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Version No. & Effective Date & Summary of Change(s) \\\\\n\\hline Draft V0.1 & 27Dec2019 & New Document \\\\\n\\hline Draft V0.2 & 16Jan2020 & Updated per sponsor comments received by 02Jan2020. \\\\\n\\hline Draft V0.3 & 05Feb2020 & Updated per sponsor comments received by 28Jan2020. \\\\\n\\hline Draft V0.3 & 11Feb2020 & Updated per Biostatistician comments received by 11Feb2020. \\\\\n\\hline Draft V0. 4 & 13Feb2020 & Updated per sponsor comments received by 12Feb2020. \\\\\n\\hline Final V1 & 14Feb2020 & SAP V1 finalization. \\\\\n\\hline Draft V1.1 & 28Apr2020 & Updated as programming comments and Full Shell comments. \\\\\n\\hline Draft V1.2 & 16Nov2020 & Updated as DMC dry run programming comments and Full Shell comments. \\\\\n\\hline Draft V1.3 & 29Apr2021 & \\begin{tabular}{l}\nUpdated as DMC2 dry run programming comments and Full Shell comments. \\\\\n- Appendix 3. 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Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[260,238],[843,238],[843,286],[260,286]],"region":{"top_left_x":260,"top_left_y":237,"width":583,"height":49},"line":4,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb77665df448461bb33124f5bed5ce28","type":"text","conversion_output":true,"text":"- Comparator: Gefitinib ( \\(n =190\\) )","text_display":"\n- Comparator: Gefitinib ( \\(n =190\\) 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will be randomized and stratified by:","text_display":"\n\nSubject will be randomized and stratified by:","confidence":1,"confidence_rate":1},{"cnt":[[258,423],[797,423],[797,471],[258,471]],"region":{"top_left_x":258,"top_left_y":422,"width":540,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b6a8254be27d4210bc9f8e705390376d","type":"text","conversion_output":true,"text":"- Race (Asian vs. Non-Asian)","text_display":"\n- Race (Asian vs. Non-Asian)","confidence":1,"confidence_rate":1},{"cnt":[[260,493],[955,493],[955,541],[260,541]],"region":{"top_left_x":260,"top_left_y":493,"width":695,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f454b8627414b4e9d7f05b85f6cc63a","type":"text","conversion_output":true,"text":"- Mutation status (Ex19del vs. L858R).","text_display":"\n- Mutation status (Ex19del vs. L858R).","confidence":1,"confidence_rate":1},{"cnt":[[192,557],[569,557],[569,610],[192,610]],"region":{"top_left_x":191,"top_left_y":557,"width":378,"height":53},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"43a6654fec894b7c9d7969da1203c830","type":"section_header","conversion_output":false,"children_ids":["18a37e5d932947389dd98ec927e73a91"],"text":"","text_display":""},{"cnt":[[196,562],[564,562],[564,605],[196,605]],"region":{"top_left_x":196,"top_left_y":561,"width":369,"height":45},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"18a37e5d932947389dd98ec927e73a91","type":"text","conversion_output":true,"parent_id":"43a6654fec894b7c9d7969da1203c830","text":"Treatment Duration","text_display":"\n\n\\section*{Treatment Duration}","confidence":1,"confidence_rate":1},{"cnt":[[196,630],[1869,630],[1869,678],[196,678]],"region":{"top_left_x":196,"top_left_y":630,"width":1673,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1e30810b9b004931b71678e2e44698e9","type":"text","conversion_output":true,"text":"The initial dose of Lazertinib 240 mg ( 3 tablets of 80 mg Lazertinib) once daily can be reduced to","text_display":"\n\nThe initial dose of Lazertinib 240 mg ( 3 tablets of 80 mg Lazertinib) once daily can be reduced to","confidence":0.6399995423853397,"confidence_rate":0.9961928398890977},{"cnt":[[196,678],[1871,678],[1871,726],[196,726]],"region":{"top_left_x":196,"top_left_y":678,"width":1675,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4af62f9c99934ce08aa35ebab99a7f77","type":"text","conversion_output":true,"text":"160 mg once daily (2 tablets of 80 mg Lazertinib). The initial dose for Gefitinib ( 250 mg once daily)","text_display":" 160 mg once daily (2 tablets of 80 mg Lazertinib). The initial dose for Gefitinib ( 250 mg once daily)","confidence":0.9956073760986328,"confidence_rate":0.9999626930703339},{"cnt":[[196,726],[1871,726],[1871,774],[196,774]],"region":{"top_left_x":196,"top_left_y":726,"width":1675,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bbfbba51c10e45bd830a9dd98cb8d29b","type":"text","conversion_output":true,"text":"cannot be reduced to a lower dose. The dose of Gefitinib may be withheld or discontinued if clinically","text_display":" cannot be reduced to a lower dose. The dose of Gefitinib may be withheld or discontinued if clinically","confidence":1,"confidence_rate":1},{"cnt":[[196,772],[1871,772],[1871,820],[196,820]],"region":{"top_left_x":196,"top_left_y":772,"width":1675,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4273f6892068429abda8c05a1517b6f5","type":"text","conversion_output":true,"text":"indicated at the discretion of the Investigator. Any change from the dosing schedule, dose","text_display":" indicated at the discretion of the Investigator. Any change from the dosing schedule, dose","confidence":1,"confidence_rate":1},{"cnt":[[196,818],[1081,818],[1081,870],[196,870]],"region":{"top_left_x":196,"top_left_y":817,"width":885,"height":54},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"602e964972da4da0b60d6e75ec3a0862","type":"text","conversion_output":true,"text":"interruptions, or dose reductions should be recorded.","text_display":" interruptions, or dose reductions should be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[196,891],[1524,891],[1524,939],[196,939]],"region":{"top_left_x":196,"top_left_y":890,"width":1328,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"533b071a282b4898ac49ac14266c31a8","type":"text","conversion_output":true,"text":"At each dispensing visit, sufficient study treatment will be dispensed as follow:","text_display":"\n\nAt each dispensing visit, sufficient study treatment will be dispensed as follow:","confidence":1,"confidence_rate":1},{"cnt":[[258,959],[1716,959],[1716,1007],[258,1007]],"region":{"top_left_x":258,"top_left_y":959,"width":1458,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ce30ae1ececb4608ae78a984466310a1","type":"text","conversion_output":true,"text":"- Cycle 1 to Cycle 4: 21 days plus the quantity covering the duration of visit window","text_display":"\n- Cycle 1 to Cycle 4: 21 days plus the quantity covering the duration of visit window","confidence":0.5537452697753906,"confidence_rate":0.9938621380692005},{"cnt":[[258,1028],[1684,1028],[1684,1076],[258,1076]],"region":{"top_left_x":258,"top_left_y":1027,"width":1426,"height":49},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e286fed76af74221b1ef569f92009575","type":"text","conversion_output":true,"text":"- Cycle 5 onwards: 42 days plus the quantity covering the duration of visit window","text_display":"\n- Cycle 5 onwards: 42 days plus the quantity covering the duration of visit window","confidence":1,"confidence_rate":1},{"cnt":[[196,1096],[1007,1096],[1007,1144],[196,1144]],"region":{"top_left_x":196,"top_left_y":1096,"width":812,"height":49},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6d0fbb1e881445c9bbd2b6e61ef86840","type":"figure_label","conversion_output":false,"text":"Table 1. 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If, due to study treatment related toxicity, a patient requires a dose interruption of \\(>21\\)","text_display":" treatment. 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See Appendix . for further details on post progression cross-over to Lazertinib.","text_display":" required. 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For binomial variables, the normal approximation methods will be employed unless otherwise","confidence":1,"confidence_rate":1},{"cnt":[[196,2143],[1871,2143],[1871,2195],[196,2195]],"region":{"top_left_x":196,"top_left_y":2142,"width":1675,"height":54},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"01d80cf7c2344d8b890d7d3a3f65ca91","type":"text","conversion_output":true,"text":"specified. Confidence intervals ( 2 -sided and \\(95 \\%\\) ) will be presented to one more decimal place than","text_display":" specified. 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However, if there is evidence that measurements are taken on","text_display":" before first study drug administration. However, if there is evidence that measurements are taken on","confidence":1,"confidence_rate":1},{"cnt":[[196,2049],[1871,2049],[1871,2097],[196,2097]],"region":{"top_left_x":196,"top_left_y":2049,"width":1675,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2418c8dff7b64358b08e03c5f90552aa","type":"text","conversion_output":true,"text":"the same day as administration of first IP, then only those values taken strictly prior to the time of IP","text_display":" the same day as administration of first IP, then only those values taken strictly prior to the time of IP","confidence":1,"confidence_rate":1},{"cnt":[[196,2097],[1871,2097],[1871,2145],[196,2145]],"region":{"top_left_x":196,"top_left_y":2097,"width":1675,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8a2dc31ef9b54503af4ab67de457e7f9","type":"text","conversion_output":true,"text":"administration or previous day(s) (closest to first 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to calculated visit windows (using study day).","confidence":1,"confidence_rate":1},{"cnt":[[196,420],[1871,420],[1871,471],[196,471]],"region":{"top_left_x":196,"top_left_y":420,"width":1675,"height":51},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f5bb6320ebd44c249134fa5902dd3073","type":"text","conversion_output":true,"text":"The time windows should be exhaustive so that data recorded at any time point has the potential to","text_display":"\n\nThe time windows should be exhaustive so that data recorded at any time point has the potential to","confidence":1,"confidence_rate":1},{"cnt":[[194,471],[1871,471],[1871,516],[194,516]],"region":{"top_left_x":194,"top_left_y":470,"width":1677,"height":47},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5db8d687a23048f08071b45a20ee9eae","type":"text","conversion_output":true,"text":"be summarized. 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plots being produced that contain many cells with meaningless","confidence":1,"confidence_rate":1},{"cnt":[[320,1389],[1871,1389],[1871,1439],[320,1439]],"region":{"top_left_x":319,"top_left_y":1388,"width":1552,"height":52},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a3ba1af069948e4887a54168189e41c","type":"text","conversion_output":true,"text":"data, summary statistics will be presented where at least 10 patients in either treatment group","text_display":" data, summary statistics will be presented where at least 10 patients in either treatment group","confidence":1,"confidence_rate":1},{"cnt":[[320,1437],[975,1437],[975,1487],[320,1487]],"region":{"top_left_x":319,"top_left_y":1436,"width":657,"height":52},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62d600e33e124e6b824bcb0508f77800","type":"text","conversion_output":true,"text":"have data recorded at a particular visit.","text_display":" have data 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Measurement value at Visit - Baseline Value (Baseline)","confidence":0.8182500392967995,"confidence_rate":0.9976429314638801},{"cnt":[[260,1750],[1871,1750],[1871,1802],[260,1802]],"region":{"top_left_x":260,"top_left_y":1749,"width":1611,"height":54},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e4737ce06c84c0da4fb3a4c5c3bc289","type":"text","conversion_output":true,"text":"- Percentage Change at Visit \\(=\\) (Measurement value at Visit - Baseline Value) \\(/\\) Baseline Value","text_display":"\n- Percentage Change at Visit \\(=\\) (Measurement value at Visit - Baseline Value) \\(/\\) Baseline 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appropriate.","confidence":1,"confidence_rate":1},{"cnt":[[196,1937],[1144,1937],[1144,1990],[196,1990]],"region":{"top_left_x":196,"top_left_y":1937,"width":949,"height":53},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2eba33e27e7645abb6a6caf552c50269","type":"text","conversion_output":true,"text":"Duration is calculated as (excluding treatment duration):","text_display":"\nDuration is calculated as (excluding treatment duration):","confidence":1,"confidence_rate":1},{"cnt":[[260,2006],[1094,2006],[1094,2058],[260,2058]],"region":{"top_left_x":260,"top_left_y":2005,"width":835,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2fb116eab9d540c68c0fd1b18d48a067","type":"text","conversion_output":true,"text":"- Duration \\((\\) days \\()=(\\) End Date - Start Date +1\\()\\)","text_display":"\n- Duration \\((\\) days \\()=(\\) End Date - Start Date 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discontinuation,","text_display":" the primary reasons of discontinuation including the study day of treatment discontinuation,","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[274,1311],[1871,1311],[1871,1364],[274,1364]],"region":{"top_left_x":274,"top_left_y":1311,"width":1597,"height":53},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"534653cf02ec46ad99d82187b1bceb06","type":"text","conversion_output":true,"text":"disease progression, adverse events, death, withdrawal by patient, lost to follow-up, physician's","text_display":" disease progression, adverse events, death, withdrawal by patient, lost to follow-up, 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This listing will be presented by","text_display":"\n\nA by-patient listing of analysis populations will be provided. 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If the Month","confidence":0.7610638532787561,"confidence_rate":0.9975209142251978},{"cnt":[[320,731],[1208,731],[1208,781],[320,781]],"region":{"top_left_x":319,"top_left_y":731,"width":890,"height":51},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a116c0ade1c146c6a1ed6768c4114677","type":"text","conversion_output":true,"text":"of age is missing, \"July\" of the year will be imputed.","text_display":" of age is missing, \"July\" of the year will be imputed.","confidence":1,"confidence_rate":1},{"cnt":[[260,800],[1382,800],[1382,850],[260,850]],"region":{"top_left_x":260,"top_left_y":799,"width":1123,"height":51},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0921f88eaded467b99851e19c64c02df","type":"text","conversion_output":true,"text":"- Target lesions: Lymph node only; Non-lymph node only; Both.","text_display":"\n- Target lesions: Lymph node only; Non-lymph node only; Both.","confidence":1,"confidence_rate":1},{"cnt":[[260,868],[806,868],[806,916],[260,916]],"region":{"top_left_x":260,"top_left_y":868,"width":547,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"667d706e3a5549639fd50750e17560c6","type":"text","conversion_output":true,"text":"- Non-target lesions: Yes; No.","text_display":"\n- Non-target lesions: Yes; No.","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[260,937],[784,937],[784,985],[260,985]],"region":{"top_left_x":260,"top_left_y":936,"width":524,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4c5c4cab6cb44e5a90e2ce0043ef1101","type":"text","conversion_output":true,"text":"- Cancer stage at enrollment.","text_display":"\n- Cancer stage at enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[260,1005],[893,1005],[893,1055],[260,1055]],"region":{"top_left_x":260,"top_left_y":1005,"width":634,"height":51},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cf23f96dfdbd411da69d286284d77779","type":"text","conversion_output":true,"text":"- TNM staging (Primary Tumor/T).","text_display":"\n- TNM staging (Primary Tumor/T).","confidence":1,"confidence_rate":1},{"cnt":[[260,1074],[1039,1074],[1039,1126],[260,1126]],"region":{"top_left_x":260,"top_left_y":1073,"width":780,"height":54},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"da7fda00b67c459695c2456b75047e54","type":"text","conversion_output":true,"text":"- TNM staging (Regional Lymph Nodes/N).","text_display":"\n- TNM staging (Regional Lymph Nodes/N).","confidence":1,"confidence_rate":1},{"cnt":[[260,1142],[953,1142],[953,1192],[260,1192]],"region":{"top_left_x":260,"top_left_y":1142,"width":693,"height":51},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f2d01983fdd24d3a96b7dce7a161f10e","type":"text","conversion_output":true,"text":"- TNM staging (Distant Metastasis/M).","text_display":"\n- TNM staging (Distant Metastasis/M).","confidence":1,"confidence_rate":1},{"cnt":[[260,1211],[1871,1211],[1871,1261],[260,1261]],"region":{"top_left_x":260,"top_left_y":1210,"width":1611,"height":51},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f7f18519b5849e7baea504dce9e797b","type":"text","conversion_output":true,"text":"- Location of metastasis at enrollment: Adrenal Gland; Bone; Brain; Liver; Lung; Lymph","text_display":"\n- Location of metastasis at enrollment: Adrenal Gland; Bone; Brain; Liver; Lung; Lymph","confidence":1,"confidence_rate":1},{"cnt":[[320,1261],[683,1261],[683,1307],[320,1307]],"region":{"top_left_x":319,"top_left_y":1260,"width":365,"height":47},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"13ba5f8c48a04df694afb7ca13fdbb44","type":"text","conversion_output":true,"text":"Node; Pleura; Other.","text_display":" Node; Pleura; Other.","confidence":1,"confidence_rate":1},{"cnt":[[194,1330],[1871,1330],[1871,1377],[194,1377]],"region":{"top_left_x":194,"top_left_y":1329,"width":1677,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8025ae8cdd3742d0bfea609376f4551b","type":"text","conversion_output":true,"text":"Number of metastasis locations involved. By-subject listings of demographics as well as baseline","text_display":"\n\nNumber of metastasis locations involved. By-subject listings of demographics as well as baseline","confidence":1,"confidence_rate":1},{"cnt":[[196,1377],[1606,1377],[1606,1428],[196,1428]],"region":{"top_left_x":196,"top_left_y":1377,"width":1410,"height":51},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2ec400be8b24b5988140888ce51c9e4","type":"text","conversion_output":true,"text":"characteristics and stratification factors will be provided (Listing analysis set: FAS).","text_display":" characteristics and stratification factors will be provided (Listing analysis set: FAS).","confidence":1,"confidence_rate":1},{"cnt":[[238,1485],[642,1485],[642,1537],[238,1537]],"region":{"top_left_x":237,"top_left_y":1484,"width":405,"height":54},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"96a720937c5740d4a64f7d5263723306","type":"section_header","conversion_output":false,"children_ids":["8f7c1c3beb26414199de7ef4fd30170e"],"text":"","text_display":""},{"cnt":[[242,1489],[637,1489],[637,1537],[242,1537]],"region":{"top_left_x":242,"top_left_y":1489,"width":396,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f7c1c3beb26414199de7ef4fd30170e","type":"text","conversion_output":true,"parent_id":"96a720937c5740d4a64f7d5263723306","text":"4.6 Medical History","text_display":"\n\n\\subsection*{4.6 Medical History}","confidence":1,"confidence_rate":1},{"cnt":[[196,1556],[1871,1556],[1871,1606],[196,1606]],"region":{"top_left_x":196,"top_left_y":1555,"width":1675,"height":51},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"daed0aa6f73348adb6120d1f6b0b5abf","type":"text","conversion_output":true,"text":"Medical conditions will be coded by the medical dictionary for regulatory activities (MedDRA). The","text_display":"\n\nMedical conditions will be coded by the medical dictionary for regulatory activities (MedDRA). The","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[196,1604],[1871,1604],[1871,1652],[196,1652]],"region":{"top_left_x":196,"top_left_y":1603,"width":1675,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cbdf2ec14f97443d9026f813685ded70","type":"text","conversion_output":true,"text":"final MedDRA version to be used will be decided prior to database lock (for both primary and final","text_display":" final MedDRA version to be used will be decided prior to database lock (for both primary and final","confidence":1,"confidence_rate":1},{"cnt":[[196,1654],[359,1654],[359,1702],[196,1702]],"region":{"top_left_x":196,"top_left_y":1653,"width":163,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"004802add5ff49eb98590595f2cd87d0","type":"text","conversion_output":true,"text":"analysis).","text_display":" analysis).","confidence":1,"confidence_rate":1},{"cnt":[[196,1722],[1869,1722],[1869,1770],[196,1770]],"region":{"top_left_x":196,"top_left_y":1722,"width":1673,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1ac13d5156c34d7eb2eb8aa67164a786","type":"text","conversion_output":true,"text":"Medical and surgical history/conditions present at screening will be summarized and listed (eCRF:","text_display":"\n\nMedical and surgical history/conditions present at screening will be summarized and listed (eCRF:","confidence":1,"confidence_rate":1},{"cnt":[[196,1768],[1869,1768],[1869,1816],[196,1816]],"region":{"top_left_x":196,"top_left_y":1768,"width":1673,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e8c72ba7d1714fa486d2e20be1064730","type":"text","conversion_output":true,"text":"Medical History). They will be summarized by primary system organ class (SOC) and preferred term.","text_display":" Medical History). They will be summarized by primary system organ class (SOC) and preferred term.","confidence":1,"confidence_rate":1},{"cnt":[[196,1816],[1873,1816],[1873,1866],[196,1866]],"region":{"top_left_x":196,"top_left_y":1816,"width":1678,"height":51},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"98ddcd0caab9445388a4af65718e949c","type":"text","conversion_output":true,"text":"Verbatim recorded history/conditions will be listed together with the coded terms, date of","text_display":" Verbatim recorded history/conditions will be listed together with the coded terms, date of","confidence":1,"confidence_rate":1},{"cnt":[[196,1864],[1871,1864],[1871,1912],[196,1912]],"region":{"top_left_x":196,"top_left_y":1864,"width":1675,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"530e126e11f64e33850d8a618ed79a0a","type":"text","conversion_output":true,"text":"diagnosis/surgery and whether the condition was ongoing at the time of first study drug","text_display":" diagnosis/surgery and whether the condition was ongoing at the time of first study drug","confidence":1,"confidence_rate":1},{"cnt":[[196,1914],[1871,1914],[1871,1962],[196,1962]],"region":{"top_left_x":196,"top_left_y":1914,"width":1675,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b1354e3bef8c41ef819a23bec0dd304c","type":"text","conversion_output":true,"text":"administration. The number and percentage of patients with each medical condition will be provided","text_display":" administration. The number and percentage of patients with each medical condition will be provided","confidence":1,"confidence_rate":1},{"cnt":[[196,1960],[1871,1960],[1871,2008],[196,2008]],"region":{"top_left_x":196,"top_left_y":1959,"width":1675,"height":49},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"45d06e40e77c4d328c761eaff3310fae","type":"text","conversion_output":true,"text":"in terms of decreasing frequency for SOC, and PT within SOC, in Lazertinib, and then similarly by","text_display":" in terms of decreasing frequency for SOC, and PT within SOC, in Lazertinib, and then similarly by","confidence":1,"confidence_rate":1},{"cnt":[[196,2008],[1837,2008],[1837,2058],[196,2058]],"region":{"top_left_x":196,"top_left_y":2007,"width":1641,"height":52},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"86739ea16db7451b8ec8c1dd6cf8dd5e","type":"text","conversion_output":true,"text":"decreasing frequency in Gefitinib, and then alphabetically for SOC, and PT within SOC treatment","text_display":" decreasing frequency in Gefitinib, and then alphabetically for SOC, and PT within SOC treatment","confidence":1,"confidence_rate":1},{"cnt":[[196,2079],[409,2079],[409,2122],[196,2122]],"region":{"top_left_x":196,"top_left_y":2078,"width":213,"height":45},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7fd6bf77a2124da085ac0126284c9325","type":"text","conversion_output":true,"text":"for the FAS.","text_display":" for the FAS.","confidence":1,"confidence_rate":1},{"cnt":[[196,2145],[1869,2145],[1869,2195],[196,2195]],"region":{"top_left_x":196,"top_left_y":2145,"width":1673,"height":51},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"eb43a9ba356843fa81029f3e4c4ddb22","type":"text","conversion_output":true,"text":"Additionally, the by-subject listing of medical and surgical history will also include SOC, PT,","text_display":"\n\nAdditionally, the by-subject listing of medical and surgical history will also include SOC, PT,","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[196,2193],[1380,2193],[1380,2241],[196,2241]],"region":{"top_left_x":196,"top_left_y":2193,"width":1184,"height":48},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31ea660fd2834e58a7a89be1a0e9a48e","type":"text","conversion_output":true,"text":"verbatim term, start date, end date and status etc. as provided in eCRF.","text_display":" verbatim term, start date, end date and status etc. as provided in eCRF.","confidence":0.99658203125,"confidence_rate":0.9999555357502582},{"cnt":[[240,2303],[1266,2303],[1266,2353],[240,2353]],"region":{"top_left_x":239,"top_left_y":2302,"width":1027,"height":51},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5efae44f1d3a4aa3b880956d38eaa328","type":"section_header","conversion_output":false,"children_ids":["8a0e523388af41b8a3928cf84c01cd7c"],"text":"","text_display":""},{"cnt":[[242,2307],[1263,2307],[1263,2351],[242,2351]],"region":{"top_left_x":242,"top_left_y":2307,"width":1022,"height":44},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8a0e523388af41b8a3928cf84c01cd7c","type":"text","conversion_output":true,"parent_id":"5efae44f1d3a4aa3b880956d38eaa328","text":"4.7 Prior, Concomitant and Post-treatment Medication","text_display":"\n\n\\subsection*{4.7 Prior, Concomitant and Post-treatment Medication}","confidence":1,"confidence_rate":1},{"cnt":[[196,2371],[1871,2371],[1871,2419],[196,2419]],"region":{"top_left_x":196,"top_left_y":2371,"width":1675,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"147e18109c084870b2ed50b460b8cc36","type":"text","conversion_output":true,"text":"Prior and concomitant medications will be presented for the FAS and summarized by treatment group","text_display":"\n\nPrior and concomitant medications will be presented for the FAS and summarized by treatment group","confidence":1,"confidence_rate":1},{"cnt":[[196,2421],[1871,2421],[1871,2469],[196,2469]],"region":{"top_left_x":196,"top_left_y":2421,"width":1675,"height":49},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9924bdc4f9224fb18d898b627035039c","type":"text","conversion_output":true,"text":"(eCRF Form: Prior and Concomitant Medication). Prior medication is defined as any medication","text_display":" (eCRF Form: Prior and Concomitant Medication). Prior medication is defined as any medication","confidence":1,"confidence_rate":1},{"cnt":[[196,2467],[1871,2467],[1871,2515],[196,2515]],"region":{"top_left_x":196,"top_left_y":2467,"width":1675,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"169499d300e24c0d8149811348eb5c16","type":"text","conversion_output":true,"text":"taken within the period from 28 days before first dose of study treatment. Concomitant medication is","text_display":" taken within the period from 28 days before first dose of study treatment. Concomitant medication is","confidence":1,"confidence_rate":1},{"cnt":[[196,2517],[1873,2517],[1873,2565],[196,2565]],"region":{"top_left_x":196,"top_left_y":2517,"width":1678,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7b8bb5ffccc94defb4523f3ca8acd20f","type":"text","conversion_output":true,"text":"defined as any medication taken during the treatment and until 28 days following the last dose of","text_display":" defined as any medication taken during the treatment and until 28 days following the last dose of","confidence":1,"confidence_rate":1},{"cnt":[[196,2565],[1871,2565],[1871,2616],[196,2616]],"region":{"top_left_x":196,"top_left_y":2565,"width":1675,"height":51},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"20128f84e5b643b1bc7a3906f673b2b9","type":"text","conversion_output":true,"text":"study treatment. Concomitant treatments must be recorded beginning at screening and continuing","text_display":" study treatment. 