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The \\\\\n\\hline & & and Crossover was changed to a & justification for using 200 mg Q3W \\\\\n\\hline 4.2.2 & Rationale for Dose Selection/ Regimen/ Modification & fixed dose of 200 mg Q3W. & fixed dose is provided in section 4.2.2. \\\\\n\\hline 5.8 & Subject Withdrawal/Discontinuation Criteria & Section 2.3 was deleted due to the change in dose for crossover subjects. & \\\\\n\\hline 6.3.1 & Second Course Phase for MK-3475 200 mg Q3W Arm & Adaptive trial design discussion was expanded to explain the transition to the 200 mg fixed dose. Material from Section 4.2.2 was moved up to Section & \\\\\n\\hline 7.1.5.5 & Crossover for Subjects in the Docetaxel Arm to MK-3475 200 mg Arm & 2.1 for this reason. & 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Abbreviated Title & MK-3475 vs. Docetaxel in Second-Line NSCLC \\\\\n\\hline Trial Phase & Phase II/III \\\\\n\\hline Clinical Indication & The treatment of subjects with non-small cell lung cancer (NSCLC) whose tumors are positive for PD-L1 who have experienced disease progression after a platinum-containing systemic therapy \\\\\n\\hline Trial Type & Interventional \\\\\n\\hline Type of control & Active control without placebo. \\\\\n\\hline Route of administration & Intravenous \\\\\n\\hline Trial Blinding & Unblinded Open-label \\\\\n\\hline Treatment Groups & \\begin{tabular}{l}\nMK-3475 \\(10 mg / kg\\) every 3 weeks \\\\\nMK-3475 \\(2 mg / kg\\) every 3 weeks \\\\\nDocetaxel \\(75 mg / m ^{2}\\) every 3 weeks \\\\\nSecond Course and Crossover MK-3475 200 mg every 3 weeks\n\\end{tabular} \\\\\n\\hline Number of trial subjects & Approximately 920 subjects will be enrolled. \\\\\n\\hline Estimated duration of trial & The sponsor estimates that the trial will require approximately 60 months from the time the first subject signs the informed consent until the last subject's last visit. \\\\\n\\hline Duration of Participation & \\begin{tabular}{l}\nEach subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of up to 42 days, eligible subjects will receive assigned treatment on Day 1 of each 3-week (Q3W) dosing cycle. Treatment with MK-3475 or docetaxel will continue for up to 35 cycles (approximately 2 years) of therapy have been administered, documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, or administrative reasons. MK-3475 treated subjects who attain a complete response may consider stopping trial treatment. These subjects will be eligible for re-treatment for up to 17 cycles (approximately 1 year) with MK-3475 after experiencing disease progression at the discretion of the investigator if they meet the criteria for re-treatment; this will be designated the Second Course phase. After the end of treatment, each subject will be followed for a minimum of 30 days for adverse event monitoring (serious adverse events will be collected for up to 90 days after the end of treatment). Subjects will have post-treatment follow-up for disease status, including initiating a non-study cancer treatment and experiencing disease progression, until death, withdrawing consent, or becoming lost to follow-up. Following demonstration of a survival benefit, eligible subjects who were allocated to docetaxel, who experienced disease progression, will be permitted to cross-over to MK-3475 200 mg Q3W. \\\\\nOnce the subject has achieved the study objective or the study has ended, the subject will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Crossover patients who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.\n\\end{tabular} \\\\\n\\hline Randomization Ratio & 1:1:1 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Abbreviated Title & MK-3475 vs. Docetaxel in Second-Line NSCLC \\\\\n\\hline Trial Phase & Phase II/III \\\\\n\\hline Clinical Indication & The treatment of subjects with non-small cell lung cancer (NSCLC) whose tumors are positive for PD-L1 who have experienced disease progression after a platinum-containing systemic therapy \\\\\n\\hline Trial Type & Interventional \\\\\n\\hline Type of control & Active control without placebo. \\\\\n\\hline Route of administration & Intravenous \\\\\n\\hline Trial Blinding & Unblinded Open-label \\\\\n\\hline Treatment Groups & \\begin{tabular}{l}\nMK-3475 \\(10 mg / kg\\) every 3 weeks \\\\\nMK-3475 \\(2 mg / kg\\) every 3 weeks \\\\\nDocetaxel \\(75 mg / m ^{2}\\) every 3 weeks \\\\\nSecond Course and Crossover MK-3475 200 mg every 3 weeks\n\\end{tabular} \\\\\n\\hline Number of trial subjects & Approximately 920 subjects will be enrolled. \\\\\n\\hline Estimated duration of trial & The sponsor estimates that the trial will require approximately 60 months from the time the first subject signs the informed consent until the last subject's last visit. \\\\\n\\hline Duration of Participation & \\begin{tabular}{l}\nEach subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. 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months","confidence":1,"confidence_rate":1},{"cnt":[[805,1104],[1849,1104],[1849,1145],[805,1145]],"region":{"top_left_x":805,"top_left_y":1103,"width":1044,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f60fe5f84f5a48c19477a9d8652c0ef6","type":"text","conversion_output":false,"parent_id":"7acfaa72f9e54d31866bfe70f81bdd51","text":"from the time the first subject signs the informed consent until the last","text_display":" from the time the first subject signs the informed consent until the last","confidence":1,"confidence_rate":1},{"cnt":[[805,1145],[1067,1145],[1067,1186],[805,1186]],"region":{"top_left_x":805,"top_left_y":1144,"width":263,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35a4b793cf024030a4b8bcda31f28e78","type":"text","conversion_output":false,"parent_id":"7acfaa72f9e54d31866bfe70f81bdd51","text":"subject's last visit.","text_display":" subject's last 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Participation","cell_row":10,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[801,1195],[1855,1195],[1855,2409],[801,2409]],"region":{"top_left_x":800,"top_left_y":1194,"width":1056,"height":1216},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a110f7ef372243c2933f69488f8a1570","type":"complex_cell","conversion_output":false,"parent_id":"036244becd17441f9370608671ee7920","children_ids":["769986f8ed0c4ebdb5b08c4eaaf54b79","ff0f306a247640319f214d63c92737fb","ea4ec25447704dbe9c773ea072e5d579","d755c46d3e0540299f9c9e9282a72361","a5360872a7e34b49a756ae6bbf68f7ce","dba169658f9b4bf99982b0a627a3cf2b","7c4954b957c946e9a0348701fe35a7bd","52b4436ee5a14e08a252e8fa4c48d76d","fe5973a9a6bb432291713620436ccb8b","2b5d2ab009be456eb2171139bc3f8c3e","5a4c206ab8ab49458d65c3d92f0e8214","4f601e522c2644e38a99c1ecba99867a","ea292088355c49f3ab6f208ac96bb2d7","574b2fa1cf8144349d35b8f43b0094b8","a4c329159b064cf88b307b3046eb0f3e","0e85b51ac27644a38f583ea04fee1ec9","2b485d3d0dc9484299576f220b9edff4","0aa2e00731db42ca8f7aeb227160732b","56e7f3dfa1e54ce4a1542618bee682ed","d7d33c377b724869a0836cf55c44615d","b477fa1acd1d40699f75e5275fab6162","2e78982af7434711b1c538ca343dceff","963577d51ef44e3ebb74d8af5acfcb33","eb47261afe7f4709b305f2e7560d7616","1ab0c41e37a74b44bf78fb7b6da7c6b4","ad14e5792f84425e8d506374e16e88d8","f130d1eb88cf468d94b4f4b9df572477","8301fd4bc44d48fa814a873745b2cc71","2dbc18c1f9f24a56a17cbca38d01203a","6039c6d328564b039035407954749136"],"text":"\\begin{tabular}{l}\nEach subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of up to 42 days, eligible subjects will receive assigned treatment on Day 1 of each 3-week (Q3W) dosing cycle. Treatment with MK-3475 or docetaxel will continue for up to 35 cycles (approximately 2 years) of therapy have been administered, documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, or administrative reasons. MK-3475 treated subjects who attain a complete response may consider stopping trial treatment. These subjects will be eligible for re-treatment for up to 17 cycles (approximately 1 year) with MK-3475 after experiencing disease progression at the discretion of the investigator if they meet the criteria for re-treatment; this will be designated the Second Course phase. After the end of treatment, each subject will be followed for a minimum of 30 days for adverse event monitoring (serious adverse events will be collected for up to 90 days after the end of treatment). Subjects will have post-treatment follow-up for disease status, including initiating a non-study cancer treatment and experiencing disease progression, until death, withdrawing consent, or becoming lost to follow-up. Following demonstration of a survival benefit, eligible subjects who were allocated to docetaxel, who experienced disease progression, will be permitted to cross-over to MK-3475 200 mg Q3W. \\\\\nOnce the subject has achieved the study objective or the study has ended, the subject will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Crossover patients who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nEach subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of up to 42 days, eligible subjects will receive assigned treatment on Day 1 of each 3-week (Q3W) dosing cycle. Treatment with MK-3475 or docetaxel will continue for up to 35 cycles (approximately 2 years) of therapy have been administered, documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, or administrative reasons. MK-3475 treated subjects who attain a complete response may consider stopping trial treatment. These subjects will be eligible for re-treatment for up to 17 cycles (approximately 1 year) with MK-3475 after experiencing disease progression at the discretion of the investigator if they meet the criteria for re-treatment; this will be designated the Second Course phase. After the end of treatment, each subject will be followed for a minimum of 30 days for adverse event monitoring (serious adverse events will be collected for up to 90 days after the end of treatment). Subjects will have post-treatment follow-up for disease status, including initiating a non-study cancer treatment and experiencing disease progression, until death, withdrawing consent, or becoming lost to follow-up. Following demonstration of a survival benefit, eligible subjects who were allocated to docetaxel, who experienced disease progression, will be permitted to cross-over to MK-3475 200 mg Q3W. \\\\\nOnce the subject has achieved the study objective or the study has ended, the subject will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Crossover patients who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.\n\\end{tabular}","cell_row":10,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9317703247070312,"confidence_rate":0.9999153692620356},{"cnt":[[805,1199],[1847,1199],[1847,1238],[805,1238]],"region":{"top_left_x":805,"top_left_y":1198,"width":1042,"height":40},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"769986f8ed0c4ebdb5b08c4eaaf54b79","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"Each subject will participate in the trial from the time the subject signs the","text_display":"Each subject will participate in the trial from the time the subject signs the","confidence":1,"confidence_rate":1},{"cnt":[[805,1238],[1847,1238],[1847,1279],[805,1279]],"region":{"top_left_x":805,"top_left_y":1237,"width":1042,"height":43},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff0f306a247640319f214d63c92737fb","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"Informed Consent Form (ICF) through the final protocol-specified","text_display":" Informed Consent Form (ICF) through the final protocol-specified","confidence":1,"confidence_rate":1},{"cnt":[[805,1277],[1847,1277],[1847,1318],[805,1318]],"region":{"top_left_x":805,"top_left_y":1276,"width":1042,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea4ec25447704dbe9c773ea072e5d579","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"contact. After a screening phase of up to 42 days, eligible subjects will","text_display":" contact. After a screening phase of up to 42 days, eligible subjects will","confidence":1,"confidence_rate":1},{"cnt":[[805,1318],[1847,1318],[1847,1359],[805,1359]],"region":{"top_left_x":805,"top_left_y":1317,"width":1042,"height":43},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d755c46d3e0540299f9c9e9282a72361","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"receive assigned treatment on Day 1 of each 3-week (Q3W) dosing cycle.","text_display":" receive assigned treatment on Day 1 of each 3-week (Q3W) dosing cycle.","confidence":1,"confidence_rate":1},{"cnt":[[805,1359],[1849,1359],[1849,1398],[805,1398]],"region":{"top_left_x":805,"top_left_y":1359,"width":1044,"height":40},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5360872a7e34b49a756ae6bbf68f7ce","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"Treatment with MK-3475 or docetaxel will continue for up to 35 cycles","text_display":" Treatment with MK-3475 or docetaxel will continue for up to 35 cycles","confidence":1,"confidence_rate":1},{"cnt":[[805,1398],[1849,1398],[1849,1439],[805,1439]],"region":{"top_left_x":805,"top_left_y":1398,"width":1044,"height":42},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dba169658f9b4bf99982b0a627a3cf2b","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"(approximately 2 years) of therapy have been administered, documented","text_display":" (approximately 2 years) of therapy have been administered, documented","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[805,1437],[1847,1437],[1847,1478],[805,1478]],"region":{"top_left_x":805,"top_left_y":1437,"width":1042,"height":42},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c4954b957c946e9a0348701fe35a7bd","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"disease progression, unacceptable adverse event(s), intercurrent illness","text_display":" disease progression, unacceptable adverse event(s), intercurrent illness","confidence":1,"confidence_rate":1},{"cnt":[[805,1478],[1849,1478],[1849,1517],[805,1517]],"region":{"top_left_x":805,"top_left_y":1478,"width":1044,"height":40},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52b4436ee5a14e08a252e8fa4c48d76d","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"that prevents further administration of treatment, investigator's decision to","text_display":" that prevents further administration of treatment, investigator's decision to","confidence":0.99755859375,"confidence_rate":0.9999701907937938},{"cnt":[[805,1517],[1849,1517],[1849,1561],[805,1561]],"region":{"top_left_x":805,"top_left_y":1517,"width":1044,"height":44},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe5973a9a6bb432291713620436ccb8b","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"withdraw the subject, subject