8851288e94ee1b2bd8070ac1ef1c4","type":"section_header","conversion_output":false,"children_ids":["d6486b7c49a341019e94262a43f53765"],"text":"","text_display":""},{"cnt":[[292,387],[1283,387],[1283,436],[292,436]],"region":{"top_left_x":292,"top_left_y":386,"width":991,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6486b7c49a341019e94262a43f53765","type":"text","conversion_output":true,"parent_id":"b1a8851288e94ee1b2bd8070ac1ef1c4","text":"6.3.2 Dose adjustments for QTcF prolongation","text_display":"\n\n\\subsection*{6.3.2 Dose adjustments for QTcF prolongation}","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[288,451],[1652,451],[1652,509],[288,509]],"region":{"top_left_x":287,"top_left_y":451,"width":1366,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce36df4b177046469bc4630533a1c733","type":"section_header","conversion_output":false,"children_ids":["232736b90e8b40e4abf6a71eb89ff8d7"],"text":"","text_display":""},{"cnt":[[292,457],[1648,455],[1648,505],[292,507]],"region":{"top_left_x":292,"top_left_y":454,"width":1356,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"232736b90e8b40e4abf6a71eb89ff8d7","type":"text","conversion_output":true,"parent_id":"ce36df4b177046469bc4630533a1c733","text":"In case of QTcF \\(> 5 0 0 ~ m s e c\\), (or QTcF prolongation \\(> 6 0\\) msec from baseline)","text_display":"\n\n\\section*{In case of QTcF \\(> 5 0 0 ~ m s e c\\), (or QTcF prolongation \\(> 6 0\\) msec from baseline)}","confidence":0.28518152904656197,"confidence_rate":0.986599952574449},{"cnt":[[292,511],[1678,511],[1678,561],[292,561]],"region":{"top_left_x":292,"top_left_y":511,"width":1386,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1093fe1bcf2f44beab242aac0cb9fca0","type":"text","conversion_output":true,"text":"1. Assess the quality of the ECG recording and the QT value and repeat if needed","text_display":"\n1. Assess the quality of the ECG recording and the QT value and repeat if needed","confidence":1,"confidence_rate":1},{"cnt":[[288,563],[1882,563],[1882,617],[288,617]],"region":{"top_left_x":287,"top_left_y":562,"width":1596,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba0e5c2433a04c798fd46e57ae61e768","type":"text","conversion_output":true,"text":"2. Determine serum electrolyte levels (in particular hypokalemia, hypomagnesemia). If","text_display":"\n2. Determine serum electrolyte levels (in particular hypokalemia, hypomagnesemia). If","confidence":1,"confidence_rate":1},{"cnt":[[352,614],[1540,614],[1540,664],[352,664]],"region":{"top_left_x":352,"top_left_y":614,"width":1189,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7f2a9c19269446bb82ce9527a2275c5","type":"text","conversion_output":true,"text":"abnormal, correct abnormalities before resuming study drug treatment.","text_display":" abnormal, correct abnormalities before resuming study drug treatment.","confidence":1,"confidence_rate":1},{"cnt":[[288,666],[1880,666],[1880,720],[288,720]],"region":{"top_left_x":287,"top_left_y":666,"width":1593,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d7c3de7d44e458da77617ff0ceb0025","type":"text","conversion_output":true,"text":"3. Review concomitant medication associated with QT prolongation, including drugs with a","text_display":"\n3. Review concomitant medication associated with QT prolongation, including drugs with a","confidence":1,"confidence_rate":1},{"cnt":[[352,718],[1880,718],[1880,767],[352,767]],"region":{"top_left_x":352,"top_left_y":717,"width":1528,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abc10c36ec5e4764992b460e95fd12ce","type":"text","conversion_output":true,"text":"\"Known\", \"Possible\", or \"Conditional risk of Torsades de Pointes, and drugs with the","text_display":" \"Known\", \"Possible\", or \"Conditional risk of Torsades de Pointes, and drugs with the","confidence":1,"confidence_rate":1},{"cnt":[[352,765],[1639,765],[1639,814],[352,814]],"region":{"top_left_x":352,"top_left_y":764,"width":1288,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5070188f1c334e0798838424aeb0ddc4","type":"text","conversion_output":true,"text":"potential to increase the risk of study drug exposure related QT prolongation","text_display":" potential to increase the risk of study drug exposure related QT prolongation","confidence":1,"confidence_rate":1},{"cnt":[[288,819],[1377,819],[1377,870],[288,870]],"region":{"top_left_x":287,"top_left_y":818,"width":1091,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49c83952162848d6a728d4537d439881","type":"text","conversion_output":true,"text":"4. Check study drug dosing schedule and treatment compliance","text_display":"\n4. Check study drug dosing schedule and treatment compliance","confidence":1,"confidence_rate":1},{"cnt":[[292,872],[1876,872],[1876,926],[292,926]],"region":{"top_left_x":292,"top_left_y":872,"width":1584,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b072da0e8f874d20afd4810219c531fc","type":"text","conversion_output":true,"text":"5. Consider collecting a time-matched PK, and record time and date of last study drug intake.","text_display":"\n5. Consider collecting a time-matched PK, and record time and date of last study drug intake.","confidence":1,"confidence_rate":1},{"cnt":[[286,939],[1336,939],[1336,999],[286,999]],"region":{"top_left_x":285,"top_left_y":938,"width":1052,"height":62},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"902e1cf66c00451286cd7e5f613929c0","type":"section_header","conversion_output":false,"children_ids":["4d2d371006eb4637902a19b732a082ee"],"text":"","text_display":""},{"cnt":[[292,945],[1334,945],[1334,995],[292,995]],"region":{"top_left_x":292,"top_left_y":945,"width":1043,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d2d371006eb4637902a19b732a082ee","type":"text","conversion_output":true,"parent_id":"902e1cf66c00451286cd7e5f613929c0","text":"After confirming ECG reading at site, if QTcF \\(> 5 0 0\\) msec","text_display":"\n\n\\section*{After confirming ECG reading at site, if QTcF \\(> 5 0 0\\) msec}","confidence":0.6724877340579951,"confidence_rate":0.9940063460550567},{"cnt":[[292,1001],[778,1001],[778,1051],[292,1051]],"region":{"top_left_x":292,"top_left_y":1001,"width":486,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92ef515bac104ee291bf08d553ef5f2e","type":"text","conversion_output":true,"text":"- Interrupt study treatment","text_display":"\n- Interrupt study treatment","confidence":1,"confidence_rate":1},{"cnt":[[292,1057],[1334,1057],[1334,1111],[292,1111]],"region":{"top_left_x":292,"top_left_y":1057,"width":1043,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"955a2def6ae44e0391937e77c25a8dd7","type":"text","conversion_output":true,"text":"- Repeat ECG and confirm ECG diagnosis by a cardiologist","text_display":"\n- Repeat ECG and confirm ECG diagnosis by a cardiologist","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[292,1117],[892,1117],[892,1167],[292,1167]],"region":{"top_left_x":292,"top_left_y":1117,"width":600,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3aea5265481d400b981a217ed82ffa79","type":"text","conversion_output":true,"text":"- If QTcF confirmed > 500 msec :","text_display":"\n- If QTcF confirmed > 500 msec :","confidence":0.9577188491821289,"confidence_rate":0.9989719330868493},{"cnt":[[365,1173],[1878,1173],[1878,1225],[365,1225]],"region":{"top_left_x":365,"top_left_y":1173,"width":1513,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe9473fb52ad490287d07d91c20e5549","type":"text","conversion_output":true,"text":"- Correct electrolytes, eliminate culprit concomitant treatments, and identify and address","text_display":"\n- Correct electrolytes, eliminate culprit concomitant treatments, and identify and address","confidence":1,"confidence_rate":1},{"cnt":[[425,1222],[1876,1222],[1876,1274],[425,1274]],"region":{"top_left_x":425,"top_left_y":1222,"width":1451,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf4b68429b494b60aeeb527af3f80f5f","type":"text","conversion_output":true,"text":"clinical conditions that could potentially prolong the QT as per the ECG and QTc","text_display":" clinical conditions that could potentially prolong the QT as per the ECG and QTc","confidence":1,"confidence_rate":1},{"cnt":[[425,1272],[1291,1272],[1291,1321],[425,1321]],"region":{"top_left_x":425,"top_left_y":1271,"width":867,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c140c557be3491db4e40b31f2fdfb11","type":"text","conversion_output":true,"text":"Clinical Safety Standards Guidelines Section 3.3.1.","text_display":" Clinical Safety Standards Guidelines Section 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These events should therefore be considered as","text_display":" be indicative of potentially severe DILI. 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For subjects with Gilbert Syndrome: total and direct","text_display":" gamma-glutamyltransferase (GGT). For subjects with Gilbert Syndrome: total and direct","confidence":1,"confidence_rate":1},{"cnt":[[288,1079],[1869,1079],[1869,1130],[288,1130]],"region":{"top_left_x":287,"top_left_y":1078,"width":1583,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9e59210308d45d0b36f1a4b26fa9c1b","type":"text","conversion_output":true,"text":"bilirubin must be monitored, intensified monitoring applies to changes in direct bilirubin only.","text_display":" bilirubin must be monitored, intensified monitoring applies to changes in direct bilirubin only.","confidence":1,"confidence_rate":1},{"cnt":[[288,1147],[1876,1147],[1876,1197],[288,1197]],"region":{"top_left_x":287,"top_left_y":1147,"width":1589,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"000ec2c98e864070b3dd66601cf2c806","type":"text","conversion_output":true,"text":"Evaluate status of liver metastasis (new or exacerbation) or vascular occlusion - CT, MRI,","text_display":"\nEvaluate status of liver metastasis (new or exacerbation) or vascular occlusion - CT, MRI,","confidence":1,"confidence_rate":1},{"cnt":[[288,1195],[625,1195],[625,1246],[288,1246]],"region":{"top_left_x":287,"top_left_y":1194,"width":339,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a74ebf7a40fc48908fa9eea412c79a11","type":"text","conversion_output":true,"text":"duplex sonography.","text_display":" duplex sonography.","confidence":1,"confidence_rate":1},{"cnt":[[288,1263],[1876,1263],[1876,1313],[288,1313]],"region":{"top_left_x":287,"top_left_y":1263,"width":1589,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e91b23c9c90b4e3cb45c5e3ac2dcfe5c","type":"text","conversion_output":true,"text":"Perform relevant examinations (Ultrasound or MRI, ERCP) as appropriate, to rule out if LFTs","text_display":"\nPerform relevant examinations (Ultrasound or MRI, ERCP) as appropriate, to rule out if LFTs","confidence":1,"confidence_rate":1},{"cnt":[[288,1311],[1876,1311],[1876,1360],[288,1360]],"region":{"top_left_x":287,"top_left_y":1310,"width":1589,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ef6a8a9abfd44c4815ee3a6805cfdc9","type":"text","conversion_output":true,"text":"are caused by cholestasis (defined as ALP elevation \\(>2.0 \\times\\) ULN with R value \\(<2\\) in subjects","text_display":" are caused by cholestasis (defined as ALP elevation \\(>2.0 \\times\\) ULN with R value \\(<2\\) in subjects","confidence":0.6824639678338826,"confidence_rate":0.9964022840642175},{"cnt":[[288,1358],[1848,1358],[1848,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1357,"width":1561,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfc25c90427648a2bb4e497058e1f127","type":"text","conversion_output":true,"text":"without bone metastasis, or elevation of ALP liver fraction in subjects with bone metastasis).","text_display":" without bone metastasis, or elevation of ALP liver fraction in subjects with bone metastasis).","confidence":1,"confidence_rate":1},{"cnt":[[288,1427],[1876,1427],[1876,1480],[288,1480]],"region":{"top_left_x":287,"top_left_y":1426,"width":1589,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7763b23813b1431d812dbe7f737341f1","type":"text","conversion_output":true,"text":"Note: The R value is calculated by dividing the ALT by the ALP, using multiples of the ULN","text_display":"\nNote: The R value is calculated by dividing the ALT by the ALP, using multiples of the ULN","confidence":0.8707310847239569,"confidence_rate":0.99854398635535},{"cnt":[[288,1474],[1876,1474],[1876,1525],[288,1525]],"region":{"top_left_x":287,"top_left_y":1473,"width":1589,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"825a06671af0402783686ba0723d167c","type":"text","conversion_output":true,"text":"for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to","text_display":" for both values. It denotes whether the relative pattern of ALT and/or ALP elevation is due to","confidence":1,"confidence_rate":1},{"cnt":[[288,1523],[1626,1523],[1626,1575],[288,1575]],"region":{"top_left_x":287,"top_left_y":1523,"width":1340,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e51f5be69aa24c6e95e207d3a5785b4b","type":"text","conversion_output":true,"text":"cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R >2\\) and \\(<5\\) ) liver injury.","text_display":" cholestatic ( \\(R \\leq 2\\) ), hepatocellular ( \\(R \\geq 5\\) ), or mixed ( \\(R >2\\) and \\(<5\\) ) liver injury.","confidence":0.9795935153961182,"confidence_rate":0.9998091147619181},{"cnt":[[288,1592],[1878,1592],[1878,1644],[288,1644]],"region":{"top_left_x":287,"top_left_y":1591,"width":1591,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce803d25b98d41fda731ad1e79f4e12a","type":"text","conversion_output":true,"text":"Table 6-3 provides guidance on specific clinical and diagnostic assessments to be (OR which","text_display":"\nTable 6-3 provides guidance on specific clinical and diagnostic assessments to be (OR which","confidence":1,"confidence_rate":1},{"cnt":[[288,1641],[1876,1641],[1876,1691],[288,1691]],"region":{"top_left_x":287,"top_left_y":1641,"width":1589,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f3abde709ff4705873a53ae2f6faf94","type":"text","conversion_output":true,"text":"can be) performed locally to rule out possible alternative causes of the observed LFT","text_display":" can be) performed locally to rule out possible alternative causes of the observed LFT","confidence":1,"confidence_rate":1},{"cnt":[[288,1689],[535,1689],[535,1734],[288,1734]],"region":{"top_left_x":287,"top_left_y":1688,"width":248,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dab1d96ee24f49dd9f3ebc8857277b54","type":"text","conversion_output":true,"text":"abnormalities.","text_display":" abnormalities.","confidence":1,"confidence_rate":1},{"cnt":[[288,1775],[1843,1775],[1843,1824],[288,1824]],"region":{"top_left_x":287,"top_left_y":1774,"width":1557,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81845f5fd421492ca2dac09d5718b2c1","type":"figure_label","conversion_output":false,"text":"Table 6-3 Clinical and diagnostic assessments for observed LFT abnormalities","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,1824],[1878,1824],[1878,2419],[288,2419]],"region":{"top_left_x":287,"top_left_y":1824,"width":1591,"height":596},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e30b1d2b94e543dd8d4ddf230922fe8a","type":"table","conversion_output":true,"children_ids":["3ff6e0c1b24a457b925786984d405f7a","b0ff51ff661043b7bedfa764f9c8a98c","eddf66d5b96648dcbcee90519fe37dbf","2015fd16e6ce42eb904827cb4418257c","65291a5aa29b40a387831a05608078a7","1e082c265fd04735aa4eda0a459fbc2d","6f3acbf71c9046e6bc70a0e324f8b5b0","0b24aa8b14e34ee89706bef9a474c4e1","ffb535f71c164c2ea4f8ace5ace0c5f8","4bfed7b051ba4427bf846df9f106deb7","938fe4fe9b7c418eabb0b4aa14ee2642","7117be1902a04d3a8206ee22699de3ca","4e59a39d24c249a895b887de432e2b4d","3150e375f48e4198bc2dc8328e00f0a4","b20defdebd824ceebde4344aa5dab7c8","14b3ecf10cc243bb985d386900fe0856","a9dd8784f3304e279307fb47b179c05e","da776b06cf594f2e8a839171db256eee","2373b1202e8a4667965f4f526c3f6568","74c05367afc2408ab5cecb7a9e009622","1eb5d509ab84415c931d956951209b6b","008a76144d014f62bcba71ef2cc6c3b6","ebbb24a588bd46a4b214460c63d7e1bc","7efd0b6a867241c4af2f045470831896","3c249105ffac4efcb99e464914aa7d2e","abc4699a6be646b3b072b3bb1dc5f2f1","bc63d1fd5a824b5786d2c8b0470eb740","44e9b5572c744df5ab20da9cbb1c86d7","4c9f17a6fd2241aa8d3c02aa11dd52db","d10e4ea7c2514b579364654d378f37ab","1e5cb6b0592947b086fda0dbdeb370e9","038f159b89ee4409942e3b3854908b1a","70c4b7be0fb64ee5838ea01de128b4ce","6ae2d941e67f42299b3856e2efd39a4a","09d3f97ac1014cfdb105f9f543c5955a"],"selected_labels":["81845f5fd421492ca2dac09d5718b2c1"],"text":"\\begin{tabular}{|l|l|}\n\\hline Disease & Assessment \\\\\n\\hline Hepatitis A, B, C, E & IgM anti-HAV; HBsAg, IgM \\& IgG anti-HBc, HBV DNA; anti-HCV, HCV RNA, IgM \\& IgG anti-HEV, HEV RNA \\\\\n\\hline CMV, HSV, EBV infection & IgM \\& IgG anti-CMV, IgM \\& IgG anti-HSV; IgM \\& IgG anti-EBV \\\\\n\\hline Autoimmune hepatitis & ANA \\& ASMA titers, total IgM, IgG, IgE, IgA \\\\\n\\hline Alcoholic hepatitis & Ethanol history, GT, MCV, CD-transferrin \\\\\n\\hline Nonalcoholic steatohepatitis & Ultrasound or MRI \\\\\n\\hline Hypoxic/ischemic hepatopathy & Medical history: acute or chronicCHF, hypotension, hypoxia, hepatic venous occlusion. Ultrasound or MRI. \\\\\n\\hline Biliary tract disease & Ultrasound or MRI, ERCP as appropriate. \\\\\n\\hline Wilson disease (if <40 yrs old) & Caeruloplasmin \\\\\n\\hline Hemochromatosis & Ferritin, transferrin \\\\\n\\hline Alpha-1-antitrypsin deficiency & Alpha-1-antitrypsin \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 6-3 Clinical and diagnostic assessments for observed LFT abnormalities}\n\\begin{tabular}{|l|l|}\n\\hline Disease & Assessment \\\\\n\\hline Hepatitis A, B, C, E & IgM anti-HAV; HBsAg, IgM \\& IgG anti-HBc, HBV DNA; anti-HCV, HCV RNA, IgM \\& IgG anti-HEV, HEV RNA \\\\\n\\hline CMV, HSV, EBV infection & IgM \\& IgG anti-CMV, IgM \\& IgG anti-HSV; IgM \\& IgG anti-EBV \\\\\n\\hline Autoimmune hepatitis & ANA \\& ASMA titers, total IgM, IgG, IgE, IgA \\\\\n\\hline Alcoholic hepatitis & Ethanol history, GT, MCV, CD-transferrin \\\\\n\\hline Nonalcoholic steatohepatitis & Ultrasound or MRI \\\\\n\\hline Hypoxic/ischemic hepatopathy & Medical history: acute or chronicCHF, hypotension, hypoxia, hepatic venous occlusion. Ultrasound or MRI. \\\\\n\\hline Biliary tract disease & Ultrasound or MRI, ERCP as appropriate. \\\\\n\\hline Wilson disease (if <40 yrs old) & Caeruloplasmin \\\\\n\\hline Hemochromatosis & Ferritin, transferrin \\\\\n\\hline Alpha-1-antitrypsin deficiency & Alpha-1-antitrypsin \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.98046875,"confidence_rate":0.99997412860976},{"cnt":[[304,1824],[744,1824],[744,2420],[304,2420]],"region":{"top_left_x":304,"top_left_y":1824,"width":440,"height":596},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ff6e0c1b24a457b925786984d405f7a","type":"table_column","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[800,1824],[1792,1824],[1792,2420],[800,2420]],"region":{"top_left_x":800,"top_left_y":1824,"width":993,"height":596},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0ff51ff661043b7bedfa764f9c8a98c","type":"table_column","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,1833],[1879,1833],[1879,1878],[287,1878]],"region":{"top_left_x":287,"top_left_y":1832,"width":1592,"height":47},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eddf66d5b96648dcbcee90519fe37dbf","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,1880],[1879,1880],[1879,1967],[287,1967]],"region":{"top_left_x":287,"top_left_y":1880,"width":1592,"height":87},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2015fd16e6ce42eb904827cb4418257c","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,1965],[1879,1965],[1879,2012],[287,2012]],"region":{"top_left_x":287,"top_left_y":1964,"width":1592,"height":49},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65291a5aa29b40a387831a05608078a7","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2010],[1876,2010],[1876,2060],[287,2060]],"region":{"top_left_x":287,"top_left_y":2010,"width":1590,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e082c265fd04735aa4eda0a459fbc2d","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2058],[1876,2058],[1876,2106],[287,2106]],"region":{"top_left_x":287,"top_left_y":2057,"width":1590,"height":49},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f3acbf71c9046e6bc70a0e324f8b5b0","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2103],[1879,2103],[1879,2149],[287,2149]],"region":{"top_left_x":287,"top_left_y":2103,"width":1592,"height":46},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0b24aa8b14e34ee89706bef9a474c4e1","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2149],[1876,2149],[1876,2233],[287,2233]],"region":{"top_left_x":287,"top_left_y":2148,"width":1590,"height":86},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffb535f71c164c2ea4f8ace5ace0c5f8","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2231],[1879,2231],[1879,2281],[287,2281]],"region":{"top_left_x":287,"top_left_y":2231,"width":1592,"height":50},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bfed7b051ba4427bf846df9f106deb7","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2279],[1879,2279],[1879,2324],[287,2324]],"region":{"top_left_x":287,"top_left_y":2278,"width":1592,"height":47},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"938fe4fe9b7c418eabb0b4aa14ee2642","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2326],[1879,2326],[1879,2372],[287,2372]],"region":{"top_left_x":287,"top_left_y":2326,"width":1592,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7117be1902a04d3a8206ee22699de3ca","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[287,2372],[1879,2372],[1879,2420],[287,2420]],"region":{"top_left_x":287,"top_left_y":2371,"width":1592,"height":49},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e59a39d24c249a895b887de432e2b4d","type":"table_row","conversion_output":false,"parent_id":"e30b1d2b94e543dd8d4ddf230922fe8a","text":"","text_display":""},{"cnt":[[309,1837],[436,1837],[436,1874],[309,1874]],"region":{"top_left_x":308,"top_left_y":1836,"width":129,"height":38},"line":47,"column":0,"font_size":28,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Further testing for acute hepatitis \\(A , B , C\\) or E infection and liver imaging (e.g. biliary tract)","text_display":"\n3. Further testing for acute hepatitis \\(A , B , C\\) or E infection and liver imaging (e.g. biliary tract)","confidence":0.8121943473815918,"confidence_rate":0.9982823394868254},{"cnt":[[352,1409],[668,1409],[668,1459],[352,1459]],"region":{"top_left_x":352,"top_left_y":1409,"width":317,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f55c76138942d3a0c549a291db17ab","type":"text","conversion_output":true,"text":"may be warranted.","text_display":" may be warranted.","confidence":1,"confidence_rate":1},{"cnt":[[288,1461],[1876,1461],[1876,1515],[288,1515]],"region":{"top_left_x":287,"top_left_y":1460,"width":1589,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18d6f899e0344743a055bd02fc702a36","type":"text","conversion_output":true,"text":"4. Obtain PK sample, as close as possible to last dose of study drug to determine exposure to","text_display":"\n4. Obtain PK sample, as close as possible to last dose of study drug to determine exposure to","confidence":1,"confidence_rate":1},{"cnt":[[352,1508],[1218,1508],[1218,1562],[352,1562]],"region":{"top_left_x":352,"top_left_y":1508,"width":867,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62194a3534384c5c8505203d4f83209e","type":"text","conversion_output":true,"text":"study drug if PK analysis is performed in the study.","text_display":" study drug if PK analysis is performed in the study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1564],[1876,1564],[1876,1618],[288,1618]],"region":{"top_left_x":287,"top_left_y":1564,"width":1589,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e08fe9987c264322bad154dfbc7a309c","type":"text","conversion_output":true,"text":"5. Additional testing for other hepatotropic viral infection (CMV, EBV or HSV), autoimmune","text_display":"\n5. Additional testing for other hepatotropic viral infection (CMV, EBV or HSV), autoimmune","confidence":0.9970703125,"confidence_rate":0.9999691163986473},{"cnt":[[350,1611],[1878,1611],[1878,1665],[350,1665]],"region":{"top_left_x":350,"top_left_y":1611,"width":1528,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f35c7dfc46564ec58a631dbd32440e4e","type":"text","conversion_output":true,"text":"hepatitis or liver biopsy may be considered as clinically indicated or after consultation with","text_display":" hepatitis or liver biopsy may be considered as clinically indicated or after consultation with","confidence":1,"confidence_rate":1},{"cnt":[[352,1663],[741,1663],[741,1712],[352,1712]],"region":{"top_left_x":352,"top_left_y":1662,"width":390,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e14cc9375261434ca4bb9a190f367c35","type":"text","conversion_output":true,"text":"specialist/hepatologist.","text_display":" specialist/hepatologist.","confidence":1,"confidence_rate":1},{"cnt":[[288,1729],[1876,1729],[1876,1781],[288,1781]],"region":{"top_left_x":287,"top_left_y":1729,"width":1589,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"339bc44a3c4144829c78211a29a2bc2e","type":"text","conversion_output":true,"text":"All cases of DILI confirmed on repeat testing meeting the laboratory criteria defined above,","text_display":"\nAll cases of DILI confirmed on repeat testing meeting the laboratory criteria defined above,","confidence":1,"confidence_rate":1},{"cnt":[[288,1779],[1876,1779],[1876,1826],[288,1826]],"region":{"top_left_x":287,"top_left_y":1778,"width":1589,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f0aefa0aa874fb1acf6433c28fadef2","type":"text","conversion_output":true,"text":"with no other alternative cause for LFT abnormalities identified should be considered as","text_display":" with no other alternative cause for LFT abnormalities identified should be considered as","confidence":1,"confidence_rate":1},{"cnt":[[288,1826],[1876,1826],[1876,1876],[288,1876]],"region":{"top_left_x":287,"top_left_y":1826,"width":1589,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b61740f401ce43dabe455fcc0ef824cf","type":"text","conversion_output":true,"text":"\"medically significant\", thus, met the definition of SAE (Section 8.2.1) and must be reported as","text_display":" \"medically significant\", thus, met the definition of SAE (Section 8.2.1) and must be reported as","confidence":1,"confidence_rate":1},{"cnt":[[288,1873],[1876,1873],[1876,1927],[288,1927]],"region":{"top_left_x":287,"top_left_y":1873,"width":1589,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f29e140bfeea4e14816904496d38d3a7","type":"text","conversion_output":true,"text":"SAE using the term \"potential drug-induced liver injury\". All events must be followed up with","text_display":" SAE using the term \"potential drug-induced liver injury\". All events must be followed up with","confidence":1,"confidence_rate":1},{"cnt":[[288,1921],[1880,1921],[1880,1972],[288,1972]],"region":{"top_left_x":287,"top_left_y":1920,"width":1593,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6780a4188187417ea62913a7883207ff","type":"text","conversion_output":true,"text":"the outcome clearly documented. Results of tests as well as other clinically important","text_display":" the outcome clearly documented. Results of tests as well as other clinically important","confidence":1,"confidence_rate":1},{"cnt":[[288,1968],[999,1968],[999,2017],[288,2017]],"region":{"top_left_x":287,"top_left_y":1967,"width":713,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89726be917bc49b28355b05aa1886380","type":"text","conversion_output":true,"text":"information will be recorded in the eCRF.","text_display":" information will be recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[288,2056],[1029,2056],[1029,2112],[288,2112]],"region":{"top_left_x":287,"top_left_y":2056,"width":743,"height":56},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"729e4e5704684dad89aad059b4e2b454","type":"section_header","conversion_output":false,"children_ids":["0f8d94dc762344e09f1b976434e7dce4"],"text":"","text_display":""},{"cnt":[[288,2060],[1025,2060],[1025,2108],[288,2108]],"region":{"top_left_x":287,"top_left_y":2060,"width":738,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f8d94dc762344e09f1b976434e7dce4","type":"text","conversion_output":true,"parent_id":"729e4e5704684dad89aad059b4e2b454","text":"6.4 Concomitant medications","text_display":"\n\n\\subsection*{6.4 Concomitant medications}","confidence":0.9873358940308208,"confidence_rate":0.9996017987007918},{"cnt":[[288,2133],[1876,2133],[1876,2185],[288,2185]],"region":{"top_left_x":287,"top_left_y":2133,"width":1589,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84a624f88384402896d491aefc5b21cc","type":"text","conversion_output":true,"text":"The investigator should instruct the subject to notify the study site about any new medications","text_display":"\n\nThe investigator should instruct the subject to notify the study site about any new medications","confidence":1,"confidence_rate":1},{"cnt":[[288,2179],[1878,2179],[1878,2230],[288,2230]],"region":{"top_left_x":287,"top_left_y":2178,"width":1591,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66977af860034df988994d3bac0ffefd","type":"text","conversion_output":true,"text":"he/she takes after signing the informed consent. All medications including supplements and","text_display":" he/she takes after signing the informed consent. 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the","text_display":" therapy and blood transfusions) taken within 30 days of screening and administered after the","confidence":1,"confidence_rate":1},{"cnt":[[288,2325],[1575,2325],[1575,2376],[288,2376]],"region":{"top_left_x":287,"top_left_y":2324,"width":1288,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"307e69dd762a4db8b7618342e853442f","type":"text","conversion_output":true,"text":"subject has signed informed consent must be listed on the appropriate eCRF.","text_display":" subject has signed informed consent must be listed on the appropriate eCRF.","confidence":0.99951171875,"confidence_rate":0.9999938950124091},{"cnt":[[288,2393],[1876,2393],[1876,2445],[288,2445]],"region":{"top_left_x":287,"top_left_y":2393,"width":1589,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c7411f0a9ea43afa8733f7d0c468efb","type":"text","conversion_output":true,"text":"For any antineoplastic therapy, surgery, or radiotherapy initiated after the start of study","text_display":"\nFor any antineoplastic therapy, surgery, or radiotherapy initiated after the start of study","confidence":1,"confidence_rate":1},{"cnt":[[288,2443],[1880,2443],[1880,2490],[288,2490]],"region":{"top_left_x":287,"top_left_y":2442,"width":1593,"height":49},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"203f29004d774b5483e136b748ceaf0b","type":"text","conversion_output":true,"text":"treatment, the reason for its use must be clearly documented and cancer recurrence must","text_display":" treatment, the reason for its use must be clearly documented and cancer recurrence 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CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1876,346],[1876,389],[288,389]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":44},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0554d00ee2e74fdcabb34322a23ecf78","type":"text","conversion_output":true,"text":"Prior treatment for TB infection should be listed on the eCRF. Influenza vaccines administered","text_display":"\n\nPrior treatment for TB infection should be listed on the eCRF. Influenza vaccines administered","confidence":1,"confidence_rate":1},{"cnt":[[288,395],[1876,395],[1876,443],[288,443]],"region":{"top_left_x":287,"top_left_y":395,"width":1589,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"537a6e106d3744a6a3c1d9cc081076c4","type":"text","conversion_output":true,"text":"two years prior to study start and pneumococcal vaccines administered five years prior to study","text_display":" two years prior to study start and pneumococcal vaccines administered five years prior to study","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[1876,443],[1876,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":1589,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d94afe727a1a48ffbf26e6e7c2008b55","type":"text","conversion_output":true,"text":"start should be recorded on the eCRF. Vaccinations taken during the trial should also be reported","text_display":" start should be recorded on the eCRF. Vaccinations taken during the trial should also be reported","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[1878,490],[1878,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ef76ed4b5cf4ca9b8c3c7932556b0a3","type":"text","conversion_output":true,"text":"on the eCRF. Subjects must be discontinued from the trial if administered any live and attenuated","text_display":" on the eCRF. 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This is a","text_display":" treatment dose adjusted accordingly within one month from starting study treatment. This is a","confidence":1,"confidence_rate":1},{"cnt":[[288,750],[1869,750],[1869,801],[288,801]],"region":{"top_left_x":287,"top_left_y":749,"width":1583,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05de375835ef4b62aad405d364a7f8f1","type":"text","conversion_output":true,"text":"general precautionary measure because canakinumab is not expected to interact with warfarin.","text_display":" general precautionary measure because canakinumab is not expected to interact with warfarin.","confidence":1,"confidence_rate":1},{"cnt":[[288,834],[917,834],[917,896],[288,896]],"region":{"top_left_x":287,"top_left_y":833,"width":631,"height":63},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047fad96e04242948f06266afc75f3e2","type":"section_header","conversion_output":false,"children_ids":["9bc4096851844f81853d2d85633bb8ee"],"text":"","text_display":""},{"cnt":[[292,838],[913,838],[913,892],[292,892]],"region":{"top_left_x":292,"top_left_y":837,"width":622,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bc4096851844f81853d2d85633bb8ee","type":"text","conversion_output":true,"parent_id":"047fad96e04242948f06266afc75f3e2","text":"Drug-drug interaction potential","text_display":"\n\n\\section*{Drug-drug interaction potential}","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[288,907],[1878,907],[1878,958],[288,958]],"region":{"top_left_x":287,"top_left_y":906,"width":1591,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de01b577116a448aaab76b5393d789f4","type":"text","conversion_output":true,"text":"No formal drug-drug interaction studies have been conducted with canakinumab. Elimination","text_display":"\n\nNo formal drug-drug interaction studies have been conducted with canakinumab. Elimination","confidence":1,"confidence_rate":1},{"cnt":[[288,958],[1878,958],[1878,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":958,"width":1591,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84ee944243264a2387a00da732cadad7","type":"text","conversion_output":true,"text":"pathways for IgG type monoclonal antibodies such as canakinumab are distinct from","text_display":" pathways for IgG type monoclonal antibodies such as canakinumab are distinct from","confidence":0.98681640625,"confidence_rate":0.9998456948277124},{"cnt":[[288,1005],[1878,1005],[1878,1055],[288,1055]],"region":{"top_left_x":287,"top_left_y":1005,"width":1591,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"568d9907858c4d01bc900f96d91414c4","type":"text","conversion_output":true,"text":"metabolic pathways of small molecules. The IgG-based molecules are cleared from the body","text_display":" metabolic pathways of small molecules. 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Details will be presented in the DMC","text_display":" trial conduct, will prepare data reports for the DMC. Details will be presented in the DMC","confidence":1,"confidence_rate":1},{"cnt":[[292,724],[711,724],[711,771],[292,771]],"region":{"top_left_x":292,"top_left_y":724,"width":420,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79529355ff3e45e3aad75d98f5b145e4","type":"text","conversion_output":true,"text":"charter (see Section 8.6).","text_display":" charter (see Section 8.6).","confidence":1,"confidence_rate":1},{"cnt":[[288,808],[1360,808],[1360,870],[288,870]],"region":{"top_left_x":287,"top_left_y":807,"width":1073,"height":64},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"893c0085fb4e47fa808e801158949059","type":"section_header","conversion_output":false,"children_ids":["8a3c8fc2a5d04dc7849248bb4d0b3177"],"text":"","text_display":""},{"cnt":[[292,812],[1356,812],[1356,866],[292,866]],"region":{"top_left_x":292,"top_left_y":812,"width":1064,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a3c8fc2a5d04dc7849248bb4d0b3177","type":"text","conversion_output":true,"parent_id":"893c0085fb4e47fa808e801158949059","text":"6.6 Study drug preparation and dispensation","text_display":"\n\n\\subsection*{6.6 Study drug preparation and dispensation}","confidence":0.99853515625,"confidence_rate":0.9999694605146209},{"cnt":[[292,885],[1876,885],[1876,935],[292,935]],"region":{"top_left_x":292,"top_left_y":885,"width":1584,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eada6b73a304cabac6bcfb5cc2d9968","type":"text","conversion_output":true,"text":"Each study site will be supplied by Novartis with study treatment in packaging of identical","text_display":"\n\nEach study site will be supplied by Novartis with study treatment in packaging of identical","confidence":1,"confidence_rate":1},{"cnt":[[292,932],[1876,932],[1876,982],[292,982]],"region":{"top_left_x":292,"top_left_y":932,"width":1584,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"041fb41b412c46b3853fa02796fbf9ac","type":"text","conversion_output":true,"text":"appearance per product volume. 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The treatment visits must occur within \\(\\pm 3\\) days of the target date.","text_display":" cycle for 18 cycles. The treatment visits must occur within \\(\\pm 3\\) days of the target date.","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[292,1708],[1876,1708],[1876,1757],[292,1757]],"region":{"top_left_x":292,"top_left_y":1708,"width":1584,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a628883c1744c449921fb44af66dc3b","type":"text","conversion_output":true,"text":"All dosages prescribed and dispensed to the subject and all dose interruptions during the study","text_display":"\n\nAll dosages prescribed and dispensed to the subject and all dose interruptions during the study","confidence":1,"confidence_rate":1},{"cnt":[[292,1757],[1016,1757],[1016,1807],[292,1807]],"region":{"top_left_x":292,"top_left_y":1757,"width":725,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70d7485a01bf4690b95727b8717ab957","type":"text","conversion_output":true,"text":"must be recorded on the appropriate eCRF.","text_display":" must be recorded on the appropriate eCRF.","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[288,1901],[288,1841],[690,1843],[690,1903]],"region":{"top_left_x":287,"top_left_y":1841,"width":403,"height":63},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb9f5815b6374de0b79e0dbcb1edb7cd","type":"section_header","conversion_output":false,"children_ids":["1e12f82f8d3346009dcaa61eab01b826"],"text":"","text_display":""},{"cnt":[[292,1846],[685,1846],[685,1897],[292,1897]],"region":{"top_left_x":292,"top_left_y":1845,"width":394,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e12f82f8d3346009dcaa61eab01b826","type":"text","conversion_output":true,"parent_id":"bb9f5815b6374de0b79e0dbcb1edb7cd","text":"Giving the injection","text_display":"\n\n\\section*{Giving the injection}","confidence":1,"confidence_rate":1},{"cnt":[[292,1916],[1250,1916],[1250,1966],[292,1966]],"region":{"top_left_x":292,"top_left_y":1916,"width":959,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1961c0adbf1c45ee8d1aab4a6a91387a","type":"text","conversion_output":true,"text":"All injections must be administered by the site staff only.","text_display":"\n\nAll injections must be administered by the site staff only.","confidence":1,"confidence_rate":1},{"cnt":[[294,1968],[1878,1968],[1878,2017],[294,2017]],"region":{"top_left_x":294,"top_left_y":1967,"width":1584,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9b1bdd9a1e44c989d55b706ce81f89b","type":"text","conversion_output":true,"text":"1. Choose an injection site on the upper arm, upper thigh, or abdomen. Do not use an area that","text_display":"\n1. Choose an injection site on the upper arm, upper thigh, or abdomen. Do not use an area that","confidence":1,"confidence_rate":1},{"cnt":[[352,2017],[1878,2017],[1878,2065],[352,2065]],"region":{"top_left_x":352,"top_left_y":2017,"width":1526,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"145b1d3d72464fe8b668ff7a7327cc5a","type":"text","conversion_output":true,"text":"has a rash or broken skin, or is bruised or lumpy. Avoid injecting into scar tissue- as this may","text_display":" has a rash or broken skin, or is bruised or lumpy. 