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Concomitant treatments should be also recorded","text_display":"\nuntil 28 days after the last dose of study treatment. Concomitant treatments should be also recorded","confidence":1,"confidence_rate":1},{"cnt":[[194,283],[1830,283],[1830,336],[194,336]],"region":{"top_left_x":194,"top_left_y":283,"width":1636,"height":53},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"06f9be05961f4d97808127595785778d","type":"text","conversion_output":true,"text":"beyond 28 days after the last dose of study treatment in conjunction with the following situations:","text_display":" beyond 28 days after the last dose of study treatment in conjunction with the following situations:","confidence":1,"confidence_rate":1},{"cnt":[[194,352],[1871,352],[1871,404],[194,404]],"region":{"top_left_x":194,"top_left_y":351,"width":1677,"height":54},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0db20acd6f134219b71b5e239bbbe812","type":"text","conversion_output":true,"text":"All medications taken by a patient (prescription or nonprescription, including vaccines, vitamins, and","text_display":"\nAll medications taken by a patient (prescription or nonprescription, including vaccines, vitamins, and","confidence":1,"confidence_rate":1},{"cnt":[[194,402],[1871,402],[1871,450],[194,450]],"region":{"top_left_x":194,"top_left_y":402,"width":1677,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3ef6cd5ff68f48859cd9adfea2a84758","type":"text","conversion_output":true,"text":"herbal/natural supplements) that are not the study treatment must be documented in the eCRF.","text_display":" herbal/natural supplements) that are not the study treatment must be documented in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[194,448],[1873,448],[1873,500],[194,500]],"region":{"top_left_x":194,"top_left_y":447,"width":1680,"height":54},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b10f92cc60ee4fedb0542803cac714ad","type":"text","conversion_output":true,"text":"Modification of an effective preexisting therapy should not be made for the explicit purpose of","text_display":" Modification of an effective preexisting therapy should not be made for the explicit purpose of","confidence":1,"confidence_rate":1},{"cnt":[[194,498],[1871,498],[1871,546],[194,546]],"region":{"top_left_x":194,"top_left_y":497,"width":1677,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ea07c2214fa04efe9a60c803322e0b21","type":"text","conversion_output":true,"text":"entering a patient into the study. Nonpharmacologic therapies such as electrical stimulation,","text_display":" entering a patient into the study. Nonpharmacologic therapies such as electrical stimulation,","confidence":1,"confidence_rate":1},{"cnt":[[194,544],[1649,544],[1649,596],[194,596]],"region":{"top_left_x":194,"top_left_y":543,"width":1456,"height":54},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d52665b1021d46189206c1c314935396","type":"text","conversion_output":true,"text":"acupuncture, special diets, and exercise regimens should also be recorded in the eCRF.","text_display":" acupuncture, special diets, and exercise regimens should also be recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[194,612],[1871,612],[1871,665],[194,665]],"region":{"top_left_x":194,"top_left_y":612,"width":1677,"height":53},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d177fb2178f8449f9e860f800cf101f9","type":"text","conversion_output":true,"text":"Medication start and stop dates will be compared to the date of first dose and last dose date of study","text_display":"\nMedication start and stop dates will be compared to the date of first dose and last dose date of study","confidence":0.998046875,"confidence_rate":0.9999817288133145},{"cnt":[[194,662],[1871,662],[1871,710],[194,710]],"region":{"top_left_x":194,"top_left_y":662,"width":1677,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3dc53df4335d4009b5f95b19b9772ee1","type":"text","conversion_output":true,"text":"medication to allow medications to be classified as either Prior, Concomitant or Post-treatment","text_display":" medication to allow medications to be classified as either Prior, Concomitant or Post-treatment","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[194,708],[423,708],[423,756],[194,756]],"region":{"top_left_x":194,"top_left_y":708,"width":229,"height":49},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91761de09d134dcb9c06d595c4c882fd","type":"text","conversion_output":true,"text":"medications .","text_display":" medications .","confidence":0.5927734375,"confidence_rate":0.9713655735857873},{"cnt":[[256,779],[1871,779],[1871,834],[256,834]],"region":{"top_left_x":255,"top_left_y":778,"width":1616,"height":56},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d2c642eadad64f29bede71ca396aa6d0","type":"text","conversion_output":true,"text":"- Prior medications - those taken prior to study treatment with a stop date prior to the first","text_display":"\n- Prior medications - those taken prior to study treatment with a stop date prior to the first","confidence":1,"confidence_rate":1},{"cnt":[[320,832],[726,832],[726,879],[320,879]],"region":{"top_left_x":319,"top_left_y":831,"width":408,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d47259393b7942b48b704ada20474ae3","type":"text","conversion_output":true,"text":"dose of study treatment.","text_display":" dose of study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[256,900],[1871,900],[1871,953],[256,953]],"region":{"top_left_x":255,"top_left_y":900,"width":1616,"height":53},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4c12d3dc034e4d09a5fa1581f3ea2839","type":"text","conversion_output":true,"text":"- Concomitant medications - those with a stop date on or after the first dose date of study","text_display":"\n- Concomitant medications - those with a stop date on or after the first dose date of study","confidence":1,"confidence_rate":1},{"cnt":[[320,946],[1373,946],[1373,998],[320,998]],"region":{"top_left_x":319,"top_left_y":945,"width":1054,"height":54},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"050a5563bc2c4b0f9734efce9841a4b2","type":"text","conversion_output":true,"text":"treatment (and could have started prior to or during treatment).","text_display":" treatment (and could have started prior to or during treatment).","confidence":1,"confidence_rate":1},{"cnt":[[256,1019],[1871,1019],[1871,1071],[256,1071]],"region":{"top_left_x":255,"top_left_y":1018,"width":1616,"height":54},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0150a20400de41208e6f2ea4be44fa8a","type":"text","conversion_output":true,"text":"- Post-treatment medications - those with a start date after the last dose date of study","text_display":"\n- Post-treatment medications - those with a start date after the last dose date of study","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[320,1069],[496,1069],[496,1112],[320,1112]],"region":{"top_left_x":319,"top_left_y":1069,"width":177,"height":44},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dade90a6aa9f4ce3b4f589c084d1377b","type":"text","conversion_output":true,"text":"treatment.","text_display":" treatment.","confidence":1,"confidence_rate":1},{"cnt":[[194,1135],[1871,1135],[1871,1190],[194,1190]],"region":{"top_left_x":194,"top_left_y":1135,"width":1677,"height":56},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c01e631aebd64a63940168e86a3c1a98","type":"text","conversion_output":true,"text":"Medications starting after the completion/withdrawal date will be listed but will not be classified or","text_display":"\n\nMedications starting after the completion/withdrawal date will be listed but will not be classified or","confidence":1,"confidence_rate":1},{"cnt":[[196,1183],[416,1183],[416,1231],[196,1231]],"region":{"top_left_x":196,"top_left_y":1183,"width":220,"height":49},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2a882605d9f347589de44425b9711702","type":"text","conversion_output":true,"text":"summarized.","text_display":" summarized.","confidence":1,"confidence_rate":1},{"cnt":[[194,1252],[1871,1252],[1871,1304],[194,1304]],"region":{"top_left_x":194,"top_left_y":1251,"width":1677,"height":54},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a11d32e8db374719aacfb542570ecd96","type":"text","conversion_output":true,"text":"Medications that start and stop prior to the date of first dose of study medication will be classified as","text_display":"\n\nMedications that start and stop prior to the date of first dose of study medication will be classified as","confidence":1,"confidence_rate":1},{"cnt":[[194,1302],[1871,1302],[1871,1352],[194,1352]],"region":{"top_left_x":194,"top_left_y":1302,"width":1677,"height":51},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"601434252c204d068055e093dc90d6cf","type":"text","conversion_output":true,"text":"Prior. If a medication starts before the date of first dose of study medication and stops on or after the","text_display":" Prior. If a medication starts before the date of first dose of study medication and stops on or after the","confidence":1,"confidence_rate":1},{"cnt":[[194,1348],[1871,1348],[1871,1400],[194,1400]],"region":{"top_left_x":194,"top_left_y":1347,"width":1677,"height":54},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"29fd43981f614cce8205075c502f4867","type":"text","conversion_output":true,"text":"date of first dose of study medication, then the medication will be classified as Concomitant.","text_display":" date of first dose of study medication, then the medication will be classified as Concomitant.","confidence":1,"confidence_rate":1},{"cnt":[[194,1398],[1871,1398],[1871,1446],[194,1446]],"region":{"top_left_x":194,"top_left_y":1398,"width":1677,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fbd1a1bc308e42e6815ec7d391525726","type":"text","conversion_output":true,"text":"Medications will be classified as Concomitant if they have a start date on or after the date of first","text_display":" Medications will be classified as Concomitant if they have a start date on or after the date of first","confidence":1,"confidence_rate":1},{"cnt":[[196,1444],[630,1444],[630,1496],[196,1496]],"region":{"top_left_x":196,"top_left_y":1443,"width":435,"height":54},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ac052ac1dcf44618b5a3f629de874a4c","type":"text","conversion_output":true,"text":"dose of study medication.","text_display":" dose of study medication.","confidence":1,"confidence_rate":1},{"cnt":[[196,1512],[1871,1512],[1871,1565],[196,1565]],"region":{"top_left_x":196,"top_left_y":1512,"width":1675,"height":53},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a140469339d94968ba454be93a2928c6","type":"text","conversion_output":true,"text":"If medication start and/or stop dates are missing or partial, the dates will be compared as far as","text_display":"\nIf medication start and/or stop dates are missing or partial, the dates will be compared as far as","confidence":1,"confidence_rate":1},{"cnt":[[194,1563],[1871,1563],[1871,1615],[194,1615]],"region":{"top_left_x":194,"top_left_y":1562,"width":1677,"height":54},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"79e5ece58b074b6b833c792e2f281de9","type":"text","conversion_output":true,"text":"possible with the date of first dose of study medication. Medication partial date imputation guideline","text_display":" possible with the date of first dose of study medication. Medication partial date imputation guideline","confidence":1,"confidence_rate":1},{"cnt":[[196,1613],[1871,1613],[1871,1658],[196,1658]],"region":{"top_left_x":196,"top_left_y":1612,"width":1675,"height":47},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8a183fc4e3e9459b9b497e6e457cb6b8","type":"text","conversion_output":true,"text":"is listed in section 4.2.9. Medications will be assumed to be Concomitant, unless there is clear","text_display":" is listed in section 4.2.9. Medications will be assumed to be Concomitant, unless there is clear","confidence":1,"confidence_rate":1},{"cnt":[[194,1658],[1871,1658],[1871,1706],[194,1706]],"region":{"top_left_x":194,"top_left_y":1658,"width":1677,"height":49},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c52ce841977445e9a76b9d90053f5658","type":"text","conversion_output":true,"text":"evidence (through comparison of partial dates) to suggest that the medication started prior to the first","text_display":" evidence (through comparison of partial dates) to suggest that the medication started prior to the first","confidence":1,"confidence_rate":1},{"cnt":[[194,1704],[1871,1704],[1871,1757],[194,1757]],"region":{"top_left_x":194,"top_left_y":1704,"width":1677,"height":53},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"713ad9d5200c4c6dbfbd8f7fa637582b","type":"text","conversion_output":true,"text":"dose of study medication. If there is clear evidence to suggest that the medication started prior to the","text_display":" dose of study medication. If there is clear evidence to suggest that the medication started prior to the","confidence":1,"confidence_rate":1},{"cnt":[[196,1754],[1871,1754],[1871,1802],[196,1802]],"region":{"top_left_x":196,"top_left_y":1754,"width":1675,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"49115b344bc846988063d58395b32316","type":"text","conversion_output":true,"text":"first dose of study medication and stopped prior to the first dose of study medication, the medication","text_display":" first dose of study medication and stopped prior to the first dose of study medication, the medication","confidence":1,"confidence_rate":1},{"cnt":[[196,1800],[669,1800],[669,1848],[196,1848]],"region":{"top_left_x":196,"top_left_y":1800,"width":474,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6092555d032242d5b51e363d234c7041","type":"text","conversion_output":true,"text":"will be assumed to be Prior.","text_display":" will be assumed to be Prior.","confidence":1,"confidence_rate":1},{"cnt":[[194,1869],[1871,1869],[1871,1921],[194,1921]],"region":{"top_left_x":194,"top_left_y":1868,"width":1677,"height":54},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1e8da5184e4641d3b2ae6a5c072d8964","type":"text","conversion_output":true,"text":"A summary of the number of patients with prior, current concomitant and post medications by","text_display":"\n\nA summary of the number of patients with prior, current concomitant and post medications by","confidence":1,"confidence_rate":1},{"cnt":[[194,1919],[1871,1919],[1871,1969],[194,1969]],"region":{"top_left_x":194,"top_left_y":1918,"width":1677,"height":52},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1bdd9d1afcbf4d618eaf64d92dfe20fa","type":"text","conversion_output":true,"text":"treatment group and overall will be generated for FAS. The numbers (n) and percentage will be","text_display":" treatment group and overall will be generated for FAS. The numbers (n) and percentage will be","confidence":0.9326171875,"confidence_rate":0.9992884118182371},{"cnt":[[194,1967],[1871,1967],[1871,2017],[194,2017]],"region":{"top_left_x":194,"top_left_y":1966,"width":1677,"height":52},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a9c93200017f4d49a3aa92f87a924a77","type":"text","conversion_output":true,"text":"provided by anatomical therapeutic chemistry (ATC) term level 1 and level 2 separately, coded by","text_display":" provided by anatomical therapeutic chemistry (ATC) term level 1 and level 2 separately, coded by","confidence":1,"confidence_rate":1},{"cnt":[[194,2015],[1871,2015],[1871,2065],[194,2065]],"region":{"top_left_x":194,"top_left_y":2014,"width":1677,"height":52},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e197e70e1429473b81bd369dfb6e3c09","type":"text","conversion_output":true,"text":"World Health Organization-Drug Dictionary (WHO-DD) will be provided and each subject will be","text_display":" World Health Organization-Drug Dictionary (WHO-DD) will be provided and each subject will be","confidence":1,"confidence_rate":1},{"cnt":[[194,2061],[1871,2061],[1871,2113],[194,2113]],"region":{"top_left_x":194,"top_left_y":2060,"width":1677,"height":54},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"76792b8bfd0f4c368fdce9a6dec4e25b","type":"text","conversion_output":true,"text":"counted once only under each category. (Analysis set: FAS) The final WHO DD version to be used","text_display":" counted once only under each category. (Analysis set: FAS) The final WHO DD version to be used","confidence":1,"confidence_rate":1},{"cnt":[[194,2111],[1451,2111],[1451,2163],[194,2163]],"region":{"top_left_x":194,"top_left_y":2110,"width":1257,"height":54},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d31228d76311494fbaa6a65e7b0a13f2","type":"text","conversion_output":true,"text":"will be decided prior to database lock (for both primary and final analysis).","text_display":" will be decided prior to database lock (for both primary and final analysis).","confidence":1,"confidence_rate":1},{"cnt":[[194,2179],[1871,2179],[1871,2232],[194,2232]],"region":{"top_left_x":194,"top_left_y":2179,"width":1677,"height":53},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"43422a4c9adc4e47b44552daa061463d","type":"text","conversion_output":true,"text":"A by-subject listing of prior/current concomitant/post-treatment medication will be generated 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Patients who have not progressed or have not died at the time of analysis will be","text_display":" progression. Patients who have not progressed or have not died at the time of analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[196,854],[1866,854],[1866,898],[196,898]],"region":{"top_left_x":196,"top_left_y":854,"width":1671,"height":44},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5be1d3dd255b4522879b24a1f39ed6ea","type":"text","conversion_output":true,"text":"censored at the time of the latest date of assessment from their last evaluable RECIST v1.1","text_display":" censored at the time of the latest date of assessment from their last evaluable RECIST v1.1","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[196,905],[395,905],[395,941],[196,941]],"region":{"top_left_x":196,"top_left_y":904,"width":200,"height":38},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3ff97ae2c843469c998fead02e78bbb0","type":"text","conversion_output":true,"text":"assessment.","text_display":" assessment.","confidence":1,"confidence_rate":1},{"cnt":[[196,969],[1871,969],[1871,1017],[196,1017]],"region":{"top_left_x":196,"top_left_y":968,"width":1675,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"350a1f8746a24a1ca0f02110128b5e51","type":"text","conversion_output":true,"text":"The primary efficacy endpoint, which is calculated as date of death - date of randomization +1 or","text_display":"\n\nThe primary efficacy endpoint, which is calculated as date of death - date of randomization +1 or","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[196,1019],[1871,1019],[1871,1065],[196,1065]],"region":{"top_left_x":196,"top_left_y":1018,"width":1675,"height":47},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74060531a9144a33825809d82b0130de","type":"text","conversion_output":true,"text":"date of progression - date of randomization +1 , whichever is smaller, will be analyzed based on the","text_display":" date of progression - date of randomization +1 , whichever is smaller, will be analyzed based on the","confidence":0.974278450012207,"confidence_rate":0.9997587500940792},{"cnt":[[196,1065],[1866,1065],[1866,1112],[196,1112]],"region":{"top_left_x":196,"top_left_y":1064,"width":1671,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65dc11bef2fd45628575c56e6b507fac","type":"text","conversion_output":true,"text":"FAS according to the treatment group patients were randomized by the strata they were assigned to","text_display":" FAS according to the treatment group patients were randomized by the strata they were assigned to","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[196,1112],[1871,1112],[1871,1160],[196,1160]],"region":{"top_left_x":196,"top_left_y":1112,"width":1675,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5e9518bf79b4b34b361a34e0e5a1a4f","type":"text","conversion_output":true,"text":"at randomization. PFS in the FAS will be analyzed using a log-rank test stratified by randomized","text_display":" at randomization. PFS in the FAS will be analyzed using a log-rank test stratified by randomized","confidence":1,"confidence_rate":1},{"cnt":[[196,1160],[1871,1160],[1871,1208],[196,1208]],"region":{"top_left_x":196,"top_left_y":1160,"width":1675,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5836d7156b784c1f93c699f02de892b7","type":"text","conversion_output":true,"text":"stratification factor mutation type (Ex19del versus L858R) and race (Asian versus non-Asian) using","text_display":" stratification factor mutation type (Ex19del versus L858R) and race (Asian versus non-Asian) using","confidence":1,"confidence_rate":1},{"cnt":[[196,1208],[857,1208],[857,1254],[196,1254]],"region":{"top_left_x":196,"top_left_y":1208,"width":661,"height":47},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9a5e454f483499e9c55c4360b314bbb","type":"text","conversion_output":true,"text":"the Breslow approach for handling ties.","text_display":" the Breslow approach for handling ties.","confidence":1,"confidence_rate":1},{"cnt":[[196,1279],[1866,1279],[1866,1325],[196,1325]],"region":{"top_left_x":196,"top_left_y":1279,"width":1671,"height":46},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7324c837c2f84a3ead762ad4b893e472","type":"text","conversion_output":true,"text":"Additional supportive analyses include K-M and Cox modelling approaches. PFS will be displayed","text_display":"\n\nAdditional supportive analyses include K-M and Cox modelling approaches. PFS will be displayed","confidence":1,"confidence_rate":1},{"cnt":[[196,1325],[1866,1325],[1866,1373],[196,1373]],"region":{"top_left_x":196,"top_left_y":1324,"width":1671,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"18c93b60dbb94820a77a9743685c19a7","type":"text","conversion_output":true,"text":"using Kaplan-Meier plot by treatment group. If data warrant, the number of events, medians, and","text_display":" using Kaplan-Meier plot by treatment group. If data warrant, the number of events, medians, and","confidence":1,"confidence_rate":1},{"cnt":[[196,1375],[1869,1375],[1869,1421],[196,1421]],"region":{"top_left_x":196,"top_left_y":1375,"width":1673,"height":46},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13887e95ad5f4d999d6aec5fbd5c1c8d","type":"text","conversion_output":true,"text":"\\(95 \\%\\) confidence intervals of the medians (calculated from the Kaplan-Meier estimate), and","text_display":" \\(95 \\%\\) confidence intervals of the medians (calculated from the Kaplan-Meier estimate), and","confidence":0.978515625,"confidence_rate":0.9997639569499949},{"cnt":[[196,1421],[1869,1421],[1869,1469],[196,1469]],"region":{"top_left_x":196,"top_left_y":1420,"width":1673,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"981bf343c73149eca670d8177082ce7b","type":"text","conversion_output":true,"text":"proportion of patients without an event at 12, 18, and 24 months along with its \\(95 \\%\\) LOGLOG","text_display":" proportion of patients without an event at 12, 18, and 24 months along with its \\(95 \\%\\) LOGLOG","confidence":0.963226318359375,"confidence_rate":0.9996291095798059},{"cnt":[[196,1469],[1871,1469],[1871,1517],[196,1517]],"region":{"top_left_x":196,"top_left_y":1468,"width":1675,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cdc9ef6191214784b40b98d7fe9853ea","type":"text","conversion_output":true,"text":"confidence intervals will be summarized for each treatment group. The Brookmeyer-Crowley method","text_display":" confidence intervals will be summarized for each treatment group. The Brookmeyer-Crowley method","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[196,1517],[1869,1517],[1869,1565],[196,1565]],"region":{"top_left_x":196,"top_left_y":1516,"width":1673,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cbd4254032e14ca1ae5c92f5f0d812cc","type":"text","conversion_output":true,"text":"will be used to calculate the standard error of the estimates of these percentiles which is further used","text_display":" will be used to calculate the standard error of the estimates of these percentiles which is further used","confidence":1,"confidence_rate":1},{"cnt":[[196,1565],[1866,1565],[1866,1610],[196,1610]],"region":{"top_left_x":196,"top_left_y":1564,"width":1671,"height":47},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43ca130f54a2484bbf3264feaef2a507","type":"text","conversion_output":true,"text":"for their confidence interval calculation. The Greenwood formula would be used to calculate the","text_display":" for their confidence interval calculation. The Greenwood formula would be used to calculate the","confidence":1,"confidence_rate":1},{"cnt":[[196,1613],[1866,1613],[1866,1661],[196,1661]],"region":{"top_left_x":196,"top_left_y":1612,"width":1671,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e038794dc4ea4b388a6d031113df0abf","type":"text","conversion_output":true,"text":"standard error of the proportion of patients without an event at 12, 18, and 24 months based on the","text_display":" standard error of the proportion of patients without an event at 12, 18, and 24 months based on the","confidence":0.7060546875,"confidence_rate":0.9967523636759227},{"cnt":[[196,1658],[592,1658],[592,1706],[196,1706]],"region":{"top_left_x":196,"top_left_y":1658,"width":396,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"74908d417c70463196663b469c9ed9ac","type":"text","conversion_output":true,"text":"Kaplan-Meier estimate.","text_display":" Kaplan-Meier estimate.","confidence":1,"confidence_rate":1},{"cnt":[[196,1732],[1866,1732],[1866,1777],[196,1777]],"region":{"top_left_x":196,"top_left_y":1731,"width":1671,"height":47},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ded939a7f16a47b28b2b150b4d2cd0b3","type":"text","conversion_output":true,"text":"A stratified Cox proportional hazard regression model will be used including treatment in order to","text_display":"\n\nA stratified Cox proportional hazard regression model will be used including treatment in order to","confidence":1,"confidence_rate":1},{"cnt":[[196,1777],[1869,1777],[1869,1825],[196,1825]],"region":{"top_left_x":196,"top_left_y":1777,"width":1673,"height":49},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"869732b406214d13825d980f92d3c8b6","type":"text","conversion_output":true,"text":"provide an estimate of the treatment effect expressed as hazard ratio (Lazertinib vs. Gefitinib), as","text_display":" provide an estimate of the treatment effect expressed as hazard ratio (Lazertinib vs. Gefitinib), as","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[196,1828],[1866,1828],[1866,1875],[196,1875]],"region":{"top_left_x":196,"top_left_y":1827,"width":1671,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"02d7040d49e24187a6fe9670ab3af464","type":"text","conversion_output":true,"text":"well as a 95\\% Wald confidence interval using the same stratification factors as for the log-rank test.","text_display":" well as a 95\\% Wald confidence interval using the same stratification factors as for the log-rank test.","confidence":0.98046875,"confidence_rate":0.9998156758183152},{"cnt":[[196,1896],[1871,1896],[1871,1942],[196,1942]],"region":{"top_left_x":196,"top_left_y":1896,"width":1675,"height":46},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"13f59248d8b54af0a708a28c0fdcf7d5","type":"text","conversion_output":true,"text":"The proportional hazards assumption may be assessed both graphically from the Kaplan-Meier plot","text_display":"\n\nThe proportional hazards assumption may be assessed both graphically from the Kaplan-Meier plot","confidence":1,"confidence_rate":1},{"cnt":[[196,1942],[1871,1942],[1871,1990],[196,1990]],"region":{"top_left_x":196,"top_left_y":1941,"width":1675,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2834cc3b7e6e4f5d83d7a547ec052fed","type":"text","conversion_output":true,"text":"as well as by adding a treatment by time interaction term to the Cox regression model. This","text_display":" as well as by adding a treatment by time interaction term to the Cox regression model. This","confidence":1,"confidence_rate":1},{"cnt":[[196,1990],[1871,1987],[1871,2035],[196,2038]],"region":{"top_left_x":196,"top_left_y":1987,"width":1675,"height":51},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a9dcd95ad7649798450b174ea8dd4ae","type":"text","conversion_output":true,"text":"assumption would also be checked by the plot of the Schoenfeld residuals against each of the","text_display":" assumption would also be checked by the plot of the Schoenfeld residuals against each of the","confidence":1,"confidence_rate":1},{"cnt":[[196,2038],[1871,2038],[1871,2086],[196,2086]],"region":{"top_left_x":196,"top_left_y":2037,"width":1675,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0de1cedbc3f8482f9424f38acd87adec","type":"text","conversion_output":true,"text":"predictors in the Cox model. If the proportional hazards assumption is not met, alternative appropriate","text_display":" predictors in the Cox model. If the proportional hazards assumption is not met, alternative appropriate","confidence":1,"confidence_rate":1},{"cnt":[[196,2088],[569,2088],[569,2131],[196,2131]],"region":{"top_left_x":196,"top_left_y":2087,"width":373,"height":45},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cfea03c1b7174a77861a35a5321c4c7f","type":"text","conversion_output":true,"text":"methods may be used.","text_display":" methods may be used.","confidence":1,"confidence_rate":1},{"cnt":[[196,2156],[1871,2156],[1871,2204],[196,2204]],"region":{"top_left_x":196,"top_left_y":2156,"width":1675,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"709578f323cb4ae7b48fb7428aace7c6","type":"text","conversion_output":true,"text":"By patient listing will be provided for PFS by treatment group and overall will be provided by","text_display":"\n\nBy patient listing will be provided for PFS by treatment group and overall will be provided by","confidence":1,"confidence_rate":1},{"cnt":[[196,2202],[921,2202],[921,2250],[196,2250]],"region":{"top_left_x":196,"top_left_y":2202,"width":725,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6774dc275a054f57a02459cb90cf0d80","type":"text","conversion_output":true,"text":"investigator assessment and central review.","text_display":" investigator assessment and central review.","confidence":1,"confidence_rate":1},{"cnt":[[192,2271],[921,2271],[921,2323],[192,2323]],"region":{"top_left_x":191,"top_left_y":2270,"width":730,"height":54},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8cda3d94ce1d4ffd87864a69991db992","type":"section_header","conversion_output":false,"children_ids":["7a136bb78c4446d197d7de0a43c2124f"],"text":"","text_display":""},{"cnt":[[196,2273],[916,2273],[916,2319],[196,2319]],"region":{"top_left_x":196,"top_left_y":2272,"width":721,"height":47},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a136bb78c4446d197d7de0a43c2124f","type":"text","conversion_output":true,"parent_id":"8cda3d94ce1d4ffd87864a69991db992","text":"Handling of Censoring for PFS Analysis","text_display":"\n\n\\section*{Handling of Censoring for PFS Analysis}","confidence":0.98046875,"confidence_rate":0.9995413957643918},{"cnt":[[196,2339],[1871,2339],[1871,2387],[196,2387]],"region":{"top_left_x":196,"top_left_y":2339,"width":1675,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e2f866d0950743d9b9a17454d17d1977","type":"text","conversion_output":true,"text":"Censoring considered here is generalized Type I right censoring. Here the entry of the patient is","text_display":"\n\nCensoring considered here is generalized Type I right censoring. Here the entry of the patient is","confidence":1,"confidence_rate":1},{"cnt":[[196,2389],[1871,2389],[1871,2435],[196,2435]],"region":{"top_left_x":196,"top_left_y":2389,"width":1675,"height":47},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"86b21413db6f47e590aa88857282ccba","type":"text","conversion_output":true,"text":"staggered with complete follow-up until the end of the study. Patients who have not progressed or","text_display":" staggered with complete follow-up until the end of the study. Patients who have not progressed or","confidence":1,"confidence_rate":1},{"cnt":[[196,2435],[1869,2435],[1869,2483],[196,2483]],"region":{"top_left_x":196,"top_left_y":2435,"width":1673,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f910d7e7bbfb4c8abdb129e585f3a7ae","type":"text","conversion_output":true,"text":"have not died at the time of analysis will be censored at the time of the latest date of radiological","text_display":" have not died at the time of analysis will be censored at the time of the latest date of radiological","confidence":1,"confidence_rate":1},{"cnt":[[196,2485],[1355,2485],[1355,2524],[196,2524]],"region":{"top_left_x":196,"top_left_y":2485,"width":1159,"height":40},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e195844dc755454394238e01177247d5","type":"text","conversion_output":true,"text":"tumor assessment from their last evaluable RECIST v1.1 assessment.","text_display":" tumor assessment from their last evaluable RECIST v1.1 assessment.","confidence":1,"confidence_rate":1},{"cnt":[[196,2554],[1869,2554],[1869,2602],[196,2602]],"region":{"top_left_x":196,"top_left_y":2553,"width":1673,"height":49},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1d981475190145dfa4c6806437057aed","type":"text","conversion_output":true,"text":"If the patient progresses or dies after 2 or more missed visits, the patient will be censored at the time","text_display":"\n\nIf the patient progresses or dies after 2 or more missed visits, the patient will be censored at the time","confidence":1,"confidence_rate":1},{"cnt":[[196,2602],[1866,2602],[1866,2648],[196,2648]],"region":{"top_left_x":196,"top_left_y":2601,"width":1671,"height":47},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"60bfb3b8defe4f7794a6790cc565f50a","type":"text","conversion_output":true,"text":"of the last evaluable RECIST v1.1 assessment. If the patient has no evaluable visits or does not have","text_display":" of the last evaluable RECIST v1.1 assessment. 