withdraws consent, pregnancy of the","text_display":" withdraw the subject, subject withdraws consent, pregnancy of the","confidence":1,"confidence_rate":1},{"cnt":[[805,1558],[1849,1558],[1849,1599],[805,1599]],"region":{"top_left_x":805,"top_left_y":1558,"width":1044,"height":42},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b5d2ab009be456eb2171139bc3f8c3e","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"subject, noncompliance with trial treatment or procedure requirements, or","text_display":" subject, noncompliance with trial treatment or procedure requirements, or","confidence":1,"confidence_rate":1},{"cnt":[[805,1597],[1849,1597],[1849,1638],[805,1638]],"region":{"top_left_x":805,"top_left_y":1597,"width":1044,"height":42},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a4c206ab8ab49458d65c3d92f0e8214","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"administrative reasons. MK-3475 treated subjects who attain a complete","text_display":" administrative reasons. MK-3475 treated subjects who attain a complete","confidence":0.9970703125,"confidence_rate":0.9999608809327069},{"cnt":[[805,1636],[1849,1636],[1849,1677],[805,1677]],"region":{"top_left_x":805,"top_left_y":1636,"width":1044,"height":42},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f601e522c2644e38a99c1ecba99867a","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"response may consider stopping trial treatment. These subjects will be","text_display":" response may consider stopping trial treatment. These subjects will be","confidence":1,"confidence_rate":1},{"cnt":[[805,1675],[1849,1675],[1849,1719],[805,1719]],"region":{"top_left_x":805,"top_left_y":1675,"width":1044,"height":44},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea292088355c49f3ab6f208ac96bb2d7","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"eligible for re-treatment for up to 17 cycles (approximately 1 year) with","text_display":" eligible for re-treatment for up to 17 cycles (approximately 1 year) with","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[805,1719],[1851,1719],[1851,1758],[805,1758]],"region":{"top_left_x":805,"top_left_y":1718,"width":1047,"height":40},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"574b2fa1cf8144349d35b8f43b0094b8","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"MK-3475 after experiencing disease progression at the discretion of the","text_display":" MK-3475 after experiencing disease progression at the discretion of the","confidence":1,"confidence_rate":1},{"cnt":[[805,1758],[1849,1758],[1849,1799],[805,1799]],"region":{"top_left_x":805,"top_left_y":1757,"width":1044,"height":42},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4c329159b064cf88b307b3046eb0f3e","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"investigator if they meet the criteria for re-treatment; this will be","text_display":" investigator if they meet the criteria for re-treatment; this will be","confidence":1,"confidence_rate":1},{"cnt":[[805,1797],[1849,1797],[1849,1838],[805,1838]],"region":{"top_left_x":805,"top_left_y":1796,"width":1044,"height":42},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e85b51ac27644a38f583ea04fee1ec9","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"designated the Second Course phase. After the end of treatment, each","text_display":" designated the Second Course phase. After the end of treatment, each","confidence":1,"confidence_rate":1},{"cnt":[[805,1838],[1849,1838],[1849,1877],[805,1877]],"region":{"top_left_x":805,"top_left_y":1837,"width":1044,"height":40},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b485d3d0dc9484299576f220b9edff4","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"subject will be followed for a minimum of 30 days for adverse event","text_display":" subject will be followed for a minimum of 30 days for adverse event","confidence":1,"confidence_rate":1},{"cnt":[[805,1879],[1849,1879],[1849,1918],[805,1918]],"region":{"top_left_x":805,"top_left_y":1878,"width":1044,"height":40},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0aa2e00731db42ca8f7aeb227160732b","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"monitoring (serious adverse events will be collected for up to 90 days","text_display":" monitoring (serious adverse events will be collected for up to 90 days","confidence":1,"confidence_rate":1},{"cnt":[[805,1918],[1847,1918],[1847,1959],[805,1959]],"region":{"top_left_x":805,"top_left_y":1917,"width":1042,"height":42},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56e7f3dfa1e54ce4a1542618bee682ed","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"after the end of treatment). Subjects will have post-treatment follow-up","text_display":" after the end of treatment). Subjects will have post-treatment follow-up","confidence":1,"confidence_rate":1},{"cnt":[[805,1957],[1849,1957],[1849,1998],[805,1998]],"region":{"top_left_x":805,"top_left_y":1956,"width":1044,"height":42},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7d33c377b724869a0836cf55c44615d","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"for disease status, including initiating a non-study cancer treatment and","text_display":" for disease status, including initiating a non-study cancer treatment and","confidence":1,"confidence_rate":1},{"cnt":[[805,1998],[1851,1998],[1851,2037],[805,2037]],"region":{"top_left_x":805,"top_left_y":1997,"width":1047,"height":40},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b477fa1acd1d40699f75e5275fab6162","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"experiencing disease progression, until death, withdrawing consent, or","text_display":" experiencing disease progression, until death, withdrawing consent, or","confidence":1,"confidence_rate":1},{"cnt":[[805,2039],[1849,2039],[1849,2080],[805,2080]],"region":{"top_left_x":805,"top_left_y":2039,"width":1044,"height":42},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e78982af7434711b1c538ca343dceff","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"becoming lost to follow-up. Following demonstration of a survival","text_display":" becoming lost to follow-up. Following demonstration of a survival","confidence":1,"confidence_rate":1},{"cnt":[[805,2078],[1849,2078],[1849,2119],[805,2119]],"region":{"top_left_x":805,"top_left_y":2078,"width":1044,"height":42},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"963577d51ef44e3ebb74d8af5acfcb33","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"benefit, eligible subjects who were allocated to docetaxel, who","text_display":" benefit, eligible subjects who were allocated to docetaxel, who","confidence":1,"confidence_rate":1},{"cnt":[[805,2117],[1849,2117],[1849,2158],[805,2158]],"region":{"top_left_x":805,"top_left_y":2117,"width":1044,"height":42},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb47261afe7f4709b305f2e7560d7616","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"experienced disease progression, will be permitted to cross-over to","text_display":" experienced disease progression, will be permitted to cross-over to","confidence":1,"confidence_rate":1},{"cnt":[[805,2156],[1165,2156],[1165,2197],[805,2197]],"region":{"top_left_x":805,"top_left_y":2156,"width":360,"height":42},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ab0c41e37a74b44bf78fb7b6da7c6b4","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"MK-3475 