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or","text_display":" Unless specifically instructed by Novartis, the Investigator must not destroy any drug labels, or","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[947,443],[947,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":661,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73f5fbcc045f4205ba82949cb27e77dd","type":"text","conversion_output":true,"text":"any partly used or unused drug supply.","text_display":" any partly used or unused drug supply.","confidence":1,"confidence_rate":1},{"cnt":[[288,511],[1878,511],[1878,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":1591,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8142e3f1add494b85aaa5d9f015508b","type":"text","conversion_output":true,"text":"At study close-out, and, as appropriate during the course of the study, the investigator will return","text_display":"\n\nAt study close-out, and, 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destruction}","confidence":1,"confidence_rate":1},{"cnt":[[288,971],[1878,971],[1878,1021],[288,1021]],"region":{"top_left_x":287,"top_left_y":971,"width":1591,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a3384e47b2542f1823ee3ce834bbccb","type":"text","conversion_output":true,"text":"The study drug supply can be destroyed at the local Novartis facility or third party, as","text_display":"\n\nThe study drug supply can be destroyed at the local Novartis facility or third party, as","confidence":1,"confidence_rate":1},{"cnt":[[288,1018],[1880,1018],[1880,1068],[288,1068]],"region":{"top_left_x":287,"top_left_y":1018,"width":1593,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"717645aca6574f28ba7b4c5fd125bcc9","type":"text","conversion_output":true,"text":"appropriate, or locally at the site only if permitted by local regulations and authorized by","text_display":" appropriate, or locally at the site only if permitted by local regulations and authorized by","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[288,1066],[453,1066],[453,1111],[288,1111]],"region":{"top_left_x":287,"top_left_y":1065,"width":167,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"835b8b4204a7461284a16cb7713bdd62","type":"text","conversion_output":true,"text":"Novartis.","text_display":" 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Each treatment cycle is 21 days (the 21 day cycle length is fixed regardless of","text_display":" performed. Each treatment cycle is 21 days (the 21 day cycle length is fixed regardless of","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[288,1444],[1880,1444],[1880,1493],[288,1493]],"region":{"top_left_x":287,"top_left_y":1443,"width":1593,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53373e93183b4296a8294187870c33ed","type":"text","conversion_output":true,"text":"whether the dose of canakinumab is withheld). All visits are to be scheduled according to the","text_display":" whether the dose of canakinumab is withheld). All visits are to be scheduled according to the","confidence":1,"confidence_rate":1},{"cnt":[[288,1491],[1880,1491],[1880,1540],[288,1540]],"region":{"top_left_x":287,"top_left_y":1491,"width":1593,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3ed1acd0a724d9b8cac8a855637d6dc","type":"text","conversion_output":true,"text":"appropriate number of calendar days from study drug administration on Cycle 1 Day 1. A visit","text_display":" appropriate number of calendar days from study drug administration on Cycle 1 Day 1. A visit","confidence":0.9931700215674937,"confidence_rate":0.9999314682535554},{"cnt":[[288,1538],[1880,1538],[1880,1588],[288,1588]],"region":{"top_left_x":287,"top_left_y":1538,"width":1593,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"292adf197762495485cb4f15444fb1b0","type":"text","conversion_output":true,"text":"window of +/- 1 day in Cycle 1 and +/- 3 days in Cycle 2 onwards through EOT and Safety","text_display":" window of +/- 1 day in Cycle 1 and +/- 3 days in Cycle 2 onwards through EOT and Safety","confidence":0.9990236759185791,"confidence_rate":0.9999906077268363},{"cnt":[[288,1586],[1882,1586],[1882,1637],[288,1637]],"region":{"top_left_x":287,"top_left_y":1585,"width":1596,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f256c78217f42e4ac28bc9d7d3fcf0f","type":"text","conversion_output":true,"text":"follow up is allowed. For Post treatment surveillance and Survival follow up, visit windows of","text_display":" follow up is allowed. For Post treatment surveillance and Survival follow up, visit windows of","confidence":1,"confidence_rate":1},{"cnt":[[288,1635],[1880,1635],[1880,1687],[288,1687]],"region":{"top_left_x":287,"top_left_y":1634,"width":1593,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af8e18602a6949c1bf9710244c57ba02","type":"text","conversion_output":true,"text":"\\(\\pm 7\\) days will apply in years 2 and 3 , and visit windows of \\(\\pm 21\\) days for years 4 and 5 . Imaging","text_display":" \\(\\pm 7\\) days will apply in years 2 and 3 , and visit windows of \\(\\pm 21\\) days for years 4 and 5 . Imaging","confidence":0.870002269744873,"confidence_rate":0.9987791716212414},{"cnt":[[288,1684],[1880,1684],[1880,1734],[288,1734]],"region":{"top_left_x":287,"top_left_y":1684,"width":1593,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d02742c9c84a549f7eddbc3ac87e8c","type":"text","conversion_output":true,"text":"evaluations may be performed \\(\\pm 14\\) days of the due date of the assessment during years 1-3 and","text_display":" evaluations may be performed \\(\\pm 14\\) days of the due date of the assessment during years 1-3 and","confidence":0.8455833792686462,"confidence_rate":0.9983241208546989},{"cnt":[[288,1729],[1880,1729],[1880,1781],[288,1781]],"region":{"top_left_x":287,"top_left_y":1729,"width":1593,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e42bf0a4eca44748a76ee5d12eebb40e","type":"text","conversion_output":true,"text":"\\(\\pm 21\\) days in years 4 and 5 . Note: If treatment with canakinumab/placebo is withheld or","text_display":" \\(\\pm 21\\) days in years 4 and 5 . Note: If treatment with canakinumab/placebo is withheld or","confidence":0.916832685470581,"confidence_rate":0.9990959268168305},{"cnt":[[288,1779],[1878,1779],[1878,1828],[288,1828]],"region":{"top_left_x":287,"top_left_y":1778,"width":1591,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd2c77d415244fb2bb261d9d7d4bb0d4","type":"text","conversion_output":true,"text":"discontinued at any time during the study, all study visits, safety and efficacy assessments","text_display":" discontinued at any time during the study, all study visits, safety and efficacy assessments","confidence":1,"confidence_rate":1},{"cnt":[[288,1826],[1880,1826],[1880,1878],[288,1878]],"region":{"top_left_x":287,"top_left_y":1826,"width":1593,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0da337eb2fc4adcbbdd0fc387668c03","type":"text","conversion_output":true,"text":"should continue according to the appropriate number of calendar days from Cycle 1 Day","text_display":" should continue according to the appropriate number of calendar days from Cycle 1 Day","confidence":1,"confidence_rate":1},{"cnt":[[288,1876],[943,1876],[943,1927],[288,1927]],"region":{"top_left_x":287,"top_left_y":1875,"width":657,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18a74e8178454c509d1e7494c5689e2a","type":"text","conversion_output":true,"text":"1 as per the schedule of assessments.","text_display":" 1 as per the schedule of assessments.","confidence":1,"confidence_rate":1},{"cnt":[[288,1942],[1880,1942],[1880,1996],[288,1996]],"region":{"top_left_x":287,"top_left_y":1942,"width":1593,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b138f6131d1a45d187535f3d43d4b361","type":"text","conversion_output":true,"text":"Imaging assessments are to continue regardless of starting a new antineoplastic therapy after","text_display":"\nImaging assessments are to continue regardless of starting a new antineoplastic therapy after","confidence":1,"confidence_rate":1},{"cnt":[[288,1989],[1880,1989],[1880,2041],[288,2041]],"region":{"top_left_x":287,"top_left_y":1989,"width":1593,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d71d24a9c7f417ea85b477622b4dd19","type":"text","conversion_output":true,"text":"discontinuation of study treatment, if the patient has not progressed from their NSCLC or been","text_display":" discontinuation of study treatment, if the patient has not progressed from their NSCLC or been","confidence":0.99658203125,"confidence_rate":0.9999654165237842},{"cnt":[[288,2039],[1880,2039],[1880,2090],[288,2090]],"region":{"top_left_x":287,"top_left_y":2038,"width":1593,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c881d188bd494ce8b3db4d59f9bbc909","type":"text","conversion_output":true,"text":"diagnosed with new lung primary. All data obtained from these assessments must be supported","text_display":" diagnosed with new lung primary. All data obtained from these assessments must be supported","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[288,2088],[939,2088],[939,2138],[288,2138]],"region":{"top_left_x":287,"top_left_y":2088,"width":652,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"264b6cbc14bf4d04a225bd599db31a46","type":"text","conversion_output":true,"text":"in the subject's source documentation.","text_display":" in the subject's source documentation.","confidence":1,"confidence_rate":1},{"cnt":[[288,2155],[1876,2155],[1876,2206],[288,2206]],"region":{"top_left_x":287,"top_left_y":2154,"width":1589,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8d61bfc2444488c88ca22472a2f7615","type":"text","conversion_output":true,"text":"Subjects who discontinue from study treatment are to return for the end of treatment visit as","text_display":"\nSubjects who discontinue from study treatment are to return for the end of treatment visit as","confidence":1,"confidence_rate":1},{"cnt":[[288,2204],[1781,2204],[1781,2254],[288,2254]],"region":{"top_left_x":287,"top_left_y":2204,"width":1495,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f055a2dc7bb84b298dcfddba09b3d705","type":"text","conversion_output":true,"text":"soon as possible, and attend the follow-up visits as indicated in the Assessment Schedule","text_display":" soon as possible, and attend the follow-up visits as indicated in the Assessment Schedule","confidence":1,"confidence_rate":1},{"cnt":[[288,2271],[1876,2271],[1876,2322],[288,2322]],"region":{"top_left_x":287,"top_left_y":2270,"width":1589,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdc5646ecc7c4eb2bbdb3528b288cfeb","type":"text","conversion_output":true,"text":"Subjects who discontinue study treatment before completing the study, and those who withdraw","text_display":"\nSubjects who discontinue study treatment before completing the study, and those who withdraw","confidence":1,"confidence_rate":1},{"cnt":[[288,2320],[1878,2320],[1878,2370],[288,2370]],"region":{"top_left_x":287,"top_left_y":2320,"width":1591,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13d461839cf545a4b992f38d8d115f2f","type":"text","conversion_output":true,"text":"from the study for any reason, should be scheduled for a visit as soon as possible, at which time","text_display":" from the study for any reason, should be scheduled for a visit as soon as possible, at which time","confidence":1,"confidence_rate":1},{"cnt":[[288,2368],[1369,2368],[1369,2417],[288,2417]],"region":{"top_left_x":287,"top_left_y":2367,"width":1082,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f6a9da8dd1040c8883cb3eb00f435f3","type":"text","conversion_output":true,"text":"all of the assessments listed for the final visit will be performed.","text_display":" all of the assessments listed for the final visit will be performed.","confidence":1,"confidence_rate":1},{"cnt":[[288,2436],[1878,2436],[1878,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":2436,"width":1591,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dfc55df0707451f9062d3a4b41b7e42","type":"text","conversion_output":true,"text":"As per Section 2.7, during a public health emergency as declared by local or regional authorities","text_display":"\n\nAs per Section 2.7, during a public health emergency as declared by local or regional authorities","confidence":1,"confidence_rate":1},{"cnt":[[288,2484],[1880,2484],[1880,2537],[288,2537]],"region":{"top_left_x":287,"top_left_y":2483,"width":1593,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec1d4dd033b249eb912c52ba82facb5a","type":"text","conversion_output":true,"text":"i.e. pandemic, epidemic or natural disaster that limits or prevents on-site study visits, alternative","text_display":" i.e. pandemic, epidemic or natural disaster that limits or prevents on-site study visits, alternative","confidence":0.9926822170382366,"confidence_rate":0.9999307128789642}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-076","page":76,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f505adb1ecd4b4ea7c12ab33b38f0fe","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9665c7d2f4f4711b9962a66075a7a78","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d55205ff1ef74044a0330d5aac1e6b12","type":"page_info","conversion_output":false,"text":"Page 76 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de3211b8559e43dca4668f7c4e15b1ea","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,249],[1871,249],[1871,290],[1414,290]],"region":{"top_left_x":1413,"top_left_y":249,"width":459,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"649ecd70dff34d7c98a8085eded35362","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bec0840389c04d23acccbd187bc4345c","type":"text","conversion_output":true,"text":"methods of providing continuing care may be implemented by the Investigator as the situation","text_display":"\nmethods of providing continuing care may be implemented by the Investigator as the situation","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[1880,391],[1880,445],[288,445]],"region":{"top_left_x":287,"top_left_y":391,"width":1593,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf0860ef43b34c038f1a8328ecc59310","type":"text","conversion_output":true,"text":"dictates. If allowable by a local health authority, national and local regulations and depending","text_display":" dictates. If allowable by a local health authority, national and local regulations and depending","confidence":1,"confidence_rate":1},{"cnt":[[288,440],[1878,440],[1878,492],[288,492]],"region":{"top_left_x":287,"top_left_y":440,"width":1591,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f458b7370f1e4f429d25d65ad70171c5","type":"text","conversion_output":true,"text":"on operational capabilities, phone calls, virtual contacts (e.g. tele consultation) or visits by site","text_display":" on operational capabilities, phone calls, virtual contacts (e.g. tele consultation) or visits by site","confidence":1,"confidence_rate":1},{"cnt":[[288,490],[1878,490],[1878,539],[288,539]],"region":{"top_left_x":287,"top_left_y":489,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a367dc5992e4647a3516725a5df85fb","type":"text","conversion_output":true,"text":"staff/ off-site healthcare professional(s) staff to the participant's home, can replace certain","text_display":" staff/ off-site healthcare professional(s) staff to the participant's home, can replace certain","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1880,537],[1880,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1593,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c3216e3d9845ea9aa44282ebc89203","type":"text","conversion_output":true,"text":"protocol assessments, for the duration of the disruption until it is safe for the participant to visit","text_display":" protocol assessments, for the duration of the disruption until it is safe for the participant to visit","confidence":1,"confidence_rate":1},{"cnt":[[288,584],[1878,584],[1878,638],[288,638]],"region":{"top_left_x":287,"top_left_y":584,"width":1591,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d04246061d30483db79b24e680dd285b","type":"text","conversion_output":true,"text":"the site again. If the Investigator delegates tasks to an off-site healthcare professional, the","text_display":" the site again. If the Investigator delegates tasks to an off-site healthcare professional, the","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1878,632],[1878,685],[288,685]],"region":{"top_left_x":287,"top_left_y":631,"width":1591,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a69ca1f537724f408519679634170d46","type":"text","conversion_output":true,"text":"Investigator must ensure the individual(s) is/are qualified and appropriately trained to perform","text_display":" Investigator must ensure the individual(s) is/are qualified and appropriately trained to perform","confidence":1,"confidence_rate":1},{"cnt":[[288,681],[1878,681],[1878,733],[288,733]],"region":{"top_left_x":287,"top_left_y":681,"width":1591,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45580d42a6e54194a31735f75979d724","type":"text","conversion_output":true,"text":"assigned duties. The Investigator must oversee their conduct and remain responsible for the","text_display":" assigned duties. The Investigator must oversee their conduct and remain responsible for the","confidence":1,"confidence_rate":1},{"cnt":[[288,728],[831,728],[831,776],[288,776]],"region":{"top_left_x":287,"top_left_y":728,"width":545,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e53442de0c74cd8ac30881c260bc179","type":"text","conversion_output":true,"text":"evaluation of the data collected.","text_display":" evaluation of the data collected.","confidence":1,"confidence_rate":1},{"cnt":[[288,795],[1639,795],[1639,849],[288,849]],"region":{"top_left_x":287,"top_left_y":794,"width":1353,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be63e30cfae34a46a434447d53d3dfbb","type":"text","conversion_output":true,"text":"Table 7-2 provides details on the assessments to be performed for the sub-study.","text_display":"\n\nTable 7-2 provides details on the assessments to be performed for the sub-study.","confidence":0.98779296875,"confidence_rate":0.9998555145685355}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-077","page":77,"lines":[{"cnt":[[198,305],[333,305],[333,337],[198,337]],"region":{"top_left_x":197,"top_left_y":305,"width":137,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c7edbdc335b4e36b81c1ee21578dabc","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1283,305],[1472,305],[1472,339],[1283,339]],"region":{"top_left_x":1282,"top_left_y":305,"width":190,"height":35},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c95c8fccb4934961b93fca917cbb5ca2","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2314,305],[2554,305],[2554,346],[2314,346]],"region":{"top_left_x":2313,"top_left_y":305,"width":242,"height":41},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4fa6572f032482ca326b24a265ec109","type":"page_info","conversion_output":false,"text":"Page 77 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[198,352],[788,352],[788,393],[198,393]],"region":{"top_left_x":197,"top_left_y":352,"width":592,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a05679851c845c28744a57217244a19","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2097,352],[2550,352],[2550,387],[2097,387]],"region":{"top_left_x":2096,"top_left_y":352,"width":455,"height":35},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12a27b2263d94d5bbfc254522d3a0aff","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[198,483],[1491,483],[1491,531],[198,531]],"region":{"top_left_x":197,"top_left_y":483,"width":1295,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b59f1837aaa14cd59507e9879c45cb20","type":"figure_label","conversion_output":false,"text":"Table 7-1 Visit evaluation schedule (main study, CACZ885T2301)","text_display":"","confidence":0.998535871389322,"confidence_rate":0.999978131560098},{"cnt":[[200,535],[2557,535],[2557,1798],[200,1798]],"region":{"top_left_x":199,"top_left_y":534,"width":2358,"height":1265},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1da0c90882e4d0c8c2431af9a1fcee5","type":"table","conversion_output":true,"children_ids":["801948116dd24f0b984311f29de040b2","55256a63245c43c596679af44cabf25f","dda9da8baff0490bbe664779cd30c4c8","20e05d9e9ce54dc3b5a638f725d6021d","cdebf53a8a8b44dbb6c68ad630355b2c","6cd34f297768447db67af8c87a2dcd9b","371f6bc2866f49e4a09d5b069d443b42","3c9ecb7f3d324c70ad22348c894e3dab","cff61db48a354421bf04eefe196e9bea","c3a6a86b7d354947baf732983474ac25","1b266d8814bf431d8c86751bd0404b1e","df9f4cd794c14572b3060cb1d46bfc81","0b7d168468c740be9eb4513563bea807","bee1a6ba54ea4040853886a1463d7b72","b3f7f241c70e482ba765f158f19d03e1","3e5185c0fdea4b72b5e14055becdbdc8","59b8bf3cb0e44a0389ddeee163fe62fd","2f397a3301714f17924881de102506a2","69ab3729077f4c848f756787ceb6ef2a","08aeef36f84340d8a8887d64b3fc40f9","7f15c83d6d7c4572bb35aace320a4aee","d77491572deb4c0eadc31ec96fe4c318","bd3d16235c9c46db9b7b2b747d520e7b","2d19209562a04734b42126e9f7d8b56a","dca38ab37a87424eadd0acca640dcacc","becf8c303a2b4494955e988419426769","a75bc6d7b110467db5b960c1419ad04d","a9c2ab616d704f1a977e7cc4694a473a","83e3e97155814712ac72cfe25c0951b0","8c302dfdb767472e8251fade05cff2f4","d7a309e02ef94ec5be4ce3ae7664a80e","410c35ca49e3429f8281b8901679b573","6623031565024e69bf166905c0be5291","28753178c3174e64b2d6c19824ed5d20","3a150a6cfb3d4e76a674ce8e4e776a1f","88dfabdb30fc4ce181b338bb4c46335f","17d3e360b31f4a0d8f9017012b709f4f","e57fc41f0cf84008a10e96db01f44d27","f1cd6f5de9eb42af8945bbdab8930aec","e29c81de74074df9abff43e397b3ed3d","4758e360edc0439083f8560bfbec6e69","e738adf9a49c453091c790cd1ed39b7b","621ad90cdcc8468cac9cb42fe0fa632e","0f72da2fd5504887a545970a3fa8c456","aeacf90526334a979228c427fa0e1e8e","9a1c8e4a59214c7a83a32bc59b8578e2","16a8c2620b1a4cfda463eec18be190e3","a1bcdd53318d4ce695e1993ab9bf22c6","d15a31951bbe410f9cf68cc8a4017797","67f5de9441e14887aff6ea9f519abd2a","52a1f978ad9d48f89b85042bf66d7b00","39558377d08f4cf89048fef878c9041b","c03c2ddf9f3e4f7cb42c57d35d257cd9","eea63bd53c1040b491dbb7f6a0d882b7","ddce8e9ba4734e4ea920b73546d61d0a","2ddc31fe9f5a492ab9f1d9ba386ec4bb","29efc6f9596942158bedee52dc833f31","293615828ce444678286fbb7d09753af","19bd3d2c994147b783c0c1d8ba5e3a9e","aee81d5ecd204901affb23bb75b401ce","32f8d76fff2a417f8ecd49f92b9c46c0","6917b42d5831477fbccf2dac8fdf3ed8","25accb7d241a4197bfea76bb5719a3ca","658d783dd7aa498280d9d914d2bfae0c","0e6f494ac2494e2d90aa1d7fe4e405ab","f24d0b36d1b84f718ca2c975053efe68","3cfca67d57df478caed3b33f8212c374","6cd75d2307a843df9a7cfb4f91e06d6b","28513bf4b6534d81afd7396b0ddf0796","4adef1d1ca56447ab7a9541510ee1620","5d6437a378ed4a1ba789acf48d333359","29516b454abf424792ef9c7f3c2c6af5","3dfd87b43901467c85b7a6d2eb1d80d6","1a038e129d3942509d88d6f2a3f1db27","b43019c06f184f21b515f19a22636cc2","477c0fbcd4e1400dba3520da569960fd","19fb418271d1489fb4a0ed1a43ff6f44","3e45ec86509640c3926a601e2b574168","489a7345331c47ccb768c417c72e6d9d","ca7843d8e0af4e0bbeb41bd5aae71e9b","a3f28a05762f48bb84c54415917c1a8c","0fe74da3e54744f88210c0857bd2bffa","7ee7e990bc454bcab7771e40e676f03a","484f49c2624d43dbb36deb497b072804","d2447eac835f4667a9c098e09dd6fb20","f1d49219bb114b27b58669040890a2f6","05c1ef991cfd41139ca9b0905580fa9d","29e2baeddba5400695622fc1920e97b9","ac85012c6d7e435a917612c05c958faf","60173a910c164885bf5d2e0ed9f4797c","ba588558c7ee4780be81ab63bb83edb2","2997aa1ce14649f887f5506a78d228e0","325b4a1c38a249c7bc2518dc56c87fca","43e57b9688d94d259439436e30acf3a9","f1efff3ef2314b10b8f535e7bf70b440","b80ee4a990ab413c8a02d3a215fa7f85","b715c19e0e1e4e949479afebf54605dc"],"selected_labels":["b59f1837aaa14cd59507e9879c45cb20"],"text":"\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Protocol Section & Screening Phase & \\multicolumn{10}{|l|}{Treatment Phase Canakinumab / placebo (18 cycles / 54 weeks)} & \\multicolumn{2}{|c|}{Post treatment surveillance (PTS)} & Follow up phase \\\\\n\\hline Visit Name & & Screening & \\multicolumn{3}{|l|}{Cycle 1} & Cycles 2 to 17 & C18/ EOT & \\multicolumn{5}{|c|}{Safety follow up (every 28d for 130d)} & \\multicolumn{2}{|l|}{Post treatment surveillance} & Survival follow up \\\\\n\\hline Study/treatment cycle day & & -28 to -1 & \\(\\bar{v}\\) & oð óm & \\(\\frac{10}{0}\\) & C2D1, C3D1, etc. & C18/EOT & Saetes & Sacty Num & Saceven & Saceve & ![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-077.jpg?height=128\\&width=38\\&top_left_y=837\\&top_left_x=1974) & Years 2 and 3 & Years 4 and 5 & Every 12 weeks \\\\\n\\hline Visit Number & & 1 & 110 & 140 & 150 & 210, 310, etc. & 1999 & 2010 & 2020 & ![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-077.jpg?height=141\\&width=35\\&top_left_y=992\\&top_left_x=1825) & 2040 & 2050 & 3010, 3020, 3030, 3040 etc. & 3050 3060 & SS \\\\\n\\hline Obtain Study Informed Consent & 7.1.2 & X & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{16}{|c|}{} \\\\\n\\hline IRT Screening (after ICF) & 7.1.2 & S & & & & & & & & & & & & & \\\\\n\\hline Study Disposition Form & 7.1.4 & \\multicolumn{14}{|l|}{Completed upon end of study treatment or when a subject exits the study for any reason (X)} \\\\\n\\hline Demography & 7.1.2.3 & X & & & & & & & & & & & & & \\\\\n\\hline Inclusion/exclusion criteria & 5.2, 5.3 & X & & & & & & & & & & & & & \\\\\n\\hline Medical history & 7.1.2.3 & X & & & & & & & & & & & & & \\\\\n\\hline Smoking history & 7.1.2.3 & X & & & & & & & & & & & & & \\\\\n\\hline Diagnosis, stage and grade of cancer & 7.1.2.3 & X & & & & & & & & & & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 7-1 Visit evaluation schedule (main study, CACZ885T2301)}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Protocol Section & Screening Phase & \\multicolumn{10}{|l|}{Treatment Phase Canakinumab / placebo (18 cycles / 54 weeks)} & \\multicolumn{2}{|c|}{Post treatment surveillance (PTS)} & Follow up phase \\\\\n\\hline Visit Name & & Screening & \\multicolumn{3}{|l|}{Cycle 1} & Cycles 2 to 17 & C18/ EOT & \\multicolumn{5}{|c|}{Safety follow up (every 28d for 130d)} & \\multicolumn{2}{|l|}{Post treatment surveillance} & Survival follow up \\\\\n\\hline Study/treatment cycle day & & -28 to -1 & \\(\\bar{v}\\) & oð óm & \\(\\frac{10}{0}\\) & C2D1, C3D1, etc. & C18/EOT & Saetes & Sacty Num & Saceven & Saceve & ![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-077.jpg?height=128\\&width=38\\&top_left_y=837\\&top_left_x=1974) & Years 2 and 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For pathological stages not requiring chemotherapy, these samples must be drawn prior to their first imaging performed since resection surgery, still within 70 days after surgery. \\\\\n****For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).\n\\end{tabular}","cell_row":8,"cell_column":0,"cell_row_span":1,"cell_col_span":6,"confidence":0.8902955055236816,"confidence_rate":0.9998055676733881},{"cnt":[[219,1091],[1537,1091],[1537,1128],[219,1128]],"region":{"top_left_x":218,"top_left_y":1091,"width":1320,"height":37},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16233b621b004d60bc2a1741f13636f5","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"\\(X =\\) assessment to be recorded in the clinical database or received electronically from a vendor","text_display":"\\(X =\\) assessment to be recorded in the clinical database or received electronically from a vendor","confidence":0.8902955055236816,"confidence_rate":0.9988501482927435},{"cnt":[[219,1134],[1585,1134],[1585,1173],[219,1173]],"region":{"top_left_x":218,"top_left_y":1134,"width":1368,"height":40},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9c160462d3942ed813db413d23ab1b8","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"*Eligibility confirmation can occur on the same day as the pre- resection surgery sample collection.","text_display":"\n*Eligibility confirmation can occur on the same day as the pre- resection surgery sample collection.","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[219,1178],[1048,1178],[1048,1214],[219,1214]],"region":{"top_left_x":218,"top_left_y":1177,"width":831,"height":38},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02b733c7361b42cda903fca6ce14a614","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"**Either one day prior to, or on the day of resection surgery.","text_display":"\n**Either one day prior to, or on the day of resection surgery.","confidence":1,"confidence_rate":1},{"cnt":[[219,1221],[2516,1221],[2516,1258],[219,1258]],"region":{"top_left_x":218,"top_left_y":1220,"width":2299,"height":38},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9ab3e99857246c790e3bd8a1b8cbfc4","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"***Prior to first administration of chemotherapy, not before 30 days after surgery but within 70 days after surgery. 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For pathological stages not requiring chemotherapy,","confidence":1,"confidence_rate":1},{"cnt":[[219,1258],[1936,1258],[1936,1295],[219,1295]],"region":{"top_left_x":218,"top_left_y":1257,"width":1718,"height":38},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aac51c6d75064a9b9a6fe708f600c0bd","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"these samples must be drawn prior to their first imaging performed since resection surgery, still within 70 days after surgery.","text_display":" these samples must be drawn prior to their first imaging performed since resection surgery, still within 70 days after surgery.","confidence":1,"confidence_rate":1},{"cnt":[[219,1299],[1908,1299],[1908,1336],[219,1336]],"region":{"top_left_x":218,"top_left_y":1298,"width":1690,"height":38},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d922fd0f062c4041ba8fb36d4e740b2b","type":"text","conversion_output":false,"parent_id":"5c407d34e7f0491b93e6fd28fdc024f9","text":"****For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. HGRAC).","text_display":"\n****For China only: biomarker collection is conditional upon approval from HA, EC and additional authorities (i.e. 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CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,382],[958,382],[958,440],[288,440]],"region":{"top_left_x":287,"top_left_y":382,"width":672,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"933420d365f54769bd2386d5efbd0e21","type":"section_header","conversion_output":false,"children_ids":["d2a63efb16f04387baf3fb1777a7eea6"],"text":"","text_display":""},{"cnt":[[292,387],[956,387],[956,436],[292,436]],"region":{"top_left_x":292,"top_left_y":386,"width":665,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2a63efb16f04387baf3fb1777a7eea6","type":"text","conversion_output":true,"parent_id":"933420d365f54769bd2386d5efbd0e21","text":"7.1.1 Molecular pre-screening","text_display":"\n\n\\subsection*{7.1.1 Molecular pre-screening}","confidence":1,"confidence_rate":1},{"cnt":[[288,455],[544,455],[544,505],[288,505]],"region":{"top_left_x":287,"top_left_y":455,"width":257,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41d746f52a684890bb8076ab7a5f3e14","type":"text","conversion_output":true,"text":"Not applicable","text_display":"\n\nNot applicable","confidence":1,"confidence_rate":1},{"cnt":[[288,541],[681,541],[681,604],[288,604]],"region":{"top_left_x":287,"top_left_y":541,"width":395,"height":63},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa008c8a1d3d4ec09d60e8f1581927fd","type":"section_header","conversion_output":false,"children_ids":["17a662a12c08488680d540647d99c616"],"text":"","text_display":""},{"cnt":[[288,546],[675,546],[675,597],[288,597]],"region":{"top_left_x":287,"top_left_y":545,"width":388,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17a662a12c08488680d540647d99c616","type":"text","conversion_output":true,"parent_id":"aa008c8a1d3d4ec09d60e8f1581927fd","text":"7.1.2 Screening","text_display":"\n\n\\subsection*{7.1.2 Screening}","confidence":1,"confidence_rate":1},{"cnt":[[288,614],[1858,614],[1858,664],[288,664]],"region":{"top_left_x":287,"top_left_y":614,"width":1572,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e7469d9acf14658ba1501597bad7ba7","type":"text","conversion_output":true,"text":"Written informed consent must be obtained before any study specific procedure is performed.","text_display":"\n\nWritten informed consent must be obtained before any study specific procedure is performed.","confidence":1,"confidence_rate":1},{"cnt":[[288,683],[1878,683],[1878,733],[288,733]],"region":{"top_left_x":287,"top_left_y":683,"width":1591,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"149db706eb4e4011a31b0c1054fe2524","type":"text","conversion_output":true,"text":"Subjects may be screened after undergoing complete surgical resection of their NSCLC and","text_display":"\nSubjects may be screened after undergoing complete surgical resection of their NSCLC and","confidence":1,"confidence_rate":1},{"cnt":[[288,730],[1880,730],[1880,780],[288,780]],"region":{"top_left_x":287,"top_left_y":730,"width":1593,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87cff0aa50b6426dba17bf1624a69e85","type":"text","conversion_output":true,"text":"having R0 status confirmed (negative margins on pathologic review), after completing adjuvant","text_display":" having R0 status confirmed (negative margins on pathologic review), after completing adjuvant","confidence":1,"confidence_rate":1},{"cnt":[[288,778],[1878,778],[1878,827],[288,827]],"region":{"top_left_x":287,"top_left_y":777,"width":1591,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d7b70d0568f4cd3b0a7925d54c353b6","type":"text","conversion_output":true,"text":"cisplatin-based doublet chemotherapy if applicable, (and, if applicable, radiation therapy is","text_display":" cisplatin-based doublet chemotherapy if applicable, (and, if applicable, radiation therapy is","confidence":1,"confidence_rate":1},{"cnt":[[288,827],[1876,827],[1876,879],[288,879]],"region":{"top_left_x":287,"top_left_y":827,"width":1589,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"907f14cd711c450c8b0a9d4eee1baf53","type":"text","conversion_output":true,"text":"allowed if indicated as per local guidelines or practice) and after all entry criteria are met.","text_display":" allowed if indicated as per local guidelines or practice) and after all entry criteria are met.","confidence":1,"confidence_rate":1},{"cnt":[[288,872],[1878,872],[1878,926],[288,926]],"region":{"top_left_x":287,"top_left_y":872,"width":1591,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5078b70df8dd43489bb7c6cd37df6861","type":"text","conversion_output":true,"text":"Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve","text_display":" Subjects must not have had preoperative neo-adjuvant chemotherapy or radiotherapy to achieve","confidence":1,"confidence_rate":1},{"cnt":[[288,924],[524,924],[524,969],[288,969]],"region":{"top_left_x":287,"top_left_y":923,"width":238,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8d61a1f247245508594be9c33efea95","type":"text","conversion_output":true,"text":"the R0 status.","text_display":" the R0 status.","confidence":1,"confidence_rate":1},{"cnt":[[288,990],[1880,990],[1880,1042],[288,1042]],"region":{"top_left_x":287,"top_left_y":990,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d0aa9669be34a38a3a42ab86e4b5982","type":"text","conversion_output":true,"text":"After signing the study ICF, the screening assessments will be done within 1 to 28 days prior","text_display":"\n\nAfter signing the study ICF, the screening assessments will be done within 1 to 28 days prior","confidence":1,"confidence_rate":1},{"cnt":[[288,1040],[1876,1040],[1876,1089],[288,1089]],"region":{"top_left_x":287,"top_left_y":1039,"width":1589,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cf8c0d38046456bb3e33c6b2b6e7684","type":"text","conversion_output":true,"text":"to randomization (see Table 7-1 for list of assessments to be performed). Laboratory parameters","text_display":" to randomization (see Table 7-1 for list of assessments to be performed). Laboratory parameters","confidence":0.984375,"confidence_rate":0.999842528830205},{"cnt":[[288,1087],[1878,1087],[1878,1139],[288,1139]],"region":{"top_left_x":287,"top_left_y":1087,"width":1591,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1523d51d0e0a47bca6ad9aca9de7cbe8","type":"text","conversion_output":true,"text":"may be retested within the 28 -day screening window (day -28 to day -1 ) period for an individual","text_display":" may be retested within the 28 -day screening window (day -28 to day -1 ) period for an individual","confidence":0.8247427567924425,"confidence_rate":0.9982656161344011},{"cnt":[[288,1134],[1878,1134],[1878,1188],[288,1188]],"region":{"top_left_x":287,"top_left_y":1134,"width":1591,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b3c1a4b2eea46f08a27ddbf8f28c785","type":"text","conversion_output":true,"text":"subject if such parameters meet an exclusion criterion when initially tested. Laboratory","text_display":" subject if such parameters meet an exclusion criterion when initially tested. Laboratory","confidence":1,"confidence_rate":1},{"cnt":[[288,1182],[1880,1182],[1880,1235],[288,1235]],"region":{"top_left_x":287,"top_left_y":1181,"width":1593,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"648af5ec8aa2455eb3f5f67812a823d3","type":"text","conversion_output":true,"text":"assessments performed as part of the screening evaluations will not be required to be repeated","text_display":" assessments performed as part of the screening evaluations will not be required to be repeated","confidence":1,"confidence_rate":1},{"cnt":[[288,1231],[1880,1231],[1880,1283],[288,1283]],"region":{"top_left_x":287,"top_left_y":1231,"width":1593,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33f4891eca3d4873a022c0c063654c21","type":"text","conversion_output":true,"text":"prior to dosing (except urine pregnancy test) unless deemed clinically necessary by investigator","text_display":" prior to dosing (except urine pregnancy test) unless deemed clinically necessary by investigator","confidence":1,"confidence_rate":1},{"cnt":[[288,1280],[1880,1280],[1880,1330],[288,1330]],"region":{"top_left_x":287,"top_left_y":1280,"width":1593,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f49cb2372a0e471f8e7cad94afcfa2e5","type":"text","conversion_output":true,"text":"and/or required as per local institutional policies. Tumor imaging assessments will be performed","text_display":" and/or required as per local institutional policies. Tumor imaging assessments will be performed","confidence":1,"confidence_rate":1},{"cnt":[[288,1328],[1699,1328],[1699,1377],[288,1377]],"region":{"top_left_x":287,"top_left_y":1327,"width":1413,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be43479bfdd43b796ec11b090b28ddf","type":"text","conversion_output":true,"text":"at screening between Day -28 and Day -1. For details of assessments, see Table 7-1.","text_display":" at screening between Day -28 and Day -1. 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Any imaging assessments obtained after randomization cannot","text_display":" baseline images for this study. 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In case of re-screening, the same subject ID will be used. All required","text_display":" subject has screen failed. In case of re-screening, the same subject ID will be used. 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An individual subject may only be re-screened once for the study. Details on capturing","confidence":1,"confidence_rate":1},{"cnt":[[288,1964],[1399,1964],[1399,2015],[288,2015]],"region":{"top_left_x":287,"top_left_y":1963,"width":1112,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d4fa75ec7334ff9b5ce94af9fb2e004","type":"text","conversion_output":true,"text":"re-screening will be outlined in the eCRF Completion Guidelines.","text_display":" re-screening will be outlined in the eCRF Completion Guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[286,2030],[724,2030],[724,2090],[286,2090]],"region":{"top_left_x":285,"top_left_y":2030,"width":440,"height":61},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f27fcd8fffae46cd9e7d8acfdaf1c17b","type":"section_header","conversion_output":false,"children_ids":["ff7a0b320cf54a8ebc735f21e4b2ca01"],"text":"","text_display":""},{"cnt":[[288,2037],[718,2037],[718,2086],[288,2086]],"region":{"top_left_x":287,"top_left_y":2036,"width":431,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff7a0b320cf54a8ebc735f21e4b2ca01","type":"text","conversion_output":true,"parent_id":"f27fcd8fffae46cd9e7d8acfdaf1c17b","text":"Sub-study participants:","text_display":"\n\n\\section*{Sub-study participants:}","confidence":1,"confidence_rate":1},{"cnt":[[288,2101],[1663,2101],[1663,2153],[288,2153]],"region":{"top_left_x":287,"top_left_y":2101,"width":1376,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71c4eb5668be4b58b63bfba9c07b2b09","type":"text","conversion_output":true,"text":"Written informed consent must be obtained prior to participation in the sub-study.","text_display":"\n\nWritten informed consent must be obtained prior to participation in the sub-study.","confidence":1,"confidence_rate":1},{"cnt":[[288,2170],[1876,2170],[1876,2221],[288,2221]],"region":{"top_left_x":287,"top_left_y":2169,"width":1589,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"962eee3d8ae64b79bcef4ab41200db56","type":"text","conversion_output":true,"text":"Subjects may be assessed for eligibility into the sub-study if they have NSCLC Stage IIA-IIIA,","text_display":"\nSubjects may be assessed for eligibility into the sub-study if they have NSCLC Stage IIA-IIIA,","confidence":1,"confidence_rate":1},{"cnt":[[288,2219],[1880,2219],[1880,2271],[288,2271]],"region":{"top_left_x":287,"top_left_y":2219,"width":1593,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df89a99ded6b4fd48b068458e0e96cfd","type":"text","conversion_output":true,"text":"IIIB ( \\(T >5 cm\\), N2 disease only) and who are candidates for complete resection surgery (and","text_display":" IIIB ( \\(T >5 cm\\), N2 disease only) and who are candidates for complete resection surgery (and","confidence":0.6648775733774528,"confidence_rate":0.9960831490706259},{"cnt":[[288,2264],[1878,2264],[1878,2318],[288,2318]],"region":{"top_left_x":287,"top_left_y":2264,"width":1591,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d62ee32ee0b84cfaa38d517a16f2b679","type":"text","conversion_output":true,"text":"therefore prospective candidates for the main study, CACZ885T2301). After signing the sub-","text_display":" therefore prospective candidates for the main study, CACZ885T2301). After signing the sub","confidence":1,"confidence_rate":1},{"cnt":[[288,2314],[1880,2314],[1880,2365],[288,2365]],"region":{"top_left_x":287,"top_left_y":2313,"width":1593,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9727484a874a45509506ee75e6d09e6a","type":"text","conversion_output":true,"text":"study ICF, and sub-study eligibility criteria are met, biomarker samples will be collected as per","text_display":"study ICF, and sub-study eligibility criteria are met, biomarker samples will be collected as per","confidence":1,"confidence_rate":1},{"cnt":[[288,2363],[471,2363],[471,2408],[288,2408]],"region":{"top_left_x":287,"top_left_y":2363,"width":184,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8ffd00a9eac453e92c355785e8e8809","type":"text","conversion_output":true,"text":"Table 7-2.","text_display":" Table 7-2.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-088","page":88,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"323e4e1ac5774648a879da3cd21677d6","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3aafc7cdf0b149edb6cda823b5a6a950","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1dfbd9fe0b624a38b2a80e7c05cf462a","type":"page_info","conversion_output":false,"text":"Page 88 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfb2c8bab20d43ed867d725bed4355de","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f3b38e925684fd585528d44271069fa","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,339],[872,339],[872,402],[288,402]],"region":{"top_left_x":287,"top_left_y":339,"width":586,"height":63},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e6da934ac58480f81cf8939077097b1","type":"section_header","conversion_output":false,"children_ids":["c2337e17cf674a3d9029830bac810cb4"],"text":"","text_display":""},{"cnt":[[292,346],[868,346],[868,397],[292,397]],"region":{"top_left_x":292,"top_left_y":345,"width":576,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2337e17cf674a3d9029830bac810cb4","type":"text","conversion_output":true,"parent_id":"0e6da934ac58480f81cf8939077097b1","text":"7.1.2.1 Eligibility screening","text_display":"\n\n\\subsection*{7.1.2.1 Eligibility screening}","confidence":1,"confidence_rate":1},{"cnt":[[288,415],[1876,415],[1876,466],[288,466]],"region":{"top_left_x":287,"top_left_y":414,"width":1589,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b220057f1c04852aeb7ddc342a406fc","type":"text","conversion_output":true,"text":"Following registering in the IRT for screening, subject eligibility will be checked once all","text_display":"\n\nFollowing registering in the IRT for screening, subject eligibility will be checked once all","confidence":1,"confidence_rate":1},{"cnt":[[288,464],[1876,464],[1876,513],[288,513]],"region":{"top_left_x":287,"top_left_y":464,"width":1589,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41eeb07745f841ed9b5fe6a88967cd74","type":"text","conversion_output":true,"text":"screening procedures are completed. The eligibility check will be embedded in the IRT system.","text_display":" screening procedures are completed. The eligibility check will be embedded in the IRT system.","confidence":1,"confidence_rate":1},{"cnt":[[288,511],[1878,511],[1878,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":1591,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"989aef4fdc5a4fbeb0e50c87ed9688c7","type":"text","conversion_output":true,"text":"Allocation to one of the two study arms will also be registered via IRT. Please refer and comply","text_display":" Allocation to one of the two study arms will also be registered via IRT. Please refer and comply","confidence":1,"confidence_rate":1},{"cnt":[[288,559],[1021,559],[1021,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":734,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c74a1d05bbb4d80a74e780166cc21b8","type":"text","conversion_output":true,"text":"with detailed guidelines in the IRT manual.","text_display":" with detailed guidelines in the IRT manual.","confidence":1,"confidence_rate":1},{"cnt":[[284,640],[1442,640],[1442,703],[284,703]],"region":{"top_left_x":283,"top_left_y":640,"width":1159,"height":63},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa9ed9617e2b4570837972335b18210e","type":"section_header","conversion_output":false,"children_ids":["50a238f7e6d645dd854b62ed01fe7924"],"text":"","text_display":""},{"cnt":[[288,645],[1437,645],[1437,698],[288,698]],"region":{"top_left_x":287,"top_left_y":644,"width":1151,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50a238f7e6d645dd854b62ed01fe7924","type":"text","conversion_output":true,"parent_id":"fa9ed9617e2b4570837972335b18210e","text":"7.1.2.2 Information to be collected on screening failures","text_display":"\n\n\\subsection*{7.1.2.2 Information to be collected on screening failures}","confidence":1,"confidence_rate":1},{"cnt":[[288,718],[1878,718],[1878,767],[288,767]],"region":{"top_left_x":287,"top_left_y":717,"width":1591,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c19a2ebc868c4d0fbcf0f7bf0703f059","type":"text","conversion_output":true,"text":"A subject who signs the main informed consent but fails to satisfy all eligibility criteria for any","text_display":"\n\nA subject who signs the main informed consent but fails to satisfy all eligibility criteria for any","confidence":1,"confidence_rate":1},{"cnt":[[288,765],[1878,765],[1878,814],[288,814]],"region":{"top_left_x":287,"top_left_y":764,"width":1591,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a54929edb694981b69ac1a77d062c2c","type":"text","conversion_output":true,"text":"reason will be considered a screen failure. The reason for not satisfying eligibility criteria and","text_display":" reason will be considered a screen failure. The reason for not satisfying eligibility criteria and","confidence":1,"confidence_rate":1},{"cnt":[[288,812],[1878,812],[1878,862],[288,862]],"region":{"top_left_x":287,"top_left_y":812,"width":1591,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1db22b8b4bcc43cabd9638f722d12eb4","type":"text","conversion_output":true,"text":"not being enrolled will be entered on the disposition eCRF. The following eCRFs must be","text_display":" not being enrolled will be entered on the disposition eCRF. 