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Given the","text_display":"\nbaseline data, they will be censored at Day 1 unless they die within 2 visits of baseline. Given the","confidence":1,"confidence_rate":1},{"cnt":[[196,283],[1871,283],[1871,334],[196,334]],"region":{"top_left_x":196,"top_left_y":283,"width":1675,"height":51},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ec45907f86db465c895784df5790870e","type":"text","conversion_output":true,"text":"scheduled visit assessment scheme (i.e., six-weekly for the first 78 weeks then twelve-weekly","text_display":" scheduled visit assessment scheme (i.e., six-weekly for the first 78 weeks then twelve-weekly","confidence":0.98779296875,"confidence_rate":0.9998784019580803},{"cnt":[[196,334],[1122,334],[1122,381],[196,381]],"region":{"top_left_x":196,"top_left_y":333,"width":926,"height":49},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"42ae6b301fa549518712c88a3b67870f","type":"text","conversion_output":true,"text":"thereafter) the definition of 2 missed visits will change.","text_display":" thereafter) the definition of 2 missed visits will change.","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[206,402],[1871,402],[1871,450],[206,450]],"region":{"top_left_x":205,"top_left_y":402,"width":1666,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6a94174a64ea4b459c3502e9f0a6dfb9","type":"text","conversion_output":true,"text":"If the previous RECIST assessment is less than study day 497 (i.e., week 71) then two missing visits","text_display":"\n\nIf the previous RECIST assessment is less than study day 497 (i.e., week 71) then two missing visits","confidence":0.9878087043762207,"confidence_rate":0.9998864303473615},{"cnt":[[196,452],[1869,452],[1869,498],[196,498]],"region":{"top_left_x":196,"top_left_y":452,"width":1673,"height":46},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0a8f4d3b6afd4e63aa2602b2ea6901c7","type":"text","conversion_output":true,"text":"will equate to 13 weeks since the previous RECIST assessment, allowing for early and late visits","text_display":" will equate to 13 weeks since the previous RECIST assessment, allowing for early and late visits","confidence":1,"confidence_rate":1},{"cnt":[[196,498],[1766,498],[1766,546],[196,546]],"region":{"top_left_x":196,"top_left_y":497,"width":1570,"height":49},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1db5dbab4f5b46d09180e49e11e78456","type":"text","conversion_output":true,"text":"(i.e., \\(2 \\times 6\\) weeks +3 days for an early assessment +3 days for a late assessment \\(=13\\) weeks).","text_display":" (i.e., \\(2 \\times 6\\) weeks +3 days for an early assessment +3 days for a late assessment \\(=13\\) weeks).","confidence":0.9099651823053136,"confidence_rate":0.9991186228336968},{"cnt":[[196,567],[1869,567],[1869,614],[196,614]],"region":{"top_left_x":196,"top_left_y":566,"width":1673,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"919812e5481a4367a0b0f97122e55929","type":"text","conversion_output":true,"text":"If the two missed visits occur over the period when the scheduled frequency of RECIST assessments","text_display":"\n\nIf the two missed visits occur over the period when the scheduled frequency of RECIST assessments","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[196,614],[1869,614],[1869,660],[196,660]],"region":{"top_left_x":196,"top_left_y":614,"width":1673,"height":47},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"99377117359544b78a22bcc00f4301b0","type":"text","conversion_output":true,"text":"changes from six-weekly to twelve-weekly (i.e., between days 497 and 553) this will equate to 19","text_display":" changes from six-weekly to twelve-weekly (i.e., between days 497 and 553) this will equate to 19","confidence":0.5995116233825684,"confidence_rate":0.9950449391907892},{"cnt":[[196,662],[1866,662],[1866,710],[196,710]],"region":{"top_left_x":196,"top_left_y":662,"width":1671,"height":49},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"05a972f7451c4b2186269d0c3f2a3840","type":"text","conversion_output":true,"text":"weeks (i.e., take the average of 6 and 12 weeks which gives 9 weeks and then apply same rationale,","text_display":" weeks (i.e., take the average of 6 and 12 weeks which gives 9 weeks and then apply same rationale,","confidence":1,"confidence_rate":1},{"cnt":[[196,710],[1871,710],[1871,756],[196,756]],"region":{"top_left_x":196,"top_left_y":710,"width":1675,"height":47},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dcb3b2d8dcc641c9876ac1149cb73a95","type":"text","conversion_output":true,"text":"hence \\(2 \\times 9\\) weeks +3 days for an early assessment +3 days for a late assessment \\(=19\\) weeks). From","text_display":" hence \\(2 \\times 9\\) weeks +3 days for an early assessment +3 days for a late assessment \\(=19\\) weeks). From","confidence":1,"confidence_rate":1},{"cnt":[[196,758],[1869,758],[1869,806],[196,806]],"region":{"top_left_x":196,"top_left_y":758,"width":1673,"height":49},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9ac2614547614967b9eef99ad8663eaf","type":"text","conversion_output":true,"text":"week 79 onwards (when the scheduling changes to twelve weekly assessments), two missing visits","text_display":" week 79 onwards (when the scheduling changes to twelve weekly assessments), two missing visits","confidence":1,"confidence_rate":1},{"cnt":[[196,806],[1871,806],[1871,854],[196,854]],"region":{"top_left_x":196,"top_left_y":806,"width":1675,"height":49},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a436abd6035a4221bd58d79803e11028","type":"text","conversion_output":true,"text":"will equate to 25 weeks (i.e., \\(2 \\times 12\\) weeks +3 days for an early assessment +3 days for a late","text_display":" will equate to 25 weeks (i.e., \\(2 \\times 12\\) weeks +3 days for an early assessment +3 days for a late","confidence":0.9766323280055076,"confidence_rate":0.9997830966893476},{"cnt":[[196,854],[610,854],[610,902],[196,902]],"region":{"top_left_x":196,"top_left_y":854,"width":414,"height":49},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5779a2f04f0c42a482fc8a21792f0344","type":"text","conversion_output":true,"text":"assessment \\(=25\\) weeks).","text_display":" assessment \\(=25\\) weeks).","confidence":0.9990234375,"confidence_rate":0.9999674325420703},{"cnt":[[196,923],[1871,923],[1871,971],[196,971]],"region":{"top_left_x":196,"top_left_y":922,"width":1675,"height":49},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2844f14750fa417b823e6554c7d63f17","type":"text","conversion_output":true,"text":"The PFS time will always be derived based on assessment dates which will be collected during the","text_display":"\n\nThe PFS time will always be derived based on assessment dates which will be collected during the","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[196,973],[916,973],[916,1021],[196,1021]],"region":{"top_left_x":196,"top_left_y":973,"width":721,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dee681ef73064e87b6e0b703942795f2","type":"text","conversion_output":true,"text":"time of tumor assessment as per the eCRF.","text_display":" time of tumor assessment as per the eCRF.","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[196,1037],[733,1037],[733,1087],[196,1087]],"region":{"top_left_x":196,"top_left_y":1037,"width":538,"height":51},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53cd802d5e194e3c9b262e191437b771","type":"figure_label","conversion_output":false,"text":"Table 2. 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A visit response of CR is defined when all target","text_display":" of complete response (CR) or partial response (PR). A visit response of CR is defined when all target","confidence":0.9951210021972656,"confidence_rate":0.999953860130807},{"cnt":[[196,1197],[1871,1197],[1871,1245],[196,1245]],"region":{"top_left_x":196,"top_left_y":1197,"width":1675,"height":48},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ecc16a1e3d914a03b604d512d7aea2ee","type":"text","conversion_output":true,"text":"lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception","text_display":" lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception","confidence":1,"confidence_rate":1},{"cnt":[[196,1247],[1871,1247],[1871,1295],[196,1295]],"region":{"top_left_x":196,"top_left_y":1247,"width":1675,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52f98559ca734bb9b81a879f70d57087","type":"text","conversion_output":true,"text":"of lymph nodes which must be \\(<10 mm\\) to be considered non-pathological) and no new lesions have","text_display":" of lymph nodes which must be \\(<10 mm\\) to be considered non-pathological) and no new lesions have","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[196,1293],[624,1293],[624,1341],[196,1341]],"region":{"top_left_x":196,"top_left_y":1292,"width":428,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"66906988d12a45ecb5ca6c395d530850","type":"text","conversion_output":true,"text":"developed since baseline.","text_display":" developed since baseline.","confidence":1,"confidence_rate":1},{"cnt":[[196,1361],[1871,1361],[1871,1409],[196,1409]],"region":{"top_left_x":196,"top_left_y":1361,"width":1675,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1a294a377874609bd6c5ffe5b241882","type":"text","conversion_output":true,"text":"A visit response of PR is defined when the sum of diameters of the TLs has decreased by \\(30 \\%\\) or","text_display":"\n\nA visit response of PR is defined when the sum of diameters of the TLs has decreased by \\(30 \\%\\) or","confidence":1,"confidence_rate":1},{"cnt":[[196,1412],[1871,1412],[1871,1457],[196,1457]],"region":{"top_left_x":196,"top_left_y":1411,"width":1675,"height":47},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c72c368c34cd4952a2d11996924c35c5","type":"text","conversion_output":true,"text":"more compared to baseline (with no evidence of progression) and the NTLs are at least stable with","text_display":" more compared to baseline (with no evidence of progression) and the NTLs are at least stable with","confidence":1,"confidence_rate":1},{"cnt":[[194,1457],[1871,1457],[1871,1505],[194,1505]],"region":{"top_left_x":194,"top_left_y":1457,"width":1677,"height":49},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d6e754bb573f4d0cb1e6acf6214bf7da","type":"text","conversion_output":true,"text":"no evidence of new lesions. Patients who do not have a tumor response assessment for any reason","text_display":" no evidence of new lesions. Patients who do not have a tumor response assessment for any reason","confidence":1,"confidence_rate":1},{"cnt":[[196,1508],[1871,1508],[1871,1556],[196,1556]],"region":{"top_left_x":196,"top_left_y":1507,"width":1675,"height":49},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9a248b5b9b254808b22459fec9a3dbc7","type":"text","conversion_output":true,"text":"will be considered non responders and will be included in the denominator when calculating the","text_display":" will be considered non responders and will be included in the denominator when calculating the","confidence":1,"confidence_rate":1},{"cnt":[[194,1553],[1873,1553],[1873,1601],[194,1601]],"region":{"top_left_x":194,"top_left_y":1553,"width":1680,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4c4c1aba74b04beb9bc2f9c72e8e2266","type":"text","conversion_output":true,"text":"response rate. Data obtained up until progression, or last evaluable assessment in the absence of","text_display":" response rate. Data obtained up until progression, or last evaluable assessment in the absence of","confidence":1,"confidence_rate":1},{"cnt":[[194,1604],[1871,1604],[1871,1652],[194,1652]],"region":{"top_left_x":194,"top_left_y":1603,"width":1677,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"527694eacf394c2b8fd1ff8f082d6549","type":"text","conversion_output":true,"text":"progression, will be included in the assessment of ORR. However, any complete response or partial","text_display":" progression, will be included in the assessment of ORR. However, any complete response or partial","confidence":1,"confidence_rate":1},{"cnt":[[196,1649],[1869,1649],[1869,1697],[196,1697]],"region":{"top_left_x":196,"top_left_y":1649,"width":1673,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd707ec9482d44ca90d7c429ff04a457","type":"text","conversion_output":true,"text":"response which occurred after the new anti-cancer therapy was received will not be included in","text_display":" response which occurred after the new anti-cancer therapy was received will not be included in","confidence":1,"confidence_rate":1},{"cnt":[[196,1700],[1473,1700],[1473,1748],[196,1748]],"region":{"top_left_x":196,"top_left_y":1699,"width":1278,"height":49},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0489dec5edf64db797909749100412b5","type":"text","conversion_output":true,"text":"numerator of the ORR calculation (where the FAS will be the denominator).","text_display":" numerator of the ORR calculation (where the FAS will be the denominator).","confidence":1,"confidence_rate":1},{"cnt":[[196,1766],[1869,1766],[1869,1816],[196,1816]],"region":{"top_left_x":196,"top_left_y":1765,"width":1673,"height":52},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f10e52bf67534c6ab0ad042c2a2b8ed3","type":"text","conversion_output":true,"text":"ORR will be analyzed based on a fitted logistic regression stratified by mutation type (L858R vs","text_display":"\n\nORR will be analyzed based on a fitted logistic regression stratified by mutation type (L858R vs","confidence":1,"confidence_rate":1},{"cnt":[[196,1814],[1871,1814],[1871,1862],[196,1862]],"region":{"top_left_x":196,"top_left_y":1813,"width":1675,"height":49},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"992e26d067dc4db193383a538e0819af","type":"text","conversion_output":true,"text":"ex19del) and race (Asian vs non-Asian). The fitted logistic regression model would use the","text_display":" ex19del) and race (Asian vs non-Asian). The fitted logistic regression model would use the","confidence":1,"confidence_rate":1},{"cnt":[[194,1864],[1869,1864],[1869,1912],[194,1912]],"region":{"top_left_x":194,"top_left_y":1864,"width":1675,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d0eee7f8bb846bc85cfd2c307f26f22","type":"text","conversion_output":true,"text":"proportion of patients with measurable disease with at least one visit response of complete response","text_display":" proportion of patients with measurable disease with at least one visit response of complete response","confidence":1,"confidence_rate":1},{"cnt":[[196,1910],[1869,1910],[1869,1958],[196,1958]],"region":{"top_left_x":196,"top_left_y":1909,"width":1673,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cd57cc566fea4d4eabceb6d6fb2b4e87","type":"text","conversion_output":true,"text":"(CR) or partial response (PR) as the response variable and use a logit link function as its canonical","text_display":" (CR) or partial response (PR) as the response variable and use a logit link function as its canonical","confidence":0.99658203125,"confidence_rate":0.9999677003013677},{"cnt":[[196,1958],[1871,1958],[1871,2006],[196,2006]],"region":{"top_left_x":196,"top_left_y":1957,"width":1675,"height":49},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4e3e5b1b194449e8a482cd4ed5f391ae","type":"text","conversion_output":true,"text":"link to model the treatment effects on the ORR. The results of the analysis will be presented in terms","text_display":" link to model the treatment effects on the ORR. The results of the analysis will be presented in terms","confidence":1,"confidence_rate":1},{"cnt":[[196,2006],[1871,2006],[1871,2054],[196,2054]],"region":{"top_left_x":196,"top_left_y":2005,"width":1675,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d123bab21520464fa64de307ce16f775","type":"text","conversion_output":true,"text":"of an estimated odds ratio for treatment effects together with its associated \\(95 \\%\\) Wald confidence","text_display":" of an estimated odds ratio for treatment effects together with its associated \\(95 \\%\\) Wald confidence","confidence":0.8125,"confidence_rate":0.9980244362402169},{"cnt":[[196,2056],[354,2056],[354,2095],[196,2095]],"region":{"top_left_x":196,"top_left_y":2055,"width":159,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8a8bf1b8248d4047ad5bb7173a3ef621","type":"text","conversion_output":true,"text":"intervals.","text_display":" intervals.","confidence":1,"confidence_rate":1},{"cnt":[[196,2124],[1871,2124],[1871,2172],[196,2172]],"region":{"top_left_x":196,"top_left_y":2124,"width":1675,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"43a3ae5cf1754fde80b7777e3245899c","type":"text","conversion_output":true,"text":"A summary of all responses will also be presented by treatment group. ORR will also be summarized","text_display":"\n\nA summary of all responses will also be presented by treatment group. ORR will also be summarized","confidence":1,"confidence_rate":1},{"cnt":[[196,2170],[669,2170],[669,2218],[196,2218]],"region":{"top_left_x":196,"top_left_y":2170,"width":474,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"58d7795ae310423e92fa5d9952e78889","type":"text","conversion_output":true,"text":"by each stratification factor.","text_display":" by each stratification factor.","confidence":1,"confidence_rate":1},{"cnt":[[196,2239],[1766,2239],[1766,2287],[196,2287]],"region":{"top_left_x":196,"top_left_y":2238,"width":1570,"height":49},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b469a806c27d446e821520c19555d20f","type":"text","conversion_output":true,"text":"A by patient listing will be provided for ORR by treatment group and by stratification factors.","text_display":"\n\nA by patient listing will be provided for ORR by treatment group and by stratification factors.","confidence":1,"confidence_rate":1},{"cnt":[[190,2325],[861,2325],[861,2383],[190,2383]],"region":{"top_left_x":189,"top_left_y":2325,"width":673,"height":58},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f2ea5f35f594d3989c1f087761b3338","type":"section_header","conversion_output":false,"children_ids":["960e2003a30a4cdd9b6757d094a893bf"],"text":"","text_display":""},{"cnt":[[196,2330],[854,2330],[854,2378],[196,2378]],"region":{"top_left_x":196,"top_left_y":2330,"width":659,"height":49},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"960e2003a30a4cdd9b6757d094a893bf","type":"text","conversion_output":true,"parent_id":"0f2ea5f35f594d3989c1f087761b3338","text":"4.10.3.3 Duration of Response (DoR)","text_display":"\n\n\\subsection*{4.10.3.3 Duration of Response (DoR)}","confidence":1,"confidence_rate":1},{"cnt":[[196,2399],[1875,2399],[1875,2447],[196,2447]],"region":{"top_left_x":196,"top_left_y":2398,"width":1680,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"34f58c2e9dd6427097badb34b9545650","type":"text","conversion_output":true,"text":"DoR is defined as the time from the date of first documented response (CR or PR) until the date of","text_display":"\n\nDoR is defined as the time from the date of first documented response (CR or PR) until the date of","confidence":1,"confidence_rate":1},{"cnt":[[196,2444],[1871,2444],[1871,2492],[196,2492]],"region":{"top_left_x":196,"top_left_y":2444,"width":1675,"height":49},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"83f13f99f6fe454685d8644747a1fb6d","type":"text","conversion_output":true,"text":"documented progression or death, whichever comes first. The end of response should coincide with","text_display":" documented progression or death, whichever comes first. The end of response should coincide with","confidence":1,"confidence_rate":1},{"cnt":[[196,2495],[1871,2495],[1871,2543],[196,2543]],"region":{"top_left_x":196,"top_left_y":2494,"width":1675,"height":49},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"974a2cc659574dd2b33e2bdb8a199e32","type":"text","conversion_output":true,"text":"the date of progression or death from any cause used for the PFS endpoint. If a patient does not","text_display":" the date of progression or death from any cause used for the PFS endpoint. If a patient does not","confidence":1,"confidence_rate":1},{"cnt":[[196,2543],[1816,2543],[1816,2590],[196,2590]],"region":{"top_left_x":196,"top_left_y":2542,"width":1621,"height":49},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b92fa4222c824a718743b2385eef07df","type":"text","conversion_output":true,"text":"progress following a response, then his/her duration of response will use the PFS censoring time.","text_display":" progress following a response, then his/her duration of response will use the PFS censoring time.","confidence":1,"confidence_rate":1},{"cnt":[[196,2609],[1720,2609],[1720,2661],[196,2661]],"region":{"top_left_x":196,"top_left_y":2608,"width":1525,"height":54},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"edbe0494912d47e2b04fd38ddfb3e107","type":"text","conversion_output":true,"text":"The analysis of DoR will be stratified by the mutation type and race as in primary analysis.","text_display":"\n\nThe analysis of DoR will be stratified by the mutation type and race as in primary analysis.","confidence":1,"confidence_rate":1},{"cnt":[[196,2750],[519,2750],[519,2785],[196,2785]],"region":{"top_left_x":196,"top_left_y":2750,"width":323,"height":35},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f203c45858c649419f7f0d6674ed56dc","type":"page_info","conversion_output":false,"text":"TP-GDO-WW-016-08","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[790,2750],[1053,2750],[1053,2785],[790,2785]],"region":{"top_left_x":790,"top_left_y":2750,"width":264,"height":35},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e1887607cf9a4b548ccf9d422fd3e9fb","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1345,2750],[1871,2750],[1871,2789],[1345,2789]],"region":{"top_left_x":1345,"top_left_y":2750,"width":526,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6dc025d271244ef996a78370dc6a6433","type":"page_info","conversion_output":false,"text":"Project Document Version No.: V2.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,2792],[569,2792],[569,2830],[196,2830]],"region":{"top_left_x":196,"top_left_y":2791,"width":373,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"690d8dc8aaf74fa59b5d6e0a67e4ab47","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999694754347522},{"cnt":[[1035,2792],[1871,2792],[1871,2835],[1035,2835]],"region":{"top_left_x":1034,"top_left_y":2791,"width":837,"height":44},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dfb36c62b51946a5a8ae93a81121e959","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[194,2837],[656,2837],[656,2876],[194,2876]],"region":{"top_left_x":194,"top_left_y":2837,"width":462,"height":40},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a1ff08ed815047cba7150f372d6c80f8","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1670,2837],[1871,2837],[1871,2881],[1670,2881]],"region":{"top_left_x":1669,"top_left_y":2837,"width":202,"height":44},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"03eae20b0ab34057a5d7d61db850508f","type":"page_info","conversion_output":false,"text":"Page 37 of 83","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2068,"languages_detected":[]},{"image_id":"43f70033-c325-4dd7-8bf3-864fe9a77081-38","page":38,"lines":[{"cnt":[[196,105],[331,105],[331,139],[196,139]],"region":{"top_left_x":196,"top_left_y":105,"width":136,"height":35},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ce38906384444ff1bc31b8fe7c02234f","type":"page_info","conversion_output":false,"text":"YUHAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,151],[400,151],[400,187],[192,187]],"region":{"top_left_x":191,"top_left_y":150,"width":209,"height":38},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dbeed2a7d09645ee9593a3fc7aaa6bed","type":"page_info","conversion_output":false,"text":"YH25448-301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1526,148],[1873,148],[1873,190],[1526,190]],"region":{"top_left_x":1525,"top_left_y":148,"width":349,"height":42},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1c395913a54348af857c708bc51e26ee","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[194,233],[1871,233],[1871,286],[194,286]],"region":{"top_left_x":194,"top_left_y":233,"width":1677,"height":53},"line":4,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6ae0e61f0ecd43089e78e4bbb36cf3c3","type":"text","conversion_output":true,"text":"DoR in responding patients will be summarized and the estimated proportion of responding patients","text_display":"\n\nDoR in responding patients will be summarized and the estimated proportion of responding patients","confidence":1,"confidence_rate":1},{"cnt":[[194,283],[1871,283],[1871,336],[194,336]],"region":{"top_left_x":194,"top_left_y":283,"width":1677,"height":53},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5d7b193fb77844698691a35b790749c0","type":"text","conversion_output":true,"text":"with a duration of response ( \\(>6 ;>9 ;>12 ;>15\\) months) will be presented by treatment group along","text_display":" with a duration of response ( \\(>6 ;>9 ;>12 ;>15\\) months) will be presented by treatment group along","confidence":0.9868340436369181,"confidence_rate":0.9998700731873178},{"cnt":[[194,331],[1871,331],[1871,381],[194,381]],"region":{"top_left_x":194,"top_left_y":331,"width":1677,"height":51},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bfb214faad8b45b3a2a3b58ee6da1b92","type":"text","conversion_output":true,"text":"with its \\(95 \\%\\) Wald confidence interval. A Kaplan-Meier plot and median DoR with \\(95 \\%\\) Wald","text_display":" with its \\(95 \\%\\) Wald confidence interval. A Kaplan-Meier plot and median DoR with \\(95 \\%\\) Wald","confidence":1,"confidence_rate":1},{"cnt":[[194,379],[1871,379],[1871,432],[194,432]],"region":{"top_left_x":194,"top_left_y":379,"width":1677,"height":53},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c8f84f1b5c23418bae8a5c4ee3aa56b7","type":"text","conversion_output":true,"text":"confidence interval (calculated from the Kaplan-Meier estimate) will be presented by treatment","text_display":" confidence interval (calculated from the Kaplan-Meier estimate) will be presented by treatment","confidence":1,"confidence_rate":1},{"cnt":[[194,429],[1871,429],[1871,477],[194,477]],"region":{"top_left_x":194,"top_left_y":429,"width":1677,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c54004cf5f6648ccbf078f275b8c9fbb","type":"text","conversion_output":true,"text":"group. The Brookmeyer-Crowley method will be used to calculate the standard error of the estimates","text_display":" group. The Brookmeyer-Crowley method will be used to calculate the standard error of the estimates","confidence":1,"confidence_rate":1},{"cnt":[[194,477],[1871,477],[1871,523],[194,523]],"region":{"top_left_x":194,"top_left_y":477,"width":1677,"height":47},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6821d4cfdd7348a1ad590105dbde8f3e","type":"text","conversion_output":true,"text":"of the median DoR which is further used for its confidence interval calculation. The Greenwood","text_display":" of the median DoR which is further used for its confidence interval calculation. The Greenwood","confidence":1,"confidence_rate":1},{"cnt":[[194,523],[1871,523],[1871,573],[194,573]],"region":{"top_left_x":194,"top_left_y":523,"width":1677,"height":51},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"255d54c397d34dbd91aed4564a772b05","type":"text","conversion_output":true,"text":"formula would be used to calculate the standard error of the estimated proportion of responding","text_display":" formula would be used to calculate the standard error of the estimated proportion of responding","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[192,571],[1263,571],[1263,624],[192,624]],"region":{"top_left_x":191,"top_left_y":571,"width":1073,"height":53},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3857192e644d432b89c7ff9e2342ac5a","type":"text","conversion_output":true,"text":"patients with a duration of response ( \\(>6 ;>9 ;>12 ;>15\\) months).","text_display":" patients with a duration of response ( \\(>6 ;>9 ;>12 ;>15\\) months).","confidence":1,"confidence_rate":1},{"cnt":[[194,640],[1487,640],[1487,692],[194,692]],"region":{"top_left_x":194,"top_left_y":639,"width":1294,"height":54},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c3d167807ff24650ae676bfcaeb399a2","type":"text","conversion_output":true,"text":"A by patient listing will be provided for DoR by treatment group and overall.","text_display":"\nA by patient listing will be provided for DoR by treatment group and overall.","confidence":0.998046875,"confidence_rate":0.9999761583959741},{"cnt":[[190,726],[861,726],[861,784],[190,784]],"region":{"top_left_x":189,"top_left_y":726,"width":673,"height":58},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d54030f8777c458795643168a38cb91e","type":"section_header","conversion_output":false,"children_ids":["e5101de7f0234e6190dd2b089213cf07"],"text":"","text_display":""},{"cnt":[[196,731],[857,731],[857,779],[196,779]],"region":{"top_left_x":196,"top_left_y":731,"width":661,"height":48},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e5101de7f0234e6190dd2b089213cf07","type":"text","conversion_output":true,"parent_id":"d54030f8777c458795643168a38cb91e","text":"4.10.3.4 Disease Control Rate (DCR)","text_display":"\n\n\\subsection*{4.10.3.4 Disease Control Rate (DCR)}","confidence":1,"confidence_rate":1},{"cnt":[[194,800],[1871,800],[1871,850],[194,850]],"region":{"top_left_x":194,"top_left_y":799,"width":1677,"height":51},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bc380f9764f54423baf14fc985635cf6","type":"text","conversion_output":true,"text":"DCR is defined as the percentage of patients who have a best objective response of CR or PR or","text_display":"\n\nDCR is defined as the percentage of patients who have a best objective response of CR or PR or","confidence":1,"confidence_rate":1},{"cnt":[[194,850],[1871,850],[1871,902],[194,902]],"region":{"top_left_x":194,"top_left_y":849,"width":1677,"height":54},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0d3fc6e9e28849548dc967015792d43c","type":"text","conversion_output":true,"text":"stable disease (SD at \\(\\geqslant 6\\) weeks). The 6 -week time point will allow for a visit window and be","text_display":" stable disease (SD at \\(\\geqslant 6\\) weeks). The 6 -week time point will allow for a visit window and be","confidence":0.99560546875,"confidence_rate":0.9999572415395579},{"cnt":[[194,900],[1323,900],[1323,953],[194,953]],"region":{"top_left_x":194,"top_left_y":900,"width":1129,"height":53},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"25f9a64ef44b43ae95ba42c253308947","type":"text","conversion_output":true,"text":"defined as on or after study day 35 (allowing for the visit window).","text_display":" defined as on or after study day 35 (allowing for the visit window).","confidence":1,"confidence_rate":1},{"cnt":[[256,973],[1734,973],[1734,1021],[256,1021]],"region":{"top_left_x":255,"top_left_y":973,"width":1479,"height":49},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"179d8fac108c4a7c8b440b26f29a47cc","type":"text","conversion_output":true,"text":"- Any CR, PR or SD occurred after PD, will not be included in numerator of the DCR","text_display":"\n- Any CR, PR or SD occurred after PD, will not be included in numerator of the DCR","confidence":1,"confidence_rate":1},{"cnt":[[320,1019],[1215,1019],[1215,1071],[320,1071]],"region":{"top_left_x":319,"top_left_y":1018,"width":897,"height":54},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"be6cc9e15fe9480480c04aff3fd06dc3","type":"text","conversion_output":true,"text":"calculation (where the FAS will be the denominator).","text_display":" calculation (where the FAS will be the denominator).","confidence":1,"confidence_rate":1},{"cnt":[[256,1069],[1732,1069],[1732,1122],[256,1122]],"region":{"top_left_x":255,"top_left_y":1069,"width":1477,"height":53},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8302b6b408064192b4bb96cb884dcc77","type":"text","conversion_output":true,"text":"- Any CR, PR or SD occurred after a new anticancer therapy was received will not be","text_display":"\n- Any CR, PR or SD occurred after a new anticancer therapy was received will not be","confidence":1,"confidence_rate":1},{"cnt":[[320,1119],[1798,1119],[1798,1172],[320,1172]],"region":{"top_left_x":319,"top_left_y":1119,"width":1479,"height":53},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"afd84ed441ed4feea13d9156d9c63748","type":"text","conversion_output":true,"text":"included in numerator of the DCR calculation (where the FAS will be the denominator).","text_display":" included in numerator of the DCR calculation (where the FAS will be the denominator).","confidence":1,"confidence_rate":1},{"cnt":[[196,1188],[1368,1188],[1368,1238],[196,1238]],"region":{"top_left_x":196,"top_left_y":1187,"width":1173,"height":52},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"90bdb5d63cb242d5b4653c93ea1397da","type":"text","conversion_output":true,"text":"DCR will be analyzed using the same method as the analysis of ORR.","text_display":"\nDCR will be analyzed using the same method as the analysis of ORR.","confidence":1,"confidence_rate":1},{"cnt":[[194,1256],[1494,1256],[1494,1309],[194,1309]],"region":{"top_left_x":194,"top_left_y":1256,"width":1300,"height":53},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"86f7ed1c522c4f8b950e3c515229b2ae","type":"text","conversion_output":true,"text":"A