200 mg Q3W.","text_display":" MK-3475 200 mg Q3W.","confidence":0.9317703247070312,"confidence_rate":0.9975661071669835},{"cnt":[[805,2204],[1847,2204],[1847,2245],[805,2245]],"region":{"top_left_x":805,"top_left_y":2203,"width":1042,"height":42},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad14e5792f84425e8d506374e16e88d8","type":"text","conversion_output":false,"parent_id":"a110f7ef372243c2933f69488f8a1570","text":"Once the subject has achieved the study objective or the study has 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High expression of PD-L1","text_display":" demonstrated to express abundant levels of this T-cell inhibitor. High expression of PD-L1","confidence":1,"confidence_rate":1},{"cnt":[[309,2256],[1878,2256],[1878,2305],[309,2305]],"region":{"top_left_x":309,"top_left_y":2255,"width":1569,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59c22fc7bedf4ad7a422ef39225c8161","type":"text","conversion_output":true,"text":"on tumor cells (and to a lesser extent of PD-L2) has been found to correlate with poor","text_display":" on tumor cells (and to a lesser extent of PD-L2) has been found to correlate with poor","confidence":1,"confidence_rate":1},{"cnt":[[309,2305],[1880,2305],[1880,2353],[309,2353]],"region":{"top_left_x":309,"top_left_y":2305,"width":1571,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78bd46bbb9944e2c804bcff1b018e883","type":"text","conversion_output":true,"text":"prognosis and survival in various cancer types, including RCC [12], pancreatic carcinoma","text_display":" prognosis and survival in various cancer types, including RCC [12], pancreatic carcinoma","confidence":1,"confidence_rate":1},{"cnt":[[309,2350],[1880,2350],[1880,2400],[309,2400]],"region":{"top_left_x":309,"top_left_y":2350,"width":1571,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d588fdfb26b94624898b0901c41b93a4","type":"text","conversion_output":true,"text":"[13], hepatocellular carcinoma [14], and ovarian carcinoma [15]. 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MK-3475 (SCH 900475)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1762,129],[1893,129],[1893,174],[1762,174]],"region":{"top_left_x":1761,"top_left_y":128,"width":132,"height":47},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5aaba35523540d9ac92e76ca44375e6","type":"page_info","conversion_output":false,"text":"Page 25","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,172],[870,172],[870,208],[309,208]],"region":{"top_left_x":309,"top_left_y":171,"width":562,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"47abfa0d81b14141a5df55b5dc2c9580","type":"page_info","conversion_output":false,"text":"Protocol/Amendment No.: 010-17","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,262],[1876,262],[1876,312],[309,312]],"region":{"top_left_x":309,"top_left_y":262,"width":1567,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e94a4b9f01c243229ae41767417453ba","type":"text","conversion_output":true,"text":"The observed correlation of clinical prognosis with PD-L expression in multiple cancers","text_display":"\n\nThe observed correlation of clinical prognosis with PD-L expression in multiple cancers","confidence":1,"confidence_rate":1},{"cnt":[[309,309],[1876,309],[1876,359],[309,359]],"region":{"top_left_x":309,"top_left_y":309,"width":1567,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98cbb141aeb9470f89c31781012d4015","type":"text","conversion_output":true,"text":"suggests that the PD-1/PD-L1 pathway plays a critical role in tumor immune evasion and","text_display":" suggests that the PD-1/PD-L1 pathway plays a critical role in tumor immune evasion and","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[309,357],[1508,357],[1508,406],[309,406]],"region":{"top_left_x":309,"top_left_y":356,"width":1200,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85725e6d19cc4370a5266d277bfb0cf7","type":"text","conversion_output":true,"text":"should be considered as an attractive target for therapeutic intervention.","text_display":" should be considered as an attractive target for therapeutic intervention.","confidence":1,"confidence_rate":1},{"cnt":[[309,447],[1876,447],[1876,494],[309,494]],"region":{"top_left_x":309,"top_left_y":446,"width":1567,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cbbdc1ea0ce4209b644db8528716adc","type":"text","conversion_output":true,"text":"Several means of quantitatively scoring PD-L1 expression were evaluated using ROC 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The best overall response rate of patients with strongly positive tumors in the training","text_display":" cutoff. 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The median overall survival in","confidence":0.8946836241159417,"confidence_rate":0.9990156607463319},{"cnt":[[305,1629],[1876,1629],[1876,1678],[305,1678]],"region":{"top_left_x":305,"top_left_y":1628,"width":1571,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5850119fd6847dc81a460d57e035c2e","type":"text","conversion_output":true,"text":"the TAX320 trial was 5.7 months for docetaxel versus 5.6 months for the control. The","text_display":" the TAX320 trial was 5.7 months for docetaxel versus 5.6 months for the control. The","confidence":1,"confidence_rate":1},{"cnt":[[305,1678],[1876,1678],[1876,1729],[305,1729]],"region":{"top_left_x":305,"top_left_y":1677,"width":1571,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce2ef8968eb747f9b9ae03ef61f50ecd","type":"text","conversion_output":true,"text":"response rate for docetaxel in TAX320 was \\(5.7 \\%\\) ( \\(95 \\%\\) CI: \\(2.3 \\%, 11.3 \\%\\) ) based on WHO","text_display":" response rate for docetaxel in TAX320 was \\(5.7 \\%\\) ( \\(95 \\%\\) CI: \\(2.3 \\%, 11.3 \\%\\) ) based on WHO","confidence":0.8663884039099062,"confidence_rate":0.9985071366015846},{"cnt":[[305,1727],[1880,1727],[1880,1777],[305,1777]],"region":{"top_left_x":305,"top_left_y":1727,"width":1575,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1a645cff2de4956aed3e91a2cd30cd2","type":"text","conversion_output":true,"text":"response criteria [17]. 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Pemetrexed's approved indication is limited to","text_display":" \\(0.81 ; 95 \\% CI , 0.70\\) to \\(0.94 ; P =.005\\) ) [19]. Pemetrexed's approved indication is limited to","confidence":0.9790332176512493,"confidence_rate":0.9997838018757946},{"cnt":[[305,2295],[1878,2295],[1878,2346],[305,2346]],"region":{"top_left_x":305,"top_left_y":2294,"width":1573,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55a0ee6fde614c6f8f96ac77722c1b91","type":"text","conversion_output":true,"text":"patients with NSCLC with non-squamous histology by both the FDA and EMA and is","text_display":" patients with NSCLC with non-squamous histology by both the FDA and EMA and is","confidence":1,"confidence_rate":1},{"cnt":[[305,2342],[1880,2342],[1880,2396],[305,2396]],"region":{"top_left_x":305,"top_left_y":2341,"width":1575,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ecf00ef3e754168ade6e746ad6bcea8","type":"text","conversion_output":true,"text":"commonly used as part of first-line therapy in patients with non-squamous NSCLC. 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More recently, the TAILOR trial has reported the","text_display":" who do not have an EGFR mutation. 