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If the subject fails to be enrolled, the IRT must be notified","text_display":" Section 8 for SAE reporting details). If the subject fails to be enrolled, the IRT must be notified","confidence":1,"confidence_rate":1},{"cnt":[[288,1534],[1371,1534],[1371,1586],[288,1586]],"region":{"top_left_x":287,"top_left_y":1533,"width":1084,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"812c4c9df2cc4da0b75203ee800a3713","type":"text","conversion_output":true,"text":"within 2 days of the screen fail that the subject was not enrolled.","text_display":" within 2 days of the screen fail that the subject was not 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For details of","confidence":0.9562708078576065,"confidence_rate":0.999586065932993},{"cnt":[[288,1929],[823,1929],[823,1979],[288,1979]],"region":{"top_left_x":287,"top_left_y":1929,"width":536,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d1bd008ed8246099684a8391b7f934f","type":"text","conversion_output":true,"text":"assessments, refer to Table 7-1.","text_display":" assessments, refer to Table 7-1.","confidence":1,"confidence_rate":1},{"cnt":[[286,2015],[1171,2015],[1171,2073],[286,2073]],"region":{"top_left_x":285,"top_left_y":2015,"width":886,"height":59},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f54a07e03b3f4f80ad7176997edba649","type":"section_header","conversion_output":false,"children_ids":["4813364b68fc4780afd35ff6fe9ab9c6"],"text":"","text_display":""},{"cnt":[[288,2020],[1164,2020],[1164,2069],[288,2069]],"region":{"top_left_x":287,"top_left_y":2019,"width":878,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4813364b68fc4780afd35ff6fe9ab9c6","type":"text","conversion_output":true,"parent_id":"f54a07e03b3f4f80ad7176997edba649","text":"7.1.4 Discontinuation of study treatment","text_display":"\n\n\\subsection*{7.1.4 Discontinuation of study treatment}","confidence":0.9951193332672119,"confidence_rate":0.9998912811084815},{"cnt":[[288,2084],[1878,2084],[1878,2138],[288,2138]],"region":{"top_left_x":287,"top_left_y":2083,"width":1591,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65dcdab14b1c411799b9d06554b986ba","type":"text","conversion_output":true,"text":"Subjects who discontinue study treatment should NOT automatically be considered withdrawn","text_display":"\n\nSubjects who discontinue study treatment should NOT automatically be considered withdrawn","confidence":1,"confidence_rate":1},{"cnt":[[288,2136],[1880,2136],[1880,2185],[288,2185]],"region":{"top_left_x":287,"top_left_y":2135,"width":1593,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14f4fce0bfc64da294bfaf6f767edd54","type":"text","conversion_output":true,"text":"from the study. See Table 7-1 for the required assessments of these subjects after","text_display":" from the study. See Table 7-1 for the required assessments of these subjects after","confidence":1,"confidence_rate":1},{"cnt":[[288,2183],[1876,2183],[1876,2232],[288,2232]],"region":{"top_left_x":287,"top_left_y":2182,"width":1589,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a626fec314a474290803a0d60ffa771","type":"text","conversion_output":true,"text":"discontinuation of study treatment. Subjects who discontinue study treatment during the","text_display":" discontinuation of study treatment. Subjects who discontinue study treatment during the","confidence":1,"confidence_rate":1},{"cnt":[[288,2230],[1876,2230],[1876,2279],[288,2279]],"region":{"top_left_x":287,"top_left_y":2230,"width":1589,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e6d5d1d84644851beefe9111120ad1c","type":"text","conversion_output":true,"text":"treatment phase should be scheduled for a visit within 7 days or as soon as possible after the","text_display":" treatment phase should be scheduled for a visit within 7 days or as soon as possible after the","confidence":1,"confidence_rate":1},{"cnt":[[288,2277],[1878,2277],[1878,2327],[288,2327]],"region":{"top_left_x":287,"top_left_y":2277,"width":1591,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0014b699ce33442a9eae4602f26f5efe","type":"text","conversion_output":true,"text":"last dose of study treatment, at which time all of the assessments listed for the EOT visit will","text_display":" last dose of study treatment, at which time all of the assessments listed for the EOT visit will","confidence":1,"confidence_rate":1},{"cnt":[[288,2325],[1878,2325],[1878,2378],[288,2378]],"region":{"top_left_x":287,"top_left_y":2324,"width":1591,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ecdb3b9d4344a4eb05957584298f50b","type":"text","conversion_output":true,"text":"be performed. If a subject withdraws from treatment at a study visit, EOT assessments that are","text_display":" be performed. If a subject withdraws from treatment at a study visit, EOT assessments that are","confidence":1,"confidence_rate":1},{"cnt":[[288,2376],[1878,2376],[1878,2426],[288,2426]],"region":{"top_left_x":287,"top_left_y":2376,"width":1591,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d51adeb731334709aaef7f38fb402477","type":"text","conversion_output":true,"text":"already part of that scheduled study visit do not need to be repeated. The disposition page should","text_display":" already part of that scheduled study visit do not need to be repeated. The disposition page should","confidence":1,"confidence_rate":1},{"cnt":[[288,2423],[1371,2423],[1371,2473],[288,2473]],"region":{"top_left_x":287,"top_left_y":2423,"width":1084,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"505defbe1b3d446591bef86f0525bf89","type":"text","conversion_output":true,"text":"be completed, giving the date and reason for stopping treatment.","text_display":" be completed, giving the date and reason for stopping 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CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1876,346],[1876,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeaf4d29605b44cb8d6c2a10d88a9f95","type":"text","conversion_output":true,"text":"For subjects who discontinue treatment for reasons other than documented disease recurrence,","text_display":"\n\nFor subjects who discontinue treatment for reasons other than documented disease recurrence,","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[290,395],[1876,395],[1876,445],[290,445]],"region":{"top_left_x":290,"top_left_y":395,"width":1586,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209be85dec094dd2878b650270a754a3","type":"text","conversion_output":true,"text":"initiation of new antineoplastic therapies, death, lost to follow-up, or withdrawal of consent,","text_display":" initiation of new antineoplastic therapies, death, lost to follow-up, or withdrawal of consent,","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[1876,443],[1876,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":1589,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82b25ccd3b1a45ef82643dcf8f8a9fb6","type":"text","conversion_output":true,"text":"assessments must continue to be performed according to Table 7-1 until disease recurrence,","text_display":" assessments must continue to be performed according to Table 7-1 until disease 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If a subject","text_display":"\n\nSubjects may voluntarily discontinue from the study for any reason at any time. If a subject","confidence":1,"confidence_rate":1},{"cnt":[[288,655],[1876,653],[1876,707],[288,709]],"region":{"top_left_x":287,"top_left_y":653,"width":1589,"height":56},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfe53e6c9bdc41e98f31c80e7ead0795","type":"text","conversion_output":true,"text":"decides to discontinue from the study, the investigator should make a reasonable effort (e.g.","text_display":" decides to discontinue from the study, the investigator should make a reasonable effort (e.g.","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1876,700],[1876,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1589,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69e33ce7de834717b47c939ede2e597c","type":"text","conversion_output":true,"text":"telephone, e-mail, letter) to understand the primary reason for this decision and record this","text_display":" telephone, e-mail, letter) to understand the primary reason for this decision and record this","confidence":1,"confidence_rate":1},{"cnt":[[288,748],[1878,748],[1878,801],[288,801]],"region":{"top_left_x":287,"top_left_y":747,"width":1591,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc2441f7c8194d7a8e771be550d2d5f7","type":"text","conversion_output":true,"text":"information in the subject's chart and on the appropriate eCRF pages. They may be considered","text_display":" information in the subject's chart and on the appropriate eCRF pages. They may be considered","confidence":1,"confidence_rate":1},{"cnt":[[288,797],[1876,797],[1876,849],[288,849]],"region":{"top_left_x":287,"top_left_y":797,"width":1589,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2afdb0f063894fc8b51aaa0c656f6b3d","type":"text","conversion_output":true,"text":"withdrawn if they state an intention to withdraw, fail to return for visits, or become lost to","text_display":" withdrawn if they state an intention to withdraw, fail to return for visits, or become lost to","confidence":1,"confidence_rate":1},{"cnt":[[288,846],[1876,846],[1876,896],[288,896]],"region":{"top_left_x":287,"top_left_y":846,"width":1589,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3589b21dadb34f47b344cecc4d757cba","type":"text","conversion_output":true,"text":"follow-up for any other reason. 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study treatment, including those who refuse to","confidence":1,"confidence_rate":1},{"cnt":[[288,1010],[1880,1010],[1880,1061],[288,1061]],"region":{"top_left_x":287,"top_left_y":1009,"width":1593,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d17e5e0ac97145dd90ce1c695590409f","type":"text","conversion_output":true,"text":"return for a final visit, will be contacted for safety evaluations during the 130 days following","text_display":" return for a final visit, will be contacted for safety evaluations during the 130 days following","confidence":1,"confidence_rate":1},{"cnt":[[288,1057],[885,1057],[885,1109],[288,1109]],"region":{"top_left_x":287,"top_left_y":1057,"width":599,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0228b5fce77c40b2a457eee18708c828","type":"text","conversion_output":true,"text":"the EOT visit (see Section 7.1.6.1).","text_display":" the EOT visit (see Section 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subject's well-being.","confidence":1,"confidence_rate":1},{"cnt":[[288,1242],[1878,1242],[1878,1296],[288,1296]],"region":{"top_left_x":287,"top_left_y":1241,"width":1591,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991c697ab0ec415fa4d9ed65bc1798f3","type":"text","conversion_output":true,"text":"In addition to mandatory study drug discontinuation criteria listed in Table 6-2, treatment must","text_display":"\nIn addition to mandatory study drug discontinuation criteria listed in Table 6-2, treatment must","confidence":1,"confidence_rate":1},{"cnt":[[288,1291],[1253,1291],[1253,1343],[288,1343]],"region":{"top_left_x":287,"top_left_y":1291,"width":966,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79e358ca493347c193a600c27b572fc1","type":"text","conversion_output":true,"text":"also be discontinued under the following circumstances:","text_display":" also be discontinued under the 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Follow-up can be done via a phone contact.","text_display":" final survival analysis. Follow-up can be done via a phone contact.","confidence":1,"confidence_rate":1},{"cnt":[[286,1671],[814,1671],[814,1732],[286,1732]],"region":{"top_left_x":285,"top_left_y":1671,"width":530,"height":61},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c3da7826904a16bec3d5cb92e6e410","type":"section_header","conversion_output":false,"children_ids":["b47ef59c7e6449278c7653089c97adf9"],"text":"","text_display":""},{"cnt":[[288,1676],[810,1676],[810,1729],[288,1729]],"region":{"top_left_x":287,"top_left_y":1675,"width":523,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b47ef59c7e6449278c7653089c97adf9","type":"text","conversion_output":true,"parent_id":"32c3da7826904a16bec3d5cb92e6e410","text":"7.1.7 Lost to follow-up","text_display":"\n\n\\subsection*{7.1.7 Lost to follow-up}","confidence":0.9951221942901611,"confidence_rate":0.9998253816392735},{"cnt":[[288,1745],[1880,1745],[1880,1796],[288,1796]],"region":{"top_left_x":287,"top_left_y":1744,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c01f0e8399934e04afcd196c8d14cc1a","type":"text","conversion_output":true,"text":"For subjects whose status is unclear because they fail to appear for study visits, or fail to respond","text_display":"\n\nFor subjects whose status is unclear because they fail to appear for study visits, or fail to respond","confidence":0.77685546875,"confidence_rate":0.9976207504041034},{"cnt":[[288,1794],[1880,1794],[1880,1846],[288,1846]],"region":{"top_left_x":287,"top_left_y":1793,"width":1593,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d361c5b573ac4bb89f8784449f684660","type":"text","conversion_output":true,"text":"to any site attempts to contact them, without stating an intention to discontinue from study","text_display":" to any site attempts to contact them, without stating an intention to discontinue from study","confidence":1,"confidence_rate":1},{"cnt":[[288,1843],[1880,1843],[1880,1893],[288,1893]],"region":{"top_left_x":287,"top_left_y":1843,"width":1593,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85f058a73cfc481b8de5ee50593b2fee","type":"text","conversion_output":true,"text":"treatment or discontinue from study or withdraw consent (or exercise other subject's data","text_display":" treatment or discontinue from study or withdraw consent (or exercise other subject's data","confidence":1,"confidence_rate":1},{"cnt":[[288,1891],[1878,1891],[1878,1940],[288,1940]],"region":{"top_left_x":287,"top_left_y":1890,"width":1591,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ebcf00b09c1492ea36249ce32d41ca8","type":"text","conversion_output":true,"text":"privacy rights), the investigator should show \"due diligence\" by documenting in the source","text_display":" privacy rights), the investigator should show \"due diligence\" by documenting in the source","confidence":1,"confidence_rate":1},{"cnt":[[288,1938],[1878,1938],[1878,1987],[288,1987]],"region":{"top_left_x":287,"top_left_y":1937,"width":1591,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81d25c4a088043c4901a03092918037b","type":"text","conversion_output":true,"text":"documents steps taken to contact the subject, e.g. dates of telephone calls, registered letters,","text_display":" documents steps taken to contact the subject, e.g. dates of telephone calls, registered letters,","confidence":1,"confidence_rate":1},{"cnt":[[288,1985],[1878,1985],[1878,2035],[288,2035]],"region":{"top_left_x":287,"top_left_y":1985,"width":1591,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61f127686c5747dbbeac9b0ab64755c8","type":"text","conversion_output":true,"text":"etc. A subject should not be considered lost to follow-up until due diligence has been","text_display":" etc. A subject should not be considered lost to follow-up until due diligence has been","confidence":1,"confidence_rate":1},{"cnt":[[288,2032],[1880,2032],[1880,2086],[288,2086]],"region":{"top_left_x":287,"top_left_y":2032,"width":1593,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66563e3f221d4ec6a442c569ede1d76a","type":"text","conversion_output":true,"text":"completed. Subjects lost to follow up should be recorded as such on the appropriate disposition","text_display":" completed. Subjects lost to follow up should be recorded as such on the appropriate disposition","confidence":0.99560546875,"confidence_rate":0.999955958813992},{"cnt":[[288,2084],[406,2084],[406,2125],[288,2125]],"region":{"top_left_x":287,"top_left_y":2083,"width":120,"height":42},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e824f6efa9344abbaf078d0538e7dee","type":"text","conversion_output":true,"text":"eCRF.","text_display":" eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[286,2166],[874,2166],[874,2230],[286,2230]],"region":{"top_left_x":285,"top_left_y":2165,"width":590,"height":66},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26a6119c11e84d349a4c70ed53ac1ac5","type":"section_header","conversion_output":false,"children_ids":["db50f68154e84c76931125fa91ff8dbd"],"text":"","text_display":""},{"cnt":[[288,2170],[870,2170],[870,2226],[288,2226]],"region":{"top_left_x":287,"top_left_y":2169,"width":584,"height":57},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db50f68154e84c76931125fa91ff8dbd","type":"text","conversion_output":true,"parent_id":"26a6119c11e84d349a4c70ed53ac1ac5","text":"7.2 Assessment types","text_display":"\n\n\\subsection*{7.2 Assessment types}","confidence":0.99951171875,"confidence_rate":0.9999804641709025},{"cnt":[[284,2258],[982,2258],[982,2314],[284,2314]],"region":{"top_left_x":283,"top_left_y":2258,"width":699,"height":56},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b1837dde3ba49c3809c2a3d791e96da","type":"section_header","conversion_output":false,"children_ids":["87af337ef81d4dbca6761e0c04778a10"],"text":"","text_display":""},{"cnt":[[288,2264],[978,2264],[978,2310],[288,2310]],"region":{"top_left_x":287,"top_left_y":2264,"width":691,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87af337ef81d4dbca6761e0c04778a10","type":"text","conversion_output":true,"parent_id":"4b1837dde3ba49c3809c2a3d791e96da","text":"7.2.1 Recurrence assessments","text_display":"\n\n\\subsection*{7.2.1 Recurrence assessments}","confidence":1,"confidence_rate":1},{"cnt":[[288,2333],[1878,2333],[1878,2383],[288,2383]],"region":{"top_left_x":287,"top_left_y":2333,"width":1591,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e2dbeb4328a4a03a063d4544f2cadf0","type":"text","conversion_output":true,"text":"Detection of first disease recurrence will be done by clinical evaluation that includes physical","text_display":"\n\nDetection of first disease recurrence will be done by clinical evaluation that includes physical","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[288,2380],[1878,2380],[1878,2430],[288,2430]],"region":{"top_left_x":287,"top_left_y":2380,"width":1591,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f6dc6a24db14c61be26db0e67863f21","type":"text","conversion_output":true,"text":"examination and radiological tumor measurements as determined by the investigator. In case","text_display":" examination and radiological tumor measurements as determined by the investigator. In case","confidence":1,"confidence_rate":1},{"cnt":[[288,2428],[1876,2428],[1876,2479],[288,2479]],"region":{"top_left_x":287,"top_left_y":2427,"width":1589,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1fb20a0a8a44ff580b163c9e8e08d25","type":"text","conversion_output":true,"text":"of non-conclusive radiological evidence, a biopsy should be performed to confirm recurrence.","text_display":" of non-conclusive radiological evidence, a biopsy should be performed to confirm recurrence.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-093","page":93,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36657a6c88e4445f9dce0c67f6329cae","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"889a04b3a6444a948152488fd70ba922","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5b3aa172b8c460b896825e5a5d11e39","type":"page_info","conversion_output":false,"text":"Page 93 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a4fe01a751d40d3bc0ad0deb863d90a","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a833e35275f44ad8655245b81f04443","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fda88cfd5b494d6a80e0de961484d90a","type":"text","conversion_output":true,"text":"If a biopsy is performed, the fresh tissue sample and the pathology report should be submitted","text_display":"\n\nIf a biopsy is performed, the fresh tissue sample and the pathology report should be submitted","confidence":1,"confidence_rate":1},{"cnt":[[288,395],[587,395],[587,436],[288,436]],"region":{"top_left_x":287,"top_left_y":395,"width":300,"height":42},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcc5e2fd77a2419b9bf565270bd16a2d","type":"text","conversion_output":true,"text":"to the central lab.","text_display":" to the central lab.","confidence":1,"confidence_rate":1},{"cnt":[[288,460],[1326,460],[1326,513],[288,513]],"region":{"top_left_x":287,"top_left_y":459,"width":1039,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fb3d4ae49d4495cb4d6c5ca294e4dc7","type":"text","conversion_output":true,"text":"The following assessments are required at screening/baseline:","text_display":"\n\nThe following assessments are required at screening/baseline:","confidence":1,"confidence_rate":1},{"cnt":[[288,520],[1008,520],[1008,569],[288,569]],"region":{"top_left_x":287,"top_left_y":519,"width":721,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13fcdef2e7064563994308e751db7868","type":"text","conversion_output":true,"text":"- Chest, abdomen and pelvis CT or MRI","text_display":"\n- Chest, abdomen and pelvis CT or MRI","confidence":1,"confidence_rate":1},{"cnt":[[288,580],[544,580],[544,621],[288,621]],"region":{"top_left_x":287,"top_left_y":580,"width":257,"height":41},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"515e74d33276451f81e2f01aa6a3c8c8","type":"text","conversion_output":true,"text":"- Brain MRI","text_display":"\n- Brain MRI","confidence":1,"confidence_rate":1},{"cnt":[[288,632],[1119,632],[1119,685],[288,685]],"region":{"top_left_x":287,"top_left_y":631,"width":833,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa76ea606c7744ed9e2f3645109efb8f","type":"text","conversion_output":true,"text":"- Whole body bone scan, if clinically indicated","text_display":"\n- Whole body bone scan, if clinically indicated","confidence":1,"confidence_rate":1},{"cnt":[[288,705],[1878,705],[1878,754],[288,754]],"region":{"top_left_x":287,"top_left_y":704,"width":1591,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9cc4818f16a4d0d918b804f497c86a6","type":"text","conversion_output":true,"text":"Subsequent imaging assessments will be done every 12 weeks for the first year (treatment","text_display":"\n\nSubsequent imaging assessments will be done every 12 weeks for the first year (treatment","confidence":1,"confidence_rate":1},{"cnt":[[288,752],[1878,752],[1878,804],[288,804]],"region":{"top_left_x":287,"top_left_y":751,"width":1591,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d4dc941ebcf487a9175221e99a28506","type":"text","conversion_output":true,"text":"phase) following Cycle 1 Day 1, then every 26 weeks during years two and three, and annually","text_display":" phase) following Cycle 1 Day 1, then every 26 weeks during years two and three, and annually","confidence":1,"confidence_rate":1},{"cnt":[[288,851],[288,799],[1876,801],[1876,853]],"region":{"top_left_x":287,"top_left_y":799,"width":1589,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0775201d9494e17aa25165b5b5a1220","type":"text","conversion_output":true,"text":"during years four and five (post-treatment surveillance phase) (see Table 7-1). The intervals","text_display":" during years four and five (post-treatment surveillance phase) (see Table 7-1). The intervals","confidence":1,"confidence_rate":1},{"cnt":[[288,849],[1876,849],[1876,900],[288,900]],"region":{"top_left_x":287,"top_left_y":848,"width":1589,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ffce97dc25f4eaf92f9d13aeacd8790","type":"text","conversion_output":true,"text":"between imaging assessments across all study phases should be respected as described","text_display":" between imaging assessments across all study phases should be respected as described","confidence":1,"confidence_rate":1},{"cnt":[[288,898],[1878,898],[1878,947],[288,947]],"region":{"top_left_x":287,"top_left_y":898,"width":1591,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7033dae01f0944b2a81f174ef58df1b2","type":"text","conversion_output":true,"text":"above regardless of whether study treatment is temporarily withheld or permanently","text_display":" above regardless of whether study treatment is temporarily withheld or permanently","confidence":1,"confidence_rate":1},{"cnt":[[288,945],[1880,945],[1880,995],[288,995]],"region":{"top_left_x":287,"top_left_y":945,"width":1593,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39cb8d4388b94180bafac9a41dc14ace","type":"text","conversion_output":true,"text":"discontinued before the last scheduled dose administration on Cycle 18 Day 1, or if","text_display":" discontinued before the last scheduled dose administration on Cycle 18 Day 1, or if","confidence":1,"confidence_rate":1},{"cnt":[[288,993],[1878,993],[1878,1042],[288,1042]],"region":{"top_left_x":287,"top_left_y":992,"width":1591,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3edb22bb4c054d4dae32c74b0943f236","type":"text","conversion_output":true,"text":"unscheduled assessments are performed. A window of \\(\\pm 14\\) days in years 1-3, then \\(\\pm 21\\) days","text_display":" unscheduled assessments are performed. A window of \\(\\pm 14\\) days in years 1-3, then \\(\\pm 21\\) days","confidence":0.9980475902557373,"confidence_rate":0.9999800581765897},{"cnt":[[288,1040],[1545,1040],[1545,1089],[288,1089]],"region":{"top_left_x":287,"top_left_y":1039,"width":1258,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0183f9b479a4e2b9bbe30be9feadf04","type":"text","conversion_output":true,"text":"in years 4 and 5 is permitted to take into account scheduling over holidays.","text_display":" in years 4 and 5 is permitted to take into account scheduling over holidays.","confidence":1,"confidence_rate":1},{"cnt":[[288,1109],[1876,1109],[1876,1158],[288,1158]],"region":{"top_left_x":287,"top_left_y":1108,"width":1589,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b5aaa3d36444b88daf3baf9ac19e1f","type":"text","conversion_output":true,"text":"First disease recurrence must be radiologically confirmed by the investigator. In case of non-","text_display":"\n\nFirst disease recurrence must be radiologically confirmed by the investigator. In case of non","confidence":1,"confidence_rate":1},{"cnt":[[288,1156],[1878,1156],[1878,1205],[288,1205]],"region":{"top_left_x":287,"top_left_y":1155,"width":1591,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d3e76f5a9da40b29762108cd61492c4","type":"text","conversion_output":true,"text":"conclusive radiological evidence, a biopsy should be performed to confirm recurrence. If a","text_display":"conclusive radiological evidence, a biopsy should be performed to confirm recurrence. If a","confidence":1,"confidence_rate":1},{"cnt":[[288,1203],[1880,1203],[1880,1257],[288,1257]],"region":{"top_left_x":287,"top_left_y":1203,"width":1593,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97f3612f16634f53806954308a4ee5a2","type":"text","conversion_output":true,"text":"biopsy is not feasible, the subject will be followed up until recurrence can be confirmed as per","text_display":" biopsy is not feasible, the subject will be followed up until recurrence can be confirmed as per","confidence":1,"confidence_rate":1},{"cnt":[[288,1250],[1145,1250],[1145,1304],[288,1304]],"region":{"top_left_x":287,"top_left_y":1250,"width":859,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bdb9ca3043a45389fa4407e238fadc8","type":"text","conversion_output":true,"text":"protocol (radiologically conclusive and/or biopsy).","text_display":" protocol (radiologically conclusive and/or biopsy).","confidence":1,"confidence_rate":1},{"cnt":[[288,1319],[1878,1319],[1878,1373],[288,1373]],"region":{"top_left_x":287,"top_left_y":1319,"width":1591,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"260a7208a0b64fb29b57015130419848","type":"text","conversion_output":true,"text":"For any antineoplastic therapy, surgery, or radiotherapy initiated after the start of study","text_display":"\nFor any antineoplastic therapy, surgery, or radiotherapy initiated after the start of study","confidence":1,"confidence_rate":1},{"cnt":[[288,1371],[1878,1371],[1878,1420],[288,1420]],"region":{"top_left_x":287,"top_left_y":1370,"width":1591,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8293fe8d9b53410689e147be5b16615e","type":"text","conversion_output":true,"text":"treatment, the reason for its use must be clearly documented and recurrence of cancer must be","text_display":" treatment, the reason for its use must be clearly documented and recurrence of cancer must be","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,1418],[1876,1418],[1876,1467],[288,1467]],"region":{"top_left_x":287,"top_left_y":1417,"width":1589,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0c4803a7bd44a56989ff06df263f0e3","type":"text","conversion_output":true,"text":"assessed and documented. Imaging assessments are to continue regardless of start of new","text_display":" assessed and documented. Imaging assessments are to continue regardless of start of new","confidence":1,"confidence_rate":1},{"cnt":[[288,1465],[698,1465],[698,1515],[288,1515]],"region":{"top_left_x":287,"top_left_y":1465,"width":412,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"916e2c41365e40a69ec14f81fbc55737","type":"text","conversion_output":true,"text":"antineoplastic therapies.","text_display":" antineoplastic therapies.","confidence":1,"confidence_rate":1},{"cnt":[[288,1534],[1876,1534],[1876,1583],[288,1583]],"region":{"top_left_x":287,"top_left_y":1533,"width":1589,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc6325ecc97340b28feaf07531a2692a","type":"text","conversion_output":true,"text":"If a subject discontinues study treatment for reasons other than recurrence, recurrence","text_display":"\n\nIf a subject discontinues study treatment for reasons other than recurrence, recurrence","confidence":1,"confidence_rate":1},{"cnt":[[288,1581],[1878,1581],[1878,1631],[288,1631]],"region":{"top_left_x":287,"top_left_y":1581,"width":1591,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99007e436a0c401b9c8f5f656114fc6f","type":"text","conversion_output":true,"text":"assessments should continue as per the scheduled visits per Table 7-1 and Table 7-2 until","text_display":" assessments should continue as per the scheduled visits per Table 7-1 and Table 7-2 until","confidence":0.8282920906785876,"confidence_rate":0.9979978641841729},{"cnt":[[288,1629],[1880,1629],[1880,1680],[288,1680]],"region":{"top_left_x":287,"top_left_y":1628,"width":1593,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe3f360dbb824102a9b86bb464f7793e","type":"text","conversion_output":true,"text":"disease recurrence, withdrawal of consent by the subject, subject is lost to follow up, death or","text_display":" disease recurrence, withdrawal of consent by the subject, subject is lost to follow up, death or","confidence":1,"confidence_rate":1},{"cnt":[[288,1678],[844,1678],[844,1727],[288,1727]],"region":{"top_left_x":287,"top_left_y":1677,"width":558,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c162b1b5025743f7913489e8e86dc517","type":"text","conversion_output":true,"text":"the sponsor terminates the study.","text_display":" the sponsor terminates the study.","confidence":1,"confidence_rate":1},{"cnt":[[288,1745],[1876,1745],[1876,1798],[288,1798]],"region":{"top_left_x":287,"top_left_y":1744,"width":1589,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c23bdf928e554a23aeabb0166252e0e7","type":"text","conversion_output":true,"text":"A whole body bone scan (e.g. Tc-99m bone scan, sodium fluoride PET [NaF-PET] bone scan)","text_display":"\nA whole body bone scan (e.g. Tc-99m bone scan, sodium fluoride PET [NaF-PET] bone scan)","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[288,1796],[1876,1796],[1876,1846],[288,1846]],"region":{"top_left_x":287,"top_left_y":1796,"width":1589,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04944c5d78cb44b5bacd06917ef46ded","type":"text","conversion_output":true,"text":"can be done to identify location of recurrence in bone tissue. If bone metastases were identified","text_display":" can be done to identify location of recurrence in bone tissue. If bone metastases were identified","confidence":1,"confidence_rate":1},{"cnt":[[288,1841],[1876,1841],[1876,1893],[288,1893]],"region":{"top_left_x":287,"top_left_y":1841,"width":1589,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"193e1495a14140d3890819c903aebbc6","type":"text","conversion_output":true,"text":"by a bone scan, it has to be confirmed histologically (preferred) or radiographically (by CT,","text_display":" by a bone scan, it has to be confirmed histologically (preferred) or radiographically (by CT,","confidence":0.99560546875,"confidence_rate":0.9999550600344739},{"cnt":[[288,1891],[1235,1891],[1235,1940],[288,1940]],"region":{"top_left_x":287,"top_left_y":1890,"width":949,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b02034cf3234ed8ac886435c2d9d198","type":"text","conversion_output":true,"text":"MRI or FDG-PET-CT) if biopsy confirmation is unsafe.","text_display":" MRI or FDG-PET-CT) if biopsy confirmation is unsafe.","confidence":1,"confidence_rate":1},{"cnt":[[288,1959],[1876,1959],[1876,2009],[288,2009]],"region":{"top_left_x":287,"top_left_y":1959,"width":1589,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cb8102175a74e309ddacec7d32af41f","type":"text","conversion_output":true,"text":"All MRI and CT should be done with contrast unless contraindicated. If a subject is known to","text_display":"\n\nAll MRI and CT should be done with contrast unless contraindicated. If a subject is known to","confidence":1,"confidence_rate":1},{"cnt":[[288,2007],[1878,2007],[1878,2056],[288,2056]],"region":{"top_left_x":287,"top_left_y":2006,"width":1591,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2d01440c8ef4eaba1b9b0fed3e138ed","type":"text","conversion_output":true,"text":"have a contraindication to CT intravenous (IV) contrast media or develops a contraindication","text_display":" have a contraindication to CT intravenous (IV) contrast media or develops a contraindication","confidence":1,"confidence_rate":1},{"cnt":[[288,2054],[1876,2054],[1876,2103],[288,2103]],"region":{"top_left_x":287,"top_left_y":2053,"width":1589,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"061633d448b543ce9c972defe4af6942","type":"text","conversion_output":true,"text":"during the trial, a non-contrast CT of the chest (Chest MRI is not recommended due to","text_display":" during the trial, a non-contrast CT of the chest (Chest MRI is not recommended due to","confidence":1,"confidence_rate":1},{"cnt":[[288,2101],[1878,2101],[1878,2155],[288,2155]],"region":{"top_left_x":287,"top_left_y":2101,"width":1591,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c80db13e8bb140f6b51e402e2064d85c","type":"text","conversion_output":true,"text":"respiratory artifacts, however if CT is not feasible per local regulations, MRI can be performed","text_display":" respiratory artifacts, however if CT is not feasible per local regulations, MRI can be performed","confidence":1,"confidence_rate":1},{"cnt":[[288,2151],[1876,2151],[1876,2202],[288,2202]],"region":{"top_left_x":287,"top_left_y":2150,"width":1589,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73a9be976750492bba4b1c21cf2b329c","type":"text","conversion_output":true,"text":"instead) plus a contrast-enhanced MRI (if possible) of the abdomen and pelvis should be","text_display":" instead) plus a contrast-enhanced MRI (if possible) of the abdomen and pelvis should be","confidence":1,"confidence_rate":1},{"cnt":[[288,2200],[483,2200],[483,2249],[288,2249]],"region":{"top_left_x":287,"top_left_y":2200,"width":197,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15d1317b30ac423bb20e7988294275a9","type":"text","conversion_output":true,"text":"performed.","text_display":" performed.","confidence":1,"confidence_rate":1},{"cnt":[[288,2264],[1876,2264],[1876,2318],[288,2318]],"region":{"top_left_x":287,"top_left_y":2264,"width":1589,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31bac117425640b5a0d3a2ba58e7efd0","type":"text","conversion_output":true,"text":"Brain MRI with contrast is required. If a subject has known contraindication or develops","text_display":"\nBrain MRI with contrast is required. If a subject has known contraindication or develops","confidence":1,"confidence_rate":1},{"cnt":[[288,2316],[1876,2316],[1876,2365],[288,2365]],"region":{"top_left_x":287,"top_left_y":2316,"width":1589,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aeadb849a744025997e4f13f8a3ca63","type":"text","conversion_output":true,"text":"contraindication to MRI contrast media, MRI without contrast may be acceptable as long as the","text_display":" contraindication to MRI contrast media, MRI without contrast may be acceptable as long as the","confidence":1,"confidence_rate":1},{"cnt":[[288,2363],[1878,2363],[1878,2413],[288,2413]],"region":{"top_left_x":287,"top_left_y":2363,"width":1591,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25857344b31146e8948fdd99fcda6036","type":"text","conversion_output":true,"text":"image quality and the slice thickness ( 5 mm or less is recommended) is high enough to confirm","text_display":" image quality and the slice thickness ( 5 mm or less is recommended) is high enough to confirm","confidence":0.9956111889332533,"confidence_rate":0.9999577079119345},{"cnt":[[288,2411],[1695,2411],[1695,2460],[288,2460]],"region":{"top_left_x":287,"top_left_y":2410,"width":1409,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"914656c7ff844491a0bca056c547be21","type":"text","conversion_output":true,"text":"disease-free status, and after discussion and approval by a Novartis study physician.","text_display":" disease-free status, and after discussion and approval by a Novartis study physician.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-094","page":94,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db4d9d8cc1714902ab694a5e9890fce1","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b89b84059c9f4f4c836c8035a967e5ef","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36c13d27cc5442cb87dc3a4332f2af7a","type":"page_info","conversion_output":false,"text":"Page 94 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b67d77557854517869cc59ce9a67e44","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,254],[1871,254],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":253,"width":457,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b12f8fb548d47078cf09a4c4b7616ef","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1876,346],[1876,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7f06bddda68422f9d8ff37fb2743f08","type":"text","conversion_output":true,"text":"Findings from radiological evaluations (evaluation of suspicion of recurrence or unconfirmed","text_display":"\n\nFindings from radiological evaluations (evaluation of suspicion of recurrence or unconfirmed","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[288,395],[952,395],[952,443],[288,443]],"region":{"top_left_x":287,"top_left_y":395,"width":665,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65af5760a1724307b710c150b64bd48b","type":"text","conversion_output":true,"text":"findings) will be recorded in the eCRF.","text_display":" findings) will be recorded in the eCRF.","confidence":0.9970703125,"confidence_rate":0.9999333206905552},{"cnt":[[288,477],[1268,477],[1268,535],[288,535]],"region":{"top_left_x":287,"top_left_y":476,"width":981,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"572fb336fe604a08a2b994ec7056becc","type":"figure_label","conversion_output":false,"text":"Table 7-3 Imaging Assessment Collection Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,529],[1878,529],[1878,1248],[288,1248]],"region":{"top_left_x":287,"top_left_y":528,"width":1591,"height":721},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de2e948cfcad409687f4c9872381db2f","type":"table","conversion_output":true,"children_ids":["050f3d55c7fc422ba3b22aeb4826e6d2","457cf79e69c1453aaed50170cf206d85","cfe59bb640064cc3b33615b07ed79c20","f65cec0f1c7240fc87f35a60647191e7","66b19805e7f84ac99b3918b451354884","c61df9586cc14e23a002a52d1fb333db","920c6965fe3e4eaaa2f0fcf7e3f61e4b","9a7be189373c462692917b671a830501","3311c2e7c904498b9606f29200d34631","fb7266ba36c44627ab7b32d1efa126b4","1b1900474d6a4041b7d821ece3d25c16","4c46f9b7f3184970909611a1c1abeb84","5a03e7dc0b384649907106a03541deba","0d2551b92bff467d9183e37a92f6d8ca","8d4253ecd0fc478fab6fb985985ac203","4d7e77f337554764b5f717d12a7e8eff","fce8d3b0034e4fb3aec8c23e2e35a1c3","ae24a57e66314e57905ad977ff4d0277","60033f9eac5a46d7934b97cfb9233847","6c38ff7cedbd4d9b90551eb7f3375784","4cdb311bd71f4e8d9509f067ba06b8da","2135899b926c49f6b01dc2627ee2e950","794416eb9be64103be8a087a011e6fd0","848257b4d3a547179d0b0d0519138570","040c1e48ebe247ff92eec4cf96ce302c","524d3761501845c39b0d696fd3939e0d","78c6651c63da457cab32be7493ffd4a0"],"selected_labels":["572fb336fe604a08a2b994ec7056becc"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline 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Physical examination","confidence":1,"confidence_rate":1},{"cnt":[[288,653],[1536,653],[1536,703],[288,703]],"region":{"top_left_x":287,"top_left_y":653,"width":1250,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53f162aedadb4affab0578b36ad9138a","type":"text","conversion_output":true,"text":"is to be performed according to the visit schedule as outlined in Table 7-1.","text_display":" is to be performed according to the visit schedule as outlined in Table 7-1.","confidence":0.9990236759185791,"confidence_rate":0.9999879408011545},{"cnt":[[288,722],[1878,722],[1878,771],[288,771]],"region":{"top_left_x":287,"top_left_y":721,"width":1591,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e3a2df8766f4302a730cc8afee68fac","type":"text","conversion_output":true,"text":"Significant findings that were present prior to the signing of informed consent must be included","text_display":"\n\nSignificant findings that were present prior to the signing of informed consent must be included","confidence":1,"confidence_rate":1},{"cnt":[[288,769],[1878,769],[1878,821],[288,821]],"region":{"top_left_x":287,"top_left_y":769,"width":1591,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a6ac3b2ec114cc092f146bfa1c4bd06","type":"text","conversion_output":true,"text":"in the medical history eCRF. Significant new findings that begin or worsen after informed","text_display":" in the medical history eCRF. Significant new findings that begin or worsen after informed","confidence":1,"confidence_rate":1},{"cnt":[[288,819],[1192,819],[1192,864],[288,864]],"region":{"top_left_x":287,"top_left_y":818,"width":906,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08ab6a96ab9c4bb7bcdcba6063dda0b3","type":"text","conversion_output":true,"text":"consent must be recorded on the adverse event eCRF.","text_display":" consent must be recorded on the adverse event 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temperature.","confidence":1,"confidence_rate":1},{"cnt":[[286,1104],[810,1104],[810,1162],[286,1162]],"region":{"top_left_x":285,"top_left_y":1104,"width":525,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3674b427854e4da29049e11248c7136c","type":"section_header","conversion_output":false,"children_ids":["b88ef7dd87604ece8b3c74d494a5464a"],"text":"","text_display":""},{"cnt":[[288,1109],[806,1109],[806,1158],[288,1158]],"region":{"top_left_x":287,"top_left_y":1108,"width":519,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b88ef7dd87604ece8b3c74d494a5464a","type":"text","conversion_output":true,"parent_id":"3674b427854e4da29049e11248c7136c","text":"7.2.2.4 Height and weight","text_display":"\n\n\\subsection*{7.2.2.4 Height and 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screening and at","confidence":1,"confidence_rate":1},{"cnt":[[288,1293],[1111,1293],[1111,1343],[288,1343]],"region":{"top_left_x":287,"top_left_y":1293,"width":824,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81614cb69cbc46dbb17030807dd13f15","type":"text","conversion_output":true,"text":"subsequent time points as specified in Table 7-1.","text_display":" subsequent time points as specified in Table 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Grade & ECOG status \\\\\n\\hline 0 & Fully active, able to carry on all pre-disease performance without restriction \\\\\n\\hline 1 & Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g., light house work, office work \\\\\n\\hline 2 & Ambulatory and capable of all self-care but unable to carry out any work activities. 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Up and about more than 50\\% of waking hours \\\\\n\\hline 3 & Capable of only limited self-care, confined to bed or chair more than 50\\% of waking hours \\\\\n\\hline 4 & Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair \\\\\n\\hline 5 & Dead 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Other blood specimens collected as part of safety","text_display":" monitoring (as detailed in Table 7-1). Other blood specimens collected as part of safety","confidence":1,"confidence_rate":1},{"cnt":[[288,2346],[1876,2346],[1876,2398],[288,2398]],"region":{"top_left_x":287,"top_left_y":2346,"width":1589,"height":52},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd9f56eeb33d4983a78f85abb3d8959d","type":"text","conversion_output":true,"text":"monitoring (e.g., HIV screen, HBsAg, HCV antibody) will be analyzed by central laboratories.","text_display":" monitoring (e.g., HIV screen, HBsAg, HCV antibody) will be analyzed by central laboratories.","confidence":1,"confidence_rate":1},{"cnt":[[288,2393],[1878,2393],[1878,2445],[288,2445]],"region":{"top_left_x":287,"top_left_y":2393,"width":1591,"height":52},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcb9ad0de4204870b66e815af7738828","type":"text","conversion_output":true,"text":"Dipstick urinalysis (macroscopic panel) will be performed at the site (unless local institution","text_display":" Dipstick urinalysis (macroscopic panel) will be performed at the site (unless local institution","confidence":1,"confidence_rate":1},{"cnt":[[288,2443],[1880,2443],[1880,2494],[288,2494]],"region":{"top_left_x":287,"top_left_y":2442,"width":1593,"height":53},"line":67,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f33e84bb6c34c59a9ecf5338720c771","type":"text","conversion_output":true,"text":"policies dictate otherwise), and in the case of any out of range parameters, a urine sample will","text_display":" policies dictate otherwise), and in the case of any out of range parameters, a urine sample will","confidence":1,"confidence_rate":1},{"cnt":[[288,2488],[1878,2488],[1878,2542],[288,2542]],"region":{"top_left_x":287,"top_left_y":2487,"width":1591,"height":55},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcee0ede696847ab8bb17b60b6c3653a","type":"text","conversion_output":true,"text":"be sent to central laboratory for further analysis (microscopic panel). 