by patient listing will be provided for DCR by treatment group and overall.","text_display":"\nA by patient listing will be provided for DCR by treatment group and overall.","confidence":1,"confidence_rate":1},{"cnt":[[192,1343],[690,1343],[690,1400],[192,1400]],"region":{"top_left_x":191,"top_left_y":1343,"width":499,"height":58},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9b0f0d85a3ee425ab64890483daf35c9","type":"section_header","conversion_output":false,"children_ids":["b50e4894398b41dab285f74a2f5c4e60"],"text":"","text_display":""},{"cnt":[[196,1348],[685,1348],[685,1396],[196,1396]],"region":{"top_left_x":196,"top_left_y":1347,"width":490,"height":49},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b50e4894398b41dab285f74a2f5c4e60","type":"text","conversion_output":true,"parent_id":"9b0f0d85a3ee425ab64890483daf35c9","text":"4.10.3.5 Depth of Response","text_display":"\n\n\\subsection*{4.10.3.5 Depth of Response}","confidence":1,"confidence_rate":1},{"cnt":[[194,1416],[1871,1416],[1871,1464],[194,1464]],"region":{"top_left_x":194,"top_left_y":1416,"width":1677,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"486463e0f34647c59206eb42947e4058","type":"text","conversion_output":true,"text":"Depth of response will be determined for patients with measurable disease at baseline (last non-","text_display":"\n\nDepth of response will be determined for patients with measurable disease at baseline (last non","confidence":1,"confidence_rate":1},{"cnt":[[194,1462],[1871,1462],[1871,1512],[194,1512]],"region":{"top_left_x":194,"top_left_y":1462,"width":1677,"height":51},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b9dfeb5e891743c780813b2dad0a88e2","type":"text","conversion_output":true,"text":"missing assessment before randomization date) and is derived at each visit by the percentage change","text_display":"missing assessment before randomization date) and is derived at each visit by the percentage change","confidence":1,"confidence_rate":1},{"cnt":[[196,1510],[1871,1510],[1871,1560],[196,1560]],"region":{"top_left_x":196,"top_left_y":1509,"width":1675,"height":52},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"53f956283ab44cb8a94ee326a1d21d51","type":"text","conversion_output":true,"text":"in the sum of the diameters of target lesions in the absence of new lesions or progression of non-","text_display":" in the sum of the diameters of target lesions in the absence of new lesions or progression of non","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[196,1558],[1871,1558],[1871,1610],[196,1610]],"region":{"top_left_x":196,"top_left_y":1557,"width":1675,"height":54},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"59eed23aa8fa4f8c94680649ba8ddbf0","type":"text","conversion_output":true,"text":"target lesions compared to baseline. The absolute change and percentage change from baseline in the","text_display":"target lesions compared to baseline. The absolute change and percentage change from baseline in the","confidence":1,"confidence_rate":1},{"cnt":[[194,1604],[1871,1604],[1871,1656],[194,1656]],"region":{"top_left_x":194,"top_left_y":1603,"width":1677,"height":54},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"213615859ee242009912572bc706c574","type":"text","conversion_output":true,"text":"sum of tumor size at each assessment will be calculated. The best change in tumor size (defined as","text_display":" sum of tumor size at each assessment will be calculated. The best change in tumor size (defined as","confidence":1,"confidence_rate":1},{"cnt":[[194,1654],[1871,1654],[1871,1702],[194,1702]],"region":{"top_left_x":194,"top_left_y":1653,"width":1677,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"65dd398b23d74a35be3b9ef21f44e932","type":"text","conversion_output":true,"text":"the maximum reduction from baseline or the minimum increase from baseline, in the absence of a","text_display":" the maximum reduction from baseline or the minimum increase from baseline, in the absence of a","confidence":1,"confidence_rate":1},{"cnt":[[194,1702],[1869,1702],[1869,1752],[194,1752]],"region":{"top_left_x":194,"top_left_y":1701,"width":1675,"height":52},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a5b80ba53aed48508d989e705c196b1b","type":"text","conversion_output":true,"text":"reduction) will include all assessments prior to progression or start of new anti-cancer therapy.","text_display":" reduction) will include all assessments prior to progression or start of new anti-cancer therapy.","confidence":1,"confidence_rate":1},{"cnt":[[194,1750],[1476,1750],[1476,1802],[194,1802]],"region":{"top_left_x":194,"top_left_y":1749,"width":1282,"height":54},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"91b78069059c4d1b962deab3c246fb0b","type":"text","conversion_output":true,"text":"Missing target lesion data at visit will be documented as not evaluable (NE).","text_display":" Missing target lesion data at visit will be documented as not evaluable (NE).","confidence":1,"confidence_rate":1},{"cnt":[[196,1818],[1871,1818],[1871,1871],[196,1871]],"region":{"top_left_x":196,"top_left_y":1818,"width":1675,"height":53},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"31b83663ef3d4e679d6a7e3fb2657ff5","type":"text","conversion_output":true,"text":"Depth of response will be examined by summarizing the absolute change in target lesion tumor size","text_display":"\nDepth of response will be examined by summarizing the absolute change in target lesion tumor size","confidence":1,"confidence_rate":1},{"cnt":[[196,1869],[1871,1869],[1871,1917],[196,1917]],"region":{"top_left_x":196,"top_left_y":1868,"width":1675,"height":49},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c73b2b252f734aa79f895001664272f6","type":"text","conversion_output":true,"text":"from baseline, and percentage change in target lesion tumor size from baseline using descriptive","text_display":" from baseline, and percentage change in target lesion tumor size from baseline using descriptive","confidence":1,"confidence_rate":1},{"cnt":[[194,1914],[1875,1914],[1875,1965],[194,1965]],"region":{"top_left_x":194,"top_left_y":1914,"width":1682,"height":51},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e61cabe27c4d41bea95bad9466dfea0a","type":"text","conversion_output":true,"text":"statistics and presented at each timepoint and by randomized treatment group. The effect of","text_display":" statistics and presented at each timepoint and by randomized treatment group. The effect of","confidence":1,"confidence_rate":1},{"cnt":[[196,1965],[1871,1965],[1871,2013],[196,2013]],"region":{"top_left_x":196,"top_left_y":1964,"width":1675,"height":49},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a142cc8e742a430f8f3a039915b25535","type":"text","conversion_output":true,"text":"Lazertinib on best percentage change in tumor size will be estimated from an ANCOVA model with","text_display":" Lazertinib on best percentage change in tumor size will be estimated from an ANCOVA model with","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[196,2010],[1869,2010],[1869,2061],[196,2061]],"region":{"top_left_x":196,"top_left_y":2010,"width":1673,"height":51},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d7a1856dea5b47108882fac2986653e8","type":"text","conversion_output":true,"text":"treatment group as fixed effect and baseline sum of target lesion target, mutation type (L858R \\&","text_display":" treatment group as fixed effect and baseline sum of target lesion target, mutation type (L858R \\&","confidence":1,"confidence_rate":1},{"cnt":[[194,2058],[1871,2058],[1871,2108],[194,2108]],"region":{"top_left_x":194,"top_left_y":2058,"width":1677,"height":51},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f9aea4830c0840c58a9ae9cbf44c1899","type":"text","conversion_output":true,"text":"Ex19del) and race (Asian Vs non-Asian) as a covariate. The number of patients, unadjusted mean,","text_display":" Ex19del) and race (Asian Vs non-Asian) as a covariate. The number of patients, unadjusted mean,","confidence":1,"confidence_rate":1},{"cnt":[[194,2106],[1871,2106],[1871,2159],[194,2159]],"region":{"top_left_x":194,"top_left_y":2106,"width":1677,"height":53},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a272a5bab6834b37bde8099548ea10ff","type":"text","conversion_output":true,"text":"and least squares means for each treatment group will be presented, together with the difference in","text_display":" and least squares means for each treatment group will be presented, together with the difference in","confidence":1,"confidence_rate":1},{"cnt":[[194,2152],[1871,2152],[1871,2204],[194,2204]],"region":{"top_left_x":194,"top_left_y":2151,"width":1677,"height":54},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5216d5b936914a7e8a06ded356eb8e74","type":"text","conversion_output":true,"text":"least squares means, \\(95 \\%\\) confidence interval, and corresponding p -value. The best percentage","text_display":" least squares means, \\(95 \\%\\) confidence interval, and corresponding p -value. The best percentage","confidence":0.980478048324585,"confidence_rate":0.9998157644328721},{"cnt":[[196,2202],[1871,2202],[1871,2255],[196,2255]],"region":{"top_left_x":196,"top_left_y":2202,"width":1675,"height":53},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"55dabf576fc34df491730648739d7e3b","type":"text","conversion_output":true,"text":"change from baseline in target lesion tumor size will also be and presented graphically using waterfall","text_display":" change from baseline in target lesion tumor size will also be and presented graphically using waterfall","confidence":1,"confidence_rate":1},{"cnt":[[194,2250],[1869,2250],[1869,2300],[194,2300]],"region":{"top_left_x":194,"top_left_y":2250,"width":1675,"height":51},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"34078d4e30aa4b30bd13bd4bef5288eb","type":"text","conversion_output":true,"text":"plots, with each patient's best percentage change in tumor size represented as a separate bar and the","text_display":" plots, with each patient's best percentage change in tumor size represented as a separate bar and the","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[194,2298],[1871,2298],[1871,2348],[194,2348]],"region":{"top_left_x":194,"top_left_y":2298,"width":1677,"height":51},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1255df7113ce48f3bed9ec8235a073d4","type":"text","conversion_output":true,"text":"bars ordered from the largest increase to the largest decreases. Reference lines at the \\(+20 \\%\\) and \\(-30 \\%\\)","text_display":" bars ordered from the largest increase to the largest decreases. Reference lines at the \\(+20 \\%\\) and \\(-30 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[194,2344],[1875,2344],[1875,2396],[194,2396]],"region":{"top_left_x":194,"top_left_y":2343,"width":1682,"height":54},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dd45329b26244044aca57a221d0de6e1","type":"text","conversion_output":true,"text":"change in tumor size levels will be added to the plots, which correspond with the definitions of","text_display":" change in tumor size levels will be added to the plots, which correspond with the definitions of","confidence":1,"confidence_rate":1},{"cnt":[[194,2394],[1871,2394],[1871,2447],[194,2447]],"region":{"top_left_x":194,"top_left_y":2394,"width":1677,"height":53},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"adfce453817042f590e3cbe6d1a3a9b3","type":"text","conversion_output":true,"text":"progression and partial response respectively. A waterfall plot will also be produced by each","text_display":" progression and partial response respectively. A waterfall plot will also be produced by each","confidence":1,"confidence_rate":1},{"cnt":[[194,2444],[532,2444],[532,2488],[194,2488]],"region":{"top_left_x":194,"top_left_y":2444,"width":339,"height":44},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"290b890d9435404db922c276560794b7","type":"text","conversion_output":true,"text":"stratification factor.","text_display":" stratification factor.","confidence":1,"confidence_rate":1},{"cnt":[[194,2511],[1711,2511],[1711,2563],[194,2563]],"region":{"top_left_x":194,"top_left_y":2510,"width":1517,"height":54},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ef78d82d38bb4557a1a0fde47d51b1f5","type":"text","conversion_output":true,"text":"A by patient listing will be provided for Depth of response by treatment group and overall.","text_display":"\n\nA by patient listing will be provided for Depth of response by treatment group and 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Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,233],[795,233],[795,290],[192,290]],"region":{"top_left_x":191,"top_left_y":233,"width":604,"height":58},"line":4,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"ce98ecd8c1154b56a58fa0f697e06201","type":"section_header","conversion_output":false,"children_ids":["616487f735524a28bb45145f513e76b4"],"text":"","text_display":""},{"cnt":[[196,238],[790,238],[790,286],[196,286]],"region":{"top_left_x":196,"top_left_y":237,"width":595,"height":49},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"616487f735524a28bb45145f513e76b4","type":"text","conversion_output":true,"parent_id":"ce98ecd8c1154b56a58fa0f697e06201","text":"4.10.3.6 Time to Response (TTR)","text_display":"\n\n\\subsection*{4.10.3.6 Time to Response (TTR)}","confidence":1,"confidence_rate":1},{"cnt":[[196,306],[1871,306],[1871,354],[196,354]],"region":{"top_left_x":196,"top_left_y":306,"width":1675,"height":49},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"898b950e186f4cc286fbf1da63f0dd70","type":"text","conversion_output":true,"text":"TTR is defined as the time from the date of randomization until the date of first documented response","text_display":"\n\nTTR is defined as the time from the date of randomization until the date of first documented response","confidence":1,"confidence_rate":1},{"cnt":[[196,354],[1871,354],[1871,404],[196,404]],"region":{"top_left_x":196,"top_left_y":354,"width":1675,"height":51},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ac7b38656d7946e1afca853ce1a325b2","type":"text","conversion_output":true,"text":"(CR or PR) prior to any disease progression and new anti-cancer therapy, for patients who have PR","text_display":" (CR or PR) prior to any disease progression and new anti-cancer therapy, for patients who have PR","confidence":1,"confidence_rate":1},{"cnt":[[196,402],[601,402],[601,450],[196,450]],"region":{"top_left_x":196,"top_left_y":402,"width":405,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7653227bc7e9401186e437ce9277cb54","type":"text","conversion_output":true,"text":"or CR as their response.","text_display":" or CR as their response.","confidence":1,"confidence_rate":1},{"cnt":[[196,471],[1871,471],[1871,519],[196,519]],"region":{"top_left_x":196,"top_left_y":470,"width":1675,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d23f35f9c1714880b68a1e83f8ee7acc","type":"text","conversion_output":true,"text":"A summary statistic will be produced for TTR by treatment group. A by patient listing will be","text_display":"\n\nA summary statistic will be produced for TTR by treatment group. 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Updated analyses of data collected","text_display":" Approximately 200 deaths will be anticipated at this time. Updated analyses of data collected","confidence":1,"confidence_rate":1},{"cnt":[[320,1074],[1382,1074],[1382,1126],[320,1126]],"region":{"top_left_x":319,"top_left_y":1073,"width":1064,"height":54},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8ef9d18154f547479ba6ba940b56366f","type":"text","conversion_output":true,"text":"post progression and safety may also be performed at this time.","text_display":" post progression and safety may also be performed at this time.","confidence":0.99951171875,"confidence_rate":0.9999928176655267},{"cnt":[[196,1142],[1871,1142],[1871,1192],[196,1192]],"region":{"top_left_x":196,"top_left_y":1142,"width":1675,"height":51},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4aa85fbe5fd543d8a41c2c0f494802cc","type":"text","conversion_output":true,"text":"The alpha will be split between the two analyses to provide strong control of the family-wise error","text_display":"\n\nThe alpha will be split between the two analyses to provide strong control of the family-wise error","confidence":1,"confidence_rate":1},{"cnt":[[194,1192],[509,1192],[509,1240],[194,1240]],"region":{"top_left_x":194,"top_left_y":1192,"width":316,"height":49},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"35b109c3fd7a4b938ce3fa3406a87e48","type":"text","conversion_output":true,"text":"rate (See 4.10.1.4)","text_display":" rate (See 4.10.1.4)","confidence":1,"confidence_rate":1},{"cnt":[[196,1256],[1871,1256],[1871,1309],[196,1309]],"region":{"top_left_x":196,"top_left_y":1256,"width":1675,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3c18ce63b9146159935b649726f302f","type":"text","conversion_output":true,"text":"OS will be analyzed using the same methodology and model as for the analysis of PFS provided there","text_display":"\n\nOS will be analyzed using the same methodology and model as for the analysis of PFS provided there","confidence":1,"confidence_rate":1},{"cnt":[[196,1307],[1871,1307],[1871,1357],[196,1357]],"region":{"top_left_x":196,"top_left_y":1306,"width":1675,"height":51},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b8e22d82c0e24d5eabad258e510a2f21","type":"text","conversion_output":true,"text":"are sufficient events available for a meaningful analysis (>20 deaths; if not, descriptive summaries","text_display":" are sufficient events available for a meaningful analysis (>20 deaths; if not, descriptive summaries","confidence":0.9560546875,"confidence_rate":0.9995720900265612},{"cnt":[[196,1357],[1871,1357],[1871,1405],[196,1405]],"region":{"top_left_x":196,"top_left_y":1356,"width":1675,"height":49},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c0db4ca01aa9463d83ab7e8775f9b91d","type":"text","conversion_output":true,"text":"will be provided). The number of events, median (calculated from the Kaplan Meier estimate), and","text_display":" will be provided). 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As appropriate, summaries of the number and percentage of patients","text_display":" the final survival follow-up. 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a \\(33 \\%\\) improvement (median OS of 40 months in the Lazertinib arm),","text_display":" \\(50 \\%\\) power to demonstrate a \\(33 \\%\\) improvement (median OS of 40 months in the Lazertinib arm),","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[194,1805],[1871,1805],[1871,1857],[194,1857]],"region":{"top_left_x":194,"top_left_y":1804,"width":1677,"height":54},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc503133c8e848c0abfbe56d0fca5482","type":"text","conversion_output":true,"text":"and approximately \\(26 \\%\\) power to demonstrate a \\(20 \\%\\) improvement (median OS of 36 months in the","text_display":" and approximately \\(26 \\%\\) power to demonstrate a \\(20 \\%\\) improvement (median OS of 36 months in 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The decision to adjust and","confidence":1,"confidence_rate":1},{"cnt":[[196,2166],[1642,2166],[1642,2214],[196,2214]],"region":{"top_left_x":196,"top_left_y":2165,"width":1447,"height":49},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04c40a6abf69493db3513fa82735add6","type":"text","conversion_output":true,"text":"final choice of methods will be based on the plausibility of the underlying assumption.","text_display":" final choice of methods will be based on the plausibility of the underlying assumption.","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[196,2234],[1266,2234],[1266,2282],[196,2282]],"region":{"top_left_x":196,"top_left_y":2234,"width":1070,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2a239deab3a74cecb5f705dfdc5f1b59","type":"text","conversion_output":true,"text":"A by patient listing will be provided for OS by treatment group.","text_display":"\n\nA by patient listing will be provided for OS by treatment group.","confidence":0.97607421875,"confidence_rate":0.9996490956152777},{"cnt":[[192,2298],[905,2298],[905,2355],[192,2355]],"region":{"top_left_x":191,"top_left_y":2298,"width":714,"height":58},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53cf96a4076145dba0b4159a20e14d3c","type":"section_header","conversion_output":false,"children_ids":["6ae07409ad4d4710b2d6234b0fe0f0ca"],"text":"","text_display":""},{"cnt":[[196,2303],[900,2303],[900,2351],[196,2351]],"region":{"top_left_x":196,"top_left_y":2302,"width":705,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6ae07409ad4d4710b2d6234b0fe0f0ca","type":"text","conversion_output":true,"parent_id":"53cf96a4076145dba0b4159a20e14d3c","text":"Handling of Censoring for OS Analysis","text_display":"\n\n\\section*{Handling of Censoring for OS Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[196,2369],[1871,2369],[1871,2419],[196,2419]],"region":{"top_left_x":196,"top_left_y":2368,"width":1675,"height":52},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5b2f754381c4b9fb6b69c5d0a44c7ea","type":"text","conversion_output":true,"text":"If a patient is not known to have died at the time of analysis cut-off, OS will be censored at the date","text_display":"\n\nIf a patient is not known to have died at the time of analysis cut-off, OS will be censored at the date","confidence":1,"confidence_rate":1},{"cnt":[[196,2417],[1871,2417],[1871,2469],[196,2469]],"region":{"top_left_x":196,"top_left_y":2416,"width":1675,"height":54},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"af8bcb0acec3446aa3cc471eea0f7331","type":"text","conversion_output":true,"text":"of last contact. 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The 6 individual symptom measures include: dyspnea, insomnia, loss","text_display":" and QoL (quality of life) scale. The 6 individual symptom measures include: dyspnea, insomnia, loss","confidence":1,"confidence_rate":1},{"cnt":[[196,1224],[1869,1224],[1869,1272],[196,1272]],"region":{"top_left_x":196,"top_left_y":1224,"width":1673,"height":49},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65ab15355eeb4b25b1b705291fd8b54c","type":"text","conversion_output":true,"text":"of appetite, constipation, diarrhea, and financial difficulties. For the 15 domains described above, the","text_display":" of appetite, constipation, diarrhea, and financial difficulties. For the 15 domains described above, the","confidence":1,"confidence_rate":1},{"cnt":[[196,1272],[1869,1272],[1869,1323],[196,1323]],"region":{"top_left_x":196,"top_left_y":1272,"width":1673,"height":51},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"27e26ec2bc794d32ba4f5d810afe8214","type":"text","conversion_output":true,"text":"total score is standardized to a range from 0 to 100, where higher scores indicate stronger functioning,","text_display":" total score is standardized to a range from 0 to 100, where higher scores indicate stronger functioning,","confidence":0.74609375,"confidence_rate":0.9973882022617153},{"cnt":[[194,1320],[898,1320],[898,1373],[194,1373]],"region":{"top_left_x":194,"top_left_y":1320,"width":704,"height":53},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6e5718a4df5b447db69b56ad1905de21","type":"text","conversion_output":true,"text":"higher HRQoL or higher symptom levels.","text_display":" higher HRQoL or higher symptom levels.","confidence":1,"confidence_rate":1},{"cnt":[[196,1389],[1848,1389],[1848,1437],[196,1437]],"region":{"top_left_x":196,"top_left_y":1388,"width":1653,"height":49},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e5a576a4e614c5db4e7191c2a6eaf50","type":"text","conversion_output":true,"text":"For ease of presentation and interpretation, all scale and item scores are linearly transformed to a 0","text_display":"\n\nFor ease of presentation and interpretation, all scale and item scores are linearly transformed to a 0","confidence":1,"confidence_rate":1},{"cnt":[[194,1437],[1843,1437],[1843,1487],[194,1487]],"region":{"top_left_x":194,"top_left_y":1436,"width":1650,"height":52},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1b6425eef5d64e70937eff620df29b6d","type":"text","conversion_output":true,"text":"to 100 scale. Higher scores on the global health status and functioning scales indicate better health","text_display":" to 100 scale. Higher scores on the global health status and functioning scales indicate better health","confidence":1,"confidence_rate":1},{"cnt":[[194,1485],[1841,1485],[1841,1535],[194,1535]],"region":{"top_left_x":194,"top_left_y":1484,"width":1648,"height":52},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0821043667004c5a97c4005e6947e391","type":"text","conversion_output":true,"text":"status/function. Higher scores on the symptoms scales indicate greater symptom burden. Note that","text_display":" status/function. Higher scores on the symptoms scales indicate greater symptom burden. Note that","confidence":1,"confidence_rate":1},{"cnt":[[194,1531],[1843,1531],[1843,1583],[194,1583]],"region":{"top_left_x":194,"top_left_y":1530,"width":1650,"height":54},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d1a55b85ede4db284759667166b4219","type":"text","conversion_output":true,"text":"the global health status scale is based on only the two specific HRQoL items (Item 29, 30) and not","text_display":" the global health status scale is based on only the two specific HRQoL items (Item 29, 30) and not","confidence":1,"confidence_rate":1},{"cnt":[[196,1581],[605,1581],[605,1629],[196,1629]],"region":{"top_left_x":196,"top_left_y":1580,"width":410,"height":49},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"19b05c5ec3da422fb1f227462da12fd4","type":"text","conversion_output":true,"text":"the entire questionnaire.","text_display":" the entire questionnaire.","confidence":1,"confidence_rate":1},{"cnt":[[203,1649],[1871,1649],[1871,1700],[203,1700]],"region":{"top_left_x":203,"top_left_y":1649,"width":1668,"height":51},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4fd3c8593194c488fb974345d203d33","type":"text","conversion_output":true,"text":"The transformed score for a subject and missing data handling can be expressed asError! Reference","text_display":"\n\nThe transformed score for a subject and missing data handling can be expressed asError! Reference","confidence":1,"confidence_rate":1},{"cnt":[[196,1695],[1345,1695],[1345,1748],[196,1748]],"region":{"top_left_x":196,"top_left_y":1695,"width":1150,"height":53},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"01e17da41f8743b2935c94152f8bdd75","type":"text","conversion_output":true,"text":"source not found. Appendix 6. Scoring the QLQ-C30 Version 3.0.","text_display":" source not found. Appendix 6. Scoring the QLQ-C30 Version 3.0.","confidence":1,"confidence_rate":1},{"cnt":[[196,1766],[1871,1766],[1871,1816],[196,1816]],"region":{"top_left_x":196,"top_left_y":1765,"width":1675,"height":52},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a77c02a5106846b790b24d10d6a93edf","type":"text","conversion_output":true,"text":"EORTC-QLQ-C30 scores during treatment period and changes from baseline will be summarized by","text_display":"\n\nEORTC-QLQ-C30 scores during treatment period and changes from baseline will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[196,1814],[1871,1814],[1871,1866],[196,1866]],"region":{"top_left_x":196,"top_left_y":1813,"width":1675,"height":54},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1ed67d6c79694a38b2e6fa9477512b39","type":"text","conversion_output":true,"text":"visit and treatment arms for FAS. A summary statistics table will be provided for all 5 function","text_display":" visit and treatment arms for FAS. A summary statistics table will be provided for all 5 function","confidence":1,"confidence_rate":1},{"cnt":[[194,1859],[1871,1859],[1871,1912],[194,1912]],"region":{"top_left_x":194,"top_left_y":1859,"width":1677,"height":54},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"77ac4906e29747009c323f2f4ad9e438","type":"text","conversion_output":true,"text":"domains and self-estimated health score by FAS population with a corresponding listing (Listing","text_display":" domains and self-estimated health score by FAS population with a corresponding listing (Listing","confidence":1,"confidence_rate":1},{"cnt":[[196,1910],[514,1910],[514,1958],[196,1958]],"region":{"top_left_x":196,"top_left_y":1909,"width":318,"height":49},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2d3f8caf50164ef2a70bb2d90cdf7f06","type":"text","conversion_output":true,"text":"analysis set: FAS).","text_display":" analysis set: FAS).","confidence":1,"confidence_rate":1},{"cnt":[[192,1997],[747,1997],[747,2049],[192,2049]],"region":{"top_left_x":191,"top_left_y":1996,"width":556,"height":54},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"46f5c12f9b834c6ea81b58e875050d73","type":"section_header","conversion_output":false,"children_ids":["eb1e9fed15264fbc8757af3f500aefc2"],"text":"","text_display":""},{"cnt":[[196,2001],[742,2001],[742,2049],[196,2049]],"region":{"top_left_x":196,"top_left_y":2001,"width":547,"height":49},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"eb1e9fed15264fbc8757af3f500aefc2","type":"text","conversion_output":true,"parent_id":"46f5c12f9b834c6ea81b58e875050d73","text":"4.10.3.8.2 EORTC QLQ-LC13","text_display":"\n\n\\subsection*{4.10.3.8.2 EORTC QLQ-LC13}","confidence":1,"confidence_rate":1},{"cnt":[[196,2067],[1871,2067],[1871,2118],[196,2118]],"region":{"top_left_x":196,"top_left_y":2067,"width":1675,"height":51},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"343cb271f5354954a856054e0fa52c52","type":"text","conversion_output":true,"text":"The EORTC-QLQ-LC13 is a 13-item self-administered questionnaire for lung cancer disease that","text_display":"\n\nThe EORTC-QLQ-LC13 is a 13-item self-administered questionnaire for lung cancer disease that","confidence":1,"confidence_rate":1},{"cnt":[[194,2115],[1871,2115],[1871,2168],[194,2168]],"region":{"top_left_x":194,"top_left_y":2115,"width":1677,"height":53},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7aa9be978ced421eb1c20edadd132c70","type":"text","conversion_output":true,"text":"will be used along with the EORTC QLQ-C30. The scale includes both multiple and single lung","text_display":" will be used along with the EORTC QLQ-C30. The scale includes both multiple and single lung","confidence":1,"confidence_rate":1},{"cnt":[[196,2166],[1871,2166],[1871,2214],[196,2214]],"region":{"top_left_x":196,"top_left_y":2165,"width":1675,"height":49},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b3df59c6709e415190901f203102510a","type":"text","conversion_output":true,"text":"cancer-related symptom parameters (i.e., cough, haemoptysis, dyspnea and pain), as well as side","text_display":" cancer-related symptom parameters (i.e., cough, haemoptysis, dyspnea and pain), as well as side","confidence":1,"confidence_rate":1},{"cnt":[[196,2211],[1871,2211],[1871,2262],[196,2262]],"region":{"top_left_x":196,"top_left_y":2211,"width":1675,"height":51},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"41dc71a57c7346d990d832c15b1fce69","type":"text","conversion_output":true,"text":"effects of conventional chemotherapy and radiotherapy (i.e., alopecia, neurological disorders, oral","text_display":" effects of conventional chemotherapy and radiotherapy (i.e., alopecia, neurological disorders, oral","confidence":1,"confidence_rate":1},{"cnt":[[194,2262],[1871,2262],[1871,2310],[194,2310]],"region":{"top_left_x":194,"top_left_y":2261,"width":1677,"height":49},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"743591dbc860478abd4cb190e0252ea4","type":"text","conversion_output":true,"text":"pain and dysphagia). Similar to the EORTC QLQ-C30, all questions (except one) are on a 4-point","text_display":" pain and dysphagia). Similar to the EORTC QLQ-C30, all questions (except one) are on a 4-point","confidence":0.9810404777526855,"confidence_rate":0.9998066696145407},{"cnt":[[196,2305],[1871,2305],[1871,2360],[196,2360]],"region":{"top_left_x":196,"top_left_y":2304,"width":1675,"height":56},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9ba7fe53e24049ec8febee189d0dd965","type":"text","conversion_output":true,"text":"scale: \"not at all\", \"a little\", \"quite a bit\", and \"very much\". Only 1 question ( \\(43{ }^{\\text {rd }}\\) question \"Did you","text_display":" scale: \"not at all\", \"a little\", \"quite a bit\", and \"very much\". Only 1 question ( \\(43{ }^{\\text {rd }}\\) question \"Did you","confidence":0.9980475902557373,"confidence_rate":0.999984732005771},{"cnt":[[196,2357],[1871,2357],[1871,2405],[196,2405]],"region":{"top_left_x":196,"top_left_y":2357,"width":1675,"height":49},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5e8e9b44f58c44169b8850c50aa32b38","type":"text","conversion_output":true,"text":"take any medicine for pain?