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is about \\(5-10 \\%\\), median progression-free survival is about 3 months,","confidence":1,"confidence_rate":1},{"cnt":[[309,1036],[1880,1036],[1880,1085],[309,1085]],"region":{"top_left_x":309,"top_left_y":1035,"width":1571,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e1a10e1b78b4e978f29c2a062c2fb99","type":"text","conversion_output":true,"text":"and the median overall survival is about 7.5 months [17] [21] [22]. Improvements in OS are","text_display":" and the median overall survival is about 7.5 months [17] [21] [22]. Improvements in OS are","confidence":1,"confidence_rate":1},{"cnt":[[309,1083],[1233,1083],[1233,1132],[309,1132]],"region":{"top_left_x":309,"top_left_y":1082,"width":925,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18e87357e2b3460d954f2dcd1a328e34","type":"text","conversion_output":true,"text":"needed since no one with progressive NSCLC is cured.","text_display":" needed since no one with progressive NSCLC is cured.","confidence":1,"confidence_rate":1},{"cnt":[[309,1173],[1878,1173],[1878,1222],[309,1222]],"region":{"top_left_x":309,"top_left_y":1173,"width":1569,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63bdb6a64e5a4d27a6f45d2450fbd966","type":"text","conversion_output":true,"text":"A large surgical series of resected NSCLC specimens revealed that about \\(25 \\%\\) of squamous","text_display":"\n\nA large surgical series of resected NSCLC specimens revealed that about \\(25 \\%\\) of squamous","confidence":1,"confidence_rate":1},{"cnt":[[309,1220],[1880,1220],[1880,1270],[309,1270]],"region":{"top_left_x":309,"top_left_y":1220,"width":1571,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3719fa528e904cd98a13103b4b8692f4","type":"text","conversion_output":true,"text":"and adenocarcinoma have tumor infiltrating lymphocytes (TILs) present [24]. These TILs","text_display":" and adenocarcinoma have tumor infiltrating lymphocytes (TILs) present [24]. These TILs","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[309,1268],[1880,1268],[1880,1317],[309,1317]],"region":{"top_left_x":309,"top_left_y":1267,"width":1571,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"545433df6d4c4f3cac315c55ec0601d2","type":"text","conversion_output":true,"text":"often contain CD8+ T cells [24]. The presence of increased CD8+ cells in the tumor sets the","text_display":" often contain CD8+ T cells [24]. The presence of increased CD8+ cells in the tumor sets the","confidence":0.9975595474243164,"confidence_rate":0.9999745478725159},{"cnt":[[309,1317],[1876,1317],[1876,1364],[309,1364]],"region":{"top_left_x":309,"top_left_y":1316,"width":1567,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c94e389e27c04e6e9359c1a2077a25d6","type":"text","conversion_output":true,"text":"stage for an immune-based response against the tumor if inhibition of the immune system can","text_display":" stage for an immune-based response against the tumor if inhibition of the immune system can","confidence":1,"confidence_rate":1},{"cnt":[[309,1364],[1876,1364],[1876,1416],[309,1416]],"region":{"top_left_x":309,"top_left_y":1364,"width":1567,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6087fdf96d304f718e2d535804b7961d","type":"text","conversion_output":true,"text":"be abrogated. Indeed, in a study of ipilimumab, an anti-CTLA4 monoclonal antibody,","text_display":" be abrogated. Indeed, in a study of ipilimumab, an anti-CTLA4 monoclonal antibody,","confidence":1,"confidence_rate":1},{"cnt":[[309,1414],[1880,1414],[1880,1463],[309,1463]],"region":{"top_left_x":309,"top_left_y":1413,"width":1571,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2974d7345aa844e6a4b2569a3baeec53","type":"text","conversion_output":true,"text":"combined with first-line carboplatin and paclitaxel, a post-hoc subset analysis identified an","text_display":" combined with first-line carboplatin and paclitaxel, a post-hoc subset analysis identified an","confidence":1,"confidence_rate":1},{"cnt":[[309,1461],[1876,1461],[1876,1510],[309,1510]],"region":{"top_left_x":309,"top_left_y":1460,"width":1567,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91a4e157a1354072965bf6a84ff6ba11","type":"text","conversion_output":true,"text":"improvement in OS that favored patients with squamous histology compared to placebo plus","text_display":" improvement in OS that favored patients with squamous histology compared to placebo plus","confidence":1,"confidence_rate":1},{"cnt":[[309,1508],[1880,1508],[1880,1558],[309,1558]],"region":{"top_left_x":309,"top_left_y":1508,"width":1571,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3d3b97d645e47a4891d7b48dcfdfef9","type":"text","conversion_output":true,"text":"carboplatin and paclitaxel (HR 0.48 [95\\% CI 0.22-1.03]). Results were not as favorable for","text_display":" carboplatin and paclitaxel (HR 0.48 [95\\% CI 0.22-1.03]). Results were not as favorable for","confidence":0.8882023283682302,"confidence_rate":0.9987909792645623},{"cnt":[[309,1555],[1880,1555],[1880,1605],[309,1605]],"region":{"top_left_x":309,"top_left_y":1555,"width":1571,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14385d5e635d489ab12bc286b118ca1c","type":"text","conversion_output":true,"text":"patients with nonsquamous histology (HR \\(1.17[95 \\% CI 0.74-1.86]\\) ). These findings have","text_display":" patients with nonsquamous histology (HR \\(1.17[95 \\% CI 0.74-1.86]\\) ). These findings have","confidence":0.9221215264361149,"confidence_rate":0.9991378372303691},{"cnt":[[309,1605],[1629,1605],[1629,1654],[309,1654]],"region":{"top_left_x":309,"top_left_y":1604,"width":1320,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a20ced9d4d34088a369a997076c708e","type":"text","conversion_output":true,"text":"led to the initiation of a Phase III trial in the same population with ipilimumab.","text_display":" led to the initiation of a Phase III trial in the same population with ipilimumab.","confidence":1,"confidence_rate":1},{"cnt":[[309,1693],[1878,1693],[1878,1742],[309,1742]],"region":{"top_left_x":309,"top_left_y":1692,"width":1569,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35c253e0c8cf44b6971d41c1bb3cc804","type":"text","conversion_output":true,"text":"Please see the end of Section 4.1.1 which discusses the classification of tumors as strongly","text_display":"\n\nPlease see the end of Section 4.1.1 which discusses the classification of tumors as strongly","confidence":0.9980475902557373,"confidence_rate":0.9999798525928524},{"cnt":[[309,1740],[1880,1740],[1880,1792],[309,1792]],"region":{"top_left_x":309,"top_left_y":1740,"width":1571,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b78ecbe19a664ab89ffc987840135c91","type":"text","conversion_output":true,"text":"positive or weakly positive based on PD-L1 scoring. 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The two brain MRIs that","confidence":1,"confidence_rate":1},{"cnt":[[434,1388],[1878,1388],[1878,1429],[434,1429]],"region":{"top_left_x":433,"top_left_y":1387,"width":1445,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1f67f33c6cf4d088cd996c8aa3beb09","type":"text","conversion_output":true,"text":"were used to make the determination of stable disease must be submitted to the","text_display":" were used to make the determination of stable disease must be submitted to the","confidence":1,"confidence_rate":1},{"cnt":[[434,1435],[1878,1435],[1878,1480],[434,1480]],"region":{"top_left_x":433,"top_left_y":1435,"width":1445,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e53c8e9f7ae045688ee9e52da1aad92d","type":"text","conversion_output":true,"text":"central imaging vendor, preferably while the subject is undergoing screening. 