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and require an action to be taken with study treatment (e.g., require dose","confidence":1,"confidence_rate":1},{"cnt":[[288,1641],[1880,1641],[1880,1691],[288,1691]],"region":{"top_left_x":287,"top_left_y":1641,"width":1593,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5b13a951f6e4bd0bb5d29a72badd530","type":"text","conversion_output":true,"text":"modification and/or interruption of study treatment, lead to clinical symptoms or signs, or","text_display":" modification and/or interruption of study treatment, lead to clinical symptoms or signs, or","confidence":1,"confidence_rate":1},{"cnt":[[288,1689],[1878,1689],[1878,1738],[288,1738]],"region":{"top_left_x":287,"top_left_y":1688,"width":1591,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"009494043c364ada91460aedd6b55588","type":"text","conversion_output":true,"text":"require therapeutic intervention), whether specifically requested in 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The severity of laboratory data will be graded using the","text_display":" recorded on the AE eCRF page. The severity of laboratory data will be graded using the","confidence":1,"confidence_rate":1},{"cnt":[[288,1783],[1878,1783],[1878,1835],[288,1835]],"region":{"top_left_x":287,"top_left_y":1783,"width":1591,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c7bfcfedcdd4456ae9f5750a13f8bb8","type":"text","conversion_output":true,"text":"Common Terminology Criteria for Adverse events (CTCAE) version 5.0. Additional analyses","text_display":" Common Terminology Criteria for Adverse events (CTCAE) version 5.0. Additional analyses","confidence":1,"confidence_rate":1},{"cnt":[[288,1830],[1021,1830],[1021,1884],[288,1884]],"region":{"top_left_x":287,"top_left_y":1830,"width":734,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62fc063a28354c9095481095515f662a","type":"text","conversion_output":true,"text":"are left to the discretion of the investigator.","text_display":" are left to the discretion of the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[288,1916],[1424,1916],[1424,1968],[288,1968]],"region":{"top_left_x":287,"top_left_y":1916,"width":1138,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae1c821ed19e4737bf4c5fd5ae3c1a3f","type":"figure_label","conversion_output":false,"text":"Table 7-5 Clinical laboratory parameters collection 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Test Category & Test Name \\\\\n\\hline Hematology & Hemoglobin, Platelets, Red blood cells (RBC), White blood cells (WBC) with Differential (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils in percentage or absolute) \\\\\n\\hline Chemistry & Albumin, ALT, AST, calcium (at screening, calcium corrected for albumin will be tested in addition to calcium), creatinine, creatinine clearance, total bilirubin, direct bilirubin (only if total bilirubin is \\(\\geq\\) grade 2 ), blood urea nitrogen (BUN) or urea, magnesium, potassium, sodium, fasting glucose, phosphate (inorganic phosphorus), alkaline phosphatase, total serum amylase, pancreatic amylase (as needed), lipase, GGT \\\\\n\\hline hs-CRP* & Biomarker assessment to be performed in Central Laboratory Testing \\\\\n\\hline Urinalysis & \\begin{tabular}{l}\nMacroscopic panel (Dipstick) (Color, bilirubin, Blood, Glucose, Ketones, Leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen) \\\\\nMicroscopic panel 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For","confidence":1,"confidence_rate":1},{"cnt":[[288,889],[1076,889],[1076,943],[288,943]],"region":{"top_left_x":287,"top_left_y":889,"width":790,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ecb632d2b734696bb58f833b68667c4","type":"text","conversion_output":true,"text":"details of the Hematology panel see Table 7-5.","text_display":" details of the Hematology panel see Table 7-5.","confidence":1,"confidence_rate":1},{"cnt":[[288,958],[1880,958],[1880,1016],[288,1016]],"region":{"top_left_x":287,"top_left_y":958,"width":1593,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69aa7faa0f6a4e68b275067269376104","type":"text","conversion_output":true,"text":"Hematology should be assessed on the actual scheduled day, even if study drug is being","text_display":"\nHematology should be assessed on the actual scheduled day, even if study drug is being","confidence":1,"confidence_rate":1},{"cnt":[[288,1010],[455,1010],[455,1055],[288,1055]],"region":{"top_left_x":287,"top_left_y":1009,"width":169,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37b87c55e0d8426e85be02ec61e19317","type":"text","conversion_output":true,"text":"withheld.","text_display":" withheld.","confidence":1,"confidence_rate":1},{"cnt":[[284,1089],[780,1089],[780,1149],[284,1149]],"region":{"top_left_x":283,"top_left_y":1089,"width":497,"height":61},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54388c037e9944a193162096ee9828d8","type":"section_header","conversion_output":false,"children_ids":["4122c144a1ae464183c039de26ce9278"],"text":"","text_display":""},{"cnt":[[288,1096],[776,1096],[776,1145],[288,1145]],"region":{"top_left_x":287,"top_left_y":1095,"width":489,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4122c144a1ae464183c039de26ce9278","type":"text","conversion_output":true,"parent_id":"54388c037e9944a193162096ee9828d8","text":"7.2.2.6.2 Clinical chemistry","text_display":"\n\n\\subsection*{7.2.2.6.2 Clinical chemistry}","confidence":1,"confidence_rate":1},{"cnt":[[288,1160],[1876,1160],[1876,1214],[288,1214]],"region":{"top_left_x":287,"top_left_y":1160,"width":1589,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a6e46ebec864314af1079ad8e6190d3","type":"text","conversion_output":true,"text":"Biochemistry tests are to be performed according to the visit schedule outlined in Table 7-1.","text_display":"\n\nBiochemistry tests are to be performed according to the visit schedule outlined in Table 7-1.","confidence":1,"confidence_rate":1},{"cnt":[[288,1212],[1880,1212],[1880,1261],[288,1261]],"region":{"top_left_x":287,"top_left_y":1211,"width":1593,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d6873797cb94dcf9a946015711a1978","type":"text","conversion_output":true,"text":"For details of the Biochemistry panel see Table 7-5. Biochemistry should be assessed on the","text_display":" For details of the Biochemistry panel see Table 7-5. Biochemistry should be assessed on the","confidence":0.99658203125,"confidence_rate":0.9999643358094245},{"cnt":[[288,1259],[1880,1259],[1880,1311],[288,1311]],"region":{"top_left_x":287,"top_left_y":1258,"width":1593,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c328a7c9634f471da52bb66e5590ee19","type":"text","conversion_output":true,"text":"actual scheduled day, even if study drug is being withheld. Estimate of GFR (via estimated","text_display":" actual scheduled day, even if study drug is being withheld. Estimate of GFR (via estimated","confidence":1,"confidence_rate":1},{"cnt":[[288,1306],[1691,1306],[1691,1360],[288,1360]],"region":{"top_left_x":287,"top_left_y":1306,"width":1404,"height":54},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94d107bdb7f54f3784b46069b0a8eb1e","type":"text","conversion_output":true,"text":"creatinine clearance rate) will be done centrally using the Cockcroft-Gault formula.","text_display":" creatinine clearance rate) will be done centrally using the Cockcroft-Gault formula.","confidence":0.99755859375,"confidence_rate":0.9999725353059057},{"cnt":[[305,1384],[1500,1384],[1500,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1383,"width":1195,"height":59},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cee1b7c13f14c2bb43519ab4f5bac38","type":"section_header","conversion_output":false,"children_ids":["f2288698bb5643319168a22978e7f329"],"text":"","text_display":""},{"cnt":[[309,1388],[1493,1388],[1493,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1387,"width":1185,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2288698bb5643319168a22978e7f329","type":"text","conversion_output":true,"parent_id":"6cee1b7c13f14c2bb43519ab4f5bac38","text":"Estimated creatinine clearance rate ( \\(e C _{ Cr }\\) ) using Cockcroft-Gault formula","text_display":"\n\n\\section*{Estimated creatinine clearance rate ( \\(e C _{ Cr }\\) ) using Cockcroft-Gault formula}","confidence":0.2969083370718912,"confidence_rate":0.9872989082281216},{"cnt":[[365,1448],[1338,1448],[1338,1566],[365,1566]],"region":{"top_left_x":365,"top_left_y":1448,"width":974,"height":119},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20545dfff254408f9bcdd7026d972bad","type":"math","conversion_output":true,"text":"\\[\ne C_{C r}=\\frac{(140-\\text { Age }) \\times \\text { Mass }(\\text { in kilograms }) \\times[0.85 \\text { if Female }]}{72 \\times \\text { Serum Creatinine }(\\text { in } mg / dL)}\n\\]","text_display":"\n\\[\ne C_{C r}=\\frac{(140-\\text { Age }) \\times \\text { Mass }(\\text { in kilograms }) \\times[0.85 \\text { if Female }]}{72 \\times \\text { Serum Creatinine }(\\text { in } mg / dL)}\n\\]","confidence":0.909495607484132,"confidence_rate":0.9992413670225792},{"cnt":[[333,1581],[930,1581],[930,1622],[333,1622]],"region":{"top_left_x":333,"top_left_y":1581,"width":598,"height":42},"line":48,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f9e40e6118d7429b8f2863f931988a32","type":"text","conversion_output":true,"text":"When serum creatinine is measured in \\(\\mu mol / L\\) :","text_display":"\n\nWhen serum creatinine is measured in \\(\\mu mol / L\\) :","confidence":0.9956119024434429,"confidence_rate":0.9999254645827409},{"cnt":[[372,1629],[1244,1629],[1244,1742],[372,1742]],"region":{"top_left_x":371,"top_left_y":1628,"width":873,"height":115},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3a03684036e4c9991939622bfde62f5","type":"math","conversion_output":true,"text":"\\[\ne C_{C r}=\\frac{(140-\\text { Age }) \\times \\text { Mass (in kilograms) } \\text { × } \\text { Constant }}{\\text { Serum Creatinine }(\\text { in } \\mu mol / L)}\n\\]","text_display":"\n\\[\ne C_{C r}=\\frac{(140-\\text { Age }) \\times \\text { Mass (in kilograms) } \\text { × } \\text { Constant }}{\\text { Serum Creatinine }(\\text { in } \\mu mol / L)}\n\\]","confidence":0.860464250392774,"confidence_rate":0.998716352706123},{"cnt":[[378,1740],[1055,1740],[1055,1781],[378,1781]],"region":{"top_left_x":378,"top_left_y":1740,"width":677,"height":42},"line":51,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d834f0312f6a46eba524b408d012c3e8","type":"text","conversion_output":true,"text":"Where Constant is 1.23 for men and 1.04 for women.","text_display":"\n\nWhere Constant is 1.23 for men and 1.04 for women.","confidence":0.96826171875,"confidence_rate":0.9994714043847729},{"cnt":[[288,1830],[1858,1830],[1858,1884],[288,1884]],"region":{"top_left_x":287,"top_left_y":1830,"width":1572,"height":55},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d9653acd0bd43dbb8ac1ac56dc52714","type":"text","conversion_output":true,"text":"7.2.2.6.3 High-sensitivity C-reactive protein (hs-CRP) and High-sensitivity Interleukin-6 (hs-","text_display":"\n7.2.2.6.3 High-sensitivity C-reactive protein (hs-CRP) and High-sensitivity Interleukin-6 (hs-","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[464,1878],[556,1878],[556,1927],[464,1927]],"region":{"top_left_x":464,"top_left_y":1877,"width":93,"height":51},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d63ec381a616491abeb7e89e9a860456","type":"text","conversion_output":true,"text":"IL-6)","text_display":"IL-6)","confidence":1,"confidence_rate":1},{"cnt":[[288,1942],[1880,1942],[1880,1996],[288,1996]],"region":{"top_left_x":287,"top_left_y":1942,"width":1593,"height":54},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53a5820f25ec4f14ac31e67699a38aa2","type":"text","conversion_output":true,"text":"This marker of inflammation will be monitored according to the visit schedule outlined in","text_display":"\nThis marker of inflammation will be monitored according to the visit schedule outlined in","confidence":1,"confidence_rate":1},{"cnt":[[288,1989],[1880,1989],[1880,2043],[288,2043]],"region":{"top_left_x":287,"top_left_y":1989,"width":1593,"height":55},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1adfd7110ecb495584e688cb20ab6499","type":"text","conversion_output":true,"text":"Table 7-1 and Table 7-5. Sample handling and shipping instructions will be provided in the","text_display":" Table 7-1 and Table 7-5. Sample handling and shipping instructions will be provided in the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,2039],[1880,2039],[1880,2090],[288,2090]],"region":{"top_left_x":287,"top_left_y":2038,"width":1593,"height":53},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d752ae5ac88f40918cc356d79e83c12f","type":"text","conversion_output":true,"text":"Laboratory Manual. Results for hs-CRP and hs-IL-6 will not be communicated to the","text_display":" Laboratory Manual. Results for hs-CRP and hs-IL-6 will not be communicated to the","confidence":0.9892578125,"confidence_rate":0.9998744229860258},{"cnt":[[288,2086],[1878,2086],[1878,2142],[288,2142]],"region":{"top_left_x":287,"top_left_y":2086,"width":1591,"height":56},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce2b45b417b40c5a64901846ff6fc94","type":"text","conversion_output":true,"text":"investigative sites during study conduct and will remain blinded until the time of database lock.","text_display":" investigative sites during study conduct and will remain blinded until the time of database lock.","confidence":1,"confidence_rate":1},{"cnt":[[284,2170],[685,2170],[685,2230],[284,2230]],"region":{"top_left_x":283,"top_left_y":2169,"width":403,"height":62},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fca516c8e95f42178ee443c2603eebaf","type":"section_header","conversion_output":false,"children_ids":["2c496144f4fe44c5b9039e500863b71d"],"text":"","text_display":""},{"cnt":[[288,2174],[679,2174],[679,2224],[288,2224]],"region":{"top_left_x":287,"top_left_y":2174,"width":392,"height":50},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c496144f4fe44c5b9039e500863b71d","type":"text","conversion_output":true,"parent_id":"fca516c8e95f42178ee443c2603eebaf","text":"7.2.2.6.4 Coagulation","text_display":"\n\n\\subsection*{7.2.2.6.4 Coagulation}","confidence":1,"confidence_rate":1},{"cnt":[[288,2256],[1775,2256],[1775,2312],[288,2312]],"region":{"top_left_x":287,"top_left_y":2255,"width":1488,"height":57},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f46611edc467434e82098baac0fad3f3","type":"text","conversion_output":true,"text":"7.2.2.6.5 INR and aPTT are to be performed according to the visit schedule outlined in","text_display":"\n7.2.2.6.5 INR and aPTT are to be performed according to the visit schedule outlined in","confidence":0.9985356330871582,"confidence_rate":0.9999838963917971},{"cnt":[[464,2305],[844,2305],[844,2361],[464,2361]],"region":{"top_left_x":464,"top_left_y":2305,"width":381,"height":57},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"259d9f0aa6074d5194d7a9ee3dd04dfc","type":"text","conversion_output":true,"text":"Table 7-1. Urinalysis","text_display":" Table 7-1. Urinalysis","confidence":1,"confidence_rate":1},{"cnt":[[288,2374],[1880,2374],[1880,2428],[288,2428]],"region":{"top_left_x":287,"top_left_y":2374,"width":1593,"height":54},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce7654efb3ae47cb85f6da6895e867b2","type":"text","conversion_output":true,"text":"Urinalysis is to be performed according to the visit schedules outlined in Table 7-1. For","text_display":"\nUrinalysis is to be performed according to the visit schedules outlined in Table 7-1. For","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[288,2423],[1033,2423],[1033,2477],[288,2477]],"region":{"top_left_x":287,"top_left_y":2423,"width":747,"height":55},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7341c896ce14621a133c94cd5b91e31","type":"text","conversion_output":true,"text":"details of the urinalysis panel see Table 7-5.","text_display":" details of the urinalysis panel see Table 7-5.","confidence":0.9990234375,"confidence_rate":0.999980842543353}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-098","page":98,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3055130ff16c4e6eb4aad629baab7748","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64f9378292824d67bf167b4ea2e06db7","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1633,206],[1876,206],[1876,247],[1633,247]],"region":{"top_left_x":1632,"top_left_y":206,"width":244,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06d374efaf7b4124a190bedc9a652551","type":"page_info","conversion_output":false,"text":"Page 98 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a663c4987452459fbe24464cdbf65b0d","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,251],[1871,251],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":251,"width":457,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"573854283e3a4e2ebe656581a999f44f","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,339],[1132,339],[1132,397],[288,397]],"region":{"top_left_x":287,"top_left_y":339,"width":846,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a32f8ab79e8412da25a2e96db8f496a","type":"section_header","conversion_output":false,"children_ids":["40171aee47454116b82b4fb4ab09563b"],"text":"","text_display":""},{"cnt":[[292,344],[1128,344],[1128,393],[292,393]],"region":{"top_left_x":292,"top_left_y":343,"width":836,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40171aee47454116b82b4fb4ab09563b","type":"text","conversion_output":true,"parent_id":"7a32f8ab79e8412da25a2e96db8f496a","text":"7.2.2.6.6 Pregnancy and assessments of fertility","text_display":"\n\n\\subsection*{7.2.2.6.6 Pregnancy and assessments of fertility}","confidence":1,"confidence_rate":1},{"cnt":[[288,408],[1876,408],[1876,460],[288,460]],"region":{"top_left_x":287,"top_left_y":408,"width":1589,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f73c7d9338684e01b6d3b9a871242b1f","type":"text","conversion_output":true,"text":"During screening, a serum pregnancy test will be completed (Day -28 to Day -1). On Cycle 1","text_display":"\n\nDuring screening, a serum pregnancy test will be completed (Day -28 to Day -1). 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The time windows granted","text_display":" performed. A serum pregnancy test will also be completed at EOT. The time windows granted","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[288,554],[1880,554],[1880,604],[288,604]],"region":{"top_left_x":287,"top_left_y":554,"width":1593,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"983e6fa314284760b58162a690684011","type":"text","conversion_output":true,"text":"for pregnancy testing are identical to the corresponding visit time windows for each visit. Refer","text_display":" for pregnancy testing are identical to the corresponding visit time windows for each visit. Refer","confidence":1,"confidence_rate":1},{"cnt":[[288,602],[1800,602],[1800,651],[288,651]],"region":{"top_left_x":287,"top_left_y":601,"width":1514,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8500c0e401d42e1bafe51c8b5dff3d4","type":"text","conversion_output":true,"text":"to Table 7-1. If local requirements dictate otherwise, local regulations should be followed.","text_display":" to Table 7-1. If local requirements dictate otherwise, local regulations should be followed.","confidence":0.9990236759185791,"confidence_rate":0.9999899299373404},{"cnt":[[288,670],[1878,670],[1878,720],[288,720]],"region":{"top_left_x":287,"top_left_y":670,"width":1591,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a1b8b5b56a34450b1cb04e83495fc3e","type":"text","conversion_output":true,"text":"As per Section 2.7, during a public health emergency as declared by local or regional authorities","text_display":"\n\nAs per Section 2.7, during a public health emergency as declared by local or regional authorities","confidence":1,"confidence_rate":1},{"cnt":[[288,718],[1882,718],[1882,767],[288,767]],"region":{"top_left_x":287,"top_left_y":717,"width":1596,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f39d80ae9004e519c0a66166ef45a9d","type":"text","conversion_output":true,"text":"i.e. pandemic, epidemic or natural disaster, that limits or prevents on-site study visits, if","text_display":" i.e. pandemic, epidemic or natural disaster, that limits or prevents on-site study visits, if","confidence":0.9907341003417969,"confidence_rate":0.9999050137447094},{"cnt":[[288,767],[1880,767],[1880,819],[288,819]],"region":{"top_left_x":287,"top_left_y":766,"width":1593,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2cc8c952a574e5cbb1b82f87c92353c","type":"text","conversion_output":true,"text":"participants cannot visit the site to have serum pregnancy tests, urine pregnancy test kits may","text_display":" participants cannot visit the site to have serum pregnancy tests, urine pregnancy test kits may","confidence":1,"confidence_rate":1},{"cnt":[[288,814],[1880,814],[1880,866],[288,866]],"region":{"top_left_x":287,"top_left_y":814,"width":1593,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0f11892a3154b44b9f3879e9248f209","type":"text","conversion_output":true,"text":"be used. Relevant subjects can perform the urine pregnancy test at home and report the result","text_display":" be used. Relevant subjects can perform the urine pregnancy test at home and report the result","confidence":1,"confidence_rate":1},{"cnt":[[288,864],[1878,864],[1878,913],[288,913]],"region":{"top_left_x":287,"top_left_y":863,"width":1591,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"350bc734ca374dc595778050b5504a63","type":"text","conversion_output":true,"text":"to the site. It is important that participants are instructed to perform the urine pregnancy test","text_display":" to the site. It is important that participants are instructed to perform the urine pregnancy test","confidence":1,"confidence_rate":1},{"cnt":[[288,911],[1876,911],[1876,960],[288,960]],"region":{"top_left_x":287,"top_left_y":910,"width":1589,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1f5e91118d54c5fa653ff45eaf577f9","type":"text","conversion_output":true,"text":"first and only if the test result is negative proceed with the administration of the study treatment.","text_display":" first and only if the test result is negative proceed with the administration of the study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[288,958],[1878,958],[1878,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":958,"width":1591,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91289b860dac4f198183d3a9888476d0","type":"text","conversion_output":true,"text":"A communication process should be established with the subject so that the Site is informed","text_display":" A communication process should be established with the subject so that the Site is informed","confidence":1,"confidence_rate":1},{"cnt":[[288,1005],[1704,1005],[1704,1057],[288,1057]],"region":{"top_left_x":287,"top_left_y":1005,"width":1417,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1800703ffa54b55ae3b5a7395152c12","type":"text","conversion_output":true,"text":"and can verify the pregnancy test results (e.g., following country specific measures).","text_display":" and can verify the pregnancy test results (e.g., following country specific measures).","confidence":1,"confidence_rate":1},{"cnt":[[288,1074],[1878,1074],[1878,1124],[288,1124]],"region":{"top_left_x":287,"top_left_y":1074,"width":1591,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90b34557ad64f28ae3a899b3dc125ce","type":"text","conversion_output":true,"text":"Women who are determined not to be of child bearing potential before the study will only be","text_display":"\nWomen who are determined not to be of child bearing potential before the study will only be","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[288,1121],[1876,1121],[1876,1173],[288,1173]],"region":{"top_left_x":287,"top_left_y":1121,"width":1589,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b2d23a33958498f95137fb0bedc18bf","type":"text","conversion_output":true,"text":"tested at screening. When non-child bearing potential status is determined during the study,","text_display":" tested at screening. When non-child bearing potential status is determined during the study,","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[288,1171],[1880,1171],[1880,1222],[288,1222]],"region":{"top_left_x":287,"top_left_y":1170,"width":1593,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88480a466f654e8f9ff9f364270c21b9","type":"text","conversion_output":true,"text":"further pregnancy testing will not be continued. Women are considered post-menopausal if they","text_display":" further pregnancy testing will not be continued. Women are considered post-menopausal if they","confidence":1,"confidence_rate":1},{"cnt":[[288,1216],[1878,1216],[1878,1270],[288,1270]],"region":{"top_left_x":287,"top_left_y":1216,"width":1591,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cf523bdc66044d3bebb5cf1afc322c2","type":"text","conversion_output":true,"text":"have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile","text_display":" have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile","confidence":1,"confidence_rate":1},{"cnt":[[288,1265],[1880,1265],[1880,1317],[288,1317]],"region":{"top_left_x":287,"top_left_y":1265,"width":1593,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"624e3ab2dbed43eb8f447f75ba4f287e","type":"text","conversion_output":true,"text":"(e.g. age appropriate, history of vasomotor symptoms), and otherwise not of child bearing","text_display":" (e.g. age appropriate, history of vasomotor symptoms), and otherwise not of child bearing","confidence":1,"confidence_rate":1},{"cnt":[[288,1315],[1878,1315],[1878,1364],[288,1364]],"region":{"top_left_x":287,"top_left_y":1314,"width":1591,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d051ed07855940f6b88e30ac485d7624","type":"text","conversion_output":true,"text":"potential if they have had surgical bilateral oophorectomy (with or without hysterectomy), total","text_display":" potential if they have had surgical bilateral oophorectomy (with or without hysterectomy), total","confidence":1,"confidence_rate":1},{"cnt":[[288,1362],[1876,1362],[1876,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1362,"width":1589,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31a2dbdc6c884a9da6f75fb3e4b818f2","type":"text","conversion_output":true,"text":"hysterectomy, or bilateral tubal ligation at least six weeks prior to first dose of study drug. In","text_display":" hysterectomy, or bilateral tubal ligation at least six weeks prior to first dose of study drug. In","confidence":1,"confidence_rate":1},{"cnt":[[288,1412],[1878,1412],[1878,1463],[288,1463]],"region":{"top_left_x":287,"top_left_y":1411,"width":1591,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18e49c6c9932441e827769fd09e19c77","type":"text","conversion_output":true,"text":"the case of oophorectomy alone, only when the reproductive status of the woman has been","text_display":" the case of oophorectomy alone, only when the reproductive status of the woman has been","confidence":1,"confidence_rate":1},{"cnt":[[288,1457],[1878,1457],[1878,1508],[288,1508]],"region":{"top_left_x":287,"top_left_y":1456,"width":1591,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5ff970fd3b240de89da4e80603437ef","type":"text","conversion_output":true,"text":"confirmed by follow up hormone level assessment is she considered not of child bearing","text_display":" confirmed by follow up hormone level assessment is she considered not of child bearing","confidence":1,"confidence_rate":1},{"cnt":[[288,1506],[1876,1506],[1876,1558],[288,1558]],"region":{"top_left_x":287,"top_left_y":1506,"width":1589,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60a64945bdd5454999709e328d5aa2d2","type":"text","conversion_output":true,"text":"potential (such testing is not covered as part of the study assessments). If local requirements","text_display":" potential (such testing is not covered as part of the study assessments). If local requirements","confidence":1,"confidence_rate":1},{"cnt":[[288,1555],[1218,1555],[1218,1605],[288,1605]],"region":{"top_left_x":287,"top_left_y":1555,"width":932,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b294065b72d1414b8253c016a8e88380","type":"text","conversion_output":true,"text":"dictate otherwise, local regulations should be followed.","text_display":" dictate otherwise, local regulations should be followed.","confidence":1,"confidence_rate":1},{"cnt":[[288,1620],[1878,1620],[1878,1674],[288,1674]],"region":{"top_left_x":287,"top_left_y":1619,"width":1591,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00c28626e84b4aa98069c892b5d06840","type":"text","conversion_output":true,"text":"If a positive pregnancy test is performed in between study visits, the subject must immediately","text_display":"\nIf a positive pregnancy test is performed in between study visits, the subject must immediately","confidence":1,"confidence_rate":1},{"cnt":[[288,1671],[677,1671],[677,1721],[288,1721]],"region":{"top_left_x":287,"top_left_y":1671,"width":390,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3021fa6f21745439abc36ba0775657d","type":"text","conversion_output":true,"text":"notify the investigator.","text_display":" notify the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[288,1755],[870,1755],[870,1807],[288,1807]],"region":{"top_left_x":287,"top_left_y":1755,"width":584,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0937064fe7243918f6c3df9923d4aec","type":"section_header","conversion_output":false,"children_ids":["4475767a47844c988ef10658768b15f6"],"text":"","text_display":""},{"cnt":[[288,1758],[866,1756],[866,1800],[288,1803]],"region":{"top_left_x":287,"top_left_y":1755,"width":579,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4475767a47844c988ef10658768b15f6","type":"text","conversion_output":true,"parent_id":"f0937064fe7243918f6c3df9923d4aec","text":"7.2.2.7 Cardiac assessments","text_display":"\n\n\\subsection*{7.2.2.7 Cardiac assessments}","confidence":1,"confidence_rate":1},{"cnt":[[288,1839],[909,1839],[909,1897],[288,1897]],"region":{"top_left_x":287,"top_left_y":1839,"width":622,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"938e8ce3bd4d46d4a769e42081e8fc8a","type":"section_header","conversion_output":false,"children_ids":["93933c7031f842ab95dbc1f87717e9f5"],"text":"","text_display":""},{"cnt":[[288,1843],[904,1843],[904,1893],[288,1893]],"region":{"top_left_x":287,"top_left_y":1843,"width":618,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93933c7031f842ab95dbc1f87717e9f5","type":"text","conversion_output":true,"parent_id":"938e8ce3bd4d46d4a769e42081e8fc8a","text":"7.2.2.7.1 Electrocardiogram (ECG)","text_display":"\n\n\\subsection*{7.2.2.7.1 Electrocardiogram (ECG)}","confidence":1,"confidence_rate":1},{"cnt":[[288,1910],[1880,1910],[1880,1962],[288,1962]],"region":{"top_left_x":287,"top_left_y":1909,"width":1593,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"137b2693a38a47bfa2bfebe33fb666e8","type":"text","conversion_output":true,"text":"Local single 12-lead ECGs should be recorded after the subject has been resting for 5-10 min","text_display":"\n\nLocal single 12-lead ECGs should be recorded after the subject has been resting for 5-10 min","confidence":0.9844031133753212,"confidence_rate":0.9998379533602888},{"cnt":[[288,1959],[1042,1959],[1042,2009],[288,2009]],"region":{"top_left_x":287,"top_left_y":1959,"width":755,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5f6e6104e67464ea70707041b7ebb44","type":"text","conversion_output":true,"text":"prior to the timepoint indicated in Table 7-1.","text_display":" prior to the timepoint indicated in Table 7-1.","confidence":1,"confidence_rate":1},{"cnt":[[288,2028],[1880,2028],[1880,2078],[288,2078]],"region":{"top_left_x":287,"top_left_y":2028,"width":1593,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8420f40dc474d8fab49ffc347ce1c2f","type":"text","conversion_output":true,"text":"An unscheduled ECG may be repeated at the discretion of the investigator at any time during","text_display":"\n\nAn unscheduled ECG may be repeated at the discretion of the investigator at any time during","confidence":1,"confidence_rate":1},{"cnt":[[288,2075],[1880,2075],[1880,2125],[288,2125]],"region":{"top_left_x":287,"top_left_y":2075,"width":1593,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d4d86e8341f477eb6940ec19671943a","type":"text","conversion_output":true,"text":"the study and as clinically indicated. Interpretation of the tracing must be made by a qualified","text_display":" the study and as clinically indicated. Interpretation of the tracing must be made by a qualified","confidence":1,"confidence_rate":1},{"cnt":[[288,2123],[1164,2123],[1164,2176],[288,2176]],"region":{"top_left_x":287,"top_left_y":2122,"width":878,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a884cd0e95d3443b9723dcbbb98e5800","type":"text","conversion_output":true,"text":"physician and documented in the appropriate eCRF.","text_display":" physician and documented in the appropriate eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1876,2191],[1876,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2191,"width":1589,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"166ae1d3931140c6b85cf75c01bad94c","type":"text","conversion_output":true,"text":"Each ECG tracing should be labeled with the study number, subject initials (where regulations","text_display":"\nEach ECG tracing should be labeled with the study number, subject initials (where regulations","confidence":1,"confidence_rate":1},{"cnt":[[288,2239],[1880,2239],[1880,2292],[288,2292]],"region":{"top_left_x":287,"top_left_y":2238,"width":1593,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55cdf85e3dca4e309025e3b7c0eea571","type":"text","conversion_output":true,"text":"permit), subject number, date, and kept in the source documents at the study site. 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pharmacodynamics}","confidence":0.99853515625,"confidence_rate":0.9999770952985276},{"cnt":[[284,425],[1768,425],[1768,535],[284,535]],"region":{"top_left_x":283,"top_left_y":425,"width":1486,"height":110},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85e57e6672ed4d13b2611adb81bbcfd3","type":"section_header","conversion_output":false,"children_ids":["896b510cbbc145259d7130dd82dc9870","97d30f9e9dc54a48930193c3cce876ff"],"text":"","text_display":""},{"cnt":[[288,430],[1764,430],[1764,479],[288,479]],"region":{"top_left_x":287,"top_left_y":429,"width":1477,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896b510cbbc145259d7130dd82dc9870","type":"text","conversion_output":true,"parent_id":"85e57e6672ed4d13b2611adb81bbcfd3","text":"7.2.3.1 Pharmacokinetic, immunogenicity and pharmacodynamics blood","text_display":"\n\n\\subsection*{7.2.3.1 Pharmacokinetic, immunogenicity and pharmacodynamics blood","confidence":0.9965834617614746,"confidence_rate":0.9999517985147867},{"cnt":[[464,477],[939,477],[939,531],[464,531]],"region":{"top_left_x":464,"top_left_y":476,"width":475,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97d30f9e9dc54a48930193c3cce876ff","type":"text","conversion_output":true,"parent_id":"85e57e6672ed4d13b2611adb81bbcfd3","text":"collection and handling","text_display":" collection and handling}","confidence":1,"confidence_rate":1},{"cnt":[[288,546],[1878,546],[1878,597],[288,597]],"region":{"top_left_x":287,"top_left_y":545,"width":1591,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d101f6870cd462392820747a8c8c19f","type":"text","conversion_output":true,"text":"Time points of blood sample collection for canakinumab PK, IG and PD are outlined in","text_display":"\n\nTime points of blood sample collection for canakinumab PK, IG and PD are outlined in","confidence":1,"confidence_rate":1},{"cnt":[[288,595],[1876,595],[1876,647],[288,647]],"region":{"top_left_x":287,"top_left_y":595,"width":1589,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a20d1aba38c04ee1b13909eb55b6b1bf","type":"text","conversion_output":true,"text":"Table 7-6. If a subject starts new antineoplastic therapy after discontinuing study treatment, no","text_display":" Table 7-6. If a subject starts new antineoplastic therapy after discontinuing study treatment, no","confidence":1,"confidence_rate":1},{"cnt":[[288,642],[1880,642],[1880,694],[288,694]],"region":{"top_left_x":287,"top_left_y":642,"width":1593,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42cba474e35b4fc8a4b660445e2ba148","type":"text","conversion_output":true,"text":"further PK/PD/IG samples need to be collected. Blood samples will be taken by either direct","text_display":" further PK/PD/IG samples need to be collected. Blood samples will be taken by either direct","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[288,692],[1388,692],[1388,741],[288,741]],"region":{"top_left_x":287,"top_left_y":691,"width":1101,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047edd1ddad14ea681378b6a12cfa453","type":"text","conversion_output":true,"text":"venipuncture or an indwelling cannula inserted in a forearm vein.","text_display":" venipuncture or an indwelling cannula inserted in a forearm vein.","confidence":0.98388671875,"confidence_rate":0.9997679624708924},{"cnt":[[288,761],[1878,761],[1878,810],[288,810]],"region":{"top_left_x":287,"top_left_y":760,"width":1591,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76a5b2ba8e4643abaf743ec0e41d63ed","type":"text","conversion_output":true,"text":"For each scheduled PK sample, 2.5 mL of blood will be collected into SST tubes. The blood","text_display":"\n\nFor each scheduled PK sample, 2.5 mL of blood will be collected into SST tubes. The blood","confidence":1,"confidence_rate":1},{"cnt":[[288,808],[1876,808],[1876,857],[288,857]],"region":{"top_left_x":287,"top_left_y":807,"width":1589,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28858bfaf35d4c03b9fcfdcd22597c67","type":"text","conversion_output":true,"text":"sample will be allowed to clot over a minimum of 30 minutes at room temperature prior to","text_display":" sample will be allowed to clot over a minimum of 30 minutes at room temperature prior to","confidence":1,"confidence_rate":1},{"cnt":[[288,855],[1878,855],[1878,907],[288,907]],"region":{"top_left_x":287,"top_left_y":855,"width":1591,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0819a5e07d5b45cba279231e1cb89423","type":"text","conversion_output":true,"text":"harvesting of the serum. The serum will be obtained by centrifugation at approximately 2500 g","text_display":" harvesting of the serum. The serum will be obtained by centrifugation at approximately 2500 g","confidence":1,"confidence_rate":1},{"cnt":[[288,902],[1878,902],[1878,952],[288,952]],"region":{"top_left_x":287,"top_left_y":902,"width":1591,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd61822850f34994be1d84c15202750c","type":"text","conversion_output":true,"text":"for 10 minutes. Serum PK samples will be split into 2 aliquots of approximately 0.5 mL serum","text_display":" for 10 minutes. Serum PK samples will be split into 2 aliquots of approximately 0.5 mL serum","confidence":0.98876953125,"confidence_rate":0.9998954313323254},{"cnt":[[288,950],[1876,950],[1876,1003],[288,1003]],"region":{"top_left_x":287,"top_left_y":949,"width":1589,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea7f8fd80f344b2f8a63a41d8cc90988","type":"text","conversion_output":true,"text":"(polypropylene tubes) and then stored (within 30 min of preparation) at \\(-24^{\\circ} C\\) (approximately)","text_display":" (polypropylene tubes) and then stored (within 30 min of preparation) at \\(-24^{\\circ} C\\) (approximately)","confidence":0.9990236759185791,"confidence_rate":0.9999915793372107},{"cnt":[[288,1001],[1878,1001],[1878,1051],[288,1051]],"region":{"top_left_x":287,"top_left_y":1001,"width":1591,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04ac949daa3049bbbd10df37e7fd0e5c","type":"text","conversion_output":true,"text":"prior to shipment to the Sponsor or central lab (see sample storage information below for","text_display":" prior to shipment to the Sponsor or central lab (see sample storage information below for","confidence":1,"confidence_rate":1},{"cnt":[[288,1044],[1878,1044],[1878,1098],[288,1098]],"region":{"top_left_x":287,"top_left_y":1044,"width":1591,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1fa05e582fd4fa295590c5cdadfdae0","type":"text","conversion_output":true,"text":"detailed stability information). One aliquot will be shipped on dry ice to the analytical","text_display":" detailed stability information). One aliquot will be shipped on dry ice to the analytical","confidence":1,"confidence_rate":1},{"cnt":[[288,1096],[1880,1096],[1880,1145],[288,1145]],"region":{"top_left_x":287,"top_left_y":1095,"width":1593,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92beb2625c7945c5a7e2f9aab80c6b64","type":"text","conversion_output":true,"text":"laboratory. The remaining aliquot must be kept at the central lab as a backup sample. Remaining","text_display":" laboratory. The remaining aliquot must be kept at the central lab as a backup sample. Remaining","confidence":1,"confidence_rate":1},{"cnt":[[288,1143],[1302,1143],[1302,1195],[288,1195]],"region":{"top_left_x":287,"top_left_y":1142,"width":1015,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d89b3390150749a1b1abab17dce5d0f9","type":"text","conversion_output":true,"text":"samples will only be disposed of after approval by Novartis.","text_display":" samples will only be disposed of after approval by Novartis.","confidence":0.99853515625,"confidence_rate":0.9999774476745767},{"cnt":[[288,1212],[1878,1212],[1878,1261],[288,1261]],"region":{"top_left_x":287,"top_left_y":1211,"width":1591,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb77bbd813d7485d8721f30c59cec58d","type":"text","conversion_output":true,"text":"For each scheduled IG sample, 2.5 mL of blood will be collected into SST tubes. The blood","text_display":"\nFor each scheduled IG sample, 2.5 mL of blood will be collected into SST tubes. The blood","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[288,1259],[1878,1259],[1878,1311],[288,1311]],"region":{"top_left_x":287,"top_left_y":1258,"width":1591,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69281f056f0e49c99b35c9fcc7e645ff","type":"text","conversion_output":true,"text":"sample will be allowed to clot over a minimum of 30 minutes at room temperature prior to","text_display":" sample will be allowed to clot over a minimum of 30 minutes at room temperature prior to","confidence":1,"confidence_rate":1},{"cnt":[[288,1308],[1880,1308],[1880,1360],[288,1360]],"region":{"top_left_x":287,"top_left_y":1308,"width":1593,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77eded8a4aed4419a73f967199736d66","type":"text","conversion_output":true,"text":"harvesting of the serum. The serum will be obtained by centrifugation at approximately 2500 g","text_display":" harvesting of the serum. The serum will be obtained by centrifugation at approximately 2500 g","confidence":1,"confidence_rate":1},{"cnt":[[288,1354],[1878,1354],[1878,1407],[288,1407]],"region":{"top_left_x":287,"top_left_y":1353,"width":1591,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f5a690143e3465eb842e435502bc3de","type":"text","conversion_output":true,"text":"for 10 minutes. Serum IG samples will be split into 3 aliquots of approximately 0.3 mL serum","text_display":" for 10 minutes. Serum IG samples will be split into 3 aliquots of approximately 0.3 mL serum","confidence":0.9985356330871582,"confidence_rate":0.9999864312018168},{"cnt":[[288,1401],[1878,1401],[1878,1454],[288,1454]],"region":{"top_left_x":287,"top_left_y":1400,"width":1591,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eff8be113b434742bcd5e79c1ff08b86","type":"text","conversion_output":true,"text":"(polypropylene tubes) and then stored (within 30 min of preparation) at \\(-70^{\\circ} C\\) (approximately)","text_display":" (polypropylene tubes) and then stored (within 30 min of preparation) at \\(-70^{\\circ} C\\) (approximately)","confidence":0.9990234375,"confidence_rate":0.9999915772798866},{"cnt":[[288,1452],[1880,1452],[1880,1502],[288,1502]],"region":{"top_left_x":287,"top_left_y":1452,"width":1593,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64ef396d0b5242c2ad0c49b400ba3307","type":"text","conversion_output":true,"text":"prior to shipment to the Sponsor or central lab (see sample storage information below for","text_display":" prior to shipment to the Sponsor or central lab (see sample storage information below for","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[288,1500],[1878,1500],[1878,1549],[288,1549]],"region":{"top_left_x":287,"top_left_y":1499,"width":1591,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fe312f72e214c7383f67e8372dc5d76","type":"text","conversion_output":true,"text":"detailed stability information). Two aliquots will be shipped on dry ice to the analytical","text_display":" detailed stability information). Two aliquots will be shipped on dry ice to the analytical","confidence":1,"confidence_rate":1},{"cnt":[[288,1547],[1878,1547],[1878,1601],[288,1601]],"region":{"top_left_x":287,"top_left_y":1546,"width":1591,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3acf2b16d61f4484ad46f80824bb7459","type":"text","conversion_output":true,"text":"laboratory. The remaining aliquot must be kept at the central lab as a backup sample. Remaining","text_display":" laboratory. The remaining aliquot must be kept at the central lab as a backup sample. Remaining","confidence":1,"confidence_rate":1},{"cnt":[[288,1594],[1880,1594],[1880,1646],[288,1646]],"region":{"top_left_x":287,"top_left_y":1594,"width":1593,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2725cfd41884420d877c662c1dc56c5b","type":"text","conversion_output":true,"text":"samples will only be disposed of after approval by Novartis. If anaphylactoid reactions occur","text_display":" samples will only be disposed of after approval by Novartis. If anaphylactoid reactions occur","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,1641],[1871,1641],[1871,1695],[288,1695]],"region":{"top_left_x":287,"top_left_y":1641,"width":1585,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f791ea98c054955a6be693ea1bb7418","type":"text","conversion_output":true,"text":"after injection, two more samples (at the time of the event and 8 weeks later) need to be taken.","text_display":" after injection, two more samples (at the time of the event and 8 weeks later) need to be taken.","confidence":1,"confidence_rate":1},{"cnt":[[288,1710],[1878,1710],[1878,1764],[288,1764]],"region":{"top_left_x":287,"top_left_y":1710,"width":1591,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"769d27cdba72456b9bd9dc00ff7da8b3","type":"text","conversion_output":true,"text":"For each scheduled PD (IL-1 \\(\\beta\\) ) sample, 3.5 mL of blood will be drawn into SST tubes, to obtain","text_display":"\nFor each scheduled PD (IL-1 \\(\\beta\\) ) sample, 3.5 mL of blood will be drawn into SST tubes, to obtain","confidence":0.8736502423549308,"confidence_rate":0.9987500858331929},{"cnt":[[288,1762],[1878,1762],[1878,1811],[288,1811]],"region":{"top_left_x":287,"top_left_y":1761,"width":1591,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f91671d8df6472385730a69cf8943aa","type":"text","conversion_output":true,"text":"1.5 mL serum. The sample will be allowed to clot during 45 minutes at room temperature. The","text_display":" 1.5 mL serum. The sample will be allowed to clot during 45 minutes at room temperature. The","confidence":0.994140625,"confidence_rate":0.9999412356418027},{"cnt":[[288,1809],[1878,1809],[1878,1858],[288,1858]],"region":{"top_left_x":287,"top_left_y":1808,"width":1591,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae121c27f48c4e6ca00098d0623bd657","type":"text","conversion_output":true,"text":"serum will be obtained by centrifugation at approximately 2500 g for 10 minutes. The sample","text_display":" serum will be obtained by centrifugation at approximately 2500 g for 10 minutes. The sample","confidence":1,"confidence_rate":1},{"cnt":[[288,1856],[1878,1856],[1878,1910],[288,1910]],"region":{"top_left_x":287,"top_left_y":1856,"width":1591,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c54fa7225d344d95ba8974464ea0d04e","type":"text","conversion_output":true,"text":"will be split into two aliquots of 0.7 mL to be transferred into freezer-proof polypropylene","text_display":" will be split into two aliquots of 0.7 mL to be transferred into freezer-proof polypropylene","confidence":1,"confidence_rate":1},{"cnt":[[288,1904],[1878,1904],[1878,1953],[288,1953]],"region":{"top_left_x":287,"top_left_y":1903,"width":1591,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86c16f74cb96413a861d3b52631193e3","type":"text","conversion_output":true,"text":"screw-cap tubes. Serum tubes will be frozen within 90 min of venipuncture and kept at \\(-24^{\\circ} C\\)","text_display":" screw-cap tubes. Serum tubes will be frozen within 90 min of venipuncture and kept at \\(-24^{\\circ} C\\)","confidence":0.9990234375,"confidence_rate":0.9999911178608298},{"cnt":[[288,1951],[1880,1951],[1880,2002],[288,2002]],"region":{"top_left_x":287,"top_left_y":1950,"width":1593,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4c252a2acd54b888f09fe317e0998a7","type":"text","conversion_output":true,"text":"pending shipment on dry ice. One aliquot will be shipped on dry ice to the analytical","text_display":" pending shipment on dry ice. One aliquot will be shipped on dry ice to the analytical","confidence":1,"confidence_rate":1},{"cnt":[[288,1998],[1714,1998],[1714,2052],[288,2052]],"region":{"top_left_x":287,"top_left_y":1998,"width":1428,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95c1519e0567458aa47ee39021c01dde","type":"text","conversion_output":true,"text":"laboratory. The remaining aliquot must be kept at the central lab as a backup sample.","text_display":" laboratory. The remaining aliquot must be kept at the central lab as a backup sample.","confidence":1,"confidence_rate":1},{"cnt":[[288,2067],[1880,2067],[1880,2121],[288,2121]],"region":{"top_left_x":287,"top_left_y":2066,"width":1593,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7c94e3369e44036978c5f04abca2d0b","type":"text","conversion_output":true,"text":"On days and time points where blood IG and PD samples are to be drawn, the PK sample must","text_display":"\nOn