\") is with response options of \"yes\" or \"no\". The QLQ-LC13 are scored","text_display":" take any medicine for pain?\") is with response options of \"yes\" or \"no\". The QLQ-LC13 are scored","confidence":1,"confidence_rate":1},{"cnt":[[196,2403],[795,2403],[795,2456],[196,2456]],"region":{"top_left_x":196,"top_left_y":2403,"width":599,"height":53},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"52065222c2454889a0bba6196021bc82","type":"text","conversion_output":true,"text":"similarly to the EORTC-QLQ-C30.","text_display":" similarly to the EORTC-QLQ-C30.","confidence":1,"confidence_rate":1},{"cnt":[[196,2472],[1869,2472],[1869,2524],[196,2524]],"region":{"top_left_x":196,"top_left_y":2471,"width":1673,"height":54},"line":48,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"76d49ccb0e134519a5cd9e1f40f03130","type":"text","conversion_output":true,"text":"For ease of presentation and interpretation, all scale and item scores are linearly transformed to a 0","text_display":"\n\nFor ease of presentation and interpretation, all scale and item scores are linearly transformed to a 0","confidence":1,"confidence_rate":1},{"cnt":[[194,2517],[1409,2517],[1409,2570],[194,2570]],"region":{"top_left_x":194,"top_left_y":2517,"width":1216,"height":53},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"87f8d6119d1546b5b1dafffa99a60dea","type":"text","conversion_output":true,"text":"to 100 scale, with higher scores representing increasing symptom levels.","text_display":" to 100 scale, with higher scores representing increasing symptom levels.","confidence":1,"confidence_rate":1},{"cnt":[[196,2750],[519,2750],[519,2785],[196,2785]],"region":{"top_left_x":196,"top_left_y":2750,"width":323,"height":35},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ff4988fc3d34447895e3c3124c2493b2","type":"page_info","conversion_output":false,"text":"TP-GDO-WW-016-08","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[790,2750],[1053,2750],[1053,2785],[790,2785]],"region":{"top_left_x":790,"top_left_y":2750,"width":264,"height":35},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9ffce858704410799d3da123266c761","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1345,2750],[1871,2750],[1871,2792],[1345,2792]],"region":{"top_left_x":1345,"top_left_y":2750,"width":526,"height":42},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"234daf95c0584f6f8dcc783275cc7ad3","type":"page_info","conversion_output":false,"text":"Project Document Version No.: V2.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,2792],[569,2792],[569,2830],[196,2830]],"region":{"top_left_x":196,"top_left_y":2791,"width":373,"height":40},"line":53,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"780405ee81d94852b1d68b1d2d7d25f2","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999694754347522},{"cnt":[[1035,2792],[1871,2792],[1871,2835],[1035,2835]],"region":{"top_left_x":1034,"top_left_y":2791,"width":837,"height":44},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0de9c560fd3d4d1584eafb66adb56345","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,2837],[656,2837],[656,2876],[196,2876]],"region":{"top_left_x":196,"top_left_y":2837,"width":460,"height":40},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b22decf8be034b348ff387b1bf88f3e4","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1672,2837],[1869,2837],[1869,2878],[1672,2878]],"region":{"top_left_x":1672,"top_left_y":2837,"width":197,"height":42},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ad163c97cf3d41b5955c0ad80888943c","type":"page_info","conversion_output":false,"text":"Page 40 of 83","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2068,"languages_detected":[]},{"image_id":"43f70033-c325-4dd7-8bf3-864fe9a77081-41","page":41,"lines":[{"cnt":[[196,105],[331,105],[331,142],[196,142]],"region":{"top_left_x":196,"top_left_y":105,"width":136,"height":37},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d08c2e3b191d4edb96e22214c23960ce","type":"page_info","conversion_output":false,"text":"YUHAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,151],[404,151],[404,190],[192,190]],"region":{"top_left_x":191,"top_left_y":150,"width":214,"height":40},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b11a2288cbc4925b3b437f82622f267","type":"page_info","conversion_output":false,"text":"YH25448-301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1526,148],[1875,148],[1875,190],[1526,190]],"region":{"top_left_x":1525,"top_left_y":148,"width":351,"height":42},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a545ec89e51b45469f4b48f4c4051eb7","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[336,224],[1729,224],[1729,345],[336,345]],"region":{"top_left_x":335,"top_left_y":223,"width":1395,"height":122},"line":4,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"aaf10d1926db43f19ee8c131b2a1fd9e","type":"math","conversion_output":true,"text":"\\[\n\\text { Transformed QLQ-LC13 score }=\\frac{\\text { Sum of item scores }- \\text { Number of items }}{3 \\times \\text { Number of items }} \\times 100\n\\]","text_display":"\n\\[\n\\text { Transformed QLQ-LC13 score }=\\frac{\\text { Sum of item scores }- \\text { Number of items }}{3 \\times \\text { Number of items }} \\times 100\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[194,427],[1871,427],[1871,477],[194,477]],"region":{"top_left_x":194,"top_left_y":427,"width":1677,"height":51},"line":6,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9d2faae580204490ac6e2a61873c1628","type":"text","conversion_output":true,"text":"The observed values and changes from baseline for overall score, sub-scores and individual scores","text_display":"\n\nThe observed values and changes from baseline for overall score, sub-scores and individual scores","confidence":1,"confidence_rate":1},{"cnt":[[194,477],[1871,477],[1871,528],[194,528]],"region":{"top_left_x":194,"top_left_y":477,"width":1677,"height":51},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4258d7bdec424dbc96a8a23a90beb4a5","type":"text","conversion_output":true,"text":"for each visit will be statistically described (Analysis set: FAS). The overall score is defined as the","text_display":" for each visit will be statistically described (Analysis set: FAS). The overall score is defined as the","confidence":1,"confidence_rate":1},{"cnt":[[196,525],[1871,525],[1871,573],[196,573]],"region":{"top_left_x":196,"top_left_y":525,"width":1675,"height":49},"line":8,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"803e874727e5461fab7298914b5127f7","type":"text","conversion_output":true,"text":"sum of all item scores except pain medication. The sub-scores are Lung cancer related symptoms","text_display":" sum of all item scores except pain medication. The sub-scores are Lung cancer related symptoms","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[196,571],[1873,571],[1873,624],[196,624]],"region":{"top_left_x":196,"top_left_y":571,"width":1678,"height":53},"line":9,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3592a08867e144739f8a2453057a6fcf","type":"text","conversion_output":true,"text":"including cough, haemoptysis and dyspnea; Treatment related side-effects including sore mouth or","text_display":" including cough, haemoptysis and dyspnea; Treatment related side-effects including sore mouth or","confidence":1,"confidence_rate":1},{"cnt":[[196,621],[1176,621],[1176,669],[196,669]],"region":{"top_left_x":196,"top_left_y":621,"width":981,"height":49},"line":10,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d6aad7c158fa44c284527ca2b431698a","type":"text","conversion_output":true,"text":"tongue, dysphagia, hair loss, tingling hands and feet; Pain.","text_display":" tongue, dysphagia, hair loss, tingling hands and feet; Pain.","confidence":1,"confidence_rate":1},{"cnt":[[194,688],[1871,688],[1871,738],[194,738]],"region":{"top_left_x":194,"top_left_y":687,"width":1677,"height":51},"line":11,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8fa504f8adcd4a908ab929bba2624e05","type":"text","conversion_output":true,"text":"The summary statistics for the overall score, sub-scores and individual scores and the changes from","text_display":"\nThe summary statistics for the overall score, sub-scores and individual scores and the changes from","confidence":1,"confidence_rate":1},{"cnt":[[194,736],[1110,736],[1110,788],[194,788]],"region":{"top_left_x":194,"top_left_y":735,"width":917,"height":54},"line":12,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"10e5faa58286432887fdddd5766fa854","type":"text","conversion_output":true,"text":"baseline will be tabulated by study treatment and visit.","text_display":" baseline will be tabulated by study treatment and visit.","confidence":1,"confidence_rate":1},{"cnt":[[196,804],[1871,804],[1871,857],[196,857]],"region":{"top_left_x":196,"top_left_y":804,"width":1675,"height":53},"line":13,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e07451b966e34eb8aaaed370e0508233","type":"text","conversion_output":true,"text":"Statistical analyses including baseline, post baseline, change from baseline are the same as the","text_display":"\nStatistical analyses including baseline, post baseline, change from baseline are the same as the","confidence":1,"confidence_rate":1},{"cnt":[[194,854],[1873,854],[1873,905],[194,905]],"region":{"top_left_x":194,"top_left_y":854,"width":1680,"height":51},"line":14,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"88598b5702554219b98c5c10a65ddac5","type":"text","conversion_output":true,"text":"EORTC-QLQ-LC13 score. A by-subject listing of EORTC-QLQ-LC13 will be provided (Listing","text_display":" EORTC-QLQ-LC13 score. A by-subject listing of EORTC-QLQ-LC13 will be provided (Listing","confidence":1,"confidence_rate":1},{"cnt":[[194,900],[516,900],[516,953],[194,953]],"region":{"top_left_x":194,"top_left_y":900,"width":323,"height":53},"line":15,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c3940cd81bec40be9931b8a895ecc447","type":"text","conversion_output":true,"text":"analysis set: FAS).","text_display":" analysis set: FAS).","confidence":1,"confidence_rate":1},{"cnt":[[187,964],[1336,964],[1336,1030],[187,1030]],"region":{"top_left_x":187,"top_left_y":964,"width":1150,"height":67},"line":16,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1df5ace339344b6a930028ab43a4cec7","type":"section_header","conversion_output":false,"children_ids":["e044c237b3bb43eab1356867a6df2ada"],"text":"","text_display":""},{"cnt":[[196,971],[1330,971],[1330,1026],[196,1026]],"region":{"top_left_x":196,"top_left_y":970,"width":1134,"height":56},"line":17,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e044c237b3bb43eab1356867a6df2ada","type":"text","conversion_output":true,"parent_id":"1df5ace339344b6a930028ab43a4cec7","text":"EORTC QLQ-C30 and EORTC QLQ-LC13 Compliance Rates","text_display":"\n\n\\section*{EORTC QLQ-C30 and EORTC QLQ-LC13 Compliance Rates}","confidence":1,"confidence_rate":1},{"cnt":[[196,1037],[1871,1037],[1871,1090],[196,1090]],"region":{"top_left_x":196,"top_left_y":1037,"width":1675,"height":53},"line":18,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"67093f1e7c4c40c1b8f81bb9bcbc7967","type":"text","conversion_output":true,"text":"Summary measures of overall compliance and compliance over time will be derived for both EORTC","text_display":"\n\nSummary measures of overall compliance and compliance over time will be derived for both EORTC","confidence":1,"confidence_rate":1},{"cnt":[[196,1087],[1250,1087],[1250,1138],[196,1138]],"region":{"top_left_x":196,"top_left_y":1087,"width":1054,"height":51},"line":19,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"806d83194f984e41b404393c5eb3a87b","type":"text","conversion_output":true,"text":"QLQ-C30 and EORTC QLQ-LC13. These will be based upon:","text_display":" QLQ-C30 and EORTC QLQ-LC13. These will be based upon:","confidence":1,"confidence_rate":1},{"cnt":[[260,1154],[1873,1154],[1873,1208],[260,1208]],"region":{"top_left_x":260,"top_left_y":1153,"width":1614,"height":56},"line":20,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1eae98aa9af84501866e274a448b8bac","type":"text","conversion_output":true,"text":"- Received questionnaire \\(=\\) a questionnaire that has been received and has a completion date","text_display":"\n- Received questionnaire \\(=\\) a questionnaire that has been received and has a completion date","confidence":0.9560527801513672,"confidence_rate":0.9995461418319499},{"cnt":[[320,1202],[1044,1202],[1044,1254],[320,1254]],"region":{"top_left_x":319,"top_left_y":1201,"width":725,"height":54},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d792fb0ee94e47a393e45d87c71a10de","type":"text","conversion_output":true,"text":"and at least one individual item completed.","text_display":" and at least one individual item completed.","confidence":1,"confidence_rate":1},{"cnt":[[260,1270],[1871,1270],[1871,1323],[260,1323]],"region":{"top_left_x":260,"top_left_y":1270,"width":1611,"height":53},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5b579d81f7c5489d8af81e84647568fd","type":"text","conversion_output":true,"text":"- Expected questionnaire \\(=\\) a questionnaire that is expected to be completed at a scheduled","text_display":"\n- Expected questionnaire \\(=\\) a questionnaire that is expected to be completed at a scheduled","confidence":0.9102857112884521,"confidence_rate":0.9990413092226138},{"cnt":[[320,1320],[1871,1320],[1871,1373],[320,1373]],"region":{"top_left_x":319,"top_left_y":1320,"width":1552,"height":53},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"840fff095a664c938cfec92b35162f27","type":"text","conversion_output":true,"text":"assessment time e.g., a questionnaire from a patient who has not died, is not lost to follow-up","text_display":" assessment time e.g., a questionnaire from a patient who has not died, is not lost to follow-up","confidence":1,"confidence_rate":1},{"cnt":[[320,1366],[1871,1366],[1871,1419],[320,1419]],"region":{"top_left_x":319,"top_left_y":1366,"width":1552,"height":53},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"9f5b89a957a849258511966b055de030","type":"text","conversion_output":true,"text":"or withdrawn from the study at the scheduled assessment time but excluding patients in","text_display":" or withdrawn from the study at the scheduled assessment time but excluding patients in","confidence":1,"confidence_rate":1},{"cnt":[[320,1416],[1875,1416],[1875,1467],[320,1467]],"region":{"top_left_x":319,"top_left_y":1416,"width":1557,"height":51},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"24b2487bf7544073831857edfc26fd02","type":"text","conversion_output":true,"text":"countries with no available translation. For patients that have progressed, the latest of","text_display":" countries with no available translation. For patients that have progressed, the latest of","confidence":1,"confidence_rate":1},{"cnt":[[320,1462],[1871,1462],[1871,1515],[320,1515]],"region":{"top_left_x":319,"top_left_y":1462,"width":1552,"height":53},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"6cf3df02495343adbf493661f1dae508","type":"text","conversion_output":true,"text":"progression and safety follow-up will be used to assess whether the patient is still under PRO","text_display":" progression and safety follow-up will be used to assess whether the patient is still under PRO","confidence":1,"confidence_rate":1},{"cnt":[[320,1512],[1871,1512],[1871,1563],[320,1563]],"region":{"top_left_x":319,"top_left_y":1512,"width":1552,"height":51},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"74c5158c6f3545d389944dd961ee8c5c","type":"text","conversion_output":true,"text":"follow-up at the specified assessment time. Date of study discontinuation will be mapped to","text_display":" follow-up at the specified assessment time. Date of study discontinuation will be mapped to","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[320,1558],[1345,1558],[1345,1610],[320,1610]],"region":{"top_left_x":319,"top_left_y":1557,"width":1027,"height":54},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d3af6ccd68ca43cba114515e20c21fc1","type":"text","conversion_output":true,"text":"the nearest visit date to define the number of expected forms.","text_display":" the nearest visit date to define the number of expected forms.","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[260,1626],[1871,1626],[1871,1679],[260,1679]],"region":{"top_left_x":260,"top_left_y":1626,"width":1611,"height":54},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0a68b9dddb0f408d929e719d06b91544","type":"text","conversion_output":true,"text":"- Evaluable questionnaire \\(=\\) a questionnaire with a completion date and at least one 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patients with an evaluable questionnaire at the time point (as defined above), divided by number","text_display":" of patients with an evaluable questionnaire at the time point (as defined above), divided by number","confidence":1,"confidence_rate":1},{"cnt":[[196,2220],[1871,2220],[1871,2268],[196,2268]],"region":{"top_left_x":196,"top_left_y":2220,"width":1675,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"eda9a57b69cc488289e92634b4587873","type":"text","conversion_output":true,"text":"of patients still expected to complete questionnaires. Similarly, the evaluable rate over time will be","text_display":" of patients still expected to complete questionnaires. Similarly, the evaluable rate over time will be","confidence":1,"confidence_rate":1},{"cnt":[[196,2266],[1871,2266],[1871,2316],[196,2316]],"region":{"top_left_x":196,"top_left_y":2266,"width":1675,"height":51},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8c99998f57924dc192cd9ade107b59d1","type":"text","conversion_output":true,"text":"calculated separately for each visit, including baseline, as the number of evaluable questionnaires","text_display":" calculated separately for each visit, including baseline, as the number of evaluable questionnaires","confidence":1,"confidence_rate":1},{"cnt":[[196,2312],[1421,2312],[1421,2364],[196,2364]],"region":{"top_left_x":196,"top_left_y":2311,"width":1225,"height":54},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"60fa4d47c6ca4f7a844fc1a46dc994a1","type":"text","conversion_output":true,"text":"(per definition above), divided by the number of received questionnaires.","text_display":" (per definition above), divided by the number of received questionnaires.","confidence":1,"confidence_rate":1},{"cnt":[[190,2376],[1775,2376],[1775,2437],[190,2437]],"region":{"top_left_x":189,"top_left_y":2375,"width":1586,"height":63},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"cc0069a4605f4cfabee698a4bf845684","type":"section_header","conversion_output":false,"children_ids":["236c7249711d439281e7bb11bdd630a7"],"text":"","text_display":""},{"cnt":[[196,2385],[1768,2385],[1768,2433],[196,2433]],"region":{"top_left_x":196,"top_left_y":2384,"width":1573,"height":49},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"236c7249711d439281e7bb11bdd630a7","type":"text","conversion_output":true,"parent_id":"cc0069a4605f4cfabee698a4bf845684","text":"Mixed Models Repeated Measures of Change from Baseline in Primary PRO Symptoms","text_display":"\n\n\\section*{Mixed Models Repeated Measures of Change from Baseline in Primary PRO Symptoms}","confidence":1,"confidence_rate":1},{"cnt":[[196,2449],[1871,2449],[1871,2501],[196,2501]],"region":{"top_left_x":196,"top_left_y":2448,"width":1675,"height":54},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a89e8ecbf8784b2cad2abeb2f2631a0e","type":"text","conversion_output":true,"text":"The analysis population for PRO data will be the FAS. Change from baseline in the primary PRO","text_display":"\n\nThe analysis population for PRO data will be the FAS. Change from baseline in the primary PRO","confidence":1,"confidence_rate":1},{"cnt":[[196,2499],[1871,2499],[1871,2552],[196,2552]],"region":{"top_left_x":196,"top_left_y":2499,"width":1675,"height":53},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d479a3bd71ee4f06a630b1a2d9df60d2","type":"text","conversion_output":true,"text":"symptom scores of dyspnea (EORTC QLQ-LC13), cough (EORTC QLQ-LC13), pain in chest","text_display":" symptom scores of dyspnea (EORTC QLQ-LC13), cough (EORTC QLQ-LC13), pain in chest","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[196,2547],[1871,2547],[1871,2597],[196,2597]],"region":{"top_left_x":196,"top_left_y":2547,"width":1675,"height":51},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3fb2991ad6374429a83d87a417638fee","type":"text","conversion_output":true,"text":"(EORTC QLQ-LC13), fatigue (EORTC QLQ-C30) and appetite loss (EORTC QLQ-LC30) will 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Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,238],[1871,238],[1871,286],[196,286]],"region":{"top_left_x":196,"top_left_y":237,"width":1675,"height":49},"line":4,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"20d87e61561b49b99c025ab19f8eef20","type":"text","conversion_output":true,"text":"model for repeated measures (MMRM) analysis of the change from baseline in PRO score for each","text_display":"\nmodel for repeated measures (MMRM) analysis of the change from baseline in PRO score for each","confidence":1,"confidence_rate":1},{"cnt":[[196,286],[286,286],[286,327],[196,327]],"region":{"top_left_x":196,"top_left_y":285,"width":90,"height":42},"line":5,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2eb04bb0e4354306bcd8ce1486d883ae","type":"text","conversion_output":true,"text":"visit.","text_display":" 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Rate}","confidence":1,"confidence_rate":1},{"cnt":[[196,2346],[1734,2346],[1734,2396],[196,2396]],"region":{"top_left_x":196,"top_left_y":2346,"width":1538,"height":51},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"57a9622089c8428b9621dea523bbb9ef","type":"text","conversion_output":true,"text":"The PRO improvement rate will be defined as the percentage of patients with 2 consecutive","text_display":"\n\nThe PRO improvement rate will be defined as the percentage of patients with 2 consecutive","confidence":1,"confidence_rate":1},{"cnt":[[194,2394],[1848,2394],[1848,2444],[194,2444]],"region":{"top_left_x":194,"top_left_y":2394,"width":1655,"height":51},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bda3d78279194f6aa08bfdd814bae9f8","type":"text","conversion_output":true,"text":"assessments which showed a clinically meaningful improvement in that symptom from baseline (a","text_display":" assessments which showed a clinically meaningful improvement in that symptom from baseline (a","confidence":1,"confidence_rate":1},{"cnt":[[194,2444],[1857,2444],[1857,2497],[194,2497]],"region":{"top_left_x":194,"top_left_y":2444,"width":1664,"height":53},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e69cfac93f644249a4c996dd94a3b9b1","type":"text","conversion_output":true,"text":"decrease from baseline score \\(\\geqslant 10\\) points for symptom scales/item; an increase from baseline score","text_display":" decrease from baseline score \\(\\geqslant 10\\) points for symptom scales/item; an increase from baseline score","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[196,2495],[1798,2495],[1798,2552],[196,2552]],"region":{"top_left_x":196,"top_left_y":2494,"width":1602,"height":58},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"41ab403370404a8a9386e676597a6a3d","type":"text","conversion_output":true,"text":"\\(\\geqslant 10\\) points for functional scales and global health status; a decrease from baseline score \\(\\geq 5\\) for","text_display":" \\(\\geqslant 10\\) points for functional scales and global health status; a decrease from baseline score \\(\\geq 5\\) for","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[196,2549],[569,2549],[569,2602],[196,2602]],"region":{"top_left_x":196,"top_left_y":2549,"width":373,"height":53},"line":50,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8555748c2be745bc8292dc2901e21407","type":"text","conversion_output":true,"text":"EORTC 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Document Version No.: V2.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[194,2792],[573,2792],[573,2830],[194,2830]],"region":{"top_left_x":194,"top_left_y":2791,"width":380,"height":40},"line":54,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"288a950574264cca9c7cd17d2c933fd2","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999694754347522},{"cnt":[[1033,2792],[1871,2792],[1871,2835],[1033,2835]],"region":{"top_left_x":1032,"top_left_y":2791,"width":839,"height":44},"line":55,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ab2234cc0ec146aeb6ba2bf7d8369397","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,2835],[656,2835],[656,2876],[192,2876]],"region":{"top_left_x":191,"top_left_y":2834,"width":465,"height":43},"line":56,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca0de65226994802b023bc9ce12c33b6","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1668,2837],[1871,2837],[1871,2881],[1668,2881]],"region":{"top_left_x":1667,"top_left_y":2837,"width":204,"height":44},"line":57,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b5634c16a44549eaad8aa0f7af9a814c","type":"page_info","conversion_output":false,"text":"Page 43 of 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Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,238],[1871,238],[1871,286],[196,286]],"region":{"top_left_x":196,"top_left_y":237,"width":1675,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c256dc64779b4224ae62e1d303dbe1ce","type":"text","conversion_output":true,"text":"The population for analysis of PRO improvement rate will include a subset of the FAS population as","text_display":"\n\nThe population for analysis of PRO improvement rate will include a subset of the FAS population as","confidence":1,"confidence_rate":1},{"cnt":[[196,286],[322,286],[322,327],[196,327]],"region":{"top_left_x":196,"top_left_y":285,"width":127,"height":42},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"803a38c93acb48cbb08417ce0f2fb745","type":"text","conversion_output":true,"text":"follow:","text_display":" 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For symptom scales, only patients who have baseline score \\(\\geq 10\\) will be included in PRO","text_display":"\n- For symptom scales, only patients who have baseline score \\(\\geq 10\\) will be included in PRO","confidence":1,"confidence_rate":1},{"cnt":[[320,475],[777,475],[777,523],[320,523]],"region":{"top_left_x":319,"top_left_y":475,"width":458,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b6695a0de9d44313a1226f9975a3df8a","type":"text","conversion_output":true,"text":"improvement rate analysis.","text_display":" improvement rate analysis.","confidence":1,"confidence_rate":1},{"cnt":[[256,544],[1805,544],[1805,594],[256,594]],"region":{"top_left_x":255,"top_left_y":543,"width":1550,"height":51},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5ed908b4686146fa96654b359593e1f0","type":"text","conversion_output":true,"text":"- For functional scales and global health status, only patients who have baseline score \\(\\leq 90\\)","text_display":"\n- For functional scales and global health status, only patients who have baseline score \\(\\leq 90\\)","confidence":1,"confidence_rate":1},{"cnt":[[320,594],[1190,594],[1190,642],[320,642]],"region":{"top_left_x":319,"top_left_y":593,"width":872,"height":49},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"55a33af109da4a838dbb04d125220c26","type":"text","conversion_output":true,"text":"will be included in PRO improvement rate analysis.","text_display":" will be included in PRO improvement rate analysis.","confidence":1,"confidence_rate":1},{"cnt":[[251,658],[642,658],[642,715],[251,715]],"region":{"top_left_x":251,"top_left_y":657,"width":391,"height":59},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c41035897acc436bba7500428e1f4f14","type":"section_header","conversion_output":false,"children_ids":["b4366d97a774421a9d5b7512053d8368"],"text":"","text_display":""},{"cnt":[[256,662],[637,662],[637,710],[256,710]],"region":{"top_left_x":255,"top_left_y":662,"width":383,"height":49},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b4366d97a774421a9d5b7512053d8368","type":"text","conversion_output":true,"parent_id":"c41035897acc436bba7500428e1f4f14","text":"EORTC-QLQ-LC13","text_display":"\n\n\\section*{EORTC-QLQ-LC13}","confidence":1,"confidence_rate":1},{"cnt":[[258,733],[1780,733],[1780,781],[258,781]],"region":{"top_left_x":258,"top_left_y":733,"width":1522,"height":49},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5740990eabb1478daa55e8bfa97347a2","type":"text","conversion_output":true,"text":"- For symptom scales, only patients who have baseline score \\(\\geq 5\\) will be included in PRO","text_display":"\n- For symptom scales, only patients who have baseline score \\(\\geq 5\\) will be included in PRO","confidence":1,"confidence_rate":1},{"cnt":[[320,781],[777,781],[777,829],[320,829]],"region":{"top_left_x":319,"top_left_y":781,"width":458,"height":49},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5700024fb1a94cd9a5a6c630cb858009","type":"text","conversion_output":true,"text":"improvement rate analysis.","text_display":" improvement rate analysis.","confidence":1,"confidence_rate":1},{"cnt":[[196,850],[1871,850],[1871,898],[196,898]],"region":{"top_left_x":196,"top_left_y":849,"width":1675,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"96574bb4c81b44e59614e24760cc41a7","type":"text","conversion_output":true,"text":"Descriptive statistics and graphs will be reported for the primary PRO symptom scores by visits as","text_display":"\n\nDescriptive statistics and graphs will be reported for the primary PRO symptom scores by visits as","confidence":1,"confidence_rate":1},{"cnt":[[194,900],[1871,900],[1871,948],[194,948]],"region":{"top_left_x":194,"top_left_y":900,"width":1677,"height":49},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"cf84c7c621984749a1665cca184d59b7","type":"text","conversion_output":true,"text":"well as change in these scores from baseline. These will also be reported for the other EORTC QLQ-","text_display":" well as change in these scores from baseline. These will also be reported for the other EORTC QLQ","confidence":1,"confidence_rate":1},{"cnt":[[196,946],[1218,946],[1218,994],[196,994]],"region":{"top_left_x":196,"top_left_y":945,"width":1022,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa341e9900bd4e3ab6fe1380e8d4318d","type":"text","conversion_output":true,"text":"C30 and EORTC QLQ-LC13 reported symptoms and scales.","text_display":"C30 and EORTC QLQ-LC13 reported symptoms and scales.","confidence":1,"confidence_rate":1},{"cnt":[[192,1010],[964,1010],[964,1071],[192,1071]],"region":{"top_left_x":191,"top_left_y":1009,"width":774,"height":63},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5d99dd23a9e04dd29ef52e1ad364b5db","type":"section_header","conversion_output":false,"children_ids":["1828926dd4ad46efbecff36f13592269"],"text":"","text_display":""},{"cnt":[[196,1014],[962,1014],[962,1067],[196,1067]],"region":{"top_left_x":196,"top_left_y":1014,"width":766,"height":53},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1828926dd4ad46efbecff36f13592269","type":"text","conversion_output":true,"parent_id":"5d99dd23a9e04dd29ef52e1ad364b5db","text":"Definition of clinically meaningful changes","text_display":"\n\n\\section*{Definition of clinically meaningful changes}","confidence":1,"confidence_rate":1},{"cnt":[[196,1083],[1574,1083],[1574,1135],[196,1135]],"region":{"top_left_x":196,"top_left_y":1082,"width":1378,"height":54},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"824091d2f98f405b9bfa52187baea9ed","type":"text","conversion_output":true,"text":"Changes in EORTC score compared to baseline will be evaluated as the following","text_display":"\n\nChanges in EORTC score compared to baseline will be evaluated as the following","confidence":1,"confidence_rate":1},{"cnt":[[194,1151],[340,1151],[340,1195],[194,1195]],"region":{"top_left_x":194,"top_left_y":1151,"width":147,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8bfa8bd9eefb4ef6b2ec85f154859d94","type":"text","conversion_output":true,"text":"Table 3.","text_display":"\nTable 3.","confidence":1,"confidence_rate":1},{"cnt":[[192,1288],[1720,1288],[1720,1341],[192,1341]],"region":{"top_left_x":191,"top_left_y":1288,"width":1530,"height":53},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e9b3a8b3f4d44b22bf00e892693b5e2d","type":"figure_label","conversion_output":false,"text":"Table 3. 