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Subjects with hypothyroidism not from autoimmune disease and","text_display":" from the study. 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Seasonal flu vaccines that do not contain live","text_display":" administration of study medication. 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Active Hepatitis B is defined as a known positive","text_display":"\n15) Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive","confidence":0.7098299043718725,"confidence_rate":0.9963215144272392},{"cnt":[[434,400],[1880,400],[1880,445],[434,445]],"region":{"top_left_x":433,"top_left_y":399,"width":1447,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a617dca84ea4e0d8df5da5326552401","type":"text","conversion_output":true,"text":"HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result","text_display":" HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result","confidence":0.5634546185289535,"confidence_rate":0.9943362140781248},{"cnt":[[434,447],[1880,447],[1880,492],[434,492]],"region":{"top_left_x":433,"top_left_y":446,"width":1447,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca3ce87ffe874320b5fcd97c4ff847bf","type":"text","conversion_output":true,"text":"and known quantitative HCV RNA results greater than the lower limits of detection","text_display":" and known quantitative HCV RNA results greater than the lower limits of detection","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[434,494],[647,494],[647,544],[434,544]],"region":{"top_left_x":433,"top_left_y":494,"width":214,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbd4cf9656cd4181939677777425e3fe","type":"text","conversion_output":true,"text":"of the assay.","text_display":" of the 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participate, in the opinion of the treating investigator.","confidence":1,"confidence_rate":1},{"cnt":[[374,816],[1880,816],[1880,866],[374,866]],"region":{"top_left_x":373,"top_left_y":816,"width":1507,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1faab4094163420790b48f8283b40ca4","type":"text","conversion_output":true,"text":"17) Has known psychiatric or substance abuse disorders that would interfere with","text_display":"\n17) Has known psychiatric or substance abuse disorders that would interfere with","confidence":1,"confidence_rate":1},{"cnt":[[434,866],[1205,866],[1205,913],[434,913]],"region":{"top_left_x":433,"top_left_y":865,"width":773,"height":49},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"403f40a2c3be47ddb9de74a29828ca1d","type":"text","conversion_output":true,"text":"cooperation with the requirements of the trial.","text_display":" cooperation with the requirements of the 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These immune-related AEs (irAEs) may occur shortly after the first dose or several","text_display":" etiology. 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Pembrolizumab","text_display":"","confidence":0.99755859375,"confidence_rate":0.9999797986227136},{"cnt":[[241,348],[574,348],[574,397],[241,397]],"region":{"top_left_x":240,"top_left_y":348,"width":334,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8d881c2e48b4d909987a4343dc55334","type":"section_header","conversion_output":false,"children_ids":["e763dd7e367a47feac384da30dab4ac0"],"text":"","text_display":""},{"cnt":[[245,352],[569,352],[569,393],[245,393]],"region":{"top_left_x":244,"top_left_y":352,"width":326,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e763dd7e367a47feac384da30dab4ac0","type":"text","conversion_output":true,"parent_id":"c8d881c2e48b4d909987a4343dc55334","text":"General instructions:","text_display":"\n\n\\section*{General 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Corticosteroid taper should be initiated upon AE improving to Grade 1 or less and continue to taper over at least 4 weeks.","text_display":"\n1. Corticosteroid taper should be initiated upon AE improving to Grade 1 or less and continue to taper over at least 4 weeks.","confidence":1,"confidence_rate":1},{"cnt":[[309,473],[2408,473],[2408,513],[309,513]],"region":{"top_left_x":309,"top_left_y":472,"width":2100,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a4b62a1f1024ad8b3400bb6f0ce3dc1","type":"text","conversion_output":true,"text":"2. For situations where pembrolizumab has been withheld, pembrolizumab can be resumed after AE has been reduced to Grade 1 or 0 and","text_display":"\n2. For situations where pembrolizumab has been withheld, pembrolizumab can be resumed after AE has been reduced to Grade 1 or 0 and","confidence":0.9580078125,"confidence_rate":0.9996979375593854},{"cnt":[[370,511],[2408,511],[2408,556],[370,556]],"region":{"top_left_x":369,"top_left_y":511,"width":2040,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c2ec36353ca4359ba4e5a2eaa44a91b","type":"text","conversion_output":true,"text":"corticosteroid has been tapered. Pembrolizumab should be permanently discontinued if AE does not resolve within 12 weeks of last dose or","text_display":" corticosteroid has been tapered. Pembrolizumab should be permanently discontinued if AE does not resolve within 12 weeks of last dose or","confidence":1,"confidence_rate":1},{"cnt":[[370,554],[1704,554],[1704,595],[370,595]],"region":{"top_left_x":369,"top_left_y":554,"width":1335,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e1966bf8d614ad9a8f6f41ff04fc30a","type":"text","conversion_output":true,"text":"corticosteroids cannot be reduced to \\(\\leq 10 mg\\) prednisone or equivalent per day within 12 weeks.","text_display":" corticosteroids cannot be reduced to \\(\\leq 10 mg\\) prednisone or equivalent per day within 12 weeks.","confidence":0.99853515625,"confidence_rate":0.9999861706835268},{"cnt":[[305,593],[2408,593],[2408,634],[305,634]],"region":{"top_left_x":305,"top_left_y":592,"width":2104,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"367939c942cd43809fe03f8920d99690","type":"text","conversion_output":true,"text":"3. For severe and life-threatening irAEs, IV corticosteroid should be initiated, first followed by oral steroid. Other immunosuppressive treatment","text_display":"\n3. For severe and life-threatening irAEs, IV corticosteroid should be initiated, first followed by oral steroid. Other immunosuppressive treatment","confidence":1,"confidence_rate":1},{"cnt":[[370,632],[1313,632],[1313,675],[370,675]],"region":{"top_left_x":369,"top_left_y":631,"width":944,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f09e2bfba0cc4255b1f99391d0d8ff1e","type":"text","conversion_output":true,"text":"should be initiated if irAEs cannot be controlled by corticosteroids.","text_display":" should be initiated if irAEs cannot be controlled by