days and time points where blood IG and PD samples are to be drawn, the PK sample must","confidence":1,"confidence_rate":1},{"cnt":[[288,2116],[1878,2116],[1878,2168],[288,2168]],"region":{"top_left_x":287,"top_left_y":2116,"width":1591,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab4715c366de488dbcf7080ecf3a7bdf","type":"text","conversion_output":true,"text":"be drawn first. The exact collection date and time of all samples must be documented on the","text_display":" be drawn first. The exact collection date and time of all samples must be documented on the","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[288,2161],[1880,2161],[1880,2215],[288,2215]],"region":{"top_left_x":287,"top_left_y":2161,"width":1593,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78906d8aece44181adf3fad67fa50ec4","type":"text","conversion_output":true,"text":"PK, IG and PD blood collection eCRF pages. The date and exact time of dosing, as well as the","text_display":" PK, IG and PD blood collection eCRF pages. The date and exact time of dosing, as well as the","confidence":1,"confidence_rate":1},{"cnt":[[288,2213],[1476,2213],[1476,2262],[288,2262]],"region":{"top_left_x":287,"top_left_y":2212,"width":1189,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8737d8245cd14805b193b112e9bfdc20","type":"text","conversion_output":true,"text":"date and actual time of blood sampling must be recorded on the eCRF.","text_display":" date and actual time of blood sampling must be recorded on the eCRF.","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[288,2282],[1560,2282],[1560,2331],[288,2331]],"region":{"top_left_x":287,"top_left_y":2281,"width":1273,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01bb2c6bf7dc47e2adb548bf494a0de1","type":"text","conversion_output":true,"text":"All samples will be given a unique sample number and a dose reference ID.","text_display":"\n\nAll samples will be given a unique sample number and a dose reference ID.","confidence":1,"confidence_rate":1},{"cnt":[[288,2348],[1876,2348],[1876,2400],[288,2400]],"region":{"top_left_x":287,"top_left_y":2348,"width":1589,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4234fa7f7dbf470f9eec03cade1df364","type":"text","conversion_output":true,"text":"Further details on labeling of the PK, IG and PD samples, instructions for the collection,","text_display":"\nFurther details on labeling of the PK, IG and PD samples, instructions for the collection,","confidence":1,"confidence_rate":1},{"cnt":[[288,2398],[1882,2398],[1882,2447],[288,2447]],"region":{"top_left_x":287,"top_left_y":2397,"width":1596,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddb88f15a432486880db1660f14c480d","type":"text","conversion_output":true,"text":"handling and shipment of samples can be found in the [CACZ885T2301 laboratory manual]. If","text_display":" handling and shipment of samples can be found in the [CACZ885T2301 laboratory manual]. If","confidence":1,"confidence_rate":1},{"cnt":[[288,2445],[1878,2445],[1878,2496],[288,2496]],"region":{"top_left_x":287,"top_left_y":2444,"width":1591,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ef2a9f4541d4bbf85509d1918ea0e75","type":"text","conversion_output":true,"text":"subjects experience a SAE or an AE leading to the discontinuation of the study treatment, an","text_display":" subjects experience a SAE or an AE leading to the discontinuation of the study treatment, an","confidence":0.98681640625,"confidence_rate":0.999863192155379},{"cnt":[[288,2494],[1880,2494],[1880,2546],[288,2546]],"region":{"top_left_x":287,"top_left_y":2494,"width":1593,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"041138a77a594a3891c73cae44246c4d","type":"text","conversion_output":true,"text":"unscheduled PK and IG blood sample should be obtained as close as possible to the event","text_display":" unscheduled PK and IG blood sample should be obtained as close as possible to the event","confidence":0.99951171875,"confidence_rate":0.9999946913130248}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-100","page":100,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8c7857e9ac74627925760e0e467dc07","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c139e9990ef46f18c2e947b6b8a11fa","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,206],[1876,206],[1876,247],[1611,247]],"region":{"top_left_x":1611,"top_left_y":206,"width":265,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c80fdb0c9e074f93b4e4f11620a07473","type":"page_info","conversion_output":false,"text":"Page 100 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,249],[883,249],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":249,"width":597,"height":46},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c6739c3ae6a4e51ab30e755b6c858ba","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,249],[1871,249],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":249,"width":457,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c68f67d51ce8450db4395d14e8e67faa","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99853515625,"confidence_rate":0.9999511372710721},{"cnt":[[288,346],[1876,346],[1876,389],[288,389]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":44},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb0a1574bb114fe090434b519a6636b5","type":"text","conversion_output":true,"text":"occurrence. The date and time of the last dose and the time of PK and IG blood draw should be","text_display":"\noccurrence. The date and time of the last dose and the time of PK and IG blood draw should be","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[453,391],[453,436],[288,436]],"region":{"top_left_x":287,"top_left_y":391,"width":167,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c8c1b2cbfc8479585a5bd2a89902134","type":"text","conversion_output":true,"text":"recorded.","text_display":" recorded.","confidence":1,"confidence_rate":1},{"cnt":[[829,511],[1878,511],[1878,561],[829,561]],"region":{"top_left_x":829,"top_left_y":511,"width":1049,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea1ee7f82a074e989b9b9dfb4928f4c3","type":"text","conversion_output":true,"text":"Collection of PK, PD and/or IG samples may be stopped upon","text_display":"\n\nCollection of PK, PD and/or IG samples may be stopped upon","confidence":1,"confidence_rate":1},{"cnt":[[288,559],[1878,559],[1878,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19f2b2245ec1497bbfa2709a002c09b2","type":"text","conversion_output":true,"text":"decision of the Sponsor, if/when sufficient data are collected, after the primary CSR cut-off date","text_display":" decision of the Sponsor, if/when sufficient data are collected, after the primary CSR cut-off date","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[288,606],[1128,606],[1128,657],[288,657]],"region":{"top_left_x":287,"top_left_y":605,"width":841,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ad3b7899615499681e0b99c54130382","type":"text","conversion_output":true,"text":"is reached or following decision to stop the study.","text_display":" is reached or following decision to stop the study.","confidence":1,"confidence_rate":1},{"cnt":[[288,690],[1798,690],[1798,788],[288,788]],"region":{"top_left_x":287,"top_left_y":689,"width":1512,"height":100},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa787f9ae89643ce897a2a1edf5a4653","type":"figure_label","conversion_output":false,"children_ids":["f7f72ca92daa471f80e4a8dd0b12e9b7","b410c5b9d5904a299db53325a9f83eb6"],"text":"","text_display":""},{"cnt":[[288,696],[1794,696],[1794,741],[288,741]],"region":{"top_left_x":287,"top_left_y":696,"width":1507,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7f72ca92daa471f80e4a8dd0b12e9b7","type":"text","conversion_output":false,"parent_id":"fa787f9ae89643ce897a2a1edf5a4653","text":"Table 7-6 Blood collection (serum) for canakinumab pharmacokinetics (PK),","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[584,739],[1502,739],[1502,784],[584,784]],"region":{"top_left_x":584,"top_left_y":739,"width":918,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b410c5b9d5904a299db53325a9f83eb6","type":"text","conversion_output":false,"parent_id":"fa787f9ae89643ce897a2a1edf5a4653","text":"immunogenicity (IG) and pharmacodynamics 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\\multicolumn{2}{|c|}{Dose Reference Identification (ID)} & \\multirow{2}{*}{PK sample number} & \\multirow{2}{*}{IG sample number \\({ }^{b}\\)} & \\multirow{2}{*}{Total IL\\(1 \\beta\\) (PD) sample number \\({ }^{b}\\)} & \\multicolumn{4}{|c|}{Scheduled time points (hours)} \\\\\n\\hline Dose ID following sampling & Dose ID prior to sampling* & & & & Cycle & Day & Scheduled time (hours) & Description \\\\\n\\hline 1 & - & 101 & 201 & 301 & 1 & 1 & \\(0 hr ^{ a }\\) & Pre-dose \\\\\n\\hline - & - & 104 & - & - & 1 & 8 & 168 hr \\(( \\pm 12 h)\\) & Post-dose \\\\\n\\hline 1 & - & 105 & - & 302 & 1 & 15 & 336 hr \\(( \\pm 24 h)\\) & Post-dose \\\\\n\\hline 2 & 1 & 106 & 202 & - & 2 & 1 & 0 hr (or 504 hr postC1D1 dose) & Pre-dose \\\\\n\\hline 3 & 400 & 107 & 203 & 303 & 4 & 1 & 0 hr & Pre-dose \\\\\n\\hline 4 & 401 & 108 & 204 & - & 6 & 1 & 0 hr & Pre-dose \\\\\n\\hline 5 & 402 & 111 & 205 & - & 9 & 1 & 0 hr & Pre-dose \\\\\n\\hline 6 & 403 & 112 & 206 & 304 & 12 & 1 & 0 hr & Pre-dose \\\\\n\\hline - & - & 115 & 209 & 306 & 18/EOT** & NA & Anytime & Pre/Post-dose** \\\\\n\\hline - & - & 116 & 210 & 307 & safety follow-up 1 & NA & Anytime & - \\\\\n\\hline - & - & 117 & - & - & safety follow-up 2 & NA & Anytime & - \\\\\n\\hline - & - & 118 & 211 & 308 & safety follow-up 3 & NA & Anytime & - \\\\\n\\hline - & - & 119 & - & - & safety follow-up 4 & NA & Anytime & - \\\\\n\\hline - & - & 120 & 212 & 309 & safety follow-up 5 & NA & Anytime & - \\\\\n\\hline NA & NA & \\(1001+^{ c }\\) & \\(2001+^{ d }\\) & 3001+e & NA & NA & Unscheduled and at the time of progression or AE & - \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 7-6 Blood collection (serum) for canakinumab pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD)}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{2}{|c|}{Dose Reference Identification (ID)} & \\multirow{2}{*}{PK sample number} & \\multirow{2}{*}{IG 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reporting}","confidence":1,"confidence_rate":1},{"cnt":[[288,1826],[1878,1826],[1878,1878],[288,1878]],"region":{"top_left_x":287,"top_left_y":1826,"width":1591,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e58097d6a8d4724b1a797a51a97338d","type":"text","conversion_output":true,"text":"An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable","text_display":"\n\nAn adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable","confidence":1,"confidence_rate":1},{"cnt":[[288,1876],[1878,1876],[1878,1927],[288,1927]],"region":{"top_left_x":287,"top_left_y":1875,"width":1591,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"822c48b9835e4a0dbe51910d0ec1da16","type":"text","conversion_output":true,"text":"sign(s), symptom(s), or medical condition(s) that occur after a subject's signed informed","text_display":" sign(s), symptom(s), or medical condition(s) that occur after a subject's signed informed","confidence":0.9980480668600649,"confidence_rate":0.9999792146772514},{"cnt":[[288,1921],[746,1921],[746,1966],[288,1966]],"region":{"top_left_x":287,"top_left_y":1920,"width":459,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbb9a3f44e69441192f4fee296f38970","type":"text","conversion_output":true,"text":"consent has been obtained.","text_display":" consent has been obtained.","confidence":1,"confidence_rate":1},{"cnt":[[288,1989],[1878,1989],[1878,2041],[288,2041]],"region":{"top_left_x":287,"top_left_y":1989,"width":1591,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac2ecce41e94e0ea001da375edb55b2","type":"text","conversion_output":true,"text":"Abnormal laboratory values or test results occurring after informed consent constitute adverse","text_display":"\n\nAbnormal laboratory values or test results occurring after informed consent constitute adverse","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,2039],[1876,2039],[1876,2090],[288,2090]],"region":{"top_left_x":287,"top_left_y":2038,"width":1589,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53549fe730e445bda770cbe07d1ad7b1","type":"text","conversion_output":true,"text":"events only if they induce clinical signs or symptoms, are considered clinically significant,","text_display":" events only if they induce clinical signs or symptoms, are considered clinically significant,","confidence":1,"confidence_rate":1},{"cnt":[[288,2088],[1878,2088],[1878,2138],[288,2138]],"region":{"top_left_x":287,"top_left_y":2088,"width":1591,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd14f204748e475faf0c1d4a5ffe1cff","type":"text","conversion_output":true,"text":"require therapy (e.g., hematologic abnormality that requires transfusion or hematological stem","text_display":" require therapy (e.g., hematologic abnormality that requires transfusion or hematological stem","confidence":1,"confidence_rate":1},{"cnt":[[288,2136],[1231,2136],[1231,2185],[288,2185]],"region":{"top_left_x":287,"top_left_y":2135,"width":945,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29114a1c85754b248a525918b523d090","type":"text","conversion_output":true,"text":"cell support), or require changes in study medication(s).","text_display":" cell support), or require changes in study medication(s).","confidence":1,"confidence_rate":1},{"cnt":[[288,2204],[1876,2204],[1876,2254],[288,2254]],"region":{"top_left_x":287,"top_left_y":2204,"width":1589,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b977199bd7d64b2896afa73c880b2b11","type":"text","conversion_output":true,"text":"Adverse events that begin or worsen after informed consent should be recorded in the AE eCRF.","text_display":"\n\nAdverse events that begin or worsen after informed consent should be recorded in the AE eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[288,2252],[1876,2252],[1876,2301],[288,2301]],"region":{"top_left_x":287,"top_left_y":2251,"width":1589,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b36e41a7abd34781a6a5b6d8a88473c9","type":"text","conversion_output":true,"text":"Conditions that were already present at the time of informed consent should be recorded in the","text_display":" Conditions that were already present at the time of informed consent should be recorded in the","confidence":1,"confidence_rate":1},{"cnt":[[288,2299],[1876,2299],[1876,2348],[288,2348]],"region":{"top_left_x":287,"top_left_y":2298,"width":1589,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d12ac729bdc44e68efb746a2a2f3389","type":"text","conversion_output":true,"text":"medical history eCRF. Adverse event monitoring should be continued for at least 130 days","text_display":" medical history eCRF. Adverse event monitoring should be continued for at least 130 days","confidence":1,"confidence_rate":1},{"cnt":[[288,2346],[1876,2346],[1876,2396],[288,2396]],"region":{"top_left_x":287,"top_left_y":2346,"width":1589,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6caebf59edd042a6aea199b13508759c","type":"text","conversion_output":true,"text":"following the EOT visit. Adverse events (including lab abnormalities that constitute AEs)","text_display":" following the EOT visit. Adverse events (including lab abnormalities that constitute AEs)","confidence":1,"confidence_rate":1},{"cnt":[[288,2393],[1878,2393],[1878,2445],[288,2445]],"region":{"top_left_x":287,"top_left_y":2393,"width":1591,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a323524b70104245a85ad7edaccdb086","type":"text","conversion_output":true,"text":"should be described using a diagnosis whenever possible, rather than individual underlying","text_display":" should be described using a diagnosis whenever possible, rather than individual underlying","confidence":0.9970703125,"confidence_rate":0.9999691163986473},{"cnt":[[288,2443],[1878,2443],[1878,2494],[288,2494]],"region":{"top_left_x":287,"top_left_y":2442,"width":1591,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a0bd4bad0fb443eb10be319c173f315","type":"text","conversion_output":true,"text":"signs and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should","text_display":" signs and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should","confidence":1,"confidence_rate":1},{"cnt":[[288,2492],[973,2492],[973,2542],[288,2542]],"region":{"top_left_x":287,"top_left_y":2492,"width":687,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00bc298207524ee19be14937f90e5ead","type":"text","conversion_output":true,"text":"be reported as a separate Adverse Event.","text_display":" be reported as a separate Adverse 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109 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f3939538591425e89a43006f0df13a3","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,249],[1871,249],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":249,"width":457,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9f7b0f17c6146d0bb6143900eb5733b","type":"page_info","conversion_output":false,"text":"Protocol No. 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collected in the Adverse Events eCRF.","text_display":" suspected to be related to study treatment will be collected in the Adverse Events eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[288,460],[1878,460],[1878,513],[288,513]],"region":{"top_left_x":287,"top_left_y":459,"width":1591,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"322e632ce4ba4d769196517800057ff3","type":"text","conversion_output":true,"text":"Adverse events will be assessed and graded according to the Common Terminology Criteria for","text_display":"\nAdverse events will be assessed and graded according to the Common Terminology Criteria for","confidence":1,"confidence_rate":1},{"cnt":[[288,511],[941,511],[941,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":655,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9606ebdf288e4a7ea0bed63ae4856db1","type":"text","conversion_output":true,"text":"Adverse 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respectively to Grades 1-5, will be","text_display":" and life-threatening, death related to the AE corresponding respectively to Grades 1-5, will be","confidence":0.9941456306260079,"confidence_rate":0.9999412859900055},{"cnt":[[288,675],[1878,675],[1878,724],[288,724]],"region":{"top_left_x":287,"top_left_y":674,"width":1591,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e2388538acd405ca1b07c6ca4a50e6c","type":"text","conversion_output":true,"text":"used. Information about any deaths (related to an adverse event or not) will also be collected","text_display":" used. Information about any deaths (related to an adverse event or not) will also be collected","confidence":1,"confidence_rate":1},{"cnt":[[288,722],[642,722],[642,771],[288,771]],"region":{"top_left_x":287,"top_left_y":721,"width":356,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d1ce989edb14d2ca5a780cb93f77412","type":"text","conversion_output":true,"text":"though a death form.","text_display":" though a death form.","confidence":0.99560546875,"confidence_rate":0.999823846893383},{"cnt":[[288,791],[1876,791],[1876,844],[288,844]],"region":{"top_left_x":287,"top_left_y":790,"width":1589,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c82d8823eda642658e09e61dc8d5ad6e","type":"text","conversion_output":true,"text":"The occurrence of adverse events should be sought by non-directive questioning of the subject","text_display":"\n\nThe occurrence of adverse events should be sought by non-directive questioning of the subject","confidence":1,"confidence_rate":1},{"cnt":[[288,838],[1876,838],[1876,889],[288,889]],"region":{"top_left_x":287,"top_left_y":837,"width":1589,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49220c721ac9487ea8da8ab7eaf3a208","type":"text","conversion_output":true,"text":"during the screening process after signing informed consent and at each visit during the study.","text_display":" during the screening process after signing informed consent and at each visit during the study.","confidence":1,"confidence_rate":1},{"cnt":[[288,887],[1876,887],[1876,939],[288,939]],"region":{"top_left_x":287,"top_left_y":887,"width":1589,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"806a82dc03c44d2098975080776f57d0","type":"text","conversion_output":true,"text":"Adverse events also may be detected when they are volunteered by the subject during the","text_display":" Adverse events also may be detected when they are volunteered by the subject during the","confidence":1,"confidence_rate":1},{"cnt":[[288,937],[1880,937],[1880,986],[288,986]],"region":{"top_left_x":287,"top_left_y":936,"width":1593,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"324888845a924b8eac32f28b735c022c","type":"text","conversion_output":true,"text":"screening process or between visits, or through physical examination, laboratory test, or other","text_display":" screening process or between visits, or through physical examination, laboratory test, or other","confidence":1,"confidence_rate":1},{"cnt":[[288,984],[1725,984],[1725,1033],[288,1033]],"region":{"top_left_x":287,"top_left_y":983,"width":1439,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9810abb7093340da8b21f32472f9610c","type":"text","conversion_output":true,"text":"assessments. As far as possible, each adverse event should be evaluated to determine:","text_display":" assessments. As far as possible, each adverse event should be evaluated to determine:","confidence":1,"confidence_rate":1},{"cnt":[[288,1040],[1124,1040],[1124,1094],[288,1094]],"region":{"top_left_x":287,"top_left_y":1039,"width":837,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1be7f8c9f3e448dbfa752e7bf54f33d","type":"text","conversion_output":true,"text":"- The severity grade (CTCAE v5.0 Grades 1-5)","text_display":"\n- The severity grade (CTCAE v5.0 Grades 1-5)","confidence":1,"confidence_rate":1},{"cnt":[[288,1096],[907,1096],[907,1149],[288,1149]],"region":{"top_left_x":287,"top_left_y":1095,"width":620,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d06929b751994c68830a23a6bc939fa8","type":"text","conversion_output":true,"text":"- Its duration (Start and end dates)","text_display":"\n- Its duration (Start and end dates)","confidence":1,"confidence_rate":1},{"cnt":[[288,1156],[1691,1156],[1691,1207],[288,1207]],"region":{"top_left_x":287,"top_left_y":1155,"width":1404,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7245d5c42a34baa9d70a31011df90c4","type":"text","conversion_output":true,"text":"- Its relationship to the study treatment. Reasonable possibility that AE is related:","text_display":"\n- Its relationship to the study treatment. 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For grade 3 and 4 adverse events only, if improvement","text_display":" date when the event worsens in toxicity. 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If a concomitant medication or non-drug","text_display":"\n\nAll adverse events should be treated appropriately. 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should be followed until its resolution or until it is judged","confidence":1,"confidence_rate":1},{"cnt":[[288,2140],[1876,2140],[1876,2194],[288,2194]],"region":{"top_left_x":287,"top_left_y":2139,"width":1589,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2b996f7b0b744e2bde2f1e5b5969109","type":"text","conversion_output":true,"text":"to be permanent, and assessment should be made at each visit (or more frequently, if necessary)","text_display":" to be permanent, and assessment should be made at each visit (or more frequently, if necessary)","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1876,2191],[1876,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2191,"width":1589,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f58c6ae4dd8247a9b908ff01f9574eaf","type":"text","conversion_output":true,"text":"of any changes in severity, the suspected relationship to the study 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significant, induce clinical signs or symptoms, require concomitant therapy or require","confidence":1,"confidence_rate":1},{"cnt":[[288,597],[1878,597],[1878,649],[288,649]],"region":{"top_left_x":287,"top_left_y":597,"width":1591,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27acb0397228443dad1573c85c7968d2","type":"text","conversion_output":true,"text":"changes in study treatment), should be recorded on the AE eCRF. Whenever possible, a","text_display":" changes in study treatment), should be recorded on the AE eCRF. 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When an","text_display":" have returned to normal or an adequate explanation of the abnormality is found. When an","confidence":1,"confidence_rate":1},{"cnt":[[288,791],[1878,791],[1878,844],[288,844]],"region":{"top_left_x":287,"top_left_y":790,"width":1591,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab23a9e077ef458bbc01b77a2f8eae04","type":"text","conversion_output":true,"text":"abnormal laboratory or test result corresponds to a sign/symptom of an already reported adverse","text_display":" abnormal laboratory or test result corresponds to a sign/symptom of an already reported adverse","confidence":1,"confidence_rate":1},{"cnt":[[288,838],[1725,838],[1725,889],[288,889]],"region":{"top_left_x":287,"top_left_y":837,"width":1439,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecaf72fe6fd34e1e9b1e5744786bcb7a","type":"text","conversion_output":true,"text":"event, it is not necessary to separately record the lab/test result as an additional event.","text_display":" event, it is not necessary to separately record the lab/test result as an additional event.","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[288,907],[1878,907],[1878,958],[288,958]],"region":{"top_left_x":287,"top_left_y":906,"width":1591,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8ba318157124286b37f81fac4b4b59c","type":"text","conversion_output":true,"text":"Laboratory abnormalities that do not meet the definition of an adverse event should not be","text_display":"\nLaboratory abnormalities that do not meet the definition of an adverse event should not be","confidence":1,"confidence_rate":1},{"cnt":[[288,954],[1880,954],[1880,1008],[288,1008]],"region":{"top_left_x":287,"top_left_y":953,"width":1593,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3ece248ae164d3daecedf25ebc7e167","type":"text","conversion_output":true,"text":"reported as adverse events. 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A dose hold or medication for the lab abnormality may be required by","text_display":" investigator's discretion. 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Potential emergent new AEs will be monitored during the course of the study.","text_display":" Brochure]. 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surgical intervention to prevent one of the outcomes listed above","confidence":1,"confidence_rate":1},{"cnt":[[288,2144],[1878,2144],[1878,2194],[288,2194]],"region":{"top_left_x":287,"top_left_y":2144,"width":1591,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8a587f137a24e76a2f9a59f127e4fef","type":"text","conversion_output":true,"text":"Medical and scientific judgment should be exercised in deciding whether other situations should","text_display":"\nMedical and scientific judgment should be exercised in deciding whether other situations should","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1878,2191],[1878,2243],[288,2243]],"region":{"top_left_x":287,"top_left_y":2191,"width":1591,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"064a782c4a7946509dc18620f852d1f5","type":"text","conversion_output":true,"text":"be considered serious reactions, such as important medical events 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CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6b16ee8a5aa4590a9a9ab1497e23ad5","type":"text","conversion_output":true,"text":"Confirmed COVID-19 infection should be considered as medically significant and should","text_display":"\n\nConfirmed COVID-19 infection should be considered as medically significant and should","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[844,391],[844,445],[288,445]],"region":{"top_left_x":287,"top_left_y":391,"width":558,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b09b64d0deb64ebfba4853d4fc8183db","type":"text","conversion_output":true,"text":"therefore be reported as an SAE.","text_display":" therefore be reported as an SAE.","confidence":1,"confidence_rate":1},{"cnt":[[288,460],[1878,460],[1878,513],[288,513]],"region":{"top_left_x":287,"top_left_y":459,"width":1591,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f40efdb8c374093b8afb17802c17007","type":"text","conversion_output":true,"text":"All new malignant neoplasms will be assessed as serious under \"medically significant\" if other","text_display":"\nAll new malignant neoplasms will be assessed as serious under \"medically significant\" if other","confidence":1,"confidence_rate":1},{"cnt":[[288,509],[1878,509],[1878,561],[288,561]],"region":{"top_left_x":287,"top_left_y":509,"width":1591,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f7411abf8bd46f3aeef97e3170ca832","type":"text","conversion_output":true,"text":"seriousness criteria are not met and the malignant neoplasm is not a disease progression of the","text_display":" seriousness criteria are not met and the malignant neoplasm is not a disease progression of the","confidence":0.9985356330871582,"confidence_rate":0.9999853457059158},{"cnt":[[288,559],[576,559],[576,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":289,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c58a305bf6c49b493c4e9ef20183c86","type":"text","conversion_output":true,"text":"study indication.","text_display":" study indication.","confidence":1,"confidence_rate":1},{"cnt":[[288,625],[1878,625],[1878,677],[288,677]],"region":{"top_left_x":287,"top_left_y":625,"width":1591,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42826a403c2343ada5f978a36d92d4db","type":"text","conversion_output":true,"text":"Any suspected transmission via a medicinal product of an infectious agent is also considered a","text_display":"\nAny suspected transmission via a medicinal product of an infectious agent is also 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adverse","confidence":1,"confidence_rate":1},{"cnt":[[288,791],[1124,791],[1124,844],[288,844]],"region":{"top_left_x":287,"top_left_y":790,"width":837,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea39f01fc7de4d75acd1cd39e3310d10","type":"text","conversion_output":true,"text":"event irrespective if a clinical event has occurred.","text_display":" event irrespective if a clinical event has 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provided informed consent and until at least 130 days after the subject has stopped study","confidence":1,"confidence_rate":1},{"cnt":[[288,1044],[1880,1044],[1880,1096],[288,1096]],"region":{"top_left_x":287,"top_left_y":1044,"width":1593,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"144fb493850944c7a0e3ae7499bd302c","type":"text","conversion_output":true,"text":"treatment must be reported to Novartis safety immediately, without undue delay, but under no","text_display":" treatment must be reported to Novartis safety immediately, without undue delay, but under no","confidence":1,"confidence_rate":1},{"cnt":[[288,1091],[1880,1091],[1880,1145],[288,1145]],"region":{"top_left_x":287,"top_left_y":1091,"width":1593,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d484aa5740a4d97876bc6ffe221befd","type":"text","conversion_output":true,"text":"circumstances later than within 24 hours of obtaining knowledge of the events (Note: If more","text_display":" circumstances later than within 24 hours of obtaining knowledge of the events (Note: If more","confidence":1,"confidence_rate":1},{"cnt":[[288,1141],[1878,1141],[1878,1192],[288,1192]],"region":{"top_left_x":287,"top_left_y":1140,"width":1591,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3c88cea6ba64db9b967c5d71dacd011","type":"text","conversion_output":true,"text":"stringent, local regulations regarding reporting timelines prevail). Detailed instructions","text_display":" stringent, local regulations regarding reporting timelines prevail). Detailed instructions","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,1190],[1880,1190],[1880,1240],[288,1240]],"region":{"top_left_x":287,"top_left_y":1190,"width":1593,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42b19758e11746759e1d2d53bedfe359","type":"text","conversion_output":true,"text":"regarding the submission process and requirements are to be found in the investigator folder","text_display":" regarding the submission process and requirements are to be found in the investigator folder","confidence":1,"confidence_rate":1},{"cnt":[[288,1238],[1878,1238],[1878,1287],[288,1287]],"region":{"top_left_x":287,"top_left_y":1237,"width":1591,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b82893ceed340cfa3b63fe18f3b57d3","type":"text","conversion_output":true,"text":"provided to each site. Information about all SAEs is collected and recorded on the eSAE Serious","text_display":" provided to each site. Information about all SAEs is collected and recorded on the eSAE Serious","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[288,1285],[1878,1285],[1878,1334],[288,1334]],"region":{"top_left_x":287,"top_left_y":1284,"width":1591,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24b4a7e310346a0867e0e6f5cf1db14","type":"text","conversion_output":true,"text":"Adverse Event Report Form; all applicable sections of the form must be completed in order to","text_display":" Adverse Event Report Form; all applicable sections of the form must be completed in order to","confidence":1,"confidence_rate":1},{"cnt":[[288,1332],[1880,1332],[1880,1386],[288,1386]],"region":{"top_left_x":287,"top_left_y":1332,"width":1593,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65ecd244f66840d39141c76681e2166f","type":"text","conversion_output":true,"text":"provide a clinically thorough report. In case of technical issue to report SAE information via","text_display":" provide a clinically thorough report. 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Adverse events separate from the recurrence of","text_display":" malignancy is related to study treatment. 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used","text_display":" concurrent with finding of disease recurrence) will be reported as per usual guidelines used","confidence":1,"confidence_rate":1},{"cnt":[[352,1959],[1571,1959],[1571,2013],[352,2013]],"region":{"top_left_x":352,"top_left_y":1959,"width":1219,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cecedef8415948c0bac3638eb73bbd2b","type":"text","conversion_output":true,"text":"for such events with proper attribution regarding relatedness to the drug.","text_display":" for such events with proper attribution regarding relatedness to the drug.","confidence":1,"confidence_rate":1},{"cnt":[[288,2015],[1624,2015],[1624,2069],[288,2069]],"region":{"top_left_x":287,"top_left_y":2015,"width":1338,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b5ab4f6167c40d1a595dad916077c60","type":"text","conversion_output":true,"text":"- New primary lung cancer malignancies should always be reported as SAEs.","text_display":"\n- New primary lung cancer malignancies should always be reported as SAEs.","confidence":1,"confidence_rate":1},{"cnt":[[288,2075],[1848,2075],[1848,2127],[288,2127]],"region":{"top_left_x":287,"top_left_y":2075,"width":1561,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f221a44f2854346b561ce97f7af09c7","type":"text","conversion_output":true,"text":"- New primary malignancies in organs other than lung should always be reported as SAEs.","text_display":"\n- New primary malignancies in organs other than lung should always be reported as SAEs.","confidence":1,"confidence_rate":1},{"cnt":[[288,2144],[1876,2144],[1876,2194],[288,2194]],"region":{"top_left_x":287,"top_left_y":2144,"width":1589,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2837eb53b564ef08c3d358325236d3b","type":"text","conversion_output":true,"text":"Any additional information for the SAE including complications, progression of the initial SAE,","text_display":"\n\nAny additional information for the SAE including complications, progression of the initial SAE,","confidence":1,"confidence_rate":1},{"cnt":[[288,2191],[1876,2191],[1876,2241],[288,2241]],"region":{"top_left_x":287,"top_left_y":2191,"width":1589,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cec5774050de4831b5168439ef491da1","type":"text","conversion_output":true,"text":"and recurrent episodes must be reported as follow-up to the original episode immediately,","text_display":" and recurrent episodes must be reported as follow-up to the original episode 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follow-up information (Note: If more stringent, local regulations regarding","confidence":1,"confidence_rate":1},{"cnt":[[288,2333],[1880,2333],[1880,2387],[288,2387]],"region":{"top_left_x":287,"top_left_y":2333,"width":1593,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0c3d30efaba41458938c7d091a96c1d","type":"text","conversion_output":true,"text":"reporting timelines prevail). An SAE occurring at a different time interval or otherwise","text_display":" reporting timelines prevail). 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all applicable sections of the form must be completed in order to provide a clinically","text_display":" Form; all applicable sections of the form must be completed in order to provide a clinically","confidence":0.9892845153808594,"confidence_rate":0.9998889411275754},{"cnt":[[288,559],[1876,559],[1876,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1589,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3263d2bd0dbd4004809e2d53980057e6","type":"text","conversion_output":true,"text":"thorough report. 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Each re-","text_display":"\nFollow-up information is submitted in the same way as the original SAE Report. Each re","confidence":1,"confidence_rate":1},{"cnt":[[288,868],[1876,868],[1876,917],[288,917]],"region":{"top_left_x":287,"top_left_y":867,"width":1589,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c7213cdea5246f189fa9d1504fcabca","type":"text","conversion_output":true,"text":"occurrence, complication, or progression of the original event should be reported as a follow-","text_display":"occurrence, complication, or progression of the original event should be reported as a follow","confidence":0.98046875,"confidence_rate":0.9998007824187028},{"cnt":[[288,915],[1876,915],[1876,965],[288,965]],"region":{"top_left_x":287,"top_left_y":915,"width":1589,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78bce444961e460fa159f3f60e9877f5","type":"text","conversion_output":true,"text":"up to that event regardless of when it occurs. The follow-up information should describe","text_display":"up to that event regardless of when it occurs. The follow-up information should describe","confidence":1,"confidence_rate":1},{"cnt":[[288,962],[1876,962],[1876,1012],[288,1012]],"region":{"top_left_x":287,"top_left_y":962,"width":1589,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a77afa3f86f94fcaac5eb9eecb0d82c4","type":"text","conversion_output":true,"text":"whether the event has resolved or continues, if and how it was treated, whether the blind was","text_display":" whether the event has resolved or continues, if and how it was treated, whether the blind was","confidence":1,"confidence_rate":1},{"cnt":[[288,1010],[1749,1010],[1749,1061],[288,1061]],"region":{"top_left_x":287,"top_left_y":1009,"width":1462,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe8f25dcfc4b4bdea7314f6c76858d39","type":"text","conversion_output":true,"text":"broken or not, and whether the subject continued or withdrew from study participation.","text_display":" broken or not, and whether the subject continued or withdrew from study participation.","confidence":1,"confidence_rate":1},{"cnt":[[288,1079],[1878,1079],[1878,1130],[288,1130]],"region":{"top_left_x":287,"top_left_y":1078,"width":1591,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57c7309a584245c885ae985c83076422","type":"text","conversion_output":true,"text":"If the SAE is not previously documented in the Investigator's Brochure or Package Insert (new","text_display":"\nIf the SAE is not previously documented in the Investigator's Brochure or Package Insert (new","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[288,1126],[1876,1126],[1876,1175],[288,1175]],"region":{"top_left_x":287,"top_left_y":1125,"width":1589,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"359d63f157ac43a092a4fdcc35d1a35b","type":"text","conversion_output":true,"text":"occurrence) and is thought to be related to the Novartis study treatment, an oncology Novartis","text_display":" occurrence) and is thought to be related to the Novartis study treatment, an oncology Novartis","confidence":1,"confidence_rate":1},{"cnt":[[288,1173],[1878,1173],[1878,1227],[288,1227]],"region":{"top_left_x":287,"top_left_y":1173,"width":1591,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f05279ffb39846688c19283b9112ca8e","type":"text","conversion_output":true,"text":"Chief Medical Office and Patient Safety (CMO\\&PS) department associate may urgently require","text_display":" Chief Medical Office and Patient Safety (CMO\\&PS) department associate may urgently require","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[288,1222],[1878,1222],[1878,1274],[288,1274]],"region":{"top_left_x":287,"top_left_y":1222,"width":1591,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95704b25aaab499bb24359d3c40aedd8","type":"text","conversion_output":true,"text":"further information from the investigator for Health Authority reporting. Novartis may need to","text_display":" further information from the investigator for Health Authority reporting. Novartis may need to","confidence":1,"confidence_rate":1},{"cnt":[[288,1268],[1880,1268],[1880,1321],[288,1321]],"region":{"top_left_x":287,"top_left_y":1267,"width":1593,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f86bf73c55f041d981e74b6589f0b956","type":"text","conversion_output":true,"text":"issue an Investigator Notification (IN), to inform all investigators involved in any study with","text_display":" issue an Investigator Notification (IN), to inform all investigators involved in any study with","confidence":1,"confidence_rate":1},{"cnt":[[288,1319],[1079,1319],[1079,1369],[288,1369]],"region":{"top_left_x":287,"top_left_y":1319,"width":792,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bba8d7eaf3114679a5ea86c443dfbfae","type":"text","conversion_output":true,"text":"the same drug that this SAE has been reported.","text_display":" the same drug that this SAE has been 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Most often, study treatment discontinuation and knowledge of the possible","text_display":" the subject. Most often, study treatment discontinuation and knowledge of the possible","confidence":1,"confidence_rate":1},{"cnt":[[288,1878],[1880,1878],[1880,1931],[288,1931]],"region":{"top_left_x":287,"top_left_y":1877,"width":1593,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f718e32d68c4b9cb53ce4703ee53a2a","type":"text","conversion_output":true,"text":"treatment assignments are sufficient to treat a study subject who presents with an emergency","text_display":" treatment assignments are sufficient to treat a study subject who presents with an emergency","confidence":1,"confidence_rate":1},{"cnt":[[288,1927],[1880,1927],[1880,1979],[288,1979]],"region":{"top_left_x":287,"top_left_y":1927,"width":1593,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"535918b4de324e45bfebc19a1869970a","type":"text","conversion_output":true,"text":"condition. 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When the investigator contacts the IRT","text_display":" Emergency code breaks are performed using the IRT. When the investigator contacts the IRT","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[288,2168],[1880,2168],[1880,2219],[288,2219]],"region":{"top_left_x":287,"top_left_y":2167,"width":1593,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14e5d8c0f15a4a01aaa71dab48f354c6","type":"text","conversion_output":true,"text":"to unblind a subject, he/she must provide the requested subject identifying information and","text_display":" to unblind a subject, he/she must provide the requested subject identifying information and","confidence":1,"confidence_rate":1},{"cnt":[[288,2213],[1878,2213],[1878,2264],[288,2264]],"region":{"top_left_x":287,"top_left_y":2212,"width":1591,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"062924b8773944c190ce8083d8a8a216","type":"text","conversion_output":true,"text":"confirm the necessity to unblind the subject. The investigator will then receive details of the","text_display":" confirm the necessity to unblind the subject. The investigator will then receive details of the","confidence":1,"confidence_rate":1},{"cnt":[[288,2260],[1878,2260],[1878,2314],[288,2314]],"region":{"top_left_x":287,"top_left_y":2260,"width":1591,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a32dfa2332ef46478f6e00a9c2f9283f","type":"text","conversion_output":true,"text":"drug treatment for the specified subject and a fax confirming this information. The system will","text_display":" drug treatment for the specified subject and a fax confirming this information. 