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started (no matter within 28 days or beyond), it should be also counted as the same sub","confidence":1,"confidence_rate":1},{"cnt":[[320,1508],[1017,1508],[1017,1556],[320,1556]],"region":{"top_left_x":319,"top_left_y":1507,"width":698,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a8bce20383594c748ad9f9b74dc3b36d","type":"text","conversion_output":true,"text":"sequential/ TEAE. 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If more than one AE is coded to the same preferred term for the same","text_display":" organ class and preferred term. 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If an AE relationship is missing,","confidence":1,"confidence_rate":1},{"cnt":[[196,2163],[1345,2163],[1345,2214],[196,2214]],"region":{"top_left_x":196,"top_left_y":2163,"width":1150,"height":51},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3c4201d322c249c68e93d0b730bec700","type":"text","conversion_output":true,"text":"it would be also classified as related as the conservative relationship.","text_display":" it would be also classified as related as the conservative relationship.","confidence":1,"confidence_rate":1},{"cnt":[[196,2234],[1871,2234],[1871,2282],[196,2282]],"region":{"top_left_x":196,"top_left_y":2234,"width":1675,"height":49},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"45f1a9f7a05a4ef1acb38e30dbf75eaf","type":"text","conversion_output":true,"text":"An overall summary table including the above specified AEs will describe number of patients with","text_display":"\n\nAn overall summary table 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A summary of death and primary cause of death will be summarized by","text_display":" AEs that led to withdrawal. A summary of death and primary cause of death will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[196,402],[1871,402],[1871,450],[196,450]],"region":{"top_left_x":196,"top_left_y":402,"width":1675,"height":49},"line":7,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"74aa99782b704d93a1bf5f8de16bbc23","type":"text","conversion_output":true,"text":"the number and percentage of patients experiencing events by treatment group and overall. A by-","text_display":" the number and percentage of patients experiencing events by treatment group and overall. 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listing of patients with clinically significant changes in post-baseline values will be provided,","confidence":1,"confidence_rate":1},{"cnt":[[196,1455],[1501,1455],[1501,1505],[196,1505]],"region":{"top_left_x":196,"top_left_y":1455,"width":1305,"height":51},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"02b24641a035408f9927950c9e841680","type":"text","conversion_output":true,"text":"including the patient number, study site and baseline and post baseline values.","text_display":" including the patient number, study site and baseline and post baseline 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The above analyses apply to the following hematology and chemistry","text_display":" (grade \\(=0,1,2,3,4\\) ). 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Shift plots of the value corresponding to the maximum absolute change from baseline","text_display":" be presented. Shift plots of the value corresponding to the maximum absolute change from baseline","confidence":1,"confidence_rate":1},{"cnt":[[196,1489],[1869,1489],[1869,1533],[196,1533]],"region":{"top_left_x":196,"top_left_y":1489,"width":1673,"height":44},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb056453348a450d93cb79c7f9ed8765","type":"text","conversion_output":true,"text":"versus the baseline value for QTcF, with reference lines for \\(450 ms, \\pm 30 ms\\) and \\(\\pm 60 ms\\) change, will","text_display":" versus the baseline value for QTcF, with reference lines for \\(450 ms, \\pm 30 ms\\) and \\(\\pm 60 ms\\) change, will","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[196,1535],[423,1535],[423,1583],[196,1583]],"region":{"top_left_x":196,"top_left_y":1535,"width":227,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb7bf9bdae1e49b8bd513faedc287b88","type":"text","conversion_output":true,"text":"be presented.","text_display":" be presented.","confidence":1,"confidence_rate":1},{"cnt":[[196,1604],[1869,1604],[1869,1652],[196,1652]],"region":{"top_left_x":196,"top_left_y":1603,"width":1673,"height":49},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"dccc0109056a41449ebabfe7778ec38a","type":"text","conversion_output":true,"text":"QTc outliers are defined as QTcF values following dosing that are greater than 450 ms or are","text_display":"\n\nQTc outliers are defined as QTcF values following dosing that are greater than 450 ms or are","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[196,1654],[1871,1654],[1871,1697],[196,1697]],"region":{"top_left_x":196,"top_left_y":1653,"width":1675,"height":45},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d9f7d5cfc9ee4e75a1b7c37ee2d325d6","type":"text","conversion_output":true,"text":"increases from baseline greater than 30 ms . QTcF outliers will be highlighted in the data listings and","text_display":" increases from baseline greater than 30 ms . QTcF outliers will be highlighted in the data listings and","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[196,1700],[927,1700],[927,1748],[196,1748]],"region":{"top_left_x":196,"top_left_y":1699,"width":732,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1da2ec063847443d8bfb6f8bee6a4f84","type":"text","conversion_output":true,"text":"summarized using the following categories:","text_display":" summarized using the following categories:","confidence":1,"confidence_rate":1},{"cnt":[[260,1768],[939,1768],[939,1816],[260,1816]],"region":{"top_left_x":260,"top_left_y":1768,"width":679,"height":49},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"efee6ec404364e53a882bdf22d06aa65","type":"text","conversion_output":true,"text":"- Values \\(>450 ms,>480 ms,>500 ms\\),","text_display":"\n- Values \\(>450 ms,>480 ms,>500 ms\\),","confidence":1,"confidence_rate":1},{"cnt":[[260,1839],[893,1839],[893,1885],[260,1885]],"region":{"top_left_x":260,"top_left_y":1838,"width":634,"height":47},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"09b6b9a2491f4ba78f848666fe9634b1","type":"text","conversion_output":true,"text":"- Increase from baseline of \\(>30 ms\\),","text_display":"\n- Increase from baseline of \\(>30 ms\\),","confidence":1,"confidence_rate":1},{"cnt":[[260,1907],[893,1907],[893,1953],[260,1953]],"region":{"top_left_x":260,"top_left_y":1907,"width":634,"height":47},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"99babf2f44434b3e98022552b22dc7f3","type":"text","conversion_output":true,"text":"- Increase from baseline of \\(>60 ms\\),","text_display":"\n- Increase from baseline of \\(>60 ms\\),","confidence":1,"confidence_rate":1},{"cnt":[[260,1976],[893,1976],[893,2022],[260,2022]],"region":{"top_left_x":260,"top_left_y":1975,"width":634,"height":47},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f159055e92e74c1d8b16660125ad2267","type":"text","conversion_output":true,"text":"- Increase from baseline of \\(>90 ms\\),","text_display":"\n- Increase from baseline of \\(>90 ms\\),","confidence":1,"confidence_rate":1},{"cnt":[[260,2042],[1021,2042],[1021,2086],[260,2086]],"region":{"top_left_x":260,"top_left_y":2042,"width":762,"height":44},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3c358c8207bc42019b802919d321c896","type":"text","conversion_output":true,"text":"- Values \\(>450 ms\\) and increases of \\(>30 ms\\).","text_display":"\n- Values \\(>450 ms\\) and increases of \\(>30 ms\\).","confidence":1,"confidence_rate":1},{"cnt":[[260,2113],[1021,2113],[1021,2154],[260,2154]],"region":{"top_left_x":260,"top_left_y":2113,"width":762,"height":42},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"89939e779c744dfeae3be69be89013f0","type":"text","conversion_output":true,"text":"- Values \\(>500 ms\\) and increases of \\(>60 ms\\).","text_display":"\n- Values \\(>500 ms\\) and increases of \\(>60 ms\\).","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[196,2184],[1869,2184],[1869,2230],[196,2230]],"region":{"top_left_x":196,"top_left_y":2183,"width":1673,"height":47},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fcfdbd2dff6a4abb9a02849c6181beb9","type":"text","conversion_output":true,"text":"The number and percentage of patients who meet the ECG outlier criteria at any assessment post-","text_display":"\n\nThe number and percentage of patients who meet the ECG outlier criteria at any assessment post","confidence":1,"confidence_rate":1},{"cnt":[[196,2230],[1871,2230],[1871,2278],[196,2278]],"region":{"top_left_x":196,"top_left_y":2229,"width":1675,"height":49},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f6a6da1fc2514a18ac2ad43b839ac6f9","type":"text","conversion_output":true,"text":"date of first dose will be summarized. Triplicate 12-ECG will be analyzed by the mean of the 3 time-","text_display":"date of first dose will be summarized. Triplicate 12-ECG will be analyzed by the mean of the 3 time","confidence":0.9819421768188477,"confidence_rate":0.9998312840911867},{"cnt":[[196,2280],[313,2280],[313,2325],[196,2325]],"region":{"top_left_x":196,"top_left_y":2279,"width":117,"height":47},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"2f8199b476d947bc8a7ae7b352a6bb54","type":"text","conversion_output":true,"text":"points.","text_display":"points.","confidence":1,"confidence_rate":1},{"cnt":[[196,2346],[1869,2346],[1869,2394],[196,2394]],"region":{"top_left_x":196,"top_left_y":2346,"width":1673,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"099ff7c8b35a4d5681482826bf7ade92","type":"text","conversion_output":true,"text":"A shift table in CTCAE Grade of QTcF will be provided. A supportive listing of patients with","text_display":"\n\nA shift table in CTCAE Grade of QTcF will be provided. A supportive listing of patients with","confidence":1,"confidence_rate":1},{"cnt":[[196,2394],[1866,2394],[1866,2442],[196,2442]],"region":{"top_left_x":196,"top_left_y":2394,"width":1671,"height":48},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"0d85ac389e6c4302b092b98e7ab44dda","type":"text","conversion_output":true,"text":"clinically significant changes in post baseline 12 lead ECG findings will be provided, including the","text_display":" clinically significant changes in post baseline 12 lead ECG findings will be provided, including the","confidence":1,"confidence_rate":1},{"cnt":[[196,2444],[1309,2444],[1309,2488],[196,2488]],"region":{"top_left_x":196,"top_left_y":2444,"width":1113,"height":44},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8866fa2a95c14118be18c71342c56122","type":"text","conversion_output":true,"text":"patient number, study site, and baseline and post-baseline findings","text_display":" patient number, study site, and baseline and post-baseline findings","confidence":1,"confidence_rate":1},{"cnt":[[192,2529],[742,2529],[742,2584],[192,2584]],"region":{"top_left_x":191,"top_left_y":2528,"width":552,"height":56},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"1b9471c6f4f64b1f9695dc4877448bd3","type":"section_header","conversion_output":false,"children_ids":["c356b1835fad4006bd05ea680168084c"],"text":"","text_display":""},{"cnt":[[196,2531],[740,2531],[740,2579],[196,2579]],"region":{"top_left_x":196,"top_left_y":2531,"width":545,"height":49},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"c356b1835fad4006bd05ea680168084c","type":"text","conversion_output":true,"parent_id":"1b9471c6f4f64b1f9695dc4877448bd3","text":"4.11.4.3 Physical Examination","text_display":"\n\n\\subsection*{4.11.4.3 Physical 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Document Version No.: V2.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,2792],[569,2792],[569,2826],[196,2826]],"region":{"top_left_x":196,"top_left_y":2791,"width":373,"height":35},"line":49,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7fc52a5b4dd94ce8a61f4485d40a3e1e","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.9985356330871582,"confidence_rate":0.9999542060440147},{"cnt":[[1037,2792],[1871,2792],[1871,2835],[1037,2835]],"region":{"top_left_x":1037,"top_left_y":2791,"width":834,"height":44},"line":50,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d2249b0bcaa0475aa35b40cf75df09aa","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,2837],[656,2837],[656,2871],[196,2871]],"region":{"top_left_x":196,"top_left_y":2837,"width":460,"height":35},"line":51,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8e2f6632b55d4a43a3dc2dcfaa3e8687","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1672,2837],[1866,2837],[1866,2876],[1672,2876]],"region":{"top_left_x":1672,"top_left_y":2837,"width":195,"height":40},"line":52,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00f2d6b564514b26b88e7291ff8b8db0","type":"page_info","conversion_output":false,"text":"Page 56 of 83","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2924,"page_width":2068,"languages_detected":[]},{"image_id":"43f70033-c325-4dd7-8bf3-864fe9a77081-57","page":57,"lines":[{"cnt":[[196,105],[331,105],[331,139],[196,139]],"region":{"top_left_x":196,"top_left_y":105,"width":136,"height":35},"line":1,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"7d1525933f0a4886881efa0493e52155","type":"page_info","conversion_output":false,"text":"YUHAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,151],[400,151],[400,190],[192,190]],"region":{"top_left_x":191,"top_left_y":150,"width":209,"height":40},"line":2,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"909fc18cac3c4467bdc48c2419da2a03","type":"page_info","conversion_output":false,"text":"YH25448-301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1526,151],[1871,151],[1871,190],[1526,190]],"region":{"top_left_x":1525,"top_left_y":150,"width":346,"height":40},"line":3,"column":0,"font_size":23,"is_printed":true,"is_handwritten":false,"id":"d62b3d427efd406cb5ff92ae69d32a69","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,238],[1871,238],[1871,286],[196,286]],"region":{"top_left_x":196,"top_left_y":237,"width":1675,"height":49},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"141939b12fc843428d57a5f684e74eda","type":"text","conversion_output":true,"text":"Results of the physical examinations will be summarized by observed time point using appropriate","text_display":"\n\nResults of the physical examinations will be summarized by observed time point using appropriate","confidence":1,"confidence_rate":1},{"cnt":[[196,286],[875,286],[875,336],[196,336]],"region":{"top_left_x":196,"top_left_y":285,"width":679,"height":51},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7e0cee7b7a5843669cbbae3ca2cd624b","type":"text","conversion_output":true,"text":"descriptive statistics by treatment group.","text_display":" descriptive statistics by treatment group.","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[196,352],[925,352],[925,404],[196,404]],"region":{"top_left_x":196,"top_left_y":351,"width":730,"height":54},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11db86b615ab4a5ea1127d09068ab04f","type":"text","conversion_output":true,"text":"The following summaries will be provided:","text_display":"\n\nThe following summaries will be provided:","confidence":1,"confidence_rate":1},{"cnt":[[260,421],[1869,419],[1869,471],[260,473]],"region":{"top_left_x":260,"top_left_y":419,"width":1609,"height":54},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f2b5c726d86d4e64ab27f9e9e2ad9d92","type":"text","conversion_output":true,"text":"- A summary of each physical examination by body system, visit and study treatment (Analysis","text_display":"\n- A summary of each physical examination by body system, visit and study treatment (Analysis","confidence":1,"confidence_rate":1},{"cnt":[[320,471],[583,471],[583,519],[320,519]],"region":{"top_left_x":319,"top_left_y":470,"width":264,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"94a8a20f21004549a3253767838a6f9d","type":"text","conversion_output":true,"text":"set: Safety set).","text_display":" set: Safety set).","confidence":1,"confidence_rate":1},{"cnt":[[260,539],[1871,539],[1871,587],[260,587]],"region":{"top_left_x":260,"top_left_y":539,"width":1611,"height":49},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e3fb465e40464fdb8c881a9ad63ad92d","type":"text","conversion_output":true,"text":"- A summary of change from baseline using shift table in each physical examination by visit","text_display":"\n- A summary of change from baseline using shift table in each physical examination by visit","confidence":1,"confidence_rate":1},{"cnt":[[320,589],[1090,589],[1090,637],[320,637]],"region":{"top_left_x":319,"top_left_y":589,"width":771,"height":49},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"14c6468b763848bc8921547ab4e8f865","type":"text","conversion_output":true,"text":"and study treatment (Analysis set: Safety set).","text_display":" and study treatment (Analysis set: Safety set).","confidence":1,"confidence_rate":1},{"cnt":[[260,653],[1869,653],[1869,706],[260,706]],"region":{"top_left_x":260,"top_left_y":653,"width":1609,"height":53},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"81f58dbded8b4b8f8a3fa393f136c55d","type":"text","conversion_output":true,"text":"- A by-subject listing of all physical examination will be provided (Listing analysis set:","text_display":"\n- A by-subject listing of all physical examination will be provided (Listing analysis 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SAEs, AE, and other safety data will be","text_display":" continue, amend, or stop the study based on findings. SAEs, AE, and other safety data will be","confidence":1,"confidence_rate":1},{"cnt":[[196,1081],[1871,1081],[1871,1131],[196,1131]],"region":{"top_left_x":196,"top_left_y":1080,"width":1675,"height":51},"line":21,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fe0d80b76155455b9416c79e9dec47f0","type":"text","conversion_output":true,"text":"reviewed, and individual and aggregated safety data will be evaluated by the IDMC. Note no alpha","text_display":" reviewed, and individual and aggregated safety data will be evaluated by the IDMC. Note no alpha","confidence":1,"confidence_rate":1},{"cnt":[[196,1128],[1871,1128],[1871,1176],[196,1176]],"region":{"top_left_x":196,"top_left_y":1128,"width":1675,"height":49},"line":22,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d3bc6404871144f29365c40c9ace9129","type":"text","conversion_output":true,"text":"adjustment is required for the IDMC data assessment as the stopping boundary would allow for ruling","text_display":" adjustment is required for the IDMC data assessment as the stopping boundary would allow for ruling","confidence":1,"confidence_rate":1},{"cnt":[[196,1176],[1871,1176],[1871,1227],[196,1227]],"region":{"top_left_x":196,"top_left_y":1176,"width":1675,"height":51},"line":23,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a3fa43cc558045208d9abbe0c1fbe061","type":"text","conversion_output":true,"text":"out harm only. Full details of the number of progression events, number of patients and boundary","text_display":" out harm only. Full details of the number of progression events, number of patients and boundary","confidence":1,"confidence_rate":1},{"cnt":[[196,1224],[1871,1224],[1871,1272],[196,1272]],"region":{"top_left_x":196,"top_left_y":1224,"width":1675,"height":49},"line":24,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f0130a08d00843eda6f1afe0d1a0d833","type":"text","conversion_output":true,"text":"hazard ratio to determine stopping for harm will be documented in the IDMC Charter prior to the","text_display":" hazard ratio to determine stopping for harm will be documented in the IDMC Charter prior to the","confidence":1,"confidence_rate":1},{"cnt":[[196,1270],[1871,1270],[1871,1320],[196,1320]],"region":{"top_left_x":196,"top_left_y":1270,"width":1675,"height":51},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a08e1a59c6e44b46be15788a7d221002","type":"text","conversion_output":true,"text":"first IDMC safety review meeting. The boundary will not be considered binding and will be used in","text_display":" first IDMC safety review meeting. The boundary will not be considered binding and will be used in","confidence":1,"confidence_rate":1},{"cnt":[[196,1320],[1871,1320],[1871,1368],[196,1368]],"region":{"top_left_x":196,"top_left_y":1320,"width":1675,"height":49},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"92abde94f56a468f966a0f04e089ce16","type":"text","conversion_output":true,"text":"addition to the accumulating available safety data to decide whether to continue the trial as planned,","text_display":" addition to the accumulating available safety data to decide whether to continue the trial as planned,","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[196,1366],[605,1366],[605,1419],[196,1419]],"region":{"top_left_x":196,"top_left_y":1366,"width":410,"height":53},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f16ce426b0a344edb056eee6fdea4304","type":"text","conversion_output":true,"text":"stop, or modify the trial.","text_display":" stop, or modify the trial.","confidence":1,"confidence_rate":1},{"cnt":[[240,1476],[861,1476],[861,1524],[240,1524]],"region":{"top_left_x":239,"top_left_y":1475,"width":623,"height":49},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8dfac36ed1ad431792ca5b8874b67548","type":"section_header","conversion_output":false,"children_ids":["fa9407c780424ba7a396632d794dbfe1"],"text":"","text_display":""},{"cnt":[[242,1480],[857,1480],[857,1519],[242,1519]],"region":{"top_left_x":242,"top_left_y":1480,"width":615,"height":40},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fa9407c780424ba7a396632d794dbfe1","type":"text","conversion_output":true,"parent_id":"8dfac36ed1ad431792ca5b8874b67548","text":"4.12 Pharmacokinetic Evaluation","text_display":"\n\n\\subsection*{4.12 Pharmacokinetic Evaluation}","confidence":1,"confidence_rate":1},{"cnt":[[192,1585],[934,1585],[934,1642],[192,1642]],"region":{"top_left_x":191,"top_left_y":1585,"width":744,"height":58},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"122dbb4be5ab4fcf932ae188376bd97f","type":"section_header","conversion_output":false,"children_ids":["7d01e2b31dfb49c3898a51da0deedbf5"],"text":"","text_display":""},{"cnt":[[196,1590],[930,1590],[930,1638],[196,1638]],"region":{"top_left_x":196,"top_left_y":1589,"width":734,"height":49},"line":31,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7d01e2b31dfb49c3898a51da0deedbf5","type":"text","conversion_output":true,"parent_id":"122dbb4be5ab4fcf932ae188376bd97f","text":"4.12.1 Listing of PK Concentration Data","text_display":"\n\n\\subsection*{4.12.1 Listing of PK Concentration Data}","confidence":1,"confidence_rate":1},{"cnt":[[196,1656],[1843,1656],[1843,1706],[196,1706]],"region":{"top_left_x":196,"top_left_y":1656,"width":1648,"height":51},"line":32,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"b729a0becd4241c8a6e0a717e40998bc","type":"text","conversion_output":true,"text":"Plasma and CSF concentration data are used as supplied by the bioanalytical laboratory. The units","text_display":"\n\nPlasma and CSF concentration data are used as supplied by the bioanalytical laboratory. The units","confidence":1,"confidence_rate":1},{"cnt":[[196,1704],[1843,1704],[1843,1752],[196,1752]],"region":{"top_left_x":196,"top_left_y":1704,"width":1648,"height":49},"line":33,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"7888be2c6b334f0a82bf11201e0997ee","type":"text","conversion_output":true,"text":"and decimal place of the concentrations will be presented as they are received from the bioanalytical","text_display":" and decimal place of the concentrations will be presented as they are received from the bioanalytical","confidence":0.99755859375,"confidence_rate":0.9999769399702094},{"cnt":[[196,1750],[1396,1750],[1396,1802],[196,1802]],"region":{"top_left_x":196,"top_left_y":1749,"width":1200,"height":54},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8f93c40039964d2ba9fb34ef2ec40c34","type":"text","conversion_output":true,"text":"laboratory. For each patient, the following concentrations will be listed.","text_display":" laboratory. For each patient, the following concentrations will be listed.","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[258,1823],[1871,1823],[1871,1875],[258,1875]],"region":{"top_left_x":258,"top_left_y":1822,"width":1613,"height":54},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"87e4ed506b054ed9a79d2a0c6c964ee4","type":"text","conversion_output":true,"text":"- Plasma concentrations of Lazertinib at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on","text_display":"\n- Plasma concentrations of Lazertinib at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on","confidence":1,"confidence_rate":1},{"cnt":[[320,1873],[884,1873],[884,1921],[320,1921]],"region":{"top_left_x":319,"top_left_y":1873,"width":566,"height":49},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"390a9871e1f546e3800194b65cbe2e81","type":"text","conversion_output":true,"text":"Day 1 of Cycles 1, 2, 5, 9, and 13","text_display":" Day 1 of Cycles 1, 2, 5, 9, and 13","confidence":1,"confidence_rate":1},{"cnt":[[258,1946],[884,1946],[884,1987],[258,1987]],"region":{"top_left_x":258,"top_left_y":1946,"width":627,"height":42},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"48e9644b651d468686f0f3812a172138","type":"text","conversion_output":true,"text":"- CSF concentrations of Lazertinib","text_display":"\n- CSF concentrations of Lazertinib","confidence":1,"confidence_rate":1},{"cnt":[[196,2015],[1866,2015],[1866,2063],[196,2063]],"region":{"top_left_x":196,"top_left_y":2014,"width":1671,"height":49},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"50294db9659643e2beac29ab437f71ba","type":"text","conversion_output":true,"text":"Plasma PK samples will be collected at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1","text_display":"\n\nPlasma PK samples will be collected at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1","confidence":0.99560546875,"confidence_rate":0.9999613672762195},{"cnt":[[196,2061],[1181,2061],[1181,2111],[196,2111]],"region":{"top_left_x":196,"top_left_y":2060,"width":986,"height":51},"line":39,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d42b2b3589454c23a118fffcaacacdf6","type":"text","conversion_output":true,"text":"of Cycles 1, 2, 5, 9, and 13 as per the assessment schedule.","text_display":" of Cycles 1, 2, 5, 9, and 13 as per the assessment schedule.","confidence":0.9883096218109131,"confidence_rate":0.9998270848349542},{"cnt":[[192,2170],[959,2170],[959,2223],[192,2223]],"region":{"top_left_x":191,"top_left_y":2170,"width":769,"height":53},"line":40,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"af3341063e1a412898ab30262a99cde2","type":"section_header","conversion_output":false,"children_ids":["167a46705c8c4f3889ecc0705a01d1b0"],"text":"","text_display":""},{"cnt":[[196,2170],[955,2170],[955,2218],[196,2218]],"region":{"top_left_x":196,"top_left_y":2170,"width":759,"height":49},"line":41,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"167a46705c8c4f3889ecc0705a01d1b0","type":"text","conversion_output":true,"parent_id":"af3341063e1a412898ab30262a99cde2","text":"4.12.2 Analysis of PK Concentration Data","text_display":"\n\n\\subsection*{4.12.2 Analysis of PK Concentration Data}","confidence":1,"confidence_rate":1},{"cnt":[[196,2239],[1871,2239],[1871,2289],[196,2289]],"region":{"top_left_x":196,"top_left_y":2238,"width":1675,"height":51},"line":42,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"f9748da78c254e5f909d45140e956f69","type":"text","conversion_output":true,"text":"Plasma concentrations of Lazertinib will be summarized by nominal sampling time. CSF","text_display":"\n\nPlasma concentrations of Lazertinib will be summarized by nominal sampling time. CSF","confidence":1,"confidence_rate":1},{"cnt":[[196,2289],[1875,2289],[1875,2337],[196,2337]],"region":{"top_left_x":196,"top_left_y":2288,"width":1680,"height":49},"line":43,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"a80165fd9dfb402486ff0c17413d2c30","type":"text","conversion_output":true,"text":"concentrations will also be summarized. The summary statistics will be presented by number of","text_display":" concentrations will also be summarized. The summary statistics will be presented by number of","confidence":0.98876953125,"confidence_rate":0.9998847616749484},{"cnt":[[194,2335],[1871,2335],[1871,2385],[194,2385]],"region":{"top_left_x":194,"top_left_y":2334,"width":1677,"height":51},"line":44,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"65a79dbce6d54653b7876ef2bcfcc77a","type":"text","conversion_output":true,"text":"patients, arithmetic mean, standard deviation, arithmetic coefficient of variation, median, minimum,","text_display":" patients, arithmetic mean, standard deviation, arithmetic coefficient of variation, median, minimum,","confidence":1,"confidence_rate":1},{"cnt":[[196,2385],[1871,2385],[1871,2433],[196,2433]],"region":{"top_left_x":196,"top_left_y":2384,"width":1675,"height":49},"line":45,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"26618dcd225c43e3a12d6010a6140d0a","type":"text","conversion_output":true,"text":"maximum, geometric mean, and geometric coefficient of variation for the PK analysis set. In the","text_display":" maximum, geometric mean, and geometric coefficient of variation for the PK analysis set. In the","confidence":1,"confidence_rate":1},{"cnt":[[196,2431],[1875,2431],[1875,2481],[196,2481]],"region":{"top_left_x":196,"top_left_y":2430,"width":1680,"height":51},"line":46,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"bb1406c0c95f46e1b142f75a1c6b37c7","type":"text","conversion_output":true,"text":"summary statistics for the concentration data, BLQ values will be treated as half of the lower limit of","text_display":" summary statistics for the concentration data, BLQ values will be treated as half of the lower limit of","confidence":1,"confidence_rate":1},{"cnt":[[196,2481],[1871,2481],[1871,2529],[196,2529]],"region":{"top_left_x":196,"top_left_y":2480,"width":1675,"height":49},"line":47,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d612cfc0d69344209f13843adf67aa04","type":"text","conversion_output":true,"text":"quantification ( \\(1 / 2\\) LLOQ) with the exception of the value for 'not detected (ND)', which is set to zero.","text_display":" quantification ( \\(1 / 2\\) LLOQ) with the exception of the value for 'not detected (ND)', which is set to zero.","confidence":0.7913977410312327,"confidence_rate":0.9979317470593225},{"cnt":[[196,2527],[1869,2527],[1869,2577],[196,2577]],"region":{"top_left_x":196,"top_left_y":2526,"width":1673,"height":51},"line":48,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"8bb8aed3321744599be537036463020f","type":"text","conversion_output":true,"text":"If all the values are BLQ in all patients by each nominal sampling time, then the arithmetic mean,","text_display":" If all the values are BLQ in all patients by each nominal sampling time, then the arithmetic mean,","confidence":1,"confidence_rate":1},{"cnt":[[196,2577],[1871,2577],[1871,2625],[196,2625]],"region":{"top_left_x":196,"top_left_y":2576,"width":1675,"height":49},"line":49,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"537b3b7d19b34cdbbf9054dba397408e","type":"text","conversion_output":true,"text":"standard deviation, median, minimum, maximum and geometric mean are presented as zero, and the","text_display":" standard deviation, median, minimum, maximum and geometric mean are presented as zero, and the","confidence":1,"confidence_rate":1},{"cnt":[[196,2622],[1871,2622],[1871,2673],[196,2673]],"region":{"top_left_x":196,"top_left_y":2622,"width":1675,"height":51},"line":50,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d65044388db54e15ab086e091d2ef22d","type":"text","conversion_output":true,"text":"arithmetic and geometric coefficient of variation are denoted as NA. Missing values of the","text_display":" arithmetic and geometric coefficient of variation are denoted as NA. 