corticosteroids.","confidence":1,"confidence_rate":1},{"cnt":[[226,683],[2428,683],[2428,1695],[226,1695]],"region":{"top_left_x":225,"top_left_y":683,"width":2203,"height":1013},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9b395530fd945fb9a6376489f1ee6d2","type":"table","conversion_output":true,"children_ids":["0d0761b16921463cb4a0b061adb4e26e","c831304869504422b68cdcc61669e870","374af6848b7346c893c520b7399850be","2c50bc5218a2429ebe196dcbf4d48f31","8f941dade54a4a99ac16aae6bc5b72bf","5b3711b5183d4edebb5ab81cf53fe032","3c667f0e1e0f4a3389635d4ab106614d","a8ed06b22f114310a9d2d1611e114514","da8c7adad08f401fb13363e852cd2c33","e1db9335da794f73b7c08598a2256578","1cab85c330a44a95ac721cfbc3c9e82b","2134982b53bf4a94a53f28fd54a6a05a","474aebf79c214746a2e70b3ec271096d","041d36d902e346acbfa14c840a1101ec","4b1ce018a1ed40419525d79c18e8de20","1d2ccf4c79d8415798ed922d5714e7c6","2f34556ba9a34a1eaf8cac1c19ed1fe3","6e20e3e1bca1479c94ab69e3298b350a","696b78769e6141959b39fad53e3c46f4","5a2892eb67d641bfaee8116e74de5389","02ff397d92e740c7aa5754b5480c5fb6","e8103ac4d1504fd0b5bb99de65a98255","eb5fc930c6c24cf8b12cd21ccd30be89","9f03352f03674a2e82931f87ff09f5fd","4403a924c55f4cb5bd6c641a2b59f846","f6f93d529caf4521a2e2051b89b92b3d","7809a774bb63411ba225d2eda1276e24"],"selected_labels":["648df0ed2bd34331974e9c3dd2e7f4ff"],"text":"\\begin{tabular}{|l|l|l|l|l|}\n\\hline Immune-related AEs & Toxicity grade or conditions (CTCAEv4.0) & Action taken to pembrolizumab & irAE management with corticosteroid and/or other therapies & Monitor and follow-up \\\\\n\\hline \\multirow[t]{2}{*}{Pneumonitis} & Grade 2 & Withhold & \\multirow[t]{2}{*}{- Administer corticosteroids (initial dose of \\(1-2 mg / kg\\) prednisone or equivalent) followed by taper} & \\\\\n\\hline & & & & \\begin{tabular}{l}\n- Monitor participants for signs and symptoms of pneumonitis \\\\\n- Evaluate participants with suspected pneumonitis with radiographic imaging and initiate corticosteroid treatment \\\\\n- Add prophylactic antibiotics for opportunistic infections\n\\end{tabular} \\\\\n\\hline \\multirow[t]{2}{*}{Diarrhea / Colitis} & Grade 2 or 3 & Withhold & \\multirow[t]{2}{*}{- Administer corticosteroids (initial dose of \\(1-2 mg / kg\\) prednisone or equivalent) followed by taper} & \\\\\n\\hline & Grade 4 & Permanently discontinue & & \\begin{tabular}{l}\n- Monitor participants for signs and symptoms of enterocolitis (ie, diarrhea, abdominal pain, blood or mucus in stool with or without fever) and of bowel perforation (ie, peritoneal signs and ileus). \\\\\n- Participants with \\(\\geq\\) Grade 2 diarrhea suspecting colitis should consider GI consultation and performing endoscopy to rule out colitis. \\\\\n- Participants with diarrhea/colitis should be advised to drink liberal quantities of clear fluids. 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Otherwise dosing will be held until symptoms resolve and the subject should be premedicated for the next scheduled dose. \\\\\nSubjects who develop Grade 2 toxicity despite adequate premedication should be permanently discontinued from further study drug treatment\n\\end{tabular} & \\begin{tabular}{l}\nSubject may be premedicated 1.5h ( ± 30 minutes) prior to infusion of pembrolizumab with: \\\\\nDiphenhydramine 50 mg po (or equivalent dose of antihistamine). \\\\\nAcetaminophen \\(500-1000 mg\\) po (or equivalent dose of analgesic).\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4 Pembrolizumab Infusion Reaction Dose Modification and Treatment Guidelines}\n\\begin{tabular}{|l|l|l|}\n\\hline NCI CTCAE Grade & Treatment & Premedication at Subsequent Dosing \\\\\n\\hline \\begin{tabular}{l}\nGrade 1 \\\\\nMild reaction; infusion interruption not indicated; intervention not indicated\n\\end{tabular} & Increase monitoring of vital signs as medically indicated until the subject is deemed medically stable, in the opinion of the investigator. & None \\\\\n\\hline \\begin{tabular}{l}\nGrade 2 \\\\\nRequires therapy or infusion interruption but responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for \\(\\leq 24 hrs\\)\n\\end{tabular} & \\begin{tabular}{l}\nStop Infusion. \\\\\nAdditional appropriate medical therapy may include but is not limited to: \\\\\nIV fluids \\\\\nAntihistamines \\\\\nNSAIDs \\\\\nAcetaminophen \\\\\nNarcotics \\\\\nIncrease monitoring of vital signs, as medically indicated, until the subject is deemed medically stable in the opinion of the investigator. \\\\\nIf symptoms resolve within 1 hour of stopping drug infusion, the infusion may be restarted at \\(50 \\%\\) of the original infusion rate (e.g. from \\(100 mL / hr\\) to \\(50 mL / hr\\) ). 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& Screening (Visit 1) & \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & -42 to -1 & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 35 & \\multirow{2}{*}{Discontinuation Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline 12-Lead ECG & X & & & & & & & & & & & & & & & \\\\\n\\hline ECOG Performance Status & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Pulmonary Function Testing \\({ }^{22}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{9}{|l|}{Laboratory Procedures / Assessments: analysis performed by local laboratory} & & & & & & & & \\\\\n\\hline Pregnancy Test Urine or Serum \\(\\beta\\) HCG \\({ }^{9}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline PT/INR and aPTT \\({ }^{10}\\) & X \\({ }^{11}\\) & & & & & & & & & & & & & & & \\\\\n\\hline CBC with Differential \\({ }^{12}\\) & X \\({ }^{11}\\) & & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{12}\\) & X \\({ }^{11}\\) & & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Urinalysis \\({ }^{12}\\) & X \\({ }^{11}\\) & & & & & X & & & & X & & & & X & X \\({ }^{13}\\) & X \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{12,14}\\) & X \\({ }^{11}\\) & & X & & X & & X & & X & & X & & X & & X \\({ }^{13}\\) & X \\\\\n\\hline ALK Translocation Testing \\({ }^{23}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline EGFR Mutation Testing \\({ }^{23}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{9}{|l|}{Laboratory Procedures / Assessments: analysis performed by central laboratory} & & & & & & & & \\\\\n\\hline Blood for Future Biomedical Research \\({ }^{15}\\) (optional) & & X & & & & & & & & & & & & & & \\\\\n\\hline Efficacy Measurements & & & & & & & & & & & & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{ 1 6 , 1 7 }\\) & X & & & & X & & & X & & & X & & & X & X \\({ }^{16}\\) & X \\\\\n\\hline \\multicolumn{2}{|l|}{Patient Reported Outcomes (PRO)} & & & & & & & & & & & & & & & \\\\\n\\hline EuroQol EQ-5D \\({ }^{ 1 8 }\\) & & X & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline EORTC QLQ-C30 \\({ }^{ 1 8 }\\) & & X & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Screening (Visit 1) & \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & -42 to -1 & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 35 & \\multirow{2}{*}{Discontinuation Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline 12-Lead ECG & X & & & & & & & & & & & & & & & \\\\\n\\hline ECOG Performance Status & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Pulmonary Function Testing \\({ }^{22}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline \\multicolumn{9}{|l|}{Laboratory Procedures / Assessments: analysis performed by local laboratory} & & & & & & & & \\\\\n\\hline Pregnancy Test Urine or Serum \\(\\beta\\) HCG \\({ }^{9}\\) & X & & & & & & & & & & & & & & & \\\\\n\\hline PT/INR and aPTT \\({ }^{10}\\) & X \\({ }^{11}\\) & & & & & & & & & & & & & & & \\\\\n\\hline CBC with Differential \\({ }^{12}\\) & X \\({ }^{11}\\) & & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{12}\\) & X \\({ }^{11}\\) & & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline 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& Screening (Visit 1) & \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & -42 to -1 & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 35 & \\multirow{2}{*}{Discontinuation Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline EORTC QLQ LC-13 \\({ }^{ 1 8 }\\) & & X & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline Health Economic Assessment \\({ }^{18}\\) & & & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline \\multicolumn{17}{|l|}{Tumor Biopsies / Archival Tissue Collection} \\\\\n\\hline Tumor Tissue Collection & X \\({ }^{19}\\) & & & \\(X ^{20}\\) & & \\(X ^{20}\\) & & & & \\(X ^{20}\\) & & & & & & \\\\\n\\hline \\multicolumn{17}{|c|}{\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment). Assign Baseline number when the study informed consent is signed. \\\\\n4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2. \\\\\n5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2. \\\\\n6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness. \\\\\n7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology). \\\\\n8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only. \\\\\n9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. Pregnancy tests (serum and/or urine tests) should be repeated if required by local guidelines. \\\\\n10 Coagulation factors (PT/INR and aPTT) should be monitored closely throughout the trial for any subject receiving anticoagulant therapy. \\\\\n11 Laboratory tests for screening are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests. \\\\\n12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. See Section 7.1.3 for details regarding laboratory tests. \\\\\n13 Perform every 4 cycles after Cycle 13; perform thyroid testing every other cycle. \\\\\n14 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service. \\\\\n15 Informed consent for future biomedical research samples must be obtained before the DNA sample. DNA sample for analysis should be obtained predose, on Cycle 1 (or with the next scheduled blood draw), as the last sample drawn, on randomized subjects only, or at a later date as soon as the informed consent is obtained. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Screening (Visit 1) & \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & -42 to -1 & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 35 & \\multirow{2}{*}{Discontinuation Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline EORTC QLQ LC-13 \\({ }^{ 1 8 }\\) & & X & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline Health Economic Assessment \\({ }^{18}\\) & & & X & X & & X & & & & X & & & & \\(X ^{13}\\) & & X \\\\\n\\hline \\multicolumn{17}{|l|}{Tumor Biopsies / Archival Tissue Collection} \\\\\n\\hline Tumor Tissue Collection & X \\({ }^{19}\\) & & & \\(X ^{20}\\) & & \\(X ^{20}\\) & & & & \\(X ^{20}\\) & & & & & & \\\\\n\\hline \\multicolumn{17}{|c|}{\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment). Assign Baseline number when the study informed consent is signed. \\\\\n4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2. \\\\\n5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2. \\\\\n6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness. \\\\\n7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology). \\\\\n8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only. \\\\\n9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. Pregnancy tests (serum and/or urine tests) should be repeated if required by local guidelines. \\\\\n10 Coagulation factors (PT/INR and aPTT) should be monitored closely throughout the trial for any subject receiving anticoagulant therapy. \\\\\n11 Laboratory tests for screening are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests. \\\\\n12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. See Section 7.1.3 for details regarding laboratory tests. \\\\\n13 Perform every 4 cycles after Cycle 13; perform thyroid testing every other cycle. \\\\\n14 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service. \\\\\n15 Informed consent for future biomedical research samples must be obtained before the DNA sample. DNA sample for analysis should be obtained predose, on Cycle 1 (or with the next scheduled blood draw), as the last sample drawn, on randomized subjects only, or at a later date as soon as the informed consent is obtained. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.\n\\end{tabular}} 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Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.\n\\end{tabular}","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":17},{"cnt":[[261,798],[2492,798],[2492,1851],[261,1851]],"region":{"top_left_x":261,"top_left_y":798,"width":2231,"height":1053},"line":105,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7fb743b60134df4b20348bbcae11b43","type":"complex_cell","conversion_output":false,"parent_id":"5e612387283d456a852c47aa763117dc","children_ids":["66a8b7a912134bc6be85855877f09cbb","975c6cc94c774c31876e12153efd28bc","4f880ed3eb0842f8afa19f130c7d1d8e","4ad99cec2df747159b71ff231d8a2663","027fbe7012574f9888bfad29224c9698","b1e84df1062343a2ae44fa166ec4cfbc","15917a8050a64418a5648be335a13bf3","848e9dbddc224192a93865bdaacdd225","09e899e800d24b46b3982bceef68f347","0ada4917cd8e4ddca1f3bb1c8b8e3c09","34d1454f2d1d41d7be9d022718af3f04","03119b5529d54ac0814b9383459dd706","d1e8668434ca431882710034ead05629","01904c7aede9435bb3bb785bc5435b10","b8fd63460aa94a55a9ba00529d048cf5","6ae3cb4cfd7e47299cd124f8533d4df1","9f0325e272934b748e89ae7960a3f123","892f95e0a2e94778844c060e90bbb97b","4df1f47fce274f49b6b8889045f38462","9d3ca05e203541999bb958aa28243665","cbef4ff5116c4229b5af372511a9daca","28dd693974b1480b96ffb6a46a4a4720","4331bb615a0a4cc9893646efc2971b47","5b3a7c6a509b4eb19a085cada7c42db2","f3b97741a87a440f9be1320936f4270f","b38f360af585449d8ae7a394b8407c22","63856028c16a44919c268e1677bdc8ea","63447dd4ba0b4afb9dff520dc12d5571","ad8b3fa0c50f40c3923b207ea55578a2"],"text":"\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment). Assign Baseline number when the study informed consent is signed. \\\\\n4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2. \\\\\n5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2. \\\\\n6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness. \\\\\n7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology). \\\\\n8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only. \\\\\n9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. Pregnancy tests (serum and/or urine tests) should be repeated if required by local guidelines. \\\\\n10 Coagulation factors (PT/INR and aPTT) should be monitored closely throughout the trial for any subject receiving anticoagulant therapy. \\\\\n11 Laboratory tests for screening are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests. \\\\\n12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. See Section 7.1.3 for details regarding laboratory tests. \\\\\n13 Perform every 4 cycles after Cycle 13; perform thyroid testing every other cycle. \\\\\n14 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service. \\\\\n15 Informed consent for future biomedical research samples must be obtained before the DNA sample. DNA sample for analysis should be obtained predose, on Cycle 1