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The investigator","text_display":" allow access to the IRT/code break cards at any time in case of emergency. The investigator","confidence":1,"confidence_rate":1},{"cnt":[[288,443],[511,443],[511,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":225,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cce061173ed48e29d9750952d5eab53","type":"text","conversion_output":true,"text":"will provide:","text_display":" will provide:","confidence":1,"confidence_rate":1},{"cnt":[[352,511],[707,511],[707,559],[352,559]],"region":{"top_left_x":352,"top_left_y":511,"width":355,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"185b2c39be994ca8ae209bf72e695ee1","type":"text","conversion_output":true,"text":"- Protocol number","text_display":"\n- Protocol number","confidence":1,"confidence_rate":1},{"cnt":[[352,584],[690,584],[690,634],[352,634]],"region":{"top_left_x":352,"top_left_y":584,"width":338,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59beb4ffc0014aed915f52803ab19522","type":"text","conversion_output":true,"text":"- Subject number","text_display":"\n- Subject number","confidence":1,"confidence_rate":1},{"cnt":[[288,653],[1878,653],[1878,703],[288,703]],"region":{"top_left_x":287,"top_left_y":653,"width":1591,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35d6efb5359547f5a7fa9fcd150059f6","type":"text","conversion_output":true,"text":"In addition, oral and written information to the subject must be provided on how to contact","text_display":"\n\nIn addition, oral and written information to the subject must be provided on how to contact","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1880,700],[1880,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1593,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6cb5105c8a742548db5c70773cfcb4a","type":"text","conversion_output":true,"text":"his/her backup in cases of emergency, or when he/she is unavailable, to ensure that un-blinding","text_display":" his/her backup in cases of emergency, or when he/she is unavailable, to ensure that un-blinding","confidence":1,"confidence_rate":1},{"cnt":[[288,750],[797,750],[797,801],[288,801]],"region":{"top_left_x":287,"top_left_y":749,"width":511,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"225323ab28724adebf631d6abe4b1c9f","type":"text","conversion_output":true,"text":"can be performed at any time.","text_display":" can be performed at any time.","confidence":1,"confidence_rate":1},{"cnt":[[288,819],[1878,819],[1878,870],[288,870]],"region":{"top_left_x":287,"top_left_y":818,"width":1591,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10f7d7dba06445edbce4676246fd7c2f","type":"text","conversion_output":true,"text":"Study treatment must be discontinued once emergency unblinding has occurred. The subject","text_display":"\nStudy treatment must be discontinued once emergency unblinding has occurred. The subject","confidence":1,"confidence_rate":1},{"cnt":[[288,868],[1878,868],[1878,917],[288,917]],"region":{"top_left_x":287,"top_left_y":867,"width":1591,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4899ee0f5d46e385b97c2ff904b529","type":"text","conversion_output":true,"text":"will have an EOT visit completed and will continue to be followed for recurrence as specified","text_display":" will have an EOT visit completed and will continue to be followed for recurrence as specified","confidence":1,"confidence_rate":1},{"cnt":[[288,915],[1611,915],[1611,965],[288,965]],"region":{"top_left_x":287,"top_left_y":915,"width":1325,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a8c0afce47543b5810e6539bfbfda6c","type":"text","conversion_output":true,"text":"in the protocol. Subject will remain in follow-up unless withdrawn from study.","text_display":" in the protocol. Subject will remain in follow-up unless withdrawn from study.","confidence":1,"confidence_rate":1},{"cnt":[[288,999],[746,999],[746,1061],[288,1061]],"region":{"top_left_x":287,"top_left_y":999,"width":459,"height":63},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"266a2da29f1946eb984261f3f240fb5b","type":"section_header","conversion_output":false,"children_ids":["5386f34e466144aebf8a0231dee663ad"],"text":"","text_display":""},{"cnt":[[288,1001],[741,1001],[741,1059],[288,1059]],"region":{"top_left_x":287,"top_left_y":1001,"width":455,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5386f34e466144aebf8a0231dee663ad","type":"text","conversion_output":true,"parent_id":"266a2da29f1946eb984261f3f240fb5b","text":"8.4 Pregnancies","text_display":"\n\n\\subsection*{8.4 Pregnancies}","confidence":1,"confidence_rate":1},{"cnt":[[288,1076],[1878,1076],[1878,1128],[288,1128]],"region":{"top_left_x":287,"top_left_y":1076,"width":1591,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31637f0031794b889883819b5ec9f513","type":"text","conversion_output":true,"text":"If a female subject becomes pregnant, the study treatment should be stopped, and the pregnancy","text_display":"\n\nIf a female subject becomes pregnant, the study treatment should be stopped, and the pregnancy","confidence":1,"confidence_rate":1},{"cnt":[[288,1126],[1878,1126],[1878,1175],[288,1175]],"region":{"top_left_x":287,"top_left_y":1125,"width":1591,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9350a13186624ec19a7bcccddf430fb8","type":"text","conversion_output":true,"text":"consent form should be presented to the trial subject. 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This consent form is necessary to allow","confidence":0.9975602623308077,"confidence_rate":0.9999748176502898},{"cnt":[[288,1220],[1880,1220],[1880,1270],[288,1270]],"region":{"top_left_x":287,"top_left_y":1220,"width":1593,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c8acabf971f46a7bb5cc3c40cdf7d8e","type":"text","conversion_output":true,"text":"the investigator to collect and report information regarding the pregnancy. To ensure subject","text_display":" the investigator to collect and report information regarding the pregnancy. 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The","text_display":" (approximately 54 weeks) of treatment or final DFS analysis (whichever occurs earlier). The","confidence":1,"confidence_rate":1},{"cnt":[[288,537],[1878,537],[1878,587],[288,587]],"region":{"top_left_x":287,"top_left_y":537,"width":1591,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b3d0707c7214a15a16020561feaf93c","type":"text","conversion_output":true,"text":"DMC will also be responsible to review efficacy and safety data in the conduct of the interim","text_display":" DMC will also be responsible to review efficacy and safety data in the conduct of the interim","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,584],[1878,584],[1878,638],[288,638]],"region":{"top_left_x":287,"top_left_y":584,"width":1591,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6402aaec3a8d40b9b7ebc984f69eb310","type":"text","conversion_output":true,"text":"DFS analyses as defined in the protocol. 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Additional checks of the consistency of the source data with the eCRFs","confidence":1,"confidence_rate":1},{"cnt":[[288,1276],[1343,1276],[1343,1326],[288,1326]],"region":{"top_left_x":287,"top_left_y":1276,"width":1056,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"657910c15b67466894619c909129b73a","type":"text","conversion_output":true,"text":"are performed according to the study-specific monitoring plan.","text_display":" are performed according to the study-specific monitoring plan.","confidence":1,"confidence_rate":1},{"cnt":[[284,1362],[799,1362],[799,1416],[284,1416]],"region":{"top_left_x":283,"top_left_y":1362,"width":517,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31fdfaca1bb94ffcbd6caf3f1871380c","type":"section_header","conversion_output":false,"children_ids":["a767305ab37749afb62085feb41594f9"],"text":"","text_display":""},{"cnt":[[288,1366],[793,1366],[793,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1366,"width":506,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a767305ab37749afb62085feb41594f9","type":"text","conversion_output":true,"parent_id":"31fdfaca1bb94ffcbd6caf3f1871380c","text":"9.3 Data collection","text_display":"\n\n\\subsection*{9.3 Data collection}","confidence":1,"confidence_rate":1},{"cnt":[[288,1435],[1878,1435],[1878,1487],[288,1487]],"region":{"top_left_x":287,"top_left_y":1435,"width":1591,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb59842966e9475796804e0441d9ad51","type":"text","conversion_output":true,"text":"For studies using Electronic Data Capture (EDC), the designated investigator staff will enter","text_display":"\n\nFor studies using Electronic Data Capture (EDC), the designated investigator staff will enter","confidence":1,"confidence_rate":1},{"cnt":[[288,1485],[1878,1485],[1878,1536],[288,1536]],"region":{"top_left_x":287,"top_left_y":1484,"width":1591,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb22c03dc17845faa951ea354919b400","type":"text","conversion_output":true,"text":"the data required by the protocol into the eCRF. 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The","text_display":" be collected by sites and sent to the Novartis designated central laboratory for processing. The","confidence":1,"confidence_rate":1},{"cnt":[[288,1955],[1878,1955],[1878,2007],[288,2007]],"region":{"top_left_x":287,"top_left_y":1955,"width":1591,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f3659f591fc4ffda8a277ad71853a0f","type":"text","conversion_output":true,"text":"laboratory results and IRT data will be sent electronically to Novartis. PRO data will be","text_display":" laboratory results and IRT data will be sent electronically to Novartis. 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The device","confidence":1,"confidence_rate":1},{"cnt":[[288,2054],[1515,2054],[1515,2103],[288,2103]],"region":{"top_left_x":287,"top_left_y":2053,"width":1228,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36910e75b93b4eb6a1521443f5edeb41","type":"text","conversion_output":true,"text":"will be programmed to ensure that all relevant observations are recorded.","text_display":" will be programmed to ensure that all relevant observations are recorded.","confidence":1,"confidence_rate":1},{"cnt":[[284,2136],[1388,2136],[1388,2202],[284,2202]],"region":{"top_left_x":283,"top_left_y":2135,"width":1105,"height":68},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f41d5e1d04df409f98a332dd0a247fe6","type":"section_header","conversion_output":false,"children_ids":["01d4745f47c94cc4b044cfc03e82ce25"],"text":"","text_display":""},{"cnt":[[288,2140],[1381,2140],[1381,2198],[288,2198]],"region":{"top_left_x":287,"top_left_y":2139,"width":1095,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01d4745f47c94cc4b044cfc03e82ce25","type":"text","conversion_output":true,"parent_id":"f41d5e1d04df409f98a332dd0a247fe6","text":"9.4 Database management and quality control","text_display":"\n\n\\subsection*{9.4 Database management and quality control}","confidence":1,"confidence_rate":1},{"cnt":[[288,2213],[1878,2213],[1878,2264],[288,2264]],"region":{"top_left_x":287,"top_left_y":2212,"width":1591,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c787dcae95dc49449a92b7050e755a09","type":"text","conversion_output":true,"text":"For studies using eCRFs, Novartis personnel (or designated CRO) will review the data entered","text_display":"\n\nFor studies using eCRFs, Novartis personnel (or designated CRO) will review the data entered","confidence":1,"confidence_rate":1},{"cnt":[[288,2264],[1878,2264],[1878,2314],[288,2314]],"region":{"top_left_x":287,"top_left_y":2264,"width":1591,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b948a3342ee469b88f8361f18be5d11","type":"text","conversion_output":true,"text":"by investigational staff for completeness and accuracy. 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The definition of","confidence":1,"confidence_rate":1},{"cnt":[[288,653],[1416,653],[1416,707],[288,707]],"region":{"top_left_x":287,"top_left_y":653,"width":1129,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"745bb9d3708d4545980373caa46ceb9c","type":"text","conversion_output":true,"text":"an evaluable PK blood sample will be further specified in the SAP.","text_display":" an evaluable PK blood sample will be further specified in the SAP.","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[288,739],[862,739],[862,801],[288,801]],"region":{"top_left_x":287,"top_left_y":739,"width":575,"height":63},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00bdd3681af844be8128d05e30508fe7","type":"section_header","conversion_output":false,"children_ids":["67ae0fa625a945368a8ea02371653f5f"],"text":"","text_display":""},{"cnt":[[292,743],[855,743],[855,795],[292,795]],"region":{"top_left_x":292,"top_left_y":743,"width":564,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67ae0fa625a945368a8ea02371653f5f","type":"text","conversion_output":true,"parent_id":"00bdd3681af844be8128d05e30508fe7","text":"10.1.5 Other analysis sets","text_display":"\n\n\\subsection*{10.1.5 Other analysis sets}","confidence":1,"confidence_rate":1},{"cnt":[[288,812],[1283,812],[1283,864],[288,864]],"region":{"top_left_x":287,"top_left_y":812,"width":996,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1055346891e043f7934fb329f35f02d5","type":"text","conversion_output":true,"text":"Other analysis sets, if needed, will be specified in the SAP.","text_display":"\n\nOther analysis sets, if needed, will be specified in the SAP.","confidence":1,"confidence_rate":1},{"cnt":[[284,896],[1611,896],[1611,965],[284,965]],"region":{"top_left_x":283,"top_left_y":895,"width":1329,"height":70},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e033a82b647404abda8500bc5143690","type":"section_header","conversion_output":false,"children_ids":["1da46fa810bf428aac317ef5408f7515"],"text":"","text_display":""},{"cnt":[[288,902],[1607,902],[1607,956],[288,956]],"region":{"top_left_x":287,"top_left_y":902,"width":1321,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1da46fa810bf428aac317ef5408f7515","type":"text","conversion_output":true,"parent_id":"4e033a82b647404abda8500bc5143690","text":"10.2 Subject demographics/other baseline characteristics","text_display":"\n\n\\subsection*{10.2 Subject demographics/other baseline characteristics}","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[288,975],[1878,975],[1878,1025],[288,1025]],"region":{"top_left_x":287,"top_left_y":975,"width":1591,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce82ec215c2946a4bcae663399d836b1","type":"text","conversion_output":true,"text":"Demographic and other baseline data including disease characteristics will be listed and","text_display":"\n\nDemographic and other baseline data including disease characteristics will be listed and","confidence":1,"confidence_rate":1},{"cnt":[[288,1023],[1876,1023],[1876,1074],[288,1074]],"region":{"top_left_x":287,"top_left_y":1022,"width":1589,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e78518e29bae472e8c6ef8c35110856a","type":"text","conversion_output":true,"text":"summarized descriptively by treatment arm for the FAS. In light of COVID-19 pandemic","text_display":" summarized descriptively by treatment arm for the FAS. In light of COVID-19 pandemic","confidence":1,"confidence_rate":1},{"cnt":[[288,1070],[1876,1070],[1876,1124],[288,1124]],"region":{"top_left_x":287,"top_left_y":1069,"width":1589,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bafeb4fc5ab14245adcf0c7932c70116","type":"text","conversion_output":true,"text":"impacting the study during the enrollment phase, it will be summarized by pandemic phases:","text_display":" impacting the study during the enrollment phase, it will be summarized by pandemic phases:","confidence":1,"confidence_rate":1},{"cnt":[[288,1121],[1016,1121],[1016,1171],[288,1171]],"region":{"top_left_x":287,"top_left_y":1121,"width":730,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2aa12ce90c3d4f8aa643d21c4f0ea22a","type":"text","conversion_output":true,"text":"pre-pandemic period and pandemic period.","text_display":" pre-pandemic period and pandemic period.","confidence":1,"confidence_rate":1},{"cnt":[[288,1188],[1876,1188],[1876,1240],[288,1240]],"region":{"top_left_x":287,"top_left_y":1188,"width":1589,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58d611a5e28e4291850bf9eaffe3d718","type":"text","conversion_output":true,"text":"Participant race and ethnicity are collected to identify variations in safety or efficacy due to","text_display":"\nParticipant race and ethnicity are collected to identify variations in safety or efficacy due to","confidence":1,"confidence_rate":1},{"cnt":[[288,1233],[1878,1233],[1878,1287],[288,1287]],"region":{"top_left_x":287,"top_left_y":1233,"width":1591,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8da823fa1ff84618bc920c9d5f9420f8","type":"text","conversion_output":true,"text":"these factors as well as to assess the diversity of the study population as required by Health","text_display":" these factors as well as to assess the diversity of the study population as required by Health","confidence":1,"confidence_rate":1},{"cnt":[[288,1285],[496,1285],[496,1330],[288,1330]],"region":{"top_left_x":287,"top_left_y":1284,"width":210,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b638cfc6befa402b9ee2cea68517f1ae","type":"text","conversion_output":true,"text":"Authorities.","text_display":" Authorities.","confidence":1,"confidence_rate":1},{"cnt":[[288,1351],[1876,1351],[1876,1403],[288,1403]],"region":{"top_left_x":287,"top_left_y":1351,"width":1589,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ae727199d6b4ef8a1e397c7f5e9054c","type":"text","conversion_output":true,"text":"Categorical data will be presented as frequencies and percentages. For continuous data,","text_display":"\n\nCategorical data will be presented as frequencies and percentages. For continuous data,","confidence":1,"confidence_rate":1},{"cnt":[[288,1401],[1876,1401],[1876,1450],[288,1450]],"region":{"top_left_x":287,"top_left_y":1400,"width":1589,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d66658633b7f40f0b6f44283035837fa","type":"text","conversion_output":true,"text":"summary statistics (mean, standard deviation, median, minimum, and maximum) will be","text_display":" summary statistics (mean, standard deviation, median, minimum, and maximum) will be","confidence":1,"confidence_rate":1},{"cnt":[[288,1448],[466,1448],[466,1502],[288,1502]],"region":{"top_left_x":287,"top_left_y":1448,"width":180,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a29ba1fcf3b74bc9951b7def42b7800c","type":"text","conversion_output":true,"text":"presented.","text_display":" presented.","confidence":1,"confidence_rate":1},{"cnt":[[288,1517],[1878,1517],[1878,1566],[288,1566]],"region":{"top_left_x":287,"top_left_y":1516,"width":1591,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8350fd3ea2ea4738a24264c217d63179","type":"text","conversion_output":true,"text":"Relevant medical histories and current medical condition at baseline will be summarized by","text_display":"\nRelevant medical histories and current medical condition at baseline will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[288,1564],[1214,1564],[1214,1618],[288,1618]],"region":{"top_left_x":287,"top_left_y":1564,"width":927,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4741228af1c84289a725cfaf576e11b9","type":"text","conversion_output":true,"text":"system organ class, preferred term, and treatment arm.","text_display":" system organ class, preferred term, and treatment arm.","confidence":0.99853515625,"confidence_rate":0.9999751542462456},{"cnt":[[284,1646],[1607,1646],[1607,1768],[284,1768]],"region":{"top_left_x":283,"top_left_y":1645,"width":1325,"height":124},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12645413c0114fc0b2c0f21711467e92","type":"section_header","conversion_output":false,"children_ids":["0637f67b49b943efbef3ac204674b844","e071be00b366450c9badcc292ab0f0ff"],"text":"","text_display":""},{"cnt":[[288,1654],[1601,1654],[1601,1710],[288,1710]],"region":{"top_left_x":287,"top_left_y":1654,"width":1314,"height":57},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0637f67b49b943efbef3ac204674b844","type":"text","conversion_output":true,"parent_id":"12645413c0114fc0b2c0f21711467e92","text":"10.3 Treatments (study treatment, concomitant therapies,","text_display":"\n\n\\subsection*{10.3 Treatments (study treatment, concomitant therapies,","confidence":0.9853515625,"confidence_rate":0.9997581147467293},{"cnt":[[464,1706],[737,1706],[737,1764],[464,1764]],"region":{"top_left_x":464,"top_left_y":1705,"width":273,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e071be00b366450c9badcc292ab0f0ff","type":"text","conversion_output":true,"parent_id":"12645413c0114fc0b2c0f21711467e92","text":"compliance)","text_display":" compliance)}","confidence":1,"confidence_rate":1},{"cnt":[[288,1779],[1876,1779],[1876,1830],[288,1830]],"region":{"top_left_x":287,"top_left_y":1778,"width":1589,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3e2ed97414942ca95b288914ef888ed","type":"text","conversion_output":true,"text":"The safety set will be used for the analyses below. Categorical data will be summarized as","text_display":"\n\nThe safety set will be used for the analyses below. Categorical data will be summarized as","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,1826],[1878,1826],[1878,1878],[288,1878]],"region":{"top_left_x":287,"top_left_y":1826,"width":1591,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13228d55ded6496fa4e692b1a2c2a34f","type":"text","conversion_output":true,"text":"frequencies and percentages. For continuous data, summary statistics (mean, standard","text_display":" frequencies and percentages. For continuous data, summary statistics (mean, standard","confidence":1,"confidence_rate":1},{"cnt":[[288,1873],[1800,1873],[1800,1927],[288,1927]],"region":{"top_left_x":287,"top_left_y":1873,"width":1514,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6675be85f4214c4893a20c981fe559f0","type":"text","conversion_output":true,"text":"deviation, median, 25th and 75th percentiles, minimum, and maximum) will be presented.","text_display":" deviation, median, 25th and 75th percentiles, minimum, and maximum) will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[288,1942],[1878,1942],[1878,1996],[288,1996]],"region":{"top_left_x":287,"top_left_y":1942,"width":1591,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af9c7e15172a459794984affe9a0c67b","type":"text","conversion_output":true,"text":"The duration of exposure to canakinumab and placebo, as well as the dose intensity (computed","text_display":"\nThe duration of exposure to canakinumab and placebo, as well as the dose intensity (computed","confidence":1,"confidence_rate":1},{"cnt":[[288,1989],[1878,1989],[1878,2043],[288,2043]],"region":{"top_left_x":287,"top_left_y":1989,"width":1591,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a279832adbd4e4d8c06e36dfeb8c90b","type":"text","conversion_output":true,"text":"as the ratio of actual cumulative dose received and actual duration of exposure) and the relative","text_display":" as the ratio of actual cumulative dose received and actual duration of exposure) and the relative","confidence":1,"confidence_rate":1},{"cnt":[[288,2039],[1878,2039],[1878,2090],[288,2090]],"region":{"top_left_x":287,"top_left_y":2038,"width":1591,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"835525866e8940aeaf23f3cefb7091c7","type":"text","conversion_output":true,"text":"dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be","text_display":" dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be","confidence":1,"confidence_rate":1},{"cnt":[[288,2088],[1697,2088],[1697,2138],[288,2138]],"region":{"top_left_x":287,"top_left_y":2088,"width":1411,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f66cdf3e169b4bdf88b8d2994c0f5c6e","type":"text","conversion_output":true,"text":"summarized by treatment arm by means of descriptive statistics using the safety set.","text_display":" summarized by treatment arm by means of descriptive statistics using the safety set.","confidence":1,"confidence_rate":1},{"cnt":[[288,2157],[1876,2157],[1876,2206],[288,2206]],"region":{"top_left_x":287,"top_left_y":2157,"width":1589,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b2edda3529c435b9db750aac1949fb2","type":"text","conversion_output":true,"text":"The number of subjects with dose adjustments (interruption, or permanent discontinuation) and","text_display":"\n\nThe number of subjects with dose adjustments (interruption, or permanent discontinuation) and","confidence":0.99658203125,"confidence_rate":0.9999650636373343},{"cnt":[[288,2204],[1631,2204],[1631,2254],[288,2254]],"region":{"top_left_x":287,"top_left_y":2204,"width":1344,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dab46a0e2e054a79a50c579ecf1abc33","type":"text","conversion_output":true,"text":"the reasons will be summarized by treatment arm. All dosing data will be listed.","text_display":" the reasons will be summarized by treatment arm. All dosing data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[288,2271],[1876,2271],[1876,2322],[288,2322]],"region":{"top_left_x":287,"top_left_y":2270,"width":1589,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14af333301424d97b7d91c33979aecfd","type":"text","conversion_output":true,"text":"Concomitant medications and significant non-drug therapies prior to and after the start of the","text_display":"\nConcomitant medications and significant non-drug therapies prior to and after the start of the","confidence":1,"confidence_rate":1},{"cnt":[[288,2320],[1876,2320],[1876,2374],[288,2374]],"region":{"top_left_x":287,"top_left_y":2320,"width":1589,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2464d6ed590545429500ffff9587a2b0","type":"text","conversion_output":true,"text":"study treatment will be listed and summarized according to the Anatomical Therapeutic","text_display":" study treatment will be listed and summarized according to the Anatomical Therapeutic","confidence":1,"confidence_rate":1},{"cnt":[[288,2368],[1250,2368],[1250,2419],[288,2419]],"region":{"top_left_x":287,"top_left_y":2367,"width":964,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fcc16a9154547ac93d17de769982f69","type":"text","conversion_output":true,"text":"Chemical (ATC) classification system, by treatment arm.","text_display":" Chemical (ATC) classification system, by treatment 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CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,339],[853,339],[853,406],[288,406]],"region":{"top_left_x":287,"top_left_y":339,"width":566,"height":68},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8117dc01214743c1930c444119739eb7","type":"section_header","conversion_output":false,"children_ids":["fc11d3bbf66f4464a5686b028f5eb3f9"],"text":"","text_display":""},{"cnt":[[292,346],[849,346],[849,402],[292,402]],"region":{"top_left_x":292,"top_left_y":345,"width":557,"height":57},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc11d3bbf66f4464a5686b028f5eb3f9","type":"text","conversion_output":true,"parent_id":"8117dc01214743c1930c444119739eb7","text":"10.4 Primary objective","text_display":"\n\n\\subsection*{10.4 Primary 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documented NSCLC disease recurrence as assessed by","confidence":1,"confidence_rate":1},{"cnt":[[288,718],[1878,718],[1878,771],[288,771]],"region":{"top_left_x":287,"top_left_y":717,"width":1591,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dc589453bf145c1a3816cb0caaebb31","type":"text","conversion_output":true,"text":"local investigator radiologically or death due to any cause. Disease recurrence includes","text_display":" local investigator radiologically or death due to any cause. Disease recurrence includes","confidence":1,"confidence_rate":1},{"cnt":[[288,767],[1880,767],[1880,819],[288,819]],"region":{"top_left_x":287,"top_left_y":766,"width":1593,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af907a5746314f94a33c3357ca1ee40c","type":"text","conversion_output":true,"text":"diagnoses of new primary lung malignancies. Clinical deterioration is not considered as a","text_display":" diagnoses of new primary lung malignancies. Clinical deterioration is not considered as a","confidence":1,"confidence_rate":1},{"cnt":[[288,816],[1880,816],[1880,866],[288,866]],"region":{"top_left_x":287,"top_left_y":816,"width":1593,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f56e65c631a74156a639deb2311a19f3","type":"text","conversion_output":true,"text":"recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment will","text_display":" recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment will","confidence":1,"confidence_rate":1},{"cnt":[[288,864],[1878,864],[1878,913],[288,913]],"region":{"top_left_x":287,"top_left_y":863,"width":1591,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b6e37f5b54f4853a9f987cb4f217a99","type":"text","conversion_output":true,"text":"be performed to confirm NSCLC recurrence; radiological assessment date will be used as DFS","text_display":" be performed to confirm NSCLC recurrence; radiological assessment date will be used as DFS","confidence":1,"confidence_rate":1},{"cnt":[[288,911],[1880,911],[1880,965],[288,965]],"region":{"top_left_x":287,"top_left_y":910,"width":1593,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3af6a72c9b1743c4bbf4f9ef994b8348","type":"text","conversion_output":true,"text":"event date. DFS events will be assessed locally. Censoring conventions are provided below in","text_display":" event date. DFS events will be assessed locally. Censoring conventions are provided below in","confidence":1,"confidence_rate":1},{"cnt":[[288,958],[548,958],[548,1003],[288,1003]],"region":{"top_left_x":287,"top_left_y":958,"width":261,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"235108863311411989ce220c3832b6f1","type":"text","conversion_output":true,"text":"Section 10.4.3.","text_display":" Section 10.4.3.","confidence":0.99755859375,"confidence_rate":0.9998777879014182},{"cnt":[[284,1042],[1540,1042],[1540,1106],[284,1106]],"region":{"top_left_x":283,"top_left_y":1041,"width":1258,"height":66},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c79e0d33a99746a3aae3cd85df853ed2","type":"section_header","conversion_output":false,"children_ids":["22699472737b40cfaf61be8c9e0e10b0"],"text":"","text_display":""},{"cnt":[[288,1048],[1534,1048],[1534,1102],[288,1102]],"region":{"top_left_x":287,"top_left_y":1048,"width":1247,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22699472737b40cfaf61be8c9e0e10b0","type":"text","conversion_output":true,"parent_id":"c79e0d33a99746a3aae3cd85df853ed2","text":"10.4.2 Statistical hypothesis, model, and method of analysis","text_display":"\n\n\\subsection*{10.4.2 Statistical hypothesis, model, and method of analysis}","confidence":1,"confidence_rate":1},{"cnt":[[288,1117],[1878,1117],[1878,1171],[288,1171]],"region":{"top_left_x":287,"top_left_y":1117,"width":1591,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b2703afd61e423394166e8c355c24e7","type":"text","conversion_output":true,"text":"Assuming proportional hazards model for DFS, the following statistical hypotheses will be","text_display":"\n\nAssuming proportional hazards model for DFS, the following statistical hypotheses will be","confidence":1,"confidence_rate":1},{"cnt":[[288,1164],[1098,1164],[1098,1218],[288,1218]],"region":{"top_left_x":287,"top_left_y":1164,"width":811,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ef3bf264ef4438e9a098db1851274b7","type":"text","conversion_output":true,"text":"tested to address the primary efficacy objective:","text_display":" tested to address the primary efficacy objective:","confidence":1,"confidence_rate":1},{"cnt":[[361,1233],[1515,1233],[1515,1285],[361,1285]],"region":{"top_left_x":360,"top_left_y":1233,"width":1155,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18c0306c9147468d9792bee4653c6342","type":"text","conversion_output":true,"text":"\\(H _{01}\\) (null hypotheses): \\(\\Theta_{1} \\geq 0\\) vs. \\(H _{ a 1}\\) (alternative hypotheses): \\(\\Theta_{1}<0\\)","text_display":"\n\\(H _{01}\\) (null hypotheses): \\(\\Theta_{1} \\geq 0\\) vs. \\(H _{ a 1}\\) (alternative hypotheses): \\(\\Theta_{1}<0\\)","confidence":1,"confidence_rate":1},{"cnt":[[288,1302],[1878,1302],[1878,1356],[288,1356]],"region":{"top_left_x":287,"top_left_y":1301,"width":1591,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09eef84535864d0e90fc9ab9549cc527","type":"text","conversion_output":true,"text":"Where \\(\\Theta_{1}\\) is the log hazard ratio of DFS in the canakinumab (investigational) arm vs. placebo","text_display":"\nWhere \\(\\Theta_{1}\\) is the log hazard ratio of DFS in the canakinumab (investigational) arm vs. placebo","confidence":0.70849609375,"confidence_rate":0.9967845197068582},{"cnt":[[288,1351],[531,1351],[531,1403],[288,1403]],"region":{"top_left_x":287,"top_left_y":1351,"width":244,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edaf95ee2ac14a2890fb7c0dd6e56302","type":"text","conversion_output":true,"text":"(control) arm.","text_display":" (control) arm.","confidence":1,"confidence_rate":1},{"cnt":[[288,1418],[1880,1418],[1880,1472],[288,1472]],"region":{"top_left_x":287,"top_left_y":1417,"width":1593,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e43f1e9ad0064389895c61becc2ec26e","type":"text","conversion_output":true,"text":"The primary efficacy analysis to test this hypothesis and compare the two treatment groups will","text_display":"\nThe primary efficacy analysis to test this hypothesis and compare the two treatment groups will","confidence":1,"confidence_rate":1},{"cnt":[[288,1470],[1878,1470],[1878,1519],[288,1519]],"region":{"top_left_x":287,"top_left_y":1469,"width":1591,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c96651ff2e94292826f128998b78e0f","type":"text","conversion_output":true,"text":"consist of a stratified log-rank test at an overall one-sided \\(2.5 \\%\\) level of significance. The","text_display":" consist of a stratified log-rank test at an overall one-sided \\(2.5 \\%\\) level of significance. The","confidence":0.9951171875,"confidence_rate":0.9999515380814779},{"cnt":[[288,1517],[1878,1517],[1878,1566],[288,1566]],"region":{"top_left_x":287,"top_left_y":1516,"width":1591,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddfe03d263c64f999abc1dfcfb2bcee3","type":"text","conversion_output":true,"text":"stratification will be based on the following randomization stratification factors: AJCC/UICC","text_display":" stratification will be based on the following randomization stratification factors: AJCC/UICC","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[288,1564],[1880,1564],[1880,1618],[288,1618]],"region":{"top_left_x":287,"top_left_y":1564,"width":1593,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7341ad321a3a4d0f97b4d38e6df09b9d","type":"text","conversion_output":true,"text":"v. 8 stage IIA versus IIB versus IIIA versus IIIB with T>5cm N2 disease; Histology: squamous","text_display":" v. 8 stage IIA versus IIB versus IIIA versus IIIB with T>5cm N2 disease; Histology: squamous","confidence":0.771249903831631,"confidence_rate":0.9974059421135516},{"cnt":[[288,1611],[1876,1611],[1876,1661],[288,1661]],"region":{"top_left_x":287,"top_left_y":1611,"width":1589,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7d7c22bbf58441eb9a519fd4c64e908","type":"text","conversion_output":true,"text":"versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs.","text_display":" versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs.","confidence":1,"confidence_rate":1},{"cnt":[[288,1659],[1880,1659],[1880,1710],[288,1710]],"region":{"top_left_x":287,"top_left_y":1658,"width":1593,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6ba4759ea7f471a8adc37ea4f22b262","type":"text","conversion_output":true,"text":"Rest of the world (RoW). The primary efficacy variable, DFS, will be analyzed at one interim","text_display":" Rest of the world (RoW). The primary efficacy variable, DFS, will be analyzed at one interim","confidence":0.97705078125,"confidence_rate":0.9997606817177294},{"cnt":[[288,1706],[1878,1706],[1878,1760],[288,1760]],"region":{"top_left_x":287,"top_left_y":1705,"width":1591,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baf61c4d63db4e248af91c6e6a589d2c","type":"text","conversion_output":true,"text":"analysis enabling the study to stop due to futility and final analysis of a group sequential design,","text_display":" analysis enabling the study to stop due to futility and final analysis of a group sequential design,","confidence":1,"confidence_rate":1},{"cnt":[[288,1755],[1878,1755],[1878,1807],[288,1807]],"region":{"top_left_x":287,"top_left_y":1755,"width":1591,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee920caa9d394f9ea80ad704874332d3","type":"text","conversion_output":true,"text":"using a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\)-spending function and a non-binding user-defined \\(\\beta\\) -","text_display":" using a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\)-spending function and a non-binding user-defined \\(\\beta\\) ","confidence":0.9985356330871582,"confidence_rate":0.9999857725269791},{"cnt":[[288,1800],[1878,1800],[1878,1854],[288,1854]],"region":{"top_left_x":287,"top_left_y":1800,"width":1591,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b191f145f10c47ab806e97ecd2d091f0","type":"text","conversion_output":true,"text":"spending function (gamma function with \\(\\gamma=-3\\) ). Analyses will be based on the FAS population","text_display":"spending function (gamma function with \\(\\gamma=-3\\) ). Analyses will be based on the FAS population","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[288,1852],[1880,1852],[1880,1901],[288,1901]],"region":{"top_left_x":287,"top_left_y":1851,"width":1593,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8093bd30df134e74a058e2370d0f9b79","type":"text","conversion_output":true,"text":"according to the treatment group and strata assigned at randomization. The DFS distribution","text_display":" according to the treatment group and strata assigned at randomization. The DFS distribution","confidence":1,"confidence_rate":1},{"cnt":[[288,1899],[1880,1899],[1880,1949],[288,1949]],"region":{"top_left_x":287,"top_left_y":1899,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c4d7a853ee842efafbc9603f70bd88c","type":"text","conversion_output":true,"text":"will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented","text_display":" will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[288,1946],[1878,1946],[1878,1998],[288,1998]],"region":{"top_left_x":287,"top_left_y":1946,"width":1591,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c46ef86739314e67bd288ed5702ab88d","type":"text","conversion_output":true,"text":"for each treatment group. The DFS Kaplan- Meier estimate along with \\(95 \\%\\) confidence intervals","text_display":" for each treatment group. The DFS Kaplan- Meier estimate along with \\(95 \\%\\) confidence intervals","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1994],[1880,1994],[1880,2047],[288,2047]],"region":{"top_left_x":287,"top_left_y":1993,"width":1593,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0496e40124849dd86ecf9684dfaea2d","type":"text","conversion_output":true,"text":"will be presented at different time points (e.g. 1 year, 2 years, 3 years, 4 years, 5 years) for each","text_display":" will be presented at different time points (e.g. 1 year, 2 years, 3 years, 4 years, 5 years) for each","confidence":0.9946362947812304,"confidence_rate":0.9999555535371109},{"cnt":[[288,2041],[1880,2041],[1880,2095],[288,2095]],"region":{"top_left_x":287,"top_left_y":2041,"width":1593,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ccd30d7acaa4c9e9588f625ee184542","type":"text","conversion_output":true,"text":"of the two treatment arms. The hazard ratio for DFS will be calculated, along with its \\(95 \\%\\)","text_display":" of the two treatment arms. The hazard ratio for DFS will be calculated, along with its \\(95 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[288,2090],[1880,2090],[1880,2142],[288,2142]],"region":{"top_left_x":287,"top_left_y":2090,"width":1593,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbaeac178ff24ec5b19170955b4eb6c2","type":"text","conversion_output":true,"text":"confidence interval, from a stratified Cox model using the same stratification factors as for the","text_display":" confidence interval, from a stratified Cox model using the same stratification factors as for the","confidence":1,"confidence_rate":1},{"cnt":[[288,2140],[518,2140],[518,2189],[288,2189]],"region":{"top_left_x":287,"top_left_y":2139,"width":231,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7e2bef22982418987e2331cf21c9b1e","type":"text","conversion_output":true,"text":"log-rank test.","text_display":" log-rank test.","confidence":1,"confidence_rate":1},{"cnt":[[284,2221],[1575,2221],[1575,2284],[284,2284]],"region":{"top_left_x":283,"top_left_y":2221,"width":1292,"height":63},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f2d829620964b989ecc963b40ebc369","type":"section_header","conversion_output":false,"children_ids":["d4c44e37b52a4fac8fecaed4f5b864d1"],"text":"","text_display":""},{"cnt":[[290,2226],[1568,2226],[1568,2279],[290,2279]],"region":{"top_left_x":290,"top_left_y":2225,"width":1279,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c44e37b52a4fac8fecaed4f5b864d1","type":"text","conversion_output":true,"parent_id":"5f2d829620964b989ecc963b40ebc369","text":"10.4.3 Handling of missing values/censoring/discontinuations","text_display":"\n\n\\subsection*{10.4.3 Handling of missing values/censoring/discontinuations}","confidence":1,"confidence_rate":1},{"cnt":[[288,2297],[1876,2297],[1876,2348],[288,2348]],"region":{"top_left_x":287,"top_left_y":2296,"width":1589,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c454f4080394caa8b22c2d2da09cbfb","type":"text","conversion_output":true,"text":"DFS will be censored if no DFS event is observed prior to the analysis cut-off date or subjects","text_display":"\n\nDFS will be censored if no DFS event is observed prior to the analysis cut-off date or subjects","confidence":1,"confidence_rate":1},{"cnt":[[288,2346],[1878,2346],[1878,2396],[288,2396]],"region":{"top_left_x":287,"top_left_y":2346,"width":1591,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffd2d80591034810a9fb1f7997e2a7cc","type":"text","conversion_output":true,"text":"who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date will be","text_display":" who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date will be","confidence":0.9794921875,"confidence_rate":0.9997795879364628},{"cnt":[[288,2393],[1880,2393],[1880,2445],[288,2445]],"region":{"top_left_x":287,"top_left_y":2393,"width":1593,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b12570987b034917987fdd56b588cfa4","type":"text","conversion_output":true,"text":"the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy","text_display":" the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy","confidence":1,"confidence_rate":1},{"cnt":[[288,2441],[380,2441],[380,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":2440,"width":94,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b8f7feacbfd436d87ecdde9d383264c","type":"text","conversion_output":true,"text":"date.","text_display":" 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statistically significant, subgroup analyses to assess the homogeneity","confidence":1,"confidence_rate":1},{"cnt":[[288,1186],[1878,1186],[1878,1235],[288,1235]],"region":{"top_left_x":287,"top_left_y":1185,"width":1591,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc089caf4e854144a48d010eb85f13d8","type":"text","conversion_output":true,"text":"of the treatment effect across demographic and baseline disease characteristics will be","text_display":" of the treatment effect across demographic and baseline disease characteristics will be","confidence":1,"confidence_rate":1},{"cnt":[[288,1233],[1878,1233],[1878,1285],[288,1285]],"region":{"top_left_x":287,"top_left_y":1233,"width":1591,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6f300b47a7746649f1c0d49ac1f8dde","type":"text","conversion_output":true,"text":"performed including AJCC/UICC v. 8 stage, histology and region. 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The secondary objectives in this","text_display":"\n\nSecondary objectives of the study are as specified in Table 3-1. The secondary objectives in this","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[288,1609],[1880,1609],[1880,1659],[288,1659]],"region":{"top_left_x":287,"top_left_y":1609,"width":1593,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa3b9dbf666943ed8e1a015cc570ae49","type":"text","conversion_output":true,"text":"study are to compare the two treatment groups with respect to overall survival (OS), lung cancer","text_display":" study are to compare the two treatment groups with respect to overall survival (OS), lung cancer","confidence":1,"confidence_rate":1},{"cnt":[[288,1659],[1878,1659],[1878,1708],[288,1708]],"region":{"top_left_x":287,"top_left_y":1658,"width":1591,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"302640387f9749619a5cb8add5532014","type":"text","conversion_output":true,"text":"specific survival (LCSS), DFS and OS in PD-L1 and CD8 subgroups, time to 10 point definitive","text_display":" specific survival (LCSS), DFS and OS in PD-L1 and CD8 subgroups, time to 10 point definitive","confidence":1,"confidence_rate":1},{"cnt":[[288,1706],[1878,1706],[1878,1755],[288,1755]],"region":{"top_left_x":287,"top_left_y":1705,"width":1591,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0be2d0ae779940248f546472feef68c4","type":"text","conversion_output":true,"text":"deterioration and first 10 point definitive deterioration in patient-reported outcomes, including","text_display":" deterioration and first 10 point definitive deterioration in patient-reported outcomes, including","confidence":1,"confidence_rate":1},{"cnt":[[288,1753],[1876,1753],[1876,1803],[288,1803]],"region":{"top_left_x":287,"top_left_y":1753,"width":1589,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d05898c0342244b9bcf62114fc86c24d","type":"text","conversion_output":true,"text":"key symptom scores, and safety. OS is identified as the key secondary endpoint. A hierarchical","text_display":" key symptom scores, and safety. OS is identified as the key secondary endpoint. A hierarchical","confidence":1,"confidence_rate":1},{"cnt":[[288,1800],[1876,1800],[1876,1850],[288,1850]],"region":{"top_left_x":287,"top_left_y":1800,"width":1589,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c563e3e11674b64b0ca9cf30b5da222","type":"text","conversion_output":true,"text":"testing strategy will be used to control the overall type I error rate, where OS will only be","text_display":" testing strategy will be used to control the overall type I error rate, where OS will only be","confidence":1,"confidence_rate":1},{"cnt":[[288,1848],[1762,1848],[1762,1899],[288,1899]],"region":{"top_left_x":287,"top_left_y":1847,"width":1475,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a145529142104115982922fd2eaa8601","type":"text","conversion_output":true,"text":"formally tested and interpreted if the primary analysis of DFS is statistically significant.","text_display":" formally tested and interpreted if the primary analysis of DFS is statistically significant.","confidence":1,"confidence_rate":1},{"cnt":[[286,1934],[1018,1934],[1018,1996],[286,1996]],"region":{"top_left_x":285,"top_left_y":1933,"width":734,"height":63},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c7f17d180ef400ab43cb0e19f757581","type":"section_header","conversion_output":false,"children_ids":["47a58a9d6a374f04969df87a756900cb"],"text":"","text_display":""},{"cnt":[[292,1938],[1012,1938],[1012,1992],[292,1992]],"region":{"top_left_x":292,"top_left_y":1937,"width":720,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47a58a9d6a374f04969df87a756900cb","type":"text","conversion_output":true,"parent_id":"0c7f17d180ef400ab43cb0e19f757581","text":"10.5.1 Key secondary objective(s)","text_display":"\n\n\\subsection*{10.5.1 Key secondary objective(s)}","confidence":1,"confidence_rate":1},{"cnt":[[288,2007],[1876,2007],[1876,2056],[288,2056]],"region":{"top_left_x":287,"top_left_y":2006,"width":1589,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f06153b4346348d9b389d0adefe57e6f","type":"text","conversion_output":true,"text":"The key secondary objective is to determine whether treatment with canakinumab prolongs OS","text_display":"\n\nThe key secondary objective is to determine whether treatment with canakinumab prolongs OS","confidence":1,"confidence_rate":1},{"cnt":[[288,2054],[1876,2054],[1876,2103],[288,2103]],"region":{"top_left_x":287,"top_left_y":2053,"width":1589,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf29a0e04edc493c9201e3cdd7978f46","type":"text","conversion_output":true,"text":"compared with placebo arm. OS is defined as the time from the date of randomization to the","text_display":" compared with placebo arm. OS is defined as the time from the date of randomization to the","confidence":1,"confidence_rate":1},{"cnt":[[288,2101],[1878,2101],[1878,2155],[288,2155]],"region":{"top_left_x":287,"top_left_y":2101,"width":1591,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"811e179b80314fe2b267dc3801c545b1","type":"text","conversion_output":true,"text":"date of death due to any cause. If a subject is not known to have died, then OS will be censored","text_display":" date of death due to any cause. 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Histology: squamous versus non-squamous; and Region: Western","text_display":" IIIB T>5cm N2 disease; Histology: squamous versus non-squamous; and Region: Western","confidence":0.9246089458465576,"confidence_rate":0.9991096648552769},{"cnt":[[288,443],[1515,443],[1515,492],[288,492]],"region":{"top_left_x":287,"top_left_y":442,"width":1228,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0060b99ed0cf44cd8c06f687ee88bb60","type":"text","conversion_output":true,"text":"Europe and North America vs. eastern Asia vs. Rest of the world (RoW).","text_display":" Europe and North America vs. eastern Asia vs. Rest of the world (RoW).","confidence":1,"confidence_rate":1},{"cnt":[[288,511],[1880,511],[1880,561],[288,561]],"region":{"top_left_x":287,"top_left_y":511,"width":1593,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f31e8053c3749bdac12267b2bd256c6","type":"text","conversion_output":true,"text":"OS analyses will be conducted as part of a group sequential design using a","text_display":"\n\nOS analyses will be conducted as part of a group sequential design using a","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[288,559],[1876,559],[1876,608],[288,608]],"region":{"top_left_x":287,"top_left_y":558,"width":1589,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a878441c12c423690385db42a8eab76","type":"text","conversion_output":true,"text":"Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\) spending function (a separate function to that used for DFS).","text_display":" Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\) spending function (a separate function to that used for DFS).","confidence":0.991714471951127,"confidence_rate":0.9999168030228315},{"cnt":[[288,606],[1878,606],[1878,655],[288,655]],"region":{"top_left_x":287,"top_left_y":605,"width":1591,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9933bdbdd5c4df0a424160adf984f24","type":"text","conversion_output":true,"text":"Analyses will be based on the FAS population according to the randomized treatment group","text_display":" Analyses will be based on the FAS population according to the randomized treatment group","confidence":1,"confidence_rate":1},{"cnt":[[288,653],[1876,653],[1876,703],[288,703]],"region":{"top_left_x":287,"top_left_y":653,"width":1589,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42a85fc3d7354868a7356a5dd3ceb423","type":"text","conversion_output":true,"text":"and strata assigned at randomization. The OS distribution will be estimated using the Kaplan-","text_display":" and strata assigned at randomization. The OS distribution will be estimated using the Kaplan","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1878,700],[1878,750],[288,750]],"region":{"top_left_x":287,"top_left_y":700,"width":1591,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baf80b601fa2490a9f2db60b6ddcbd8d","type":"text","conversion_output":true,"text":"Meier method, and Kaplan-Meier curves, medians and \\(95 \\%\\) confidence intervals of the medians","text_display":"Meier method, and Kaplan-Meier curves, medians and \\(95 \\%\\) confidence intervals of the medians","confidence":1,"confidence_rate":1},{"cnt":[[288,748],[1880,748],[1880,801],[288,801]],"region":{"top_left_x":287,"top_left_y":747,"width":1593,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48da883e63eb47789fdb5f646a2cbf13","type":"text","conversion_output":true,"text":"will be presented for each treatment group. The hazard ratio for OS will be calculated, along","text_display":" will be presented for each treatment group. The hazard ratio for OS will be calculated, along","confidence":1,"confidence_rate":1},{"cnt":[[288,797],[1345,797],[1345,849],[288,849]],"region":{"top_left_x":287,"top_left_y":797,"width":1058,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d02791b0f028465a94a93133362eec53","type":"text","conversion_output":true,"text":"with its \\(95 \\%\\) confidence interval, using a stratified Cox model.","text_display":" with its \\(95 \\%\\) confidence interval, using a stratified Cox model.","confidence":0.9990236759185791,"confidence_rate":0.9999862423341275},{"cnt":[[288,866],[836,866],[836,917],[288,917]],"region":{"top_left_x":287,"top_left_y":865,"width":549,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ecc2e5af9f94f9d8a7296c6d1bc22c2","type":"text","conversion_output":true,"text":"OS will be tested hierarchically:","text_display":"\nOS will be tested hierarchically:","confidence":1,"confidence_rate":1},{"cnt":[[288,924],[1760,924],[1760,975],[288,975]],"region":{"top_left_x":287,"top_left_y":923,"width":1473,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92194a68841f4a05b4d8d63d50c5cc52","type":"text","conversion_output":true,"text":"- If DFS is statistically significant at the final analysis, OS will be tested. If OS is not","text_display":"\n- If DFS is statistically significant at the final analysis, OS will be tested. If OS is not","confidence":1,"confidence_rate":1},{"cnt":[[288,982],[1878,982],[1878,1033],[288,1033]],"region":{"top_left_x":287,"top_left_y":981,"width":1591,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0df99b82e9ee4c9787a5e69c5ec48c1d","type":"text","conversion_output":true,"text":"- statistically significant at this stage, an additional IA for OS and a final OS analysis will be","text_display":"\n- statistically significant at this stage, an additional IA for OS and a final OS analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[350,1031],[1457,1031],[1457,1081],[350,1081]],"region":{"top_left_x":350,"top_left_y":1031,"width":1107,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"100552bf348d43d3b7a7b4254a07c297","type":"text","conversion_output":true,"text":"planned at approximately 418 deaths and 504 deaths respectively.","text_display":" planned at approximately 418 deaths and 504 deaths respectively.","confidence":1,"confidence_rate":1},{"cnt":[[288,1087],[1824,1087],[1824,1137],[288,1137]],"region":{"top_left_x":287,"top_left_y":1087,"width":1538,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc97ff2cc74c4c0bbc28a5b4845be729","type":"text","conversion_output":true,"text":"- If DFS is not statistically significant at the final analysis for DFS, OS will not be tested.","text_display":"\n- If DFS is not statistically significant at the final analysis for DFS, OS will not be tested.","confidence":1,"confidence_rate":1},{"cnt":[[288,1156],[1878,1156],[1878,1205],[288,1205]],"region":{"top_left_x":287,"top_left_y":1155,"width":1591,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3986ca334f32462cb4589bdfdc30dd6c","type":"text","conversion_output":true,"text":"The number of subjects censored and reasons for censoring for OS will be summarized by","text_display":"\n\nThe number of subjects censored and reasons for censoring for OS will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[288,1205],[1021,1205],[1021,1257],[288,1257]],"region":{"top_left_x":287,"top_left_y":1205,"width":734,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"337a86ef19ef4b69afde0e1c509840b1","type":"text","conversion_output":true,"text":"treatment group using descriptive statistics.","text_display":" treatment group using descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[288,1289],[1192,1289],[1192,1349],[288,1349]],"region":{"top_left_x":287,"top_left_y":1289,"width":906,"height":61},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"379eb2acb0bd4a9da7188209c65c24e4","type":"section_header","conversion_output":false,"children_ids":["ca27c5bc7ade422c84ab126843b20ab9"],"text":"","text_display":""},{"cnt":[[292,1293],[1188,1293],[1188,1343],[292,1343]],"region":{"top_left_x":292,"top_left_y":1293,"width":897,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca27c5bc7ade422c84ab126843b20ab9","type":"text","conversion_output":true,"parent_id":"379eb2acb0bd4a9da7188209c65c24e4","text":"10.5.2 Other secondary efficacy objectives","text_display":"\n\n\\subsection*{10.5.2 Other secondary efficacy objectives}","confidence":0.9990236759185791,"confidence_rate":0.9999792172160455},{"cnt":[[288,1362],[1876,1362],[1876,1412],[288,1412]],"region":{"top_left_x":287,"top_left_y":1362,"width":1589,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e33f66b06bf34d04baeacb7e981dbc87","type":"text","conversion_output":true,"text":"In order to evaluate the effect of canakinumab within PD-L1 subgroups, DFS and OS analyses","text_display":"\n\nIn order to evaluate the effect of canakinumab within PD-L1 subgroups, DFS and OS analyses","confidence":1,"confidence_rate":1},{"cnt":[[288,1412],[1878,1412],[1878,1463],[288,1463]],"region":{"top_left_x":287,"top_left_y":1411,"width":1591,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f6e6d8e288d4fd798177f907cf67ea2","type":"text","conversion_output":true,"text":"will be performed by PD-L1 subgroups with \\(1 \\%\\) cut-off on tumor cells (TC) to define positive","text_display":" will be performed by PD-L1 subgroups with \\(1 \\%\\) cut-off on tumor cells (TC) to define positive","confidence":0.98779296875,"confidence_rate":0.9998759455843587},{"cnt":[[288,1457],[1880,1457],[1880,1508],[288,1508]],"region":{"top_left_x":287,"top_left_y":1456,"width":1593,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7cf8bec576c47aca46144ef1e5b81ed","type":"text","conversion_output":true,"text":"or negative status as determined by IHC. Additionally, PD-L1 subgroups will also be assessed","text_display":" or negative status as determined by IHC. Additionally, PD-L1 subgroups will also be assessed","confidence":1,"confidence_rate":1},{"cnt":[[288,1506],[1876,1506],[1876,1558],[288,1558]],"region":{"top_left_x":287,"top_left_y":1506,"width":1589,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0daba20f40af4a72915105d284c6ba95","type":"text","conversion_output":true,"text":"using \\(\\geq 50 \\%\\) cut-off. Therefore, a comparison between \\(<1 \\%, \\geq 1-49 \\%\\), and \\(\\geq 50 \\%\\) PD-L1","text_display":" using \\(\\geq 50 \\%\\) cut-off. Therefore, a comparison between \\(<1 \\%, \\geq 1-49 \\%\\), and \\(\\geq 50 \\%\\) PD-L1","confidence":0.99755859375,"confidence_rate":0.9999737165675469},{"cnt":[[288,1555],[978,1555],[978,1605],[288,1605]],"region":{"top_left_x":287,"top_left_y":1555,"width":691,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"255f1225f25e4befb4cd20740723992d","type":"text","conversion_output":true,"text":"expression level subgroups will be done.","text_display":" expression level subgroups will be done.","confidence":1,"confidence_rate":1},{"cnt":[[288,1624],[1876,1624],[1876,1674],[288,1674]],"region":{"top_left_x":287,"top_left_y":1624,"width":1589,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c0c66f322db40e4a69875b4c85f79e6","type":"text","conversion_output":true,"text":"In order to evaluate the effect of canakinumab within CD8 subgroups, DFS and OS analyses","text_display":"\n\nIn order to evaluate the effect of canakinumab within CD8 subgroups, DFS and OS analyses","confidence":1,"confidence_rate":1},{"cnt":[[288,1671],[1878,1671],[1878,1721],[288,1721]],"region":{"top_left_x":287,"top_left_y":1671,"width":1591,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ad2bdccb0a44539b198a5b41db64cb2","type":"text","conversion_output":true,"text":"will be performed by CD8 subgroups with the median and quartiles (including quartile-","text_display":" will be performed by CD8 subgroups with the median and quartiles (including quartile","confidence":1,"confidence_rate":1},{"cnt":[[288,1719],[1876,1719],[1876,1772],[288,1772]],"region":{"top_left_x":287,"top_left_y":1718,"width":1589,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e4f4854869485f994da169eb1550d4","type":"text","conversion_output":true,"text":"complements, e.g. below lower quartile and above lower quartile) of baseline CD8 as cut-offs.","text_display":"complements, e.g. below lower quartile and above lower quartile) of baseline CD8 as cut-offs.","confidence":1,"confidence_rate":1},{"cnt":[[288,1766],[1878,1766],[1878,1815],[288,1815]],"region":{"top_left_x":287,"top_left_y":1766,"width":1591,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b399dda3a2874ddea864f758ec9a973e","type":"text","conversion_output":true,"text":"In addition, the relation between CD8 expression in resected tumor sample and clinical outcome","text_display":" In addition, the relation between CD8 expression in resected tumor sample and clinical outcome","confidence":1,"confidence_rate":1},{"cnt":[[288,1813],[1876,1813],[1876,1865],[288,1865]],"region":{"top_left_x":287,"top_left_y":1813,"width":1589,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"458a425f6e5f4dcd852defc527f9a635","type":"text","conversion_output":true,"text":"will be evaluated using CD8 as continuous, potentially log-transformed, co-variate as well as","text_display":" will be evaluated using CD8 as continuous, potentially log-transformed, co-variate as well as","confidence":1,"confidence_rate":1},{"cnt":[[288,1861],[1880,1861],[1880,1914],[288,1914]],"region":{"top_left_x":287,"top_left_y":1860,"width":1593,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7c33b9f63544184b4d0ab89093c0a1d","type":"text","conversion_output":true,"text":"categorical covariates in a Cox model. These analyses will support the establishment of CD8 as","text_display":" categorical covariates in a Cox model. These analyses will support the establishment of CD8 as","confidence":1,"confidence_rate":1},{"cnt":[[288,1912],[1833,1912],[1833,1962],[288,1962]],"region":{"top_left_x":287,"top_left_y":1912,"width":1546,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e18982fefd34e45904349a0453a2d0b","type":"text","conversion_output":true,"text":"a prognostic/predictive factor if there is an expressions level correlating to clinical outcome.","text_display":" a prognostic/predictive factor if there is an expressions level correlating to clinical outcome.","confidence":1,"confidence_rate":1},{"cnt":[[288,1979],[1878,1979],[1878,2030],[288,2030]],"region":{"top_left_x":287,"top_left_y":1978,"width":1591,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b377d17e066488ca690d6da49a6e231","type":"text","conversion_output":true,"text":"Lung cancer specific survival (LCSS) is defined as the time from the date of randomization to","text_display":"\nLung cancer specific survival (LCSS) is defined as the time from the date of randomization to","confidence":1,"confidence_rate":1},{"cnt":[[288,2028],[1880,2028],[1880,2078],[288,2078]],"region":{"top_left_x":287,"top_left_y":2028,"width":1593,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86eb69b7da6a431a801330d43633ca8e","type":"text","conversion_output":true,"text":"the date of death due to lung cancer. Analyses will be based on the FAS population according","text_display":" the date of death due to lung cancer. Analyses will be based on the FAS population according","confidence":1,"confidence_rate":1},{"cnt":[[288,2075],[1880,2075],[1880,2125],[288,2125]],"region":{"top_left_x":287,"top_left_y":2075,"width":1593,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10910f03d0bc4763bf750b756a304c9a","type":"text","conversion_output":true,"text":"to the randomized treatment group and strata assigned at randomization. The LCSS distribution","text_display":" to the randomized treatment group and strata assigned at randomization. The LCSS distribution","confidence":1,"confidence_rate":1},{"cnt":[[288,2123],[1878,2123],[1878,2174],[288,2174]],"region":{"top_left_x":287,"top_left_y":2122,"width":1591,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e0585a7881d4719b91cbd8eb1848884","type":"text","conversion_output":true,"text":"will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and \\(95 \\%\\)","text_display":" will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and \\(95 \\%\\)","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[288,2170],[1878,2170],[1878,2224],[288,2224]],"region":{"top_left_x":287,"top_left_y":2169,"width":1591,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01a90d26b2bb4015b3eb8f57127d5712","type":"text","conversion_output":true,"text":"confidence intervals of the medians will be presented for each treatment group. The hazard ratio","text_display":" confidence intervals of the medians will be presented for each treatment group. 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from EQ-5D-5L are secondary PRO variables of interest.","text_display":" with the utilities derived from EQ-5D-5L are secondary PRO variables of interest.","confidence":1,"confidence_rate":1},{"cnt":[[288,700],[1798,700],[1798,752],[288,752]],"region":{"top_left_x":287,"top_left_y":700,"width":1512,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50c78c6038d541759e5d542927dc8995","type":"text","conversion_output":true,"text":"Time to deterioration in symptoms and in global health status/QoL are defined as follows:","text_display":"\nTime to deterioration in symptoms and in global health status/QoL are defined as follows:","confidence":1,"confidence_rate":1},{"cnt":[[288,758],[1882,758],[1882,810],[288,810]],"region":{"top_left_x":287,"top_left_y":758,"width":1596,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7de8854f210f4adb8aa52c85c4861cf1","type":"text","conversion_output":true,"text":"- The time to definitive 10 point deterioration is defined as the time from the date of","text_display":"\n- The time to definitive 10 point deterioration is defined as the time from the date of","confidence":1,"confidence_rate":1},{"cnt":[[350,808],[1878,808],[1878,857],[350,857]],"region":{"top_left_x":350,"top_left_y":807,"width":1528,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79f663e2eac0471eb5f05cdbdb2a2d17","type":"text","conversion_output":true,"text":"randomization to the date of event, which is defined as at least 10 points absolute increase","text_display":" randomization to the date of event, which is defined as at least 10 points absolute increase","confidence":1,"confidence_rate":1},{"cnt":[[352,855],[1878,855],[1878,904],[352,904]],"region":{"top_left_x":352,"top_left_y":855,"width":1526,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a70d6a6177eb4ca19b4d276f632661f5","type":"text","conversion_output":true,"text":"from baseline (worsening) of the corresponding scale score, with no later change below this","text_display":" from baseline (worsening) of the corresponding scale score, with no later change below this","confidence":1,"confidence_rate":1},{"cnt":[[352,902],[1880,902],[1880,954],[352,954]],"region":{"top_left_x":352,"top_left_y":902,"width":1528,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ebee47d7fbe43848e7b84749236621f","type":"text","conversion_output":true,"text":"threshold i.e. \\(<10\\) points was observed or if this increase was observed at the last assessment","text_display":" threshold i.e. \\(<10\\) points was observed or if this increase was observed at the last assessment","confidence":0.9165695272386074,"confidence_rate":0.9991462729374941},{"cnt":[[352,950],[1878,950],[1878,1003],[352,1003]],"region":{"top_left_x":352,"top_left_y":949,"width":1526,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3b4da3debc84ae99681ebb6effe2a70","type":"text","conversion_output":true,"text":"for the subject, or death due to any cause, whichever occurs earlier. If a subject has not had","text_display":" for the subject, or death due to any cause, whichever occurs earlier. If a subject has not had","confidence":1,"confidence_rate":1},{"cnt":[[352,1001],[1876,1001],[1876,1051],[352,1051]],"region":{"top_left_x":352,"top_left_y":1001,"width":1524,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab2b49b04133466fafeaace176d24939","type":"text","conversion_output":true,"text":"an event, time to definitive deterioration will be censored at the date of the last adequate","text_display":" an event, time to definitive deterioration will be censored at the date of the last adequate","confidence":1,"confidence_rate":1},{"cnt":[[352,1044],[1876,1044],[1876,1098],[352,1098]],"region":{"top_left_x":352,"top_left_y":1044,"width":1524,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f04a8bef56534ce4beaec9c0be0ed7e7","type":"text","conversion_output":true,"text":"assessment. The distribution will be presented descriptively using Kaplan-Meier curves.","text_display":" assessment. The distribution will be presented descriptively using Kaplan-Meier curves.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[352,1096],[1878,1096],[1878,1145],[352,1145]],"region":{"top_left_x":352,"top_left_y":1095,"width":1526,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb46c1b1885f49119685a01ffa3326a0","type":"text","conversion_output":true,"text":"Summary statistics from Kaplan-Meier distributions will be determined, including the","text_display":" Summary statistics from Kaplan-Meier distributions will be determined, including the","confidence":1,"confidence_rate":1},{"cnt":[[352,1143],[1878,1143],[1878,1192],[352,1192]],"region":{"top_left_x":352,"top_left_y":1142,"width":1526,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ff3bdf20bfc4973b2c05e450edd09ba","type":"text","conversion_output":true,"text":"median time to definitive 10 point deterioration along with two-sided \\(95 \\%\\) confidence","text_display":" median time to definitive 10 point deterioration along with two-sided \\(95 \\%\\) confidence","confidence":1,"confidence_rate":1},{"cnt":[[352,1190],[1880,1190],[1880,1242],[352,1242]],"region":{"top_left_x":352,"top_left_y":1190,"width":1528,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d95a355856a4296b0fbe018f6f7e7b2","type":"text","conversion_output":true,"text":"interval. Additionally, time to definitive deterioration with different definition for","text_display":" interval. Additionally, time to definitive deterioration with different definition for","confidence":1,"confidence_rate":1},{"cnt":[[352,1238],[1878,1238],[1878,1291],[352,1291]],"region":{"top_left_x":352,"top_left_y":1237,"width":1526,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e5e59026784a6ebf1fbeb3077882fe","type":"text","conversion_output":true,"text":"deterioration may be specified in the SAP as deemed appropriate. A stratified Cox","text_display":" deterioration may be specified in the SAP as deemed appropriate. A stratified Cox","confidence":1,"confidence_rate":1},{"cnt":[[352,1285],[1878,1285],[1878,1336],[352,1336]],"region":{"top_left_x":352,"top_left_y":1284,"width":1526,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dee4bc01ec34c9395818642084c1c44","type":"text","conversion_output":true,"text":"regression will be used to estimate the hazard ratio (HR), along with two-sided \\(95 \\%\\)","text_display":" regression will be used to estimate the hazard ratio (HR), along with two-sided \\(95 \\%\\)","confidence":0.8837890625,"confidence_rate":0.9985810437418925},{"cnt":[[352,1334],[690,1334],[690,1381],[352,1381]],"region":{"top_left_x":352,"top_left_y":1334,"width":338,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0eb472b9d3c45eea677c49648f1cd3a","type":"text","conversion_output":true,"text":"confidence interval.","text_display":" confidence interval.","confidence":1,"confidence_rate":1},{"cnt":[[288,1392],[1878,1392],[1878,1442],[288,1442]],"region":{"top_left_x":287,"top_left_y":1392,"width":1591,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11f54d60e3424733a57774a0ebf91568","type":"text","conversion_output":true,"text":"- Thetime to first 10 point deterioration is defined as the time from the date of randomization","text_display":"\n- Thetime to first 10 point deterioration is defined as the time from the date of randomization","confidence":1,"confidence_rate":1},{"cnt":[[350,1439],[1878,1439],[1878,1491],[350,1491]],"region":{"top_left_x":350,"top_left_y":1439,"width":1528,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbcf52b5815e4e018916434c42375814","type":"text","conversion_output":true,"text":"to the first onset of at least 10 points absolute increase from baseline (worsening) in","text_display":" to the first onset of at least 10 points absolute increase from baseline (worsening) in","confidence":1,"confidence_rate":1},{"cnt":[[352,1489],[1876,1489],[1876,1540],[352,1540]],"region":{"top_left_x":352,"top_left_y":1488,"width":1524,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d625bf7140a541d3865cdc683df887a3","type":"text","conversion_output":true,"text":"symptoms scores or at least 10 points absolute decrease from baseline (worsening) in global","text_display":" symptoms scores or at least 10 points absolute decrease from baseline (worsening) in global","confidence":1,"confidence_rate":1},{"cnt":[[352,1538],[1878,1538],[1878,1588],[352,1588]],"region":{"top_left_x":352,"top_left_y":1538,"width":1526,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"672dc979df884fb18124adf472921428","type":"text","conversion_output":true,"text":"health status/QoL, or death due to any cause, whichever occurs earlier. If a subject has not","text_display":" health status/QoL, or death due to any cause, whichever occurs earlier. If a subject has not","confidence":1,"confidence_rate":1},{"cnt":[[352,1586],[1876,1586],[1876,1635],[352,1635]],"region":{"top_left_x":352,"top_left_y":1585,"width":1524,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed1386f4facf458eb766898e6cb995f1","type":"text","conversion_output":true,"text":"had an event, time to deterioration will be censored at the date of the last adequate","text_display":" had an event, time to deterioration will be censored at the date of the last adequate","confidence":1,"confidence_rate":1},{"cnt":[[352,1629],[1876,1629],[1876,1682],[352,1682]],"region":{"top_left_x":352,"top_left_y":1628,"width":1524,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef7fbc2821b4f2e813935bbffa94589","type":"text","conversion_output":true,"text":"assessment. The distribution will be presented descriptively using Kaplan-Meier curves.","text_display":" assessment. The distribution will be presented descriptively using Kaplan-Meier curves.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[352,1680],[1878,1680],[1878,1729],[352,1729]],"region":{"top_left_x":352,"top_left_y":1680,"width":1526,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f999e640d0ed432dbfc6b297efe32231","type":"text","conversion_output":true,"text":"Summary statistics from Kaplan-Meier distributions will be determined, including the","text_display":" Summary statistics from Kaplan-Meier distributions will be determined, including the","confidence":1,"confidence_rate":1},{"cnt":[[352,1727],[1876,1727],[1876,1777],[352,1777]],"region":{"top_left_x":352,"top_left_y":1727,"width":1524,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"335d31eecce84216a48f6eceefaa848e","type":"text","conversion_output":true,"text":"median time to 10 point deterioration along with two-sided \\(95 \\%\\) confidence interval.","text_display":" median time to 10 point deterioration along with two-sided \\(95 \\%\\) confidence interval.","confidence":1,"confidence_rate":1},{"cnt":[[352,1775],[1876,1775],[1876,1826],[352,1826]],"region":{"top_left_x":352,"top_left_y":1774,"width":1524,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caa4b2d568ab47e2a87434db1eb8ab43","type":"text","conversion_output":true,"text":"Additionally, time to first deterioration with different definitions for deterioration may be","text_display":" Additionally, time to first deterioration with different definitions for deterioration may be","confidence":1,"confidence_rate":1},{"cnt":[[352,1822],[1878,1822],[1878,1876],[352,1876]],"region":{"top_left_x":352,"top_left_y":1821,"width":1526,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b27a8ad517014f239bca156335d162e1","type":"text","conversion_output":true,"text":"specified in the SAP as deemed appropriate. A stratified Cox regression will be used to","text_display":" specified in the SAP as deemed appropriate. A stratified Cox regression will be used to","confidence":1,"confidence_rate":1},{"cnt":[[352,1869],[1665,1869],[1665,1921],[352,1921]],"region":{"top_left_x":352,"top_left_y":1869,"width":1314,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db7f34ab4ff14c71a4f54b48e1a5f220","type":"text","conversion_output":true,"text":"estimate the hazard ratio (HR), along with two-sided \\(95 \\%\\) confidence interval.","text_display":" estimate the hazard ratio (HR), along with two-sided \\(95 \\%\\) confidence interval.","confidence":0.9926791191101074,"confidence_rate":0.9999135589121402},{"cnt":[[288,1938],[1876,1938],[1876,1992],[288,1992]],"region":{"top_left_x":287,"top_left_y":1937,"width":1589,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c833097c5e6047c984b27ff702989197","type":"text","conversion_output":true,"text":"Descriptive statistics will be used to summarize the original scores, as well as change from","text_display":"\nDescriptive statistics will be used to summarize the original scores, as well as change from","confidence":1,"confidence_rate":1},{"cnt":[[288,1987],[1880,1987],[1880,2039],[288,2039]],"region":{"top_left_x":287,"top_left_y":1987,"width":1593,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2365b6a790540e0a224cd2e6726875f","type":"text","conversion_output":true,"text":"baseline, of the QLQC30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point","text_display":" baseline, of the QLQC30/ QLQ-LC13 and EQ-5D-5L at each scheduled assessment time point","confidence":1,"confidence_rate":1},{"cnt":[[288,2037],[1876,2037],[1876,2086],[288,2086]],"region":{"top_left_x":287,"top_left_y":2036,"width":1589,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e229d2b3d82848449f6b27df39089839","type":"text","conversion_output":true,"text":"for each treatment group. Additionally, change from baseline in the scale and subscale values","text_display":" for each treatment group. Additionally, change from baseline in the scale and subscale values","confidence":1,"confidence_rate":1},{"cnt":[[288,2084],[1876,2084],[1876,2133],[288,2133]],"region":{"top_left_x":287,"top_left_y":2083,"width":1589,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7516e3d751bc48628272c686f059426d","type":"text","conversion_output":true,"text":"at the time of each assessment will be summarized. Subjects with an evaluable baseline score","text_display":" at the time of each assessment will be summarized. Subjects with an evaluable baseline score","confidence":1,"confidence_rate":1},{"cnt":[[288,2131],[1878,2131],[1878,2185],[288,2185]],"region":{"top_left_x":287,"top_left_y":2131,"width":1591,"height":54},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97d65831a0264b1b9a0cf5f9f717a89e","type":"text","conversion_output":true,"text":"and at least one evaluable post baseline score during the treatment period will be included in","text_display":" and at least one evaluable post baseline score during the treatment period will be included in","confidence":1,"confidence_rate":1},{"cnt":[[288,2179],[879,2179],[879,2230],[288,2230]],"region":{"top_left_x":287,"top_left_y":2178,"width":592,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89ecb432da85472babc2cfec7b403894","type":"text","conversion_output":true,"text":"the change from baseline analyses.","text_display":" the change from baseline analyses.","confidence":1,"confidence_rate":1},{"cnt":[[288,2247],[1878,2247],[1878,2299],[288,2299]],"region":{"top_left_x":287,"top_left_y":2247,"width":1591,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b073655b6fe84b689241c27cdaa1b67d","type":"text","conversion_output":true,"text":"The number of subjects completing each questionnaire and the number of missing or incomplete","text_display":"\nThe number of subjects completing each questionnaire and the number of missing or incomplete","confidence":1,"confidence_rate":1},{"cnt":[[288,2297],[1876,2297],[1876,2348],[288,2348]],"region":{"top_left_x":287,"top_left_y":2296,"width":1589,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a96fbc7fb9b14502a50a7d6fb370c5f7","type":"text","conversion_output":true,"text":"assessments will be summarized by treatment group for each scheduled assessment time point.","text_display":" assessments will be summarized by treatment group for each scheduled assessment time point.","confidence":1,"confidence_rate":1},{"cnt":[[288,2344],[1880,2344],[1880,2396],[288,2396]],"region":{"top_left_x":287,"top_left_y":2343,"width":1593,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bc1fe9310184f78ac4fdfb7a9d287f3","type":"text","conversion_output":true,"text":"No formal statistical tests will be performed for PRO data and hence no multiplicity adjustment","text_display":" No formal statistical tests will be performed for PRO data and hence no multiplicity adjustment","confidence":1,"confidence_rate":1},{"cnt":[[288,2393],[1343,2393],[1343,2443],[288,2443]],"region":{"top_left_x":287,"top_left_y":2393,"width":1056,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8ce2bd0c9af46508525dd1639739a20","type":"text","conversion_output":true,"text":"will be applied. The FAS will be used for analyzing PRO data.","text_display":" will be applied. 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The","text_display":" well as the thermometer and utility scores of the EQ-5D-5L, longitudinally over time. 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(DFS)}","confidence":1,"confidence_rate":1},{"cnt":[[292,1955],[1878,1955],[1878,2004],[292,2004]],"region":{"top_left_x":292,"top_left_y":1955,"width":1586,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfe7b62184944a9195d6b852e79126df","type":"text","conversion_output":true,"text":"One interim analysis is planned after approximately 196 of the approximately 392 targeted","text_display":"\n\nOne interim analysis is planned after approximately 196 of the approximately 392 targeted","confidence":1,"confidence_rate":1},{"cnt":[[288,2002],[1876,2002],[1876,2052],[288,2052]],"region":{"top_left_x":287,"top_left_y":2002,"width":1589,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29c27ca42b7c4429abaaa9a2afef027f","type":"text","conversion_output":true,"text":"DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The","text_display":" DFS events (i.e., at approximately \\(50 \\%\\) information fraction) have been documented. The","confidence":0.98876953125,"confidence_rate":0.9998798582110203},{"cnt":[[288,2050],[1876,2050],[1876,2103],[288,2103]],"region":{"top_left_x":287,"top_left_y":2049,"width":1589,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a81e48cca78f434a8a0ffba59d2ac60e","type":"text","conversion_output":true,"text":"primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no","text_display":" primary intent of the interim analysis is to stop early for lack of efficacy (futility). There is no","confidence":1,"confidence_rate":1},{"cnt":[[288,2101],[1876,2101],[1876,2151],[288,2151]],"region":{"top_left_x":287,"top_left_y":2101,"width":1589,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91c8fa58173142dda716404a23965d1b","type":"text","conversion_output":true,"text":"intent to carry out an analysis to declare superior efficacy at the time of the interim analysis.","text_display":" intent to carry out an analysis to declare superior efficacy at the time of the interim analysis.","confidence":1,"confidence_rate":1},{"cnt":[[288,2148],[1878,2148],[1878,2198],[288,2198]],"region":{"top_left_x":287,"top_left_y":2148,"width":1591,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7eafc5ebec4475e8501496f2760a868","type":"text","conversion_output":true,"text":"An \\(\\alpha\\)-spending function according to a two-look (Lan-DeMets) group sequential design with","text_display":" An \\(\\alpha\\)-spending function according to a two-look (Lan-DeMets) group sequential design with","confidence":1,"confidence_rate":1},{"cnt":[[288,2196],[1878,2196],[1878,2245],[288,2245]],"region":{"top_left_x":287,"top_left_y":2195,"width":1591,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bf594c3b9894af390f047e5b0bf6594","type":"text","conversion_output":true,"text":"(O'Brien-Fleming) type stopping boundary (as implemented in East 6.4 ) will be used to","text_display":" (O'Brien-Fleming) type stopping boundary (as implemented in East 6.4 ) will be used to","confidence":0.5849609375,"confidence_rate":0.994311875082023},{"cnt":[[288,2243],[1878,2243],[1878,2292],[288,2292]],"region":{"top_left_x":287,"top_left_y":2242,"width":1591,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7560a979c67c40f89ff095e36474383d","type":"text","conversion_output":true,"text":"construct the efficacy stopping boundaries (Lan and DeMets 1983). A user-defined gamma","text_display":" construct the efficacy stopping boundaries (Lan and DeMets 1983). A user-defined gamma","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[288,2290],[1880,2290],[1880,2342],[288,2342]],"region":{"top_left_x":287,"top_left_y":2290,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b34868906bc34684a7fb08284777a95f","type":"text","conversion_output":true,"text":"function with \\(\\gamma=-3\\) stopping boundary as implemented in East 6.4 will be used as a \\(\\beta\\)-spending","text_display":" function with \\(\\gamma=-3\\) stopping boundary as implemented in East 6.4 will be used as a \\(\\beta\\)-spending","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[288,2340],[1880,2340],[1880,2391],[288,2391]],"region":{"top_left_x":287,"top_left_y":2339,"width":1593,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b09b35dade1415ea0c15c9c5830191b","type":"text","conversion_output":true,"text":"function to determine the non-binding futility boundary. The choice of non-binding nature of","text_display":" function to determine the non-binding futility boundary. The choice of non-binding nature of","confidence":1,"confidence_rate":1},{"cnt":[[288,2385],[1876,2385],[1876,2436],[288,2436]],"region":{"top_left_x":287,"top_left_y":2384,"width":1589,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e4bed81cee470fb8c370bd7fc3fea0","type":"text","conversion_output":true,"text":"the futility stopping boundary ensures that the efficacy stopping boundaries are not affected.","text_display":" the futility stopping boundary ensures that the efficacy stopping boundaries are not affected.","confidence":1,"confidence_rate":1},{"cnt":[[288,2436],[1878,2436],[1878,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":2436,"width":1591,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d6a8fd3a9784b5f85b41a9fed91f4c0","type":"text","conversion_output":true,"text":"Based on the choice of \\(\\alpha\\)-spending and \\(\\beta\\)-spending function described above and if the interim","text_display":" Based on the choice of \\(\\alpha\\)-spending and \\(\\beta\\)-spending function described above and if the interim","confidence":1,"confidence_rate":1},{"cnt":[[288,2484],[1878,2484],[1878,2533],[288,2533]],"region":{"top_left_x":287,"top_left_y":2483,"width":1591,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9058b9cb91994cc3ad27b9a0a6d690ea","type":"text","conversion_output":true,"text":"analysis is performed exactly at 196 DFS events, the futility boundary expressed on the p -value","text_display":" analysis is performed exactly at 196 DFS events, the futility boundary expressed on the p -value","confidence":0.5231819152832031,"confidence_rate":0.9941279804138602}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-128","page":128,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23d20aa8225c40f78c743a6160930dfd","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ff58607cbf74037b014a9f5eb582834","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,206],[1876,206],[1876,247],[1611,247]],"region":{"top_left_x":1611,"top_left_y":206,"width":265,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2f48dadee27477a846366349c4ff264","type":"page_info","conversion_output":false,"text":"Page 128 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,251],[883,251],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":251,"width":597,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ba9923954bb4c36b7c63036647ed151","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,251],[1871,251],[1871,290],[1414,290]],"region":{"top_left_x":1413,"top_left_y":251,"width":459,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f86cc844f6b648d7b67710a25effda29","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999837201159151},{"cnt":[[288,346],[1878,346],[1878,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1591,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d5c6d27b9fe433998537bf77bdea7cb","type":"text","conversion_output":true,"text":"scale (or the Z-statistic scale) at the first interim is calculated as \\(p =0.411\\) (or \\(Z =0.226\\) ). The","text_display":"\nscale (or the Z-statistic scale) at the first interim is calculated as \\(p =0.411\\) (or \\(Z =0.226\\) ). 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The","text_display":" interim and the total number of targeted events to calculate the exact information fraction. The","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[288,679],[1880,679],[1880,733],[288,733]],"region":{"top_left_x":287,"top_left_y":678,"width":1593,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"704318b4a3cb417f84eec75f664885fb","type":"text","conversion_output":true,"text":"observed p -value (or Z-test statistic) at the interim analyses will then be compared against the","text_display":" observed p -value (or Z-test statistic) at the interim analyses will then be compared against the","confidence":0.9501953125,"confidence_rate":0.9995270773871182},{"cnt":[[288,728],[827,728],[827,780],[288,780]],"region":{"top_left_x":287,"top_left_y":728,"width":541,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e8762986f9a4af48e3e2fdf8fe2583d","type":"text","conversion_output":true,"text":"re-calculated futility boundary.","text_display":" re-calculated futility boundary.","confidence":1,"confidence_rate":1},{"cnt":[[288,795],[1878,795],[1878,849],[288,849]],"region":{"top_left_x":287,"top_left_y":794,"width":1591,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a12a73e59c24253aa4f106852714106","type":"text","conversion_output":true,"text":"If the study continues to the final DFS analysis, the final DFS analysis will be performed when","text_display":"\nIf the study continues to the final DFS analysis, the final DFS analysis will be performed when","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,846],[1878,846],[1878,896],[288,896]],"region":{"top_left_x":287,"top_left_y":846,"width":1591,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"067db08c0fdd4dd3a418d5f1698ff245","type":"text","conversion_output":true,"text":"approximately 392 DFS events have been documented. If exactly 196 events are observed at","text_display":" approximately 392 DFS events have been documented. If exactly 196 events are observed at","confidence":0.9415948390960693,"confidence_rate":0.999404333875142},{"cnt":[[288,889],[1878,889],[1878,943],[288,943]],"region":{"top_left_x":287,"top_left_y":889,"width":1591,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f93e86d691b643839a95a7a7345cb6e8","type":"text","conversion_output":true,"text":"the interim analysis, the study continued and exactly 392 events are obtained at the final","text_display":" the interim analysis, the study continued and exactly 392 events are obtained at the final","confidence":1,"confidence_rate":1},{"cnt":[[288,941],[1878,941],[1878,993],[288,993]],"region":{"top_left_x":287,"top_left_y":941,"width":1591,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d15e00466664e62bdf215adcee282e2","type":"text","conversion_output":true,"text":"analysis, the observed p -value will have to be less than 0.024 (or the observed Z statistics has","text_display":" analysis, the observed p -value will have to be less than 0.024 (or the observed Z statistics has","confidence":0.6713213380426168,"confidence_rate":0.9964162804881324},{"cnt":[[288,988],[1880,988],[1880,1040],[288,1040]],"region":{"top_left_x":287,"top_left_y":988,"width":1593,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48b29b9c9306448d9d45c78379c50caa","type":"text","conversion_output":true,"text":"to be \\(>1.969\\) ) to declare statistical significance. In practice, the final analysis will be based on","text_display":" to be \\(>1.969\\) ) to declare statistical significance. In practice, the final analysis will be based on","confidence":0.9985356330871582,"confidence_rate":0.9999864312018168},{"cnt":[[288,1036],[1880,1036],[1880,1089],[288,1089]],"region":{"top_left_x":287,"top_left_y":1035,"width":1593,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f6dfb6d884e4ddab37c141ed697342f","type":"text","conversion_output":true,"text":"the actual number of DFS events documented at the cut-off date for the final DFS analysis and","text_display":" the actual number of DFS events documented at the cut-off date for the final DFS analysis and","confidence":1,"confidence_rate":1},{"cnt":[[288,1085],[1878,1085],[1878,1137],[288,1137]],"region":{"top_left_x":287,"top_left_y":1084,"width":1591,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"262d102a2e3e4080819510e1c9ef5073","type":"text","conversion_output":true,"text":"\\(\\alpha\\) already spent at the interim analysis. The boundary for the final analysis will be derived","text_display":" \\(\\alpha\\) already spent at the interim analysis. The boundary for the final analysis will be derived","confidence":1,"confidence_rate":1},{"cnt":[[288,1130],[1880,1130],[1880,1184],[288,1184]],"region":{"top_left_x":287,"top_left_y":1130,"width":1593,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e806cb9cdd0454b95ad890c611affc2","type":"text","conversion_output":true,"text":"accordingly from the pre-specified \\(\\alpha\\)-spending function such that the overall significance level","text_display":" accordingly from the pre-specified \\(\\alpha\\)-spending function such that the overall significance level","confidence":0.99951171875,"confidence_rate":0.9999953038523913},{"cnt":[[288,1182],[995,1182],[995,1231],[288,1231]],"region":{"top_left_x":287,"top_left_y":1181,"width":708,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9b79b28a7c94f0882b40c1ec8c8ee7b","type":"text","conversion_output":true,"text":"across all analyses is maintained at 0.025 .","text_display":" across all analyses is maintained at 0.025 .","confidence":1,"confidence_rate":1},{"cnt":[[288,1248],[1876,1248],[1876,1300],[288,1300]],"region":{"top_left_x":287,"top_left_y":1248,"width":1589,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8102e8759c3d40ff9350740e23c29577","type":"text","conversion_output":true,"text":"The statistical properties of the group sequential design are summarized for DFS in Table 10-1","text_display":"\nThe statistical properties of the group sequential design are summarized for DFS in Table 10-1","confidence":1,"confidence_rate":1},{"cnt":[[288,1298],[410,1298],[410,1343],[288,1343]],"region":{"top_left_x":287,"top_left_y":1297,"width":124,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fed0a807c6c24ac2af3c5190d1607dae","type":"text","conversion_output":true,"text":"below.","text_display":" below.","confidence":1,"confidence_rate":1},{"cnt":[[284,1379],[1848,1379],[1848,1485],[284,1485]],"region":{"top_left_x":283,"top_left_y":1379,"width":1565,"height":106},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3705f52507594194b16a5529e405fbee","type":"figure_label","conversion_output":false,"children_ids":["fa6e4d2316f74ed499b93bc853505eeb","b13dc83bdf454b82954a9ce7070fbfec"],"text":"","text_display":""},{"cnt":[[288,1384],[1841,1384],[1841,1435],[288,1435]],"region":{"top_left_x":287,"top_left_y":1383,"width":1555,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa6e4d2316f74ed499b93bc853505eeb","type":"text","conversion_output":false,"parent_id":"3705f52507594194b16a5529e405fbee","text":"Table 10-1 Simulated probabilities to stop for futility or efficacy at the interim 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\\multirow[t]{2}{*}{Scenario} & \\multirow[t]{2}{*}{Look} & \\multirow[t]{2}{*}{\\# DFS events} & \\multicolumn{2}{|c|}{Simulated cumulative probabilities (\\%)} & \\multicolumn{2}{|c|}{Simulated incremental probabilities (\\%)} \\\\\n\\hline & & & Stop for efficacy & Stop for futility & Stop for efficacy & Stop for futility \\\\\n\\hline Under \\(H _{01}\\) (HR=1) & 1st IA (futility) & 196 & - & 59.34 & - & 59.34 \\\\\n\\hline & Final & 392 & 2.36 & - & 2.18 & - \\\\\n\\hline Under \\(H _{ a 1}\\) (HR=0.716) & 1st IA (futility) & 196 & - & 1.83 & - & 1.83 \\\\\n\\hline & Final & 392 & 89.56 & - & 63.7 & - \\\\\n\\hline Under HR=0.8 & 1st IA (futility) & 196 & - & 9.28 & - & 9.28 \\\\\n\\hline & Final & 392 & 58.65 & - & 50.49 & - \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 10-1 Simulated probabilities to stop for futility or efficacy at the interim or final DFS 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The hypotheses to be tested","text_display":"\n\nThe sample size calculation is based on the primary variable DFS. The hypotheses to be tested","confidence":1,"confidence_rate":1},{"cnt":[[288,466],[1721,466],[1721,518],[288,518]],"region":{"top_left_x":287,"top_left_y":466,"width":1434,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1fd3ab1e08d49a992d4c057e9e24f41","type":"text","conversion_output":true,"text":"and details of the testing strategy are described in Sections 10.4.2 and Section 10.7.1.","text_display":" and details of the testing strategy are described in Sections 10.4.2 and Section 10.7.1.","confidence":1,"confidence_rate":1},{"cnt":[[288,535],[1878,535],[1878,587],[288,587]],"region":{"top_left_x":287,"top_left_y":534,"width":1591,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec800b4ca2542d5bd5a4ac1f889f67a","type":"text","conversion_output":true,"text":"Based on available data, the median DFS in the placebo arm is expected to be around 48 months","text_display":"\nBased on available data, the median DFS in the placebo arm is expected to be around 48 months","confidence":1,"confidence_rate":1},{"cnt":[[288,580],[1880,580],[1880,634],[288,634]],"region":{"top_left_x":287,"top_left_y":580,"width":1593,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59598cec31aa42a18e1c66ad06724a02","type":"text","conversion_output":true,"text":"(Kelly 2015). It is expected that treatment with canakinumab will result in a \\(28.4 \\%\\) reduction","text_display":" (Kelly 2015). It is expected that treatment with canakinumab will result in a \\(28.4 \\%\\) reduction","confidence":1,"confidence_rate":1},{"cnt":[[288,629],[1880,629],[1880,681],[288,681]],"region":{"top_left_x":287,"top_left_y":629,"width":1593,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6080eccef8354fca94beab9f74896d7a","type":"text","conversion_output":true,"text":"in the hazard rate for DFS (corresponding to an increase in median DFS from 48 months to 67","text_display":" in the hazard rate for DFS (corresponding to an increase in median DFS from 48 months to 67","confidence":1,"confidence_rate":1},{"cnt":[[288,679],[1132,679],[1132,730],[288,730]],"region":{"top_left_x":287,"top_left_y":678,"width":846,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"704958ba2133438590a286661b1784e1","type":"text","conversion_output":true,"text":"months under the exponential model assumption).","text_display":" months under the exponential model assumption).","confidence":1,"confidence_rate":1},{"cnt":[[288,748],[1878,748],[1878,797],[288,797]],"region":{"top_left_x":287,"top_left_y":747,"width":1591,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4cf7d1bf751423ab3e4ff876a52dc10","type":"text","conversion_output":true,"text":"Then, in order to ensure \\(90.4 \\%\\) power to test the null hypothesis: DFS hazard ratio \\(=1\\), versus","text_display":"\nThen, in order to ensure \\(90.4 \\%\\) power to test the null hypothesis: DFS hazard ratio \\(=1\\), versus","confidence":0.9970715045928955,"confidence_rate":0.9999720690392205},{"cnt":[[288,795],[1878,795],[1878,846],[288,846]],"region":{"top_left_x":287,"top_left_y":794,"width":1591,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c0f53ec70f74c2284bdaec3b9a5fb69","type":"text","conversion_output":true,"text":"the specific alternative hypothesis: DFS hazard ratio \\(=0.716\\), it is calculated that a total of 392","text_display":" the specific alternative hypothesis: DFS hazard ratio \\(=0.716\\), it is calculated that a total of 392","confidence":0.9951193332672119,"confidence_rate":0.9999538443097061},{"cnt":[[288,842],[1880,842],[1880,896],[288,896]],"region":{"top_left_x":287,"top_left_y":842,"width":1593,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d46ae0b9287b42518759dab067e114d3","type":"text","conversion_output":true,"text":"DFS events need to be observed. This calculation assumes analysis by a one-sided log-rank test","text_display":" DFS events need to be observed. This calculation assumes analysis by a one-sided log-rank test","confidence":1,"confidence_rate":1},{"cnt":[[288,889],[1880,889],[1880,943],[288,943]],"region":{"top_left_x":287,"top_left_y":889,"width":1593,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"066338a50ec549a8b50865ef316c761c","type":"text","conversion_output":true,"text":"at the overall \\(2.5 \\%\\) level of significance, subjects randomized to the two treatment groups in a","text_display":" at the overall \\(2.5 \\%\\) level of significance, subjects randomized to the two treatment groups in a","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[288,939],[1880,939],[1880,990],[288,990]],"region":{"top_left_x":287,"top_left_y":938,"width":1593,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02680e7f57c44146ad3c3c79cfafa933","type":"text","conversion_output":true,"text":"1:1 ratio, and a 2 -look group sequential design with a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\) -","text_display":" 1:1 ratio, and a 2 -look group sequential design with a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\) ","confidence":0.9478235244750977,"confidence_rate":0.9994588641469156},{"cnt":[[288,986],[1878,986],[1878,1038],[288,1038]],"region":{"top_left_x":287,"top_left_y":986,"width":1591,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14b9d34dc3584b98b37dcd7d5c5684f6","type":"text","conversion_output":true,"text":"spending function and a user-defined gamma function (with \\(\\gamma=-3\\) ) \\(\\beta\\)-spending function to","text_display":"spending function and a user-defined gamma function (with \\(\\gamma=-3\\) ) \\(\\beta\\)-spending function to","confidence":0.9975595474243164,"confidence_rate":0.9999753191395884},{"cnt":[[288,1036],[1880,1036],[1880,1085],[288,1085]],"region":{"top_left_x":287,"top_left_y":1035,"width":1593,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac1d6c9738f54280810bfa9d997ea061","type":"text","conversion_output":true,"text":"define a non-binding futility rule at the interim analyses, using an information fraction of \\(50 \\%\\)","text_display":" define a non-binding futility rule at the interim analyses, using an information fraction of \\(50 \\%\\)","confidence":0.98779296875,"confidence_rate":0.9998771860523339},{"cnt":[[288,1079],[1880,1079],[1880,1132],[288,1132]],"region":{"top_left_x":287,"top_left_y":1078,"width":1593,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75d2788b66fc4dfda51e40ef1a07d063","type":"text","conversion_output":true,"text":"for the interim analysis (futility only) . Assuming that enrolment will continue for","text_display":" for the interim analysis (futility only) . Assuming that enrolment will continue for","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[288,1130],[1880,1130],[1880,1182],[288,1182]],"region":{"top_left_x":287,"top_left_y":1130,"width":1593,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62f24a4ed1d74415a98259b0e6b1245f","type":"text","conversion_output":true,"text":"approximately 30 months at a rate of 50 subjects per month and a \\(5 \\%\\) yearly dropout rate by the","text_display":" approximately 30 months at a rate of 50 subjects per month and a \\(5 \\%\\) yearly dropout rate by the","confidence":0.9990236759185791,"confidence_rate":0.9999909555872323},{"cnt":[[288,1177],[1880,1177],[1880,1229],[288,1229]],"region":{"top_left_x":287,"top_left_y":1177,"width":1593,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78b611b184254f1cabf8a58b85ba3999","type":"text","conversion_output":true,"text":"time of the final DFS analysis, approximately 1500 subjects may be randomized to observe","text_display":" time of the final DFS analysis, approximately 1500 subjects may be randomized to observe","confidence":1,"confidence_rate":1},{"cnt":[[288,1225],[1878,1225],[1878,1278],[288,1278]],"region":{"top_left_x":287,"top_left_y":1224,"width":1591,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ab9b4c485b64ab6a8a02469294010a2","type":"text","conversion_output":true,"text":"the targeted 392 DFS events at about 12 months after the randomization date of the last subject,","text_display":" the targeted 392 DFS events at about 12 months after the randomization date of the last subject,","confidence":1,"confidence_rate":1},{"cnt":[[288,1274],[1880,1274],[1880,1326],[288,1326]],"region":{"top_left_x":287,"top_left_y":1274,"width":1593,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6ae15e7543e4d2b97ecde544f582e5d","type":"text","conversion_output":true,"text":"i.e, 42 months after the randomization date of the first subject. It is required that all enrolled","text_display":" i.e, 42 months after the randomization date of the first subject. It is required that all enrolled","confidence":0.740234375,"confidence_rate":0.9971663956535475},{"cnt":[[288,1319],[1878,1319],[1878,1373],[288,1373]],"region":{"top_left_x":287,"top_left_y":1319,"width":1591,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0127c339e514f34a8de7cf419a1754c","type":"text","conversion_output":true,"text":"subjects have a minimal efficacy follow-up of 3 months to ensure all subjects have at least one","text_display":" subjects have a minimal efficacy follow-up of 3 months to ensure all subjects have at least one","confidence":0.99609375,"confidence_rate":0.9999620016994184},{"cnt":[[288,1371],[1880,1371],[1880,1422],[288,1422]],"region":{"top_left_x":287,"top_left_y":1370,"width":1593,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb6aacb9e34947f2a29e64a8c879a067","type":"text","conversion_output":true,"text":"post-baseline recurrence assessment. These calculations were made using the software package","text_display":" post-baseline recurrence assessment. These calculations were made using the software package","confidence":1,"confidence_rate":1},{"cnt":[[288,1418],[445,1418],[445,1463],[288,1463]],"region":{"top_left_x":287,"top_left_y":1417,"width":158,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6c8813ebebb4e0fbed84e5cfc7f346e","type":"text","conversion_output":true,"text":"East 6.4.","text_display":" East 6.4.","confidence":0.99951171875,"confidence_rate":0.9999651148586358},{"cnt":[[284,1500],[1467,1500],[1467,1566],[284,1566]],"region":{"top_left_x":283,"top_left_y":1499,"width":1185,"height":68},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8faa1cf800d442fa9abea8f777c21dac","type":"section_header","conversion_output":false,"children_ids":["f9d68ee657b84ba4afd419247291fec0"],"text":"","text_display":""},{"cnt":[[292,1506],[1463,1506],[1463,1562],[292,1562]],"region":{"top_left_x":292,"top_left_y":1506,"width":1172,"height":56},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9d68ee657b84ba4afd419247291fec0","type":"text","conversion_output":true,"parent_id":"8faa1cf800d442fa9abea8f777c21dac","text":"10.9 Power for analysis of key secondary variables","text_display":"\n\n\\subsection*{10.9 Power for analysis of key secondary variables}","confidence":1,"confidence_rate":1},{"cnt":[[288,1577],[1880,1577],[1880,1631],[288,1631]],"region":{"top_left_x":287,"top_left_y":1576,"width":1593,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1594b70c8fc942e1a198fbcffbd7d2ad","type":"text","conversion_output":true,"text":"OS, as the key secondary variable, will be formally statistically tested, provided that the primary","text_display":"\n\nOS, as the key secondary variable, will be formally statistically tested, provided that the primary","confidence":1,"confidence_rate":1},{"cnt":[[288,1629],[1880,1629],[1880,1680],[288,1680]],"region":{"top_left_x":287,"top_left_y":1628,"width":1593,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88eeb195fcc14b3b917b7f1490e47cce","type":"text","conversion_output":true,"text":"variable DFS is statistically significant. The hypotheses to be tested and details of the testing","text_display":" variable DFS is statistically significant. The hypotheses to be tested and details of the testing","confidence":1,"confidence_rate":1},{"cnt":[[288,1676],[1880,1676],[1880,1725],[288,1725]],"region":{"top_left_x":287,"top_left_y":1675,"width":1593,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a098682db1c4e2090cdca07e1e00d07","type":"text","conversion_output":true,"text":"strategy are provided in Section 10.5.1 and Section 10.7.2. Based on available data, the median","text_display":" strategy are provided in Section 10.5.1 and Section 10.7.2. Based on available data, the median","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[288,1723],[1880,1723],[1880,1777],[288,1777]],"region":{"top_left_x":287,"top_left_y":1723,"width":1593,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc0880e769d34484a47e7cb4cc9a77dc","type":"text","conversion_output":true,"text":"OS in the placebo arm is expected to be approximately 5 years (Pignon 2008). In addition, the","text_display":" OS in the placebo arm is expected to be approximately 5 years (Pignon 2008). In addition, the","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[288,1772],[1878,1772],[1878,1824],[288,1824]],"region":{"top_left_x":287,"top_left_y":1772,"width":1591,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7ea5683e53e420e99b27a4bc0d67e96","type":"text","conversion_output":true,"text":"OS result presented in Kelly (2015) was not mature as the median was not reached at 5 years,","text_display":" OS result presented in Kelly (2015) was not mature as the median was not reached at 5 years,","confidence":1,"confidence_rate":1},{"cnt":[[288,1818],[1878,1818],[1878,1871],[288,1871]],"region":{"top_left_x":287,"top_left_y":1817,"width":1591,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bf141c6fc7a489a8a34c3fd7ac923fe","type":"text","conversion_output":true,"text":"but the overall trend indicates a median OS greater than 5 years. After taking these into","text_display":" but the overall trend indicates a median OS greater than 5 years. After taking these into","confidence":1,"confidence_rate":1},{"cnt":[[288,1867],[1876,1867],[1876,1919],[288,1919]],"region":{"top_left_x":287,"top_left_y":1866,"width":1589,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bf65e6a1f6946e2b9f397fb5fc28069","type":"text","conversion_output":true,"text":"consideration, the median OS for the placebo arm is assumed to be approximately 66 months.","text_display":" consideration, the median OS for the placebo arm is assumed to be approximately 66 months.","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[288,1916],[1880,1916],[1880,1966],[288,1966]],"region":{"top_left_x":287,"top_left_y":1916,"width":1593,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e2f9d4755a247248c66796ebb94e45c","type":"text","conversion_output":true,"text":"It is hypothesized that treatment with canakinumab will result in a \\(22.4 \\%\\) reduction in the hazard","text_display":" It is hypothesized that treatment with canakinumab will result in a \\(22.4 \\%\\) reduction in the hazard","confidence":1,"confidence_rate":1},{"cnt":[[288,1964],[1880,1964],[1880,2013],[288,2013]],"region":{"top_left_x":287,"top_left_y":1963,"width":1593,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca5311198cd04093af8db55da83d4bda","type":"text","conversion_output":true,"text":"rate for OS, i.e., an expected hazard ratio of 0.776 (which corresponds to an increase in median","text_display":" rate for OS, i.e., an expected hazard ratio of 0.776 (which corresponds to an increase in median","confidence":0.9926877021789551,"confidence_rate":0.9999294336080162},{"cnt":[[288,2011],[1880,2011],[1880,2060],[288,2060]],"region":{"top_left_x":287,"top_left_y":2010,"width":1593,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6baeea4bcd84c22ac65f248de38e12b","type":"text","conversion_output":true,"text":"66 to 85 months under the exponential model assumption). Then, in order to ensure \\(80 \\%\\) power","text_display":" 66 to 85 months under the exponential model assumption). Then, in order to ensure \\(80 \\%\\) power","confidence":1,"confidence_rate":1},{"cnt":[[288,2058],[1878,2058],[1878,2108],[288,2108]],"region":{"top_left_x":287,"top_left_y":2058,"width":1591,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e6207a056d54f3ba294c9a82452c1d8","type":"text","conversion_output":true,"text":"to test the null hypothesis: OS hazard ratio \\(=1\\), versus the specific alternative hypothesis: OS","text_display":" to test the null hypothesis: OS hazard ratio \\(=1\\), versus the specific alternative hypothesis: OS","confidence":0.9931700215674937,"confidence_rate":0.9999341040031097},{"cnt":[[288,2105],[1878,2105],[1878,2155],[288,2155]],"region":{"top_left_x":287,"top_left_y":2105,"width":1591,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09ec1710dc3141d695f304eb2b0e08ca","type":"text","conversion_output":true,"text":"hazard ratio \\(=0.776\\), it is calculated that a total of 504 deaths need to be observed. This","text_display":" hazard ratio \\(=0.776\\), it is calculated that a total of 504 deaths need to be observed. This","confidence":1,"confidence_rate":1},{"cnt":[[288,2153],[1882,2153],[1882,2206],[288,2206]],"region":{"top_left_x":287,"top_left_y":2152,"width":1596,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56d8ff523aa748cda2e6f3e4ea79fb19","type":"text","conversion_output":true,"text":"calculation assumes analysis by a one-sided log-rank test at the overall \\(2.5 \\%\\) level of","text_display":" calculation assumes analysis by a one-sided log-rank test at the overall \\(2.5 \\%\\) level of","confidence":1,"confidence_rate":1},{"cnt":[[288,2204],[1878,2204],[1878,2254],[288,2254]],"region":{"top_left_x":287,"top_left_y":2204,"width":1591,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"522ac2734a7a4bc8995e1edf209aaab1","type":"text","conversion_output":true,"text":"significance, subjects randomized to the two treatment arms in a \\(1: 1\\) ratio, and a 3 -look group","text_display":" significance, subjects randomized to the two treatment arms in a \\(1: 1\\) ratio, and a 3 -look group","confidence":0.9306640625,"confidence_rate":0.9993223344177381},{"cnt":[[288,2252],[1880,2252],[1880,2301],[288,2301]],"region":{"top_left_x":287,"top_left_y":2251,"width":1593,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63d0e255735d4eb4a46b082d8cb544bc","type":"text","conversion_output":true,"text":"sequential design with a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\)-spending function using","text_display":" sequential design with a Lan-DeMets (O'Brien-Fleming) \\(\\alpha\\)-spending function using","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[288,2299],[1880,2299],[1880,2348],[288,2348]],"region":{"top_left_x":287,"top_left_y":2298,"width":1593,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab23c9834019484dbe122572f9c4d6b8","type":"text","conversion_output":true,"text":"information fractions of \\(63 \\%, 83 \\%\\) and \\(100 \\%\\). Based on the same number of subjects that are","text_display":" information fractions of \\(63 \\%, 83 \\%\\) and \\(100 \\%\\). Based on the same number of subjects that are","confidence":0.975597620010376,"confidence_rate":0.9997529799928961},{"cnt":[[288,2346],[1878,2346],[1878,2398],[288,2398]],"region":{"top_left_x":287,"top_left_y":2346,"width":1591,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e1b7d395a8542e6b04790651ef08514","type":"text","conversion_output":true,"text":"planned to be enrolled in this study to provide sufficient power for the primary endpoint (i.e.,","text_display":" planned to be enrolled in this study to provide sufficient power for the primary endpoint (i.e.,","confidence":0.9975600242614746,"confidence_rate":0.9999758125961802},{"cnt":[[288,2396],[1878,2396],[1878,2447],[288,2447]],"region":{"top_left_x":287,"top_left_y":2395,"width":1591,"height":53},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de84c0cf93314be6bb702e34e220b290","type":"text","conversion_output":true,"text":"1500 subjects), and assuming losses to follow-up for OS of \\(3 \\%\\) yearly, it is estimated that these","text_display":" 1500 subjects), and assuming losses to follow-up for OS of \\(3 \\%\\) yearly, it is estimated that these","confidence":1,"confidence_rate":1},{"cnt":[[288,2443],[1880,2443],[1880,2494],[288,2494]],"region":{"top_left_x":287,"top_left_y":2442,"width":1593,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"429eba227b6443ddb530e4d4f7473cb7","type":"text","conversion_output":true,"text":"504 deaths will be observed approximately 63 months after the randomization date of the first","text_display":" 504 deaths will be observed approximately 63 months after the randomization date of the first","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[288,2492],[1880,2492],[1880,2542],[288,2542]],"region":{"top_left_x":287,"top_left_y":2492,"width":1593,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e6d3b1c55f24772af0f2bd7bca39129","type":"text","conversion_output":true,"text":"subject. Therefore the cut-off date for the final analysis of OS will be approximately 21 months","text_display":" subject. Therefore the cut-off date for the final analysis of OS will be approximately 21 months","confidence":0.984375,"confidence_rate":0.9998485849551061}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-131","page":131,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4c01476a7024b29bee503c508928e8e","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35aa388a350d46b9b2c248ecf923b022","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,206],[1876,206],[1876,247],[1611,247]],"region":{"top_left_x":1611,"top_left_y":206,"width":265,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"903ba7ad89a9465da197884adc35a68e","type":"page_info","conversion_output":false,"text":"Page 131 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf3994451ba1437baf742b79a2682f5c","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,251],[1871,251],[1871,290],[1414,290]],"region":{"top_left_x":1413,"top_left_y":251,"width":459,"height":40},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bcd71e9cecb4724850746592513c229","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,346],[1876,346],[1876,397],[288,397]],"region":{"top_left_x":287,"top_left_y":345,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79cf67b7992d44fd94434a7050006377","type":"text","conversion_output":true,"text":"after the cut-off date for the final analysis of DFS. These calculations were made using the","text_display":"\nafter the cut-off date for the final analysis of DFS. These calculations were made using the","confidence":1,"confidence_rate":1},{"cnt":[[288,391],[746,391],[746,445],[288,445]],"region":{"top_left_x":287,"top_left_y":391,"width":459,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e9d27fba1cb4271a9711f61192f8a39","type":"text","conversion_output":true,"text":"software package East 6.4.","text_display":" software package East 6.4.","confidence":1,"confidence_rate":1},{"cnt":[[284,477],[1412,477],[1412,544],[284,544]],"region":{"top_left_x":283,"top_left_y":476,"width":1129,"height":68},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e05f4a87c8b499f88198efc1c50c47d","type":"section_header","conversion_output":false,"children_ids":["3bc464883d7b494f88cce62b617a2a8f"],"text":"","text_display":""},{"cnt":[[288,481],[1405,481],[1405,539],[288,539]],"region":{"top_left_x":287,"top_left_y":481,"width":1119,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bc464883d7b494f88cce62b617a2a8f","type":"text","conversion_output":true,"parent_id":"0e05f4a87c8b499f88198efc1c50c47d","text":"10.10 Sample size consideration in the sub-study","text_display":"\n\n\\subsection*{10.10 Sample size consideration in the sub-study}","confidence":1,"confidence_rate":1},{"cnt":[[288,554],[1880,554],[1880,608],[288,608]],"region":{"top_left_x":287,"top_left_y":554,"width":1593,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f41c49d41e3146b4bcae5904d7331188","type":"text","conversion_output":true,"text":"Enrollment into the sub-study will end when the enrollment into the main study has been","text_display":"\n\nEnrollment into the sub-study will end when the enrollment into the main study has been","confidence":1,"confidence_rate":1},{"cnt":[[288,604],[1878,604],[1878,655],[288,655]],"region":{"top_left_x":287,"top_left_y":603,"width":1591,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"843c2f74a3784e33a7f1811fe0a9f6a4","type":"text","conversion_output":true,"text":"completed. This section explores the impact of different sample sizes on testing DFS hypotheses","text_display":" completed. This section explores the impact of different sample sizes on testing DFS hypotheses","confidence":1,"confidence_rate":1},{"cnt":[[288,649],[707,649],[707,703],[288,703]],"region":{"top_left_x":287,"top_left_y":648,"width":420,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"453ebaee945a4ccfa9a093755b577bdf","type":"text","conversion_output":true,"text":"in biomarker subgroups.","text_display":" in biomarker subgroups.","confidence":1,"confidence_rate":1},{"cnt":[[288,718],[1880,718],[1880,771],[288,771]],"region":{"top_left_x":287,"top_left_y":717,"width":1593,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cca78518905142458ec92a29775ad189","type":"text","conversion_output":true,"text":"It is assumed that canakinumab will result in a \\(28.4 \\%\\) reduction in hazard rate for DFS (hazard","text_display":"\nIt is assumed that canakinumab will result in a \\(28.4 \\%\\) reduction in hazard rate for DFS (hazard","confidence":1,"confidence_rate":1},{"cnt":[[288,767],[1880,767],[1880,819],[288,819]],"region":{"top_left_x":287,"top_left_y":766,"width":1593,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0e3de3f919d40f79431497fa86af123","type":"text","conversion_output":true,"text":"ratio of 0.716 ) in the biomarker subgroup of interest assessed at pre/post-surgery and","text_display":" ratio of 0.716 ) in the biomarker subgroup of interest assessed at pre/post-surgery and","confidence":0.9858684539794922,"confidence_rate":0.9998501970416489},{"cnt":[[288,816],[1880,816],[1880,866],[288,866]],"region":{"top_left_x":287,"top_left_y":816,"width":1593,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f909548e65b04b6095bcbcb4c320a99e","type":"text","conversion_output":true,"text":"approximately \\(50 \\%\\) enrolled subjects in the sub-study are expected to be randomized in the","text_display":" approximately \\(50 \\%\\) enrolled subjects in the sub-study are expected to be randomized in the","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[288,864],[1882,864],[1882,913],[288,913]],"region":{"top_left_x":287,"top_left_y":863,"width":1596,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63616a59baf24481a892cebcf6367028","type":"text","conversion_output":true,"text":"main study. Assuming an equal distribution of subjects across the biomarker subgroups of","text_display":" main study. Assuming an equal distribution of subjects across the biomarker subgroups of","confidence":1,"confidence_rate":1},{"cnt":[[288,911],[1880,911],[1880,965],[288,965]],"region":{"top_left_x":287,"top_left_y":910,"width":1593,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccd1d303e33b447c8e64dd62ed78cf8a","type":"text","conversion_output":true,"text":"interest and a similar DFS event rate ( \\(\\sim 26 \\%\\) ) from all randomized subjects is expected to be","text_display":" interest and a similar DFS event rate ( \\(\\sim 26 \\%\\) ) from all randomized subjects is expected to be","confidence":0.9975600242614746,"confidence_rate":0.9999758125961802},{"cnt":[[288,958],[1880,958],[1880,1010],[288,1010]],"region":{"top_left_x":287,"top_left_y":958,"width":1593,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63d81dedc23743f0bf3461520060b302","type":"text","conversion_output":true,"text":"observed 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In cases where the subject's representative gives consent, the subject should be","text_display":" subject. In cases where the subject's representative gives consent, the subject should be","confidence":1,"confidence_rate":1},{"cnt":[[288,795],[1876,795],[1876,844],[288,844]],"region":{"top_left_x":287,"top_left_y":794,"width":1589,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3e1dcd5dbf447329e041238ab66c485","type":"text","conversion_output":true,"text":"informed about the study to the extent possible given his/her understanding. If the subject is","text_display":" informed about the study to the extent possible given his/her understanding. 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If there is any question that the subject will not reliably comply, they","text_display":" duration of the study. 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syringe}","confidence":1,"confidence_rate":1},{"cnt":[[288,722],[1878,722],[1878,776],[288,776]],"region":{"top_left_x":287,"top_left_y":721,"width":1591,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4eda11194ae415d823a43abe30d09ed","type":"text","conversion_output":true,"text":"This safety syringe consists of the actual prefilled syringe and a safety device type X100L (CE-","text_display":"\n\nThis safety syringe consists of the actual prefilled syringe and a safety device type X100L (CE","confidence":0.9404520988464355,"confidence_rate":0.9993923177520999},{"cnt":[[288,769],[1364,769],[1364,821],[288,821]],"region":{"top_left_x":287,"top_left_y":769,"width":1078,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e041cdc1e1f6436b9b953bc03e774dc3","type":"text","conversion_output":true,"text":"marked and 510(k) K060743 cleared) from SafetySyringes, Inc.","text_display":"marked and 510(k) K060743 cleared) from SafetySyringes, Inc.","confidence":1,"confidence_rate":1},{"cnt":[[309,913],[1834,911],[1835,1432],[309,1434]],"region":{"top_left_x":308,"top_left_y":910,"width":1528,"height":525},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56f0c18fbfd649fbaa9b336b0e92f025","type":"diagram","conversion_output":true,"text":"","text_display":"\n![](https://cdn.mathpix.com/cropped/dd675652-6f7c-4d74-a978-285e9b45665d-140.jpg?height=525&width=1528&top_left_y=910&top_left_x=308)"},{"cnt":[[288,1491],[1878,1491],[1878,1543],[288,1543]],"region":{"top_left_x":287,"top_left_y":1491,"width":1591,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"688c38f72bc5417fbd10703b16fd23bc","type":"text","conversion_output":true,"text":"This needle guard system is intended to aid in the protection of healthcare professionals, subjects","text_display":"\n\nThis needle guard system is intended to aid in the protection of healthcare professionals, subjects","confidence":0.9980475902557373,"confidence_rate":0.9999812086555921},{"cnt":[[288,1538],[1878,1538],[1878,1592],[288,1592]],"region":{"top_left_x":287,"top_left_y":1538,"width":1591,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e26c2b7e8348b5b5b4e4b67cd00944","type":"text","conversion_output":true,"text":"who self-inject doctor prescribed medications, and individuals that assist self- injecting subjects","text_display":" who self-inject doctor prescribed medications, and individuals that assist self- injecting subjects","confidence":0.99072265625,"confidence_rate":0.9999103824165342},{"cnt":[[288,1588],[793,1588],[793,1635],[288,1635]],"region":{"top_left_x":287,"top_left_y":1587,"width":506,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2ffafd1822b475495cb52d6ca2f3f4f","type":"text","conversion_output":true,"text":"form accidental needle 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Do not open the sealed outer box until you are ready to use the safety syringe.","text_display":"\n1. Do not open the sealed outer box until you are ready to use the safety syringe.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[288,1856],[1876,1856],[1876,1910],[288,1910]],"region":{"top_left_x":287,"top_left_y":1856,"width":1589,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84f67c8a335d4201ad8367ce9f5ff7fd","type":"text","conversion_output":true,"text":"2. Do not use the safety syringe if either the seal on the outer box or the plastic wrapper is","text_display":"\n2. Do not use the safety syringe if either the seal on the outer box or the plastic wrapper is","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[350,1904],[1089,1904],[1089,1955],[350,1955]],"region":{"top_left_x":350,"top_left_y":1903,"width":740,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38f100ca8f6449a389ed95cdbdd774d3","type":"text","conversion_output":true,"text":"broken, as it may be not safe for you to use.","text_display":" broken, as it may be not safe for you to use.","confidence":1,"confidence_rate":1},{"cnt":[[288,1959],[1566,1959],[1566,2013],[288,2013]],"region":{"top_left_x":287,"top_left_y":1959,"width":1280,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e5ff11779ae429482bf5def9bea6634","type":"text","conversion_output":true,"text":"3. Never leave the safety syringe lying around where other might tamper it.","text_display":"\n3. Never leave the safety syringe lying around where other might tamper it.","confidence":1,"confidence_rate":1},{"cnt":[[288,2011],[1880,2011],[1880,2065],[288,2065]],"region":{"top_left_x":287,"top_left_y":2010,"width":1593,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f2add0e7574c46bed4952a09d5fcd3","type":"text","conversion_output":true,"text":"4. Be careful not to touch the Safety Fingers at any time. By touching them, the safety syringe","text_display":"\n4. Be careful not to touch the Safety Fingers at any time. By touching them, the safety syringe","confidence":1,"confidence_rate":1},{"cnt":[[350,2062],[655,2062],[655,2116],[350,2116]],"region":{"top_left_x":350,"top_left_y":2062,"width":306,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f21455f5ef142bcb05e7216bfda56bb","type":"text","conversion_output":true,"text":"may self-activate.","text_display":" may self-activate.","confidence":1,"confidence_rate":1},{"cnt":[[288,2116],[1515,2116],[1515,2170],[288,2170]],"region":{"top_left_x":287,"top_left_y":2116,"width":1228,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d2dbcf4ab8e4ddb9aba052b179af5c2","type":"text","conversion_output":true,"text":"5. Do not remove the needle cap until just before you give the injection.","text_display":"\n5. Do not remove the needle cap until just before you give the injection.","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[288,2170],[1880,2170],[1880,2224],[288,2224]],"region":{"top_left_x":287,"top_left_y":2169,"width":1593,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1daeda3827d84012a5f367e00b0bd1f1","type":"text","conversion_output":true,"text":"6. The safety syringe cannot be re-used. Dispose of the used safety syringe immediately after","text_display":"\n6. The safety syringe cannot be re-used. Dispose of the used safety syringe immediately after","confidence":1,"confidence_rate":1},{"cnt":[[350,2221],[1682,2221],[1682,2271],[350,2271]],"region":{"top_left_x":350,"top_left_y":2221,"width":1333,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0afb794f0b5c4e25862948c51eb55ccb","type":"text","conversion_output":true,"text":"use in a sharps container OR according to the regulatory needs of your country.","text_display":" use in a sharps container OR according to the regulatory needs of your country.","confidence":0.99755859375,"confidence_rate":0.999970900526472}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"dd675652-6f7c-4d74-a978-285e9b45665d-141","page":141,"lines":[{"cnt":[[292,206],[423,206],[423,243],[292,243]],"region":{"top_left_x":292,"top_left_y":206,"width":132,"height":37},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5264435b84e141a990e448f1144be30c","type":"page_info","conversion_output":false,"text":"Novartis","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[988,206],[1179,206],[1179,243],[988,243]],"region":{"top_left_x":988,"top_left_y":206,"width":192,"height":37},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c4f2442a2cb4a47a2991dc9784bd94f","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1611,206],[1876,206],[1876,247],[1611,247]],"region":{"top_left_x":1611,"top_left_y":206,"width":265,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0c74c18103c74da780a7299db3a584f9","type":"page_info","conversion_output":false,"text":"Page 141 of 144","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,254],[883,254],[883,294],[288,294]],"region":{"top_left_x":287,"top_left_y":253,"width":597,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61dae29784384ff4af6b116724e1eadd","type":"page_info","conversion_output":false,"text":"Amended Protocol Version 03 (Clean)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1416,254],[1871,254],[1871,290],[1416,290]],"region":{"top_left_x":1415,"top_left_y":253,"width":457,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d26c5fed23e4651878027249c742ed9","type":"page_info","conversion_output":false,"text":"Protocol No. CACZ885T2301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,339],[874,339],[874,397],[288,397]],"region":{"top_left_x":287,"top_left_y":339,"width":588,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9b4077b286b4ca1b0a8090751cb7e91","type":"section_header","conversion_output":false,"children_ids":["d5a6082528a84eaaab657ea99c096127"],"text":"","text_display":""},{"cnt":[[292,344],[870,344],[870,397],[292,397]],"region":{"top_left_x":292,"top_left_y":343,"width":579,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5a6082528a84eaaab657ea99c096127","type":"text","conversion_output":true,"parent_id":"f9b4077b286b4ca1b0a8090751cb7e91","text":"Storage of the safety syringe","text_display":"\n\n\\section*{Storage of the safety syringe}","confidence":1,"confidence_rate":1},{"cnt":[[292,404],[1876,404],[1876,453],[292,453]],"region":{"top_left_x":292,"top_left_y":403,"width":1584,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbea08069b9f49f39341a09922a0567c","type":"text","conversion_output":true,"text":"1. Store the safety syringe sealed in its outer box in the refrigerator between \\(2^{\\circ} C\\) and \\(8^{\\circ} C\\) ( \\(36^{\\circ} F\\)","text_display":"\n1. Store the safety syringe sealed in its outer box in the refrigerator between \\(2^{\\circ} C\\) and \\(8^{\\circ} C\\) ( \\(36^{\\circ} F\\)","confidence":0.595900297164917,"confidence_rate":0.9962557091971944},{"cnt":[[352,451],[1796,451],[1796,501],[352,501]],"region":{"top_left_x":352,"top_left_y":451,"width":1445,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d967121ee55a4edb9b3b4b9b1cd93ed6","type":"text","conversion_output":true,"text":"and \\(46^{\\circ} F\\) ). DO NOT STORE IT IN THE FREEZER AND PROTECT FROM LIGHT.","text_display":" and \\(46^{\\circ} F\\) ). DO NOT STORE IT IN THE FREEZER AND PROTECT FROM LIGHT.","confidence":0.9917030334472656,"confidence_rate":0.9999008194668199},{"cnt":[[288,507],[1876,507],[1876,556],[288,556]],"region":{"top_left_x":287,"top_left_y":507,"width":1589,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a13fdd5a4e61417c90390954a0b3ccc5","type":"text","conversion_output":true,"text":"2. Remember to take the safety syringe out of the refrigerator and allow it to reach room","text_display":"\n2. Remember to take the safety syringe out of the refrigerator and allow it to reach room","confidence":1,"confidence_rate":1},{"cnt":[[352,554],[1420,554],[1420,604],[352,604]],"region":{"top_left_x":352,"top_left_y":554,"width":1069,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"351e46b7fcf54378a5debe6d547ff80b","type":"text","conversion_output":true,"text":"temperature before preparing it for injection (15 to 30 minutes).","text_display":" temperature before preparing it for injection (15 to 30 minutes).","confidence":0.8361530303955078,"confidence_rate":0.9975517193106238},{"cnt":[[288,610],[1876,610],[1876,660],[288,660]],"region":{"top_left_x":287,"top_left_y":610,"width":1589,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e42bf41e9f440ebbd0a0f5a72ba9fc2","type":"text","conversion_output":true,"text":"3. Do not use the safety syringe after the expiration date shown on the outer box or syringe","text_display":"\n3. Do not use the safety syringe after the expiration date shown on the outer box or syringe","confidence":1,"confidence_rate":1},{"cnt":[[352,657],[1388,657],[1388,707],[352,707]],"region":{"top_left_x":352,"top_left_y":657,"width":1036,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fabc614c5917480fb11551116858c0e1","type":"text","conversion_output":true,"text":"label. If it has expired, return the entire pack to the pharmacy.","text_display":" label. 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If you need more than one injection at a time, repeat the injection in the opposite thigh or","text_display":" arm. If you need more than one injection at a time, repeat the injection in the opposite thigh or","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[288,967],[372,967],[372,1003],[288,1003]],"region":{"top_left_x":287,"top_left_y":966,"width":85,"height":38},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf6e4f68a04d4fc2be54bb47018e98ce","type":"text","conversion_output":true,"text":"arm.","text_display":" arm.","confidence":1,"confidence_rate":1},{"cnt":[[288,1044],[1137,1044],[1137,1102],[288,1102]],"region":{"top_left_x":287,"top_left_y":1044,"width":850,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"746bf36d2e984c879969135d7b260e99","type":"section_header","conversion_output":false,"children_ids":["76500cabdb4a4638896ad95d73c3d2a7"],"text":"","text_display":""},{"cnt":[[292,1048],[1130,1048],[1130,1098],[292,1098]],"region":{"top_left_x":292,"top_left_y":1048,"width":839,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76500cabdb4a4638896ad95d73c3d2a7","type":"text","conversion_output":true,"parent_id":"746bf36d2e984c879969135d7b260e99","text":"Preparing the safety syringe ready for use","text_display":"\n\n\\section*{Preparing the safety syringe ready for use}","confidence":1,"confidence_rate":1},{"cnt":[[292,1109],[1878,1109],[1878,1158],[292,1158]],"region":{"top_left_x":292,"top_left_y":1108,"width":1586,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b6f448d4ad34a649eb7d1bec8a5e03a","type":"text","conversion_output":true,"text":"1. Take the box containing the safety syringe out of the refrigerator and leave it unopened for","text_display":"\n1. Take the box containing the safety syringe out of the refrigerator and leave it unopened for","confidence":1,"confidence_rate":1},{"cnt":[[352,1156],[1351,1156],[1351,1205],[352,1205]],"region":{"top_left_x":352,"top_left_y":1155,"width":1000,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5d46acf92d843e59f16b8c15a9861a8","type":"text","conversion_output":true,"text":"about 15 to 30 minutes so that it reaches room temperature.","text_display":" about 15 to 30 minutes so that it reaches room temperature.","confidence":1,"confidence_rate":1},{"cnt":[[288,1210],[1878,1210],[1878,1261],[288,1261]],"region":{"top_left_x":287,"top_left_y":1209,"width":1591,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e82356913154f16b878dc0d3e9af02b","type":"text","conversion_output":true,"text":"2. When you are ready to use the safety syringe, wash your hands thoroughly with soap and","text_display":"\n2. 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