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Activities & Screening & \\multicolumn{3}{|c|}{Cycle 1} & Cycle 2 & Cycle 3 & Cycle 4 & Cycle 5 onward \\({ }^{ 1 }\\) & Unsched uled visit \\({ }^{ 2 }\\) & Disconti nuation \\({ }^{ 3 }\\) & 28-day Safety F/U \\({ }^{4}\\) & Progression \\(F / U ^{ 5 }\\) & Survival \\(F / U ^{ 6 }\\) \\\\\n\\hline Visit & 1 & 2 & 3 & 4 & 5 & 6 & 7 & After 8 & & & & & \\\\\n\\hline Cycle \\({ }^{7}\\) / Day & NA & Cycle 1 / Day 1 & Cycle 1 / Day 8 & Cyc1e 1 / Day 15 & Cycle 2 / Day 1 & Cycle 3 / Day 1 & Cycle 4/ Day 1 & Cycle 5 / Day 1 & & & & & \\\\\n\\hline Day & \\multirow{2}{*}{-28} & 1 & 8 & 15 & 22 & 43 & 64 & 85 & & & & & \\\\\n\\hline Visit window \\({ }^{8}\\) & & 0 & \\(\\pm 2\\) & \\(\\pm 2\\) & -2~+3 & -7~+3 & -7~+3 & -7~+3 & NA & +7 & +7 & \\(\\pm 7\\) & \\(\\pm 7\\) \\\\\n\\hline scan (for LVEF) \\({ }^{16}\\) & & & \\multicolumn{11}{|c|}{} \\\\\n\\hline Laboratory tests \\({ }^{ 1 7 }\\) & \\multicolumn{13}{|c|}{} \\\\\n\\hline Clinical chemistry & X & X & X & X & X & X & X & X & (X) & 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The discontinuation visit should occur before the start of any new treatment and the reason should be documented on the electronic Case","confidence":0.9990234375,"confidence_rate":0.9999938551154344},{"cnt":[[302,1156],[496,1156],[496,1195],[302,1195]],"region":{"top_left_x":301,"top_left_y":1155,"width":195,"height":40},"line":121,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5b61f4006ee347dfa893774d8958fc48","type":"text","conversion_output":true,"text":"Report Form.","text_display":" Report Form.","confidence":0.9931640625,"confidence_rate":0.9995965867135663},{"cnt":[[233,1192],[2255,1192],[2255,1236],[233,1236]],"region":{"top_left_x":233,"top_left_y":1192,"width":2022,"height":44},"line":122,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"8878c0d5a43a48ffb57f51b002333369","type":"text","conversion_output":true,"text":"\\({ }^{4}\\) 28-day safety \\(F / U\\) will be made via at least a telephone contact within 28 days ( +7 days) after permanent discontinuation of study treatment.","text_display":"\n\\({ }^{4}\\) 28-day safety \\(F / U\\) will be made via at least a telephone contact within 28 days ( +7 days) after permanent discontinuation of study treatment.","confidence":0.7482921478804201,"confidence_rate":0.9982857207313535},{"cnt":[[233,1234],[2533,1234],[2533,1275],[233,1275]],"region":{"top_left_x":233,"top_left_y":1233,"width":2301,"height":42},"line":123,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"e889b084166b422491e16e19c991518e","type":"text","conversion_output":true,"text":"\\({ }^{5}\\) If patients discontinue study treatment for reasons other than objective disease progression, Progression F/U will be made every 6 weeks. Tumor assessment per","text_display":"\n\\({ }^{5}\\) If patients discontinue study treatment for reasons other than objective disease progression, Progression F/U will be made every 6 weeks. Tumor assessment per","confidence":0.9985356330871582,"confidence_rate":0.9999915779656613},{"cnt":[[302,1275],[2533,1275],[2533,1314],[302,1314]],"region":{"top_left_x":301,"top_left_y":1274,"width":2233,"height":40},"line":124,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95b0990e955446259817023390b27f00","type":"text","conversion_output":true,"text":"RECIST v1.1 for the Progression F/U should be continued every 6 weeks for the first 18 months and then every 12 weeks relative to date of randomization until","text_display":" RECIST v1.1 for the Progression F/U should be continued every 6 weeks for the first 18 months and then every 12 weeks relative to date of randomization until","confidence":0.98828125,"confidence_rate":0.9999310669622364},{"cnt":[[302,1311],[724,1311],[724,1355],[302,1355]],"region":{"top_left_x":301,"top_left_y":1311,"width":424,"height":44},"line":125,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7123615edde24ea3ae7fecc06d541406","type":"text","conversion_output":true,"text":"objective disease progression.","text_display":" objective disease progression.","confidence":1,"confidence_rate":1},{"cnt":[[233,1352],[2561,1352],[2561,1396],[233,1396]],"region":{"top_left_x":233,"top_left_y":1352,"width":2328,"height":44},"line":126,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"67e7ef23edff428b860f0ed964742a0c","type":"text","conversion_output":true,"text":"\\({ }^{6}\\) All patients will be followed for survival, disease progression (per local standard practice) and any post-study anticancer treatment via at least a telephone contact","text_display":"\n\\({ }^{6}\\) All patients will be followed for survival, disease progression (per local standard practice) and any post-study anticancer treatment via at least a telephone contact","confidence":1,"confidence_rate":1},{"cnt":[[302,1393],[2469,1393],[2469,1435],[302,1435]],"region":{"top_left_x":301,"top_left_y":1393,"width":2169,"height":42},"line":127,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c1e5e40a0c1d4cb6adb6390e84c73ca2","type":"text","conversion_output":true,"text":"every 6 weeks following discontinuation of study treatment, until lost to follow up, the withdrawal of consent, or death (whichever is earlier). However, the","text_display":" every 6 weeks following discontinuation of study treatment, until lost to follow up, the withdrawal of consent, or death (whichever is earlier). However, the","confidence":1,"confidence_rate":1},{"cnt":[[302,1435],[2556,1435],[2556,1473],[302,1473]],"region":{"top_left_x":301,"top_left_y":1434,"width":2256,"height":40},"line":128,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6268ebee91f04729861dfbe5a5ccf389","type":"text","conversion_output":true,"text":"patients who discontinue study treatment for reasons other than objective disease progression will conduct survival follow-up following confirmation of objective","text_display":" patients who discontinue study treatment for reasons other than objective disease progression will conduct survival follow-up following confirmation of objective","confidence":0.99951171875,"confidence_rate":0.9999970578326528},{"cnt":[[302,1476],[587,1476],[587,1515],[302,1515]],"region":{"top_left_x":301,"top_left_y":1475,"width":287,"height":40},"line":129,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4837726153934dd5ad4dfa6de582a6e9","type":"text","conversion_output":true,"text":"disease progression.","text_display":" disease progression.","confidence":0.99951171875,"confidence_rate":0.9999804641709025},{"cnt":[[233,1512],[948,1512],[948,1556],[233,1556]],"region":{"top_left_x":233,"top_left_y":1512,"width":716,"height":44},"line":130,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"65ff94c2b8c64770b91ace452d23ab8b","type":"text","conversion_output":true,"text":"7 A cycle is defined as 21-day treatment period.","text_display":"\n7 A cycle is defined as 21-day treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[233,1553],[1181,1553],[1181,1592],[233,1592]],"region":{"top_left_x":233,"top_left_y":1553,"width":949,"height":40},"line":131,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7c2a12cc16dd4050857a43fe088a5ed2","type":"text","conversion_output":true,"text":"\\({ }^{8}\\) Visit window is calculated based on the date of randomization.","text_display":"\n\\({ }^{8}\\) Visit window is calculated based on the date of randomization.","confidence":0.9072265625,"confidence_rate":0.9987026680398418},{"cnt":[[233,1590],[1738,1590],[1738,1633],[233,1633]],"region":{"top_left_x":233,"top_left_y":1589,"width":1506,"height":45},"line":132,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f671b0375ed44a17889deb64eab9eea5","type":"text","conversion_output":true,"text":"9 Signed informed consent must be obtained before the patient undergoes any study-specific procedures.","text_display":"\n9 Signed informed consent must be obtained before the patient undergoes any study-specific procedures.","confidence":0.70556640625,"confidence_rate":0.9967152708521071},{"cnt":[[233,1631],[2451,1631],[2451,1674],[233,1674]],"region":{"top_left_x":233,"top_left_y":1631,"width":2219,"height":44},"line":133,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4ddf1073262a4e8b98f3ca724c97840f","type":"text","conversion_output":true,"text":"10 Tumor samples for screening EGFR mutations test should be assessed by an accredited local laboratory, or by central testing in a designated laboratory. 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Document Version No.: draft V1.5","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,1937],[569,1937],[569,1971],[196,1971]],"region":{"top_left_x":196,"top_left_y":1937,"width":373,"height":35},"line":138,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d3c7629668614320a041c040dbc82a92","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[1896,1937],[2730,1937],[2730,1976],[1896,1976]],"region":{"top_left_x":1896,"top_left_y":1937,"width":834,"height":39},"line":139,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"1dfd8483195f434ba3a5897297803fe3","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[194,1981],[651,1981],[651,2013],[194,2013]],"region":{"top_left_x":194,"top_left_y":1980,"width":458,"height":33},"line":140,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"996bc63e2dc94fac81b5f138a52d5d01","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2527,1983],[2725,1983],[2725,2019],[2527,2019]],"region":{"top_left_x":2526,"top_left_y":1982,"width":200,"height":38},"line":141,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dcd28d5283ac4c58a8d8d5430440cf99","type":"page_info","conversion_output":false,"text":"Page 65 of 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Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[279,251],[2661,251],[2661,295],[279,295]],"region":{"top_left_x":278,"top_left_y":251,"width":2384,"height":44},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f6eb577723d645c596290763c3d7d2b1","type":"text","conversion_output":true,"text":"EGFR Mutation Detection Kit RGQ (Scorpions ARMS), the Amoy Diagnostics-the AmoyDx \\({ }^{\\circledR}\\) EGFR Mutation Test Kit, the PANAGENE-PANAMutyper \\({ }^{\\text {TM }}\\) or","text_display":"\n\nEGFR Mutation Detection Kit RGQ (Scorpions ARMS), the Amoy Diagnostics-the AmoyDx \\({ }^{\\circledR}\\) EGFR Mutation Test Kit, the PANAGENE-PANAMutyper \\({ }^{\\text {TM }}\\) or","confidence":0.7828708724118769,"confidence_rate":0.9985439924940833},{"cnt":[[279,295],[1103,295],[1103,338],[279,338]],"region":{"top_left_x":278,"top_left_y":294,"width":826,"height":45},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be0733bcd7fb480dbef7c068de553b0e","type":"text","conversion_output":true,"text":"the Roche Diagnotics-Cobas \\({ }^{\\circledR}\\) EGFR Mutation Test v2.","text_display":" the Roche Diagnotics-Cobas \\({ }^{\\circledR}\\) EGFR Mutation Test v2.","confidence":0.9306640625,"confidence_rate":0.9989118515248187},{"cnt":[[208,336],[2088,336],[2088,381],[208,381]],"region":{"top_left_x":207,"top_left_y":335,"width":1881,"height":47},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c42d660fd7bf47f38f36ca00973f9e72","type":"text","conversion_output":true,"text":"\\({ }^{11}\\) Collected tumor (Formalin-Fixed Paraffin-Embedded Tissue) and blood samples must be submitted to central laboratory.","text_display":"\n\\({ }^{11}\\) Collected tumor (Formalin-Fixed Paraffin-Embedded Tissue) and blood samples must be submitted to central laboratory.","confidence":0.76611328125,"confidence_rate":0.9979526737647323},{"cnt":[[206,379],[1019,379],[1019,425],[206,425]],"region":{"top_left_x":205,"top_left_y":379,"width":814,"height":46},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b01264361dc14f91b0f5bc8f7440b452","type":"text","conversion_output":true,"text":"12 May include neurologic examination, if required.","text_display":"\n12 May include neurologic examination, if required.","confidence":0.92822265625,"confidence_rate":0.9986466685133626},{"cnt":[[208,420],[2625,420],[2625,468],[208,468]],"region":{"top_left_x":207,"top_left_y":420,"width":2418,"height":49},"line":8,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc29d8f186234c40b3b473214e654798","type":"text","conversion_output":true,"text":"13 Vital signs (heart rate, blood pressure and body temperature) will be obtained after the patient has rested for 10 minutes. The date and time of the assessment","text_display":"\n13 Vital signs (heart rate, blood pressure and body temperature) will be obtained after the patient has rested for 10 minutes. The date and time of the assessment","confidence":0.7578125,"confidence_rate":0.9983604030927931},{"cnt":[[279,466],[578,466],[578,505],[279,505]],"region":{"top_left_x":278,"top_left_y":466,"width":300,"height":39},"line":9,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"f785fae0549e4a74b603c2e701a1b9fd","type":"text","conversion_output":true,"text":"should be recorded.","text_display":" should be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[206,507],[2712,507],[2712,553],[206,553]],"region":{"top_left_x":205,"top_left_y":507,"width":2507,"height":46},"line":10,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"00d6efb0f16e4199968165723046ce7f","type":"text","conversion_output":true,"text":"\\({ }^{14}\\) Hepatitis B (HBV) surface antigen (HBsAg) and hepatitis C antibody (anti-HCV) test will be performed. Additional hepatitis examination could be conducted if","text_display":"\n\\({ }^{14}\\) Hepatitis B (HBV) surface antigen (HBsAg) and hepatitis C antibody (anti-HCV) test will be performed. Additional hepatitis examination could be conducted if","confidence":0.8052706718444824,"confidence_rate":0.9987268298769361},{"cnt":[[279,553],[2707,553],[2707,596],[279,596]],"region":{"top_left_x":278,"top_left_y":552,"width":2429,"height":45},"line":11,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"089a5738fcb148bbb6143efa5a62d905","type":"text","conversion_output":true,"text":"required. Evaluation for HIV seropositivity will be performed, and, if positive, further tests can be determined at the discretion of the Investigator, if needed.","text_display":" required. Evaluation for HIV seropositivity will be performed, and, if positive, further tests can be determined at the discretion of the Investigator, if needed.","confidence":1,"confidence_rate":1},{"cnt":[[279,596],[2707,596],[2707,637],[279,637]],"region":{"top_left_x":278,"top_left_y":596,"width":2429,"height":42},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"29c2236501fe4c9f96ca457bd6210396","type":"text","conversion_output":true,"text":"Appropriate counseling will be made available by the Investigator in the event of a positive finding. Notification of regional and/or national authorities, if required","text_display":" Appropriate counseling will be made available by the Investigator in the event of a positive finding. Notification of regional and/or national authorities, if required","confidence":1,"confidence_rate":1},{"cnt":[[279,640],[1062,640],[1062,683],[279,683]],"region":{"top_left_x":278,"top_left_y":639,"width":785,"height":45},"line":13,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"62c72366b1e24156a3ce014a4099a5a5","type":"text","conversion_output":true,"text":"by law, will be the responsibility of the Investigator.","text_display":" by law, will be the responsibility of the Investigator.","confidence":1,"confidence_rate":1},{"cnt":[[208,678],[2707,678],[2707,724],[208,724]],"region":{"top_left_x":207,"top_left_y":678,"width":2500,"height":47},"line":14,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"71f049d0e3914aa99283645f7130acfe","type":"text","conversion_output":true,"text":"15 All ECG data will be collected digitally and transferred electronically for central analysis. 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For ECGs recorded in parallel with PK sampling at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on","confidence":0.9990234375,"confidence_rate":0.9999944169318835},{"cnt":[[279,768],[2702,768],[2702,811],[279,811]],"region":{"top_left_x":278,"top_left_y":767,"width":2425,"height":44},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c736f640010e49a9be0e66cd64857392","type":"text","conversion_output":true,"text":"Day 1 of Cycles 1, 2, 5, 9, and 13, the PK blood samples should be collected subsequently after the triplicate ECGs have been performed. Other ECGs will not be","text_display":" Day 1 of Cycles 1, 2, 5, 9, and 13, the PK blood samples should be collected subsequently after the triplicate ECGs have been performed. Other ECGs will not be","confidence":0.9990236759185791,"confidence_rate":0.9999941509093442},{"cnt":[[279,811],[1218,811],[1218,852],[279,852]],"region":{"top_left_x":278,"top_left_y":810,"width":940,"height":43},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"aa4b1882d7484c4792a883f5445a044f","type":"text","conversion_output":true,"text":"time-matched and can be performed regardless of dosing time.","text_display":" time-matched and can be performed regardless of dosing time.","confidence":1,"confidence_rate":1},{"cnt":[[206,850],[2593,850],[2593,898],[206,898]],"region":{"top_left_x":205,"top_left_y":849,"width":2388,"height":49},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6fcfc6547b3e45548b3bd522338e6b03","type":"text","conversion_output":true,"text":"\\({ }^{16}\\) LVEF will be assessed using an echocardiogram or MUGA scan at screening and every 12 weeks ( -7 days, +3 days) relative to date of randomization until","text_display":"\n\\({ }^{16}\\) LVEF will be assessed using an echocardiogram or MUGA scan at screening and every 12 weeks ( -7 days, +3 days) relative to date of randomization until","confidence":0.98583984375,"confidence_rate":0.9999175677454327},{"cnt":[[279,895],[2629,895],[2629,939],[279,939]],"region":{"top_left_x":278,"top_left_y":895,"width":2352,"height":44},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"54a643480c944d3298a18966ecdd63ae","type":"text","conversion_output":true,"text":"discontinuation visit. Additional assessments may be performed if clinically indicated. For any patient who has at least one echocardiogram or MUGA that is","text_display":" discontinuation visit. Additional assessments may be performed if clinically indicated. For any patient who has at least one echocardiogram or MUGA that is","confidence":0.99951171875,"confidence_rate":0.9999969475015457},{"cnt":[[279,939],[2666,939],[2666,982],[279,982]],"region":{"top_left_x":278,"top_left_y":938,"width":2388,"height":45},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4168240722d649efac97e186bfd12090","type":"text","conversion_output":true,"text":"considered abnormal by local assessment, the Sponsor will collect all echocardiograms or MUGA scans (obtained at Screening and all subsequent assessments)","text_display":" considered abnormal by local assessment, the Sponsor will collect all echocardiograms or MUGA scans (obtained at Screening and all subsequent assessments)","confidence":1,"confidence_rate":1},{"cnt":[[279,982],[770,982],[770,1026],[279,1026]],"region":{"top_left_x":278,"top_left_y":982,"width":492,"height":44},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a82c030bb0c144c5acaedb66859c15d8","type":"text","conversion_output":true,"text":"for the purpose of a central read.","text_display":" for the purpose of a central read.","confidence":1,"confidence_rate":1},{"cnt":[[206,1023],[2675,1023],[2675,1067],[206,1067]],"region":{"top_left_x":205,"top_left_y":1023,"width":2471,"height":44},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f1f03186cc243e8a1905eac26627700","type":"text","conversion_output":true,"text":"\\({ }^{17}\\) Clinical laboratory tests are not required at Cycle 1 Day 1 if acceptable screening is performed within 7 days prior to randomization, unless the patient's clinical","text_display":"\n\\({ }^{17}\\) Clinical laboratory tests are not required at Cycle 1 Day 1 if acceptable screening is performed within 7 days prior to randomization, unless the patient's clinical","confidence":0.98583984375,"confidence_rate":0.9999237389088453},{"cnt":[[279,1069],[2552,1069],[2552,1110],[279,1110]],"region":{"top_left_x":278,"top_left_y":1069,"width":2274,"height":42},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11d42dd9eaaa453e986e90a903897471","type":"text","conversion_output":true,"text":"condition has changed significantly, otherwise clinical laboratory tests should be performed at Cycle 1 Day 1 before randomization. In addition, clinical","text_display":" condition has changed significantly, otherwise clinical laboratory tests should be performed at Cycle 1 Day 1 before randomization. In addition, clinical","confidence":1,"confidence_rate":1},{"cnt":[[279,1110],[2677,1110],[2677,1154],[279,1154]],"region":{"top_left_x":278,"top_left_y":1110,"width":2400,"height":44},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ef33b8285fc34979a4ee77ab6f4975b0","type":"text","conversion_output":true,"text":"laboratory test at Cycle 1 Day 1 can be performed within 7 days prior to randomization. If needed, any clinical laboratory tests may also be performed for safety","text_display":" laboratory test at Cycle 1 Day 1 can be performed within 7 days prior to randomization. If needed, any clinical laboratory tests may also be performed for safety","confidence":1,"confidence_rate":1},{"cnt":[[279,1154],[614,1154],[614,1195],[279,1195]],"region":{"top_left_x":278,"top_left_y":1153,"width":337,"height":42},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"089afb028d9f4197a668e4bf7459b35f","type":"text","conversion_output":true,"text":"evaluation of patients.","text_display":" evaluation of patients.","confidence":1,"confidence_rate":1},{"cnt":[[208,1192],[2680,1192],[2680,1238],[208,1238]],"region":{"top_left_x":207,"top_left_y":1192,"width":2473,"height":47},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"30616692159f4925a6c86c79617c94a2","type":"text","conversion_output":true,"text":"18 At screening and discontinuation visit, all WOCBP should complete a serum pregnancy test per the practice of the site. Repeat as necessary during the treatment","text_display":"\n18 At screening and discontinuation visit, all WOCBP should complete a serum pregnancy test per the practice of the site. Repeat as necessary during the treatment","confidence":0.9907269477844238,"confidence_rate":0.9999438791975921},{"cnt":[[279,1238],[2634,1238],[2634,1282],[279,1282]],"region":{"top_left_x":278,"top_left_y":1238,"width":2356,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"d954af1f15604f738cc6de725fb7002f","type":"text","conversion_output":true,"text":"period if clinically indicated. In addition, it can be performed every 6 weeks relative to date of randomization considering the local health authorities-specific","text_display":" period if clinically indicated. In addition, it can be performed every 6 weeks relative to date of randomization considering the local health authorities-specific","confidence":1,"confidence_rate":1},{"cnt":[[279,1282],[2040,1282],[2040,1325],[279,1325]],"region":{"top_left_x":278,"top_left_y":1281,"width":1762,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b7ee94465f9a4de3a23bbaf25dfcae20","type":"text","conversion_output":true,"text":"requirement or guidance. At other times during study, a serum or urine pregnancy test may be performed as indicated.","text_display":" requirement or guidance. At other times during study, a serum or urine pregnancy test may be performed as indicated.","confidence":1,"confidence_rate":1},{"cnt":[[206,1320],[2182,1320],[2182,1366],[206,1366]],"region":{"top_left_x":205,"top_left_y":1320,"width":1977,"height":47},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"fa8d4bcf0c304b19b05f22ae04b5c9c6","type":"text","conversion_output":true,"text":"19 Plasma PK samples will be collected at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 of Cycles 1, 2, 5, 9, and 13.","text_display":"\n19 Plasma PK samples will be collected at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 of Cycles 1, 2, 5, 9, and 13.","confidence":0.7298866419587284,"confidence_rate":0.997889036312436},{"cnt":[[206,1366],[2597,1366],[2597,1409],[206,1409]],"region":{"top_left_x":205,"top_left_y":1366,"width":2393,"height":44},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5cf3627640bc435d9e9bb01a62302ef2","type":"text","conversion_output":true,"text":"\\({ }^{20}\\) Blood samples for cfDNA and blood-borne biomarkers analysis will be collected on the same day of any scheduled and unscheduled tumor assessments, if","text_display":"\n\\({ }^{20}\\) Blood samples for cfDNA and blood-borne biomarkers analysis will be collected on the same day of any scheduled and unscheduled tumor assessments, if","confidence":1,"confidence_rate":1},{"cnt":[[279,1412],[418,1412],[418,1455],[279,1455]],"region":{"top_left_x":278,"top_left_y":1411,"width":141,"height":45},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"315025ef0c004e4aa39529e3f3bb8ee1","type":"text","conversion_output":true,"text":"possible.","text_display":" possible.","confidence":1,"confidence_rate":1},{"cnt":[[206,1451],[2620,1451],[2620,1496],[206,1496]],"region":{"top_left_x":205,"top_left_y":1450,"width":2416,"height":47},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dd047250242e420eafb2c64401fc5d91","type":"text","conversion_output":true,"text":"\\({ }^{21}\\) Baseline tumor assessment during screening must be performed within 28 days before randomization. The patient must have at least 1 lesion, not previously","text_display":"\n\\({ }^{21}\\) Baseline tumor assessment during screening must be performed within 28 days before randomization. The patient must have at least 1 lesion, not previously","confidence":0.9887795448303223,"confidence_rate":0.9999347773909295},{"cnt":[[279,1494],[2707,1494],[2707,1537],[279,1537]],"region":{"top_left_x":278,"top_left_y":1493,"width":2429,"height":45},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"abcf5e2fa4d3425483cf4327af79aef2","type":"text","conversion_output":true,"text":"irradiated, that can be accurately measured. If there is only 1 measurable lesion and it is chosen for biopsy, tumor assessment should be performed after at least 14","text_display":" irradiated, that can be accurately measured. If there is only 1 measurable lesion and it is chosen for biopsy, tumor assessment should be performed after at least 14","confidence":1,"confidence_rate":1},{"cnt":[[279,1540],[2684,1540],[2684,1583],[279,1583]],"region":{"top_left_x":278,"top_left_y":1539,"width":2407,"height":45},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f7c10670b67493c87a21b85e1570302","type":"text","conversion_output":true,"text":"days following the biopsy. Follow-up tumor assessments will be performed every 6 weeks ( -7 days, +3 days) for the first 18 months and then every 12 weeks ( -7","text_display":" days following the biopsy. Follow-up tumor assessments will be performed every 6 weeks ( -7 days, +3 days) for the first 18 months and then every 12 weeks ( -7","confidence":0.9873106479644775,"confidence_rate":0.9999282579135317},{"cnt":[[279,1581],[1889,1581],[1889,1624],[279,1624]],"region":{"top_left_x":278,"top_left_y":1580,"width":1612,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a7919a34ed9246be869eec1074491ac2","type":"text","conversion_output":true,"text":"days, +3 days) relative to date of randomization using the RECIST v1.1 until objective disease progression.","text_display":" days, +3 days) relative to date of randomization using the RECIST v1.1 until objective disease progression.","confidence":1,"confidence_rate":1},{"cnt":[[279,1622],[2634,1622],[2634,1668],[279,1668]],"region":{"top_left_x":278,"top_left_y":1621,"width":2356,"height":47},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"838c975a3bb04977b4dc7837414062fc","type":"text","conversion_output":true,"text":"Tumor assessment will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest and abdomen (including liver and","text_display":"\nTumor assessment will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest and abdomen (including liver and","confidence":1,"confidence_rate":1},{"cnt":[[279,1668],[2622,1668],[2622,1711],[279,1711]],"region":{"top_left_x":278,"top_left_y":1667,"width":2345,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0f8bcd39eb28474ea97747b63e362336","type":"text","conversion_output":true,"text":"adrenal glands). Any other sites where disease is suspected or known at baseline must also be imaged. Specifically, patients with confirmed BM at screening","text_display":" adrenal glands). Any other sites where disease is suspected or known at baseline must also be imaged. Specifically, patients with confirmed BM at screening","confidence":1,"confidence_rate":1},{"cnt":[[279,1709],[2689,1709],[2689,1754],[279,1754]],"region":{"top_left_x":278,"top_left_y":1708,"width":2411,"height":47},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"469489020a6f4f94a11d11586432cc45","type":"text","conversion_output":true,"text":"should be followed up on study with repeated MRI assessment at the same frequency as the other RECIST v1.1 assessments. The same modality for MRI should","text_display":" should be followed up on study with repeated MRI assessment at the same frequency as the other RECIST v1.1 assessments. The same modality for MRI should","confidence":1,"confidence_rate":1},{"cnt":[[279,1754],[916,1754],[916,1798],[279,1798]],"region":{"top_left_x":278,"top_left_y":1754,"width":639,"height":44},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ccba1f89f9c941c497dab5c4a6d5c79c","type":"text","conversion_output":true,"text":"be used for a patient throughout the study.","text_display":" be used for a patient throughout the study.","confidence":1,"confidence_rate":1},{"cnt":[[279,1796],[2547,1796],[2547,1839],[279,1839]],"region":{"top_left_x":278,"top_left_y":1795,"width":2270,"height":44},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"363ff59c2e3947aaab8dd67796ada671","type":"text","conversion_output":true,"text":"Images will be sent to central reading center timely for BICR. Especially, the Investigator should make every effort to immediately submit radiographic","text_display":"\nImages will be sent to central reading center timely for BICR. Especially, the Investigator should make every effort to immediately submit radiographic","confidence":1,"confidence_rate":1},{"cnt":[[196,1896],[514,1896],[514,1930],[196,1930]],"region":{"top_left_x":196,"top_left_y":1896,"width":318,"height":35},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"04379c3bb68a417ba70fa588e397eda5","type":"page_info","conversion_output":false,"text":"TP-GDO-WW-016-08","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1033,1896],[1291,1896],[1291,1926],[1033,1926]],"region":{"top_left_x":1032,"top_left_y":1896,"width":259,"height":30},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bb8afcada3a6442992832bf11d7b91d0","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2129,1894],[2725,1894],[2725,1935],[2129,1935]],"region":{"top_left_x":2129,"top_left_y":1893,"width":597,"height":42},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dc2e3d610cae4d98bd9f8fec7914dc10","type":"page_info","conversion_output":false,"text":"Project Document Version No.: draft V1.5","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,1937],[569,1937],[569,1971],[196,1971]],"region":{"top_left_x":196,"top_left_y":1937,"width":373,"height":35},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ca4d773458384ccbaac8efb0e15ab1a6","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[1896,1937],[2730,1937],[2730,1976],[1896,1976]],"region":{"top_left_x":1896,"top_left_y":1937,"width":834,"height":39},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6682060e18ac4717977c9eb3b8490a7e","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[196,1981],[651,1981],[651,2015],[196,2015]],"region":{"top_left_x":196,"top_left_y":1980,"width":456,"height":35},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"2b3c76b2c54941f1adb0123b1b57f5da","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2529,1983],[2725,1983],[2725,2022],[2529,2022]],"region":{"top_left_x":2528,"top_left_y":1982,"width":198,"height":40},"line":47,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"5494c11500d7485582a29ede7f957763","type":"page_info","conversion_output":false,"text":"Page 66 of 83","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2068,"page_width":2924,"languages_detected":[]},{"image_id":"43f70033-c325-4dd7-8bf3-864fe9a77081-67","page":67,"lines":[{"cnt":[[192,105],[327,105],[327,139],[192,139]],"region":{"top_left_x":191,"top_left_y":105,"width":136,"height":35},"line":1,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3c261e2c13154012a51f847040b1e64d","type":"page_info","conversion_output":false,"text":"YUHAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,151],[395,151],[395,185],[192,185]],"region":{"top_left_x":191,"top_left_y":150,"width":205,"height":36},"line":2,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"506722bcf550453cb4787ad2bab62d0d","type":"page_info","conversion_output":false,"text":"YH25448-301","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2385,151],[2730,151],[2730,190],[2385,190]],"region":{"top_left_x":2384,"top_left_y":150,"width":346,"height":40},"line":3,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c5a66f69f2b9483398cc70f6cceafe82","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[295,242],[1953,242],[1953,283],[295,283]],"region":{"top_left_x":294,"top_left_y":242,"width":1660,"height":42},"line":4,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"bc8fb82a8df447dda7b193d559014a18","type":"text","conversion_output":true,"text":"assessments for central review when progressive disease is either suspected or confirmed, or uncertainty exists.","text_display":"\nassessments for central review when progressive disease is either suspected or confirmed, or uncertainty exists.","confidence":1,"confidence_rate":1},{"cnt":[[222,281],[2638,281],[2638,327],[222,327]],"region":{"top_left_x":221,"top_left_y":280,"width":2418,"height":47},"line":5,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"53d133fb224b459eb5aeb6d7510d1c38","type":"text","conversion_output":true,"text":"22 Questionnaires should be completed prior to any visit-specific procedures. All questionnaires will be performed at Cycle 1 Day 1, Cycle 2 Day 1 ( -2 days, +3","text_display":"\n22 Questionnaires should be completed prior to any visit-specific procedures. All questionnaires will be performed at Cycle 1 Day 1, Cycle 2 Day 1 ( -2 days, +3","confidence":0.8550353050231934,"confidence_rate":0.9991054716522484},{"cnt":[[295,324],[2611,324],[2611,368],[295,368]],"region":{"top_left_x":294,"top_left_y":324,"width":2318,"height":44},"line":6,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c199036ad8a24f5e935ef4c91538fb2b","type":"text","conversion_output":true,"text":"days) and then every 6 weeks ( -7 days, +3 days) relative to date of randomization until 28-day safety F/U visit or progression F/U visit (whichever is later).","text_display":" days) and then every 6 weeks ( -7 days, +3 days) relative to date of randomization until 28-day safety F/U visit or progression F/U visit (whichever is later).","confidence":0.5311917811632156,"confidence_rate":0.9963498448168622},{"cnt":[[222,366],[2702,366],[2702,413],[222,413]],"region":{"top_left_x":221,"top_left_y":365,"width":2482,"height":49},"line":7,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"be0825df2ae74ccea58330618284852f","type":"text","conversion_output":true,"text":"\\({ }^{23}\\) One CSF sample will be collected at any time from Cycle 5 Day 1 onwards. If possible, the CSF sample should be taken on the same day as planned PK samples.","text_display":" \\({ }^{23}\\) One CSF sample will be collected at any time from Cycle 5 Day 1 onwards. 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A set of triplicate 12-lead ECGs, approximately 2 minutes apart, will be","text_display":"\n\\({ }^{14}\\) All ECG data will be collected digitally and transferred electronically for central analysis. A set of triplicate 12-lead ECGs, approximately 2 minutes apart, will be","confidence":0.9410562515258789,"confidence_rate":0.9996680749751033},{"cnt":[[288,704],[1099,704],[1099,745],[288,745]],"region":{"top_left_x":287,"top_left_y":703,"width":812,"height":42},"line":15,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"ee715709a2a74613aad8f8082a1eeada","type":"text","conversion_output":true,"text":"performed as scheduled with reading by a cardiologist.","text_display":" performed as scheduled with reading by a cardiologist.","confidence":0.69580078125,"confidence_rate":0.9938715358869368},{"cnt":[[219,740],[2648,740],[2648,788],[219,788]],"region":{"top_left_x":219,"top_left_y":740,"width":2429,"height":49},"line":16,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"45744296db524638841934fb5737b94e","type":"text","conversion_output":true,"text":"15 LVEF will be assessed using an echocardiogram or MUGA scan at pre-crossover screening and every 12 weeks ( -7 days, +3 days) relative to date of first-dosing","text_display":"\n15 LVEF will be assessed using an echocardiogram or MUGA scan at pre-crossover screening and every 12 weeks ( -7 days, +3 days) relative to date of first-dosing","confidence":0.99853515625,"confidence_rate":0.9999915265232845},{"cnt":[[288,786],[2641,786],[2641,829],[288,829]],"region":{"top_left_x":287,"top_left_y":785,"width":2354,"height":45},"line":17,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"885ba598b3bf4a86999cb3d27371488f","type":"text","conversion_output":true,"text":"until discontinuation visit. Additional assessments may be performed if clinically indicated. For any patient who has at least one echocardiogram or MUGA that","text_display":" until discontinuation visit. Additional assessments may be performed if clinically indicated. For any patient who has at least one echocardiogram or MUGA that","confidence":0.9990234375,"confidence_rate":0.9999940059096958},{"cnt":[[288,827],[2620,827],[2620,873],[288,873]],"region":{"top_left_x":287,"top_left_y":826,"width":2334,"height":47},"line":18,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"972c7813604f4094be6e420a9d3ae6c7","type":"text","conversion_output":true,"text":"is considered abnormal by local assessment, the Sponsor collects all echocardiograms or MUGA scans (obtained at pre-crossover screening and all subsequent","text_display":" is considered abnormal by local assessment, the Sponsor collects all echocardiograms or MUGA scans (obtained at pre-crossover screening and all subsequent","confidence":1,"confidence_rate":1},{"cnt":[[288,868],[971,868],[971,916],[288,916]],"region":{"top_left_x":287,"top_left_y":868,"width":684,"height":49},"line":19,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"11df66eb3f3643679f2088715a95a728","type":"text","conversion_output":true,"text":"assessments) for the purpose of a central read.","text_display":" assessments) for the purpose of a central read.","confidence":1,"confidence_rate":1},{"cnt":[[219,909],[1684,909],[1684,957],[219,957]],"region":{"top_left_x":219,"top_left_y":909,"width":1465,"height":49},"line":20,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69af0fe3229e495f983de0a0c68c662c","type":"text","conversion_output":true,"text":"\\({ }^{16}\\) If needed, any clinical laboratory tests may also be performed for safety evaluation of patients.","text_display":"\n\\({ }^{16}\\) If needed, any clinical laboratory tests may also be performed for safety evaluation of patients.","confidence":1,"confidence_rate":1},{"cnt":[[219,950],[2652,950],[2652,998],[219,998]],"region":{"top_left_x":219,"top_left_y":950,"width":2434,"height":49},"line":21,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0b2feb51b492429baca23c8130fa26df","type":"text","conversion_output":true,"text":"\\({ }^{17}\\) At pre-crossover screening and discontinuation visit, all WOCBP should complete a serum pregnancy test per the practice of the site. Repeat as necessary during","text_display":"\n\\({ }^{17}\\) At pre-crossover screening and discontinuation visit, all WOCBP should complete a serum pregnancy test per the practice of the site. Repeat as necessary during","confidence":0.9762125015258789,"confidence_rate":0.9998608478947207},{"cnt":[[288,996],[2645,996],[2645,1039],[288,1039]],"region":{"top_left_x":287,"top_left_y":995,"width":2359,"height":45},"line":22,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"3d749eb6ebaa4e578144d716b5b9dcdb","type":"text","conversion_output":true,"text":"the treatment period if clinically indicated. In addition, it can be performed every 6 weeks relative to date of first-dosing considering the local health authorities-","text_display":" the treatment period if clinically indicated. In addition, it can be performed every 6 weeks relative to date of first-dosing considering the local health authorities","confidence":1,"confidence_rate":1},{"cnt":[[288,1037],[2140,1037],[2140,1081],[288,1081]],"region":{"top_left_x":287,"top_left_y":1037,"width":1854,"height":44},"line":23,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9b9d9ec8e71446c9bf5823d3b463841","type":"text","conversion_output":true,"text":"specific requirement or guidance. At other times during study, a serum or urine pregnancy test may be performed as indicated.","text_display":"specific requirement or guidance. At other times during study, a serum or urine pregnancy test may be performed as indicated.","confidence":1,"confidence_rate":1},{"cnt":[[219,1078],[2565,1078],[2565,1124],[219,1124]],"region":{"top_left_x":219,"top_left_y":1078,"width":2347,"height":46},"line":24,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"48a4f3346a484ebd97a265d4415fc796","type":"text","conversion_output":true,"text":"18 Blood samples for cfDNA and blood-borne biomarkers analysis will be collected on the same day of any scheduled and unscheduled tumor assessments, if","text_display":"\n18 Blood samples for cfDNA and blood-borne biomarkers analysis will be collected on the same day of any scheduled and unscheduled tumor assessments, if","confidence":0.989750862121582,"confidence_rate":0.9999335375510074},{"cnt":[[288,1122],[427,1122],[427,1165],[288,1165]],"region":{"top_left_x":287,"top_left_y":1121,"width":141,"height":45},"line":25,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4f195d699d674d16a82a4d81a8c93231","type":"text","conversion_output":true,"text":"possible.","text_display":" possible.","confidence":1,"confidence_rate":1},{"cnt":[[219,1160],[2565,1160],[2565,1208],[219,1208]],"region":{"top_left_x":219,"top_left_y":1160,"width":2347,"height":49},"line":26,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"dce21a260a544fd69744d82245d83714","type":"text","conversion_output":true,"text":"19 Baseline tumor assessment during pre-crossover screening must be performed within 28 days before first-dosing of open-label lazertinib. Follow-up tumor","text_display":"\n19 Baseline tumor assessment during pre-crossover screening must be performed within 28 days before first-dosing of open-label lazertinib. Follow-up tumor","confidence":1,"confidence_rate":1},{"cnt":[[288,1206],[2661,1206],[2661,1250],[288,1250]],"region":{"top_left_x":287,"top_left_y":1206,"width":2375,"height":44},"line":27,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"c9355e4a1c4b4998840337988f28b665","type":"text","conversion_output":true,"text":"assessments will be performed every 6 weeks ( -7 days, +3 days) for the first 12 months and then every 12 weeks ( -7 days, +3 days) relative to date of first-dosing","text_display":" assessments will be performed every 6 weeks ( -7 days, +3 days) for the first 12 months and then every 12 weeks ( -7 days, +3 days) relative to date of first-dosing","confidence":0.9717561649276831,"confidence_rate":0.9998492199730825},{"cnt":[[288,1247],[1510,1247],[1510,1291],[288,1291]],"region":{"top_left_x":287,"top_left_y":1247,"width":1223,"height":44},"line":28,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"31ba45fc24b54b03a45ce81ff23d8fb8","type":"text","conversion_output":true,"text":"of open-label lazertinib using the RECIST v1.1 until objective disease progression.","text_display":" of open-label lazertinib using the RECIST v1.1 until objective disease progression.","confidence":1,"confidence_rate":1},{"cnt":[[288,1288],[2597,1288],[2597,1334],[288,1334]],"region":{"top_left_x":287,"top_left_y":1288,"width":2311,"height":47},"line":29,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0454b861dca44695818fe7f8ab9064ab","type":"text","conversion_output":true,"text":"Tumor assessment will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest and abdomen (including liver and","text_display":"\nTumor assessment will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest and abdomen (including liver and","confidence":1,"confidence_rate":1},{"cnt":[[288,1330],[2602,1330],[2602,1377],[288,1377]],"region":{"top_left_x":287,"top_left_y":1329,"width":2315,"height":49},"line":30,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"69c5a16e3fc7434eb072bb9c36bcdff3","type":"text","conversion_output":true,"text":"adrenal glands). Any other sites where disease is suspected or known at baseline must also be imaged. Images will be sent to central reading center timely for","text_display":" adrenal glands). Any other sites where disease is suspected or known at baseline must also be imaged. Images will be sent to central reading center timely for","confidence":1,"confidence_rate":1},{"cnt":[[288,1375],[395,1375],[395,1414],[288,1414]],"region":{"top_left_x":287,"top_left_y":1375,"width":109,"height":40},"line":31,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a0594a2a512045d4a50b42383a3736bb","type":"text","conversion_output":true,"text":"BICR.","text_display":" BICR.","confidence":1,"confidence_rate":1},{"cnt":[[215,1412],[2597,1412],[2597,1460],[215,1460]],"region":{"top_left_x":214,"top_left_y":1411,"width":2384,"height":49},"line":32,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a9017ffa69864edcb29d19ca82b5b0ae","type":"text","conversion_output":true,"text":"\\({ }^{20}\\) Questionnaires should be completed prior to any visit-specific procedures. All questionnaires will be performed at Cycle 1 Day 1, Cycle 2 Day 1 ( -2 days, +3","text_display":"\n\\({ }^{20}\\) Questionnaires should be completed prior to any visit-specific procedures. All questionnaires will be performed at Cycle 1 Day 1, Cycle 2 Day 1 ( -2 days, +3","confidence":0.8021867275238037,"confidence_rate":0.9987896678189266},{"cnt":[[288,1457],[2529,1457],[2529,1501],[288,1501]],"region":{"top_left_x":287,"top_left_y":1457,"width":2242,"height":44},"line":33,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7d4e272396484b39923a7527041cdff7","type":"text","conversion_output":true,"text":"days) and then every 6 weeks (-7 days, +3 days) relative to date of first-dosing until 28-day safety F/U visit or progression F/U visit (whichever is later).","text_display":" days) and then every 6 weeks (-7 days, +3 days) relative to date of first-dosing until 28-day safety F/U visit or progression F/U visit (whichever is later).","confidence":0.8736234800153397,"confidence_rate":0.9991961221102045},{"cnt":[[219,1499],[2645,1499],[2645,1544],[219,1544]],"region":{"top_left_x":219,"top_left_y":1498,"width":2427,"height":47},"line":34,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0d48e3f6eaa0424b9fbd8f1097981449","type":"text","conversion_output":true,"text":"\\({ }^{21}\\) Lazertinib should be taken orally once daily at approximately the similar time with a glass of water. Patients may continue lazertinib following objective disease","text_display":"\n\\({ }^{21}\\) Lazertinib should be taken orally once daily at approximately the similar time with a glass of water. Patients may continue lazertinib following objective disease","confidence":0.998535871389322,"confidence_rate":0.9999916750261623},{"cnt":[[288,1542],[1460,1542],[1460,1585],[288,1585]],"region":{"top_left_x":287,"top_left_y":1541,"width":1173,"height":45},"line":35,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"9f4c125d775f4fce8ec357fa01a4d7ef","type":"text","conversion_output":true,"text":"progression if patient is receiving clinical benefit, as judged by the investigator.","text_display":" progression if patient is receiving clinical benefit, as judged by the investigator.","confidence":1,"confidence_rate":1},{"cnt":[[219,1581],[2597,1581],[2597,1629],[219,1629]],"region":{"top_left_x":219,"top_left_y":1580,"width":2379,"height":49},"line":36,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a2f3f14c410b4366961d9fde2485e154","type":"text","conversion_output":true,"text":"22 All adverse events and special reporting situations, whether serious or non-serious, will be reported from the time a signed and dated ICF is obtained until 28","text_display":"\n22 All adverse events and special reporting situations, whether serious or non-serious, will be reported from the time a signed and dated ICF is obtained until 28","confidence":0.99755859375,"confidence_rate":0.9999851856167535},{"cnt":[[288,1626],[2570,1626],[2570,1670],[288,1670]],"region":{"top_left_x":287,"top_left_y":1626,"width":2283,"height":44},"line":37,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"38f777e959b9478d8a4e7307dbb47baa","type":"text","conversion_output":true,"text":"days following the last dose of lazertinib. Adverse events occurring after 28 days following the last dose of lazertinib should also be reported, if considered","text_display":" days following the last dose of lazertinib. Adverse events occurring after 28 days following the last dose of lazertinib should also be reported, if considered","confidence":1,"confidence_rate":1},{"cnt":[[288,1668],[2643,1668],[2643,1711],[288,1711]],"region":{"top_left_x":287,"top_left_y":1667,"width":2357,"height":44},"line":38,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"834baa5f95ba47838c8daa932b138065","type":"text","conversion_output":true,"text":"related to lazertinib. Reported all AEs must be followed until recovery to baseline or Grade \\(\\leq 1\\) or until deemed irreversible, and all relevant information must be","text_display":" related to lazertinib. Reported all AEs must be followed until recovery to baseline or Grade \\(\\leq 1\\) or until deemed irreversible, and all relevant information must be","confidence":1,"confidence_rate":1},{"cnt":[[288,1709],[628,1709],[628,1748],[288,1748]],"region":{"top_left_x":287,"top_left_y":1708,"width":342,"height":40},"line":39,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"0594d5a01f4c4a59a0f7641315d00cea","type":"text","conversion_output":true,"text":"recorded on the eCRF.","text_display":" recorded on the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[192,1891],[514,1891],[514,1930],[192,1930]],"region":{"top_left_x":191,"top_left_y":1891,"width":323,"height":40},"line":40,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"b16915b297154781b66af1e7660f311d","type":"page_info","conversion_output":false,"text":"TP-GDO-WW-016-08","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1033,1894],[1291,1894],[1291,1928],[1033,1928]],"region":{"top_left_x":1032,"top_left_y":1893,"width":259,"height":36},"line":41,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"a5b85155bafd4379b6016e0ed3fd1bcb","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2127,1891],[2725,1891],[2725,1935],[2127,1935]],"region":{"top_left_x":2126,"top_left_y":1891,"width":600,"height":44},"line":42,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"7a029128b60c4850bbea154d5a5f49df","type":"page_info","conversion_output":false,"text":"Project Document Version No.: draft V1.5","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[194,1937],[569,1937],[569,1971],[194,1971]],"region":{"top_left_x":194,"top_left_y":1937,"width":375,"height":35},"line":43,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"942b751928ff49b9ac24bd05a5d6ad23","type":"page_info","conversion_output":false,"text":"Effective Date: 26 Nov 19","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999694754347522},{"cnt":[[1896,1937],[2730,1937],[2730,1976],[1896,1976]],"region":{"top_left_x":1896,"top_left_y":1937,"width":834,"height":39},"line":44,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"6bd3fa5ce6b349efa90411e1e7dea476","type":"page_info","conversion_output":false,"text":"Project Document Effective Date: Date of the last signature","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[192,1978],[651,1978],[651,2017],[192,2017]],"region":{"top_left_x":191,"top_left_y":1978,"width":461,"height":40},"line":45,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"4b85339ffc1144dcb7101654451d3c10","type":"page_info","conversion_output":false,"text":"Related to: SOP-GDO-WW-019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2527,1981],[2725,1981],[2725,2022],[2527,2022]],"region":{"top_left_x":2526,"top_left_y":1980,"width":200,"height":42},"line":46,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"95d8cecb12cf4b378348375e62fe4622","type":"page_info","conversion_output":false,"text":"Page 71 of 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Hematology Parameters of NCI-CTCAE V5.0","text_display":"\n\n\\section*{Appendix 3. 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Excess bilirubin is associated with jaundice.} \\\\\n\\hline Creatinine & Increase & Investigations & Creatinine increased & >ULN - 1.5 x ULN & \\begin{tabular}{l}\n\\(>1.5-3.0 \\times\\) baseline; \\(>1.5-3.0 \\times\\) ULN \\\\\n(Baseline grade: \\(>1.5-3.0 \\times ULN\\) )\n\\end{tabular} & \\begin{tabular}{l}\n\\(>3.0 \\times\\) baseline; >3.0-6.0 x ULN \\\\\n(Baseline grade: >3.0-6.0 x ULN)\n\\end{tabular} & \\(>6.0 \\times\\) ULN & - \\\\\n\\hline \\multicolumn{9}{|l|}{Definition: A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.} \\\\\n\\hline Potassium - Low & Decrease & Metabolism and nutrition disorders & Hypokalemia & <LLN - \\(3.0 mmol / L\\) & Symptomatic with <LLN \\(-3.0 mmol / L\\); intervention indicated & \\(<3.0-2.5 mmol / L\\); hospitalization indicated & \\(<2.5 mmol / L\\); life-threatening consequences & Death \\\\\n\\hline \\multicolumn{9}{|l|}{Definition: A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.} \\\\\n\\hline \\multicolumn{9}{|l|}{Definition: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|}\n\\hline Lab Test Name & Direction toxicity & CTCAE v5.0 SOC & CTCAE v5.0 Term & Grade 1 & Grade 2 & Grade 3 & Grade 4 & Grade 5 \\\\\n\\hline Aspartate aminotransferase (AST) & Increase & Investigations & Aspartate aminotransferase increased & \\begin{tabular}{l}\n>ULN - 3.0 x ULN if baseline was normal; 1.5-3.0 x baseline if baseline was abnormal \\\\\n(Baseline grade: \\(>\\) ULN - 3.0 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\n>3.0-5.0 x ULN if baseline was normal; \\(>3.0-5.0 \\times\\) baseline if baseline was abnormal \\\\\n(Baseline grade: >3.0-5.0 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\n>5.0-20.0 x ULN if baseline was normal; >5.0-20.0 x baseline if baseline was abnormal \\\\\n(Baseline grade: >5.0-20.0 x ULN)\n\\end{tabular} & \\begin{tabular}{l}\n\\(>20.0 \\times\\) ULN if baseline was normal; \\(>20.0 \\times\\) baseline if baseline was abnormal. \\\\\n(Baseline grade: >20.0 x ULN)\n\\end{tabular} & - \\\\\n\\hline \\multicolumn{9}{|l|}{Definition: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.} \\\\\n\\hline \\multicolumn{9}{|l|}{Definition: A finding based on laboratory test results that indicate an abnormally high level of bilirubin in the blood. 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score}","confidence":1,"confidence_rate":1},{"cnt":[[274,1549],[674,1549],[674,1588],[274,1588]],"region":{"top_left_x":274,"top_left_y":1548,"width":400,"height":40},"line":25,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"e5ff64abd6fa4e7d937675b6bc06e95d","type":"text","conversion_output":true,"text":"Calculate the raw score","text_display":"\n\nCalculate the raw score","confidence":1,"confidence_rate":1},{"cnt":[[274,1592],[893,1592],[893,1652],[274,1652]],"region":{"top_left_x":274,"top_left_y":1592,"width":620,"height":60},"line":26,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"5d87e5206a034c2fa8a6798d7e2df2aa","type":"text","conversion_output":true,"text":"RawScore \\(=R S=\\left(I_{1}+I_{2}+\\ldots+I_{n}\\right) / n\\)","text_display":"\nRawScore \\(=R S=\\left(I_{1}+I_{2}+\\ldots+I_{n}\\right) / n\\)","confidence":1,"confidence_rate":1},{"cnt":[[270,1709],[688,1709],[688,1757],[270,1757]],"region":{"top_left_x":269,"top_left_y":1708,"width":419,"height":49},"line":27,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"fe04640c02ab408d8544ba73984dc7e0","type":"section_header","conversion_output":false,"children_ids":["3896f711c8b94adf84e28bf09b059840"],"text":"","text_display":""},{"cnt":[[274,1711],[683,1711],[683,1752],[274,1752]],"region":{"top_left_x":274,"top_left_y":1710,"width":410,"height":43},"line":28,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"3896f711c8b94adf84e28bf09b059840","type":"text","conversion_output":true,"parent_id":"fe04640c02ab408d8544ba73984dc7e0","text":"Linear transformation","text_display":"\n\n\\section*{Linear transformation}","confidence":1,"confidence_rate":1},{"cnt":[[274,1759],[1318,1759],[1318,1812],[274,1812]],"region":{"top_left_x":274,"top_left_y":1758,"width":1045,"height":54},"line":29,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"143bee63766a4659bb573d03b7ecb653","type":"text","conversion_output":true,"text":"Apply the linear transformation to \\(0-100\\) to obtain the score \\(S\\),","text_display":"\n\nApply the linear transformation to \\(0-100\\) to obtain the score \\(S\\),","confidence":0.99951171875,"confidence_rate":0.9999934880145616},{"cnt":[[274,1841],[578,1841],[578,1885],[274,1885]],"region":{"top_left_x":274,"top_left_y":1841,"width":304,"height":44},"line":30,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"461a2e9cf67b4edd96976aa6676fcf68","type":"text","conversion_output":true,"text":"Functional scales:","text_display":"\nFunctional 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\\(\\} \\times 100\\)","confidence":0.9990236759185791,"confidence_rate":0.9999819112562659},{"cnt":[[274,1987],[1199,1987],[1199,2049],[274,2049]],"region":{"top_left_x":274,"top_left_y":1987,"width":926,"height":63},"line":34,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"d05185afea61437fa194eb043606bec5","type":"text","conversion_output":true,"text":"Global health status / QoL: \\(\\quad S=\\{(R S-1) /\\) range \\(\\} \\times 100\\)","text_display":"\nGlobal health status / QoL: \\(\\quad S=\\{(R S-1) /\\) range \\(\\} \\times 100\\)","confidence":0.9693342916593792,"confidence_rate":0.9994631486329661},{"cnt":[[274,2054],[1841,2054],[1841,2104],[274,2104]],"region":{"top_left_x":274,"top_left_y":2053,"width":1568,"height":51},"line":35,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"557521236bc9484a85529283e158ecbb","type":"text","conversion_output":true,"text":"Range is the difference between the maximum possible value of \\(R S\\) and the minimum possible","text_display":"\nRange is the difference between the maximum possible value of \\(R S\\) and the minimum possible","confidence":1,"confidence_rate":1},{"cnt":[[274,2104],[1843,2104],[1843,2154],[274,2154]],"region":{"top_left_x":274,"top_left_y":2103,"width":1570,"height":52},"line":36,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4efee8bf88b4448d805fd2bcbe3db992","type":"text","conversion_output":true,"text":"value. The QLQ-C30 has been designed so that all items in any scale take the same range of","text_display":" value. The QLQ-C30 has been designed so that all items in any scale take the same range of","confidence":1,"confidence_rate":1},{"cnt":[[274,2152],[1841,2152],[1841,2204],[274,2204]],"region":{"top_left_x":274,"top_left_y":2151,"width":1568,"height":54},"line":37,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"daeff5b454cf45059f5da359115762bf","type":"text","conversion_output":true,"text":"values. Therefore, the range of \\(R S\\) equals the range of the item values. Most items are","text_display":" values. Therefore, the range of \\(R S\\) equals the range of the item values. Most items are","confidence":1,"confidence_rate":1},{"cnt":[[274,2204],[1843,2204],[1843,2255],[274,2255]],"region":{"top_left_x":274,"top_left_y":2204,"width":1570,"height":51},"line":38,"column":0,"font_size":37,"is_printed":true,"is_handwritten":false,"id":"4c4e071be6734ae797a82a0e59b8bdcc","type":"text","conversion_output":true,"text":"scored 1 to 4, giving range \\(=3\\). The exceptions are the items contributing to the global","text_display":" scored 1 to 4, giving range \\(=3\\). 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& Scale & Number of items & Item range* & Version 3.0 Item numbers & Function scales \\\\\n\\hline \\multicolumn{6}{|l|}{Global health status / QoL} \\\\\n\\hline \\multicolumn{6}{|l|}{Functional scales} \\\\\n\\hline Physical functioning (revised) \\({ }^{\\dagger}\\) & PF2 & 5 & 3 & 1 to 5 & F \\\\\n\\hline Role functioning (revised) \\({ }^{\\dagger}\\) & RF2 & 2 & 3 & 6, 7 & F \\\\\n\\hline Emotional functioning & EF & 4 & 3 & 21 to 24 & F \\\\\n\\hline Cognitive functioning & CF & 2 & 3 & 20, 25 & F \\\\\n\\hline Social functioning & SF & 2 & 3 & 26, 27 & F \\\\\n\\hline \\multicolumn{6}{|l|}{Symptom scales / items} \\\\\n\\hline Fatigue & FA & 3 & 3 & 10, 12, 18 & \\\\\n\\hline Nausea and vomiting & NV & 2 & 3 & 14, 15 & \\\\\n\\hline Pain & PA & 2 & 3 & 9, 19 & \\\\\n\\hline Dyspnoea & DY & 1 & 3 & 8 & \\\\\n\\hline Insomnia & SL & 1 & 3 & 11 & \\\\\n\\hline Appetite loss & AP & 1 & 3 & 13 & \\\\\n\\hline Constipation & CO & 1 & 3 & 16 & \\\\\n\\hline Diarrhoea & DI & 1 & 3 & 17 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Scoring the QLQ-LC13","text_display":"\n\n\\section*{Appendix 7. 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symptom scales /","confidence":1,"confidence_rate":1},{"cnt":[[233,612],[660,612],[660,656],[233,656]],"region":{"top_left_x":233,"top_left_y":612,"width":428,"height":44},"line":12,"column":0,"font_size":30,"is_printed":true,"is_handwritten":false,"id":"795c48c97c3145a985688766bf9f29c4","type":"text","conversion_output":true,"text":"single items of the QLQ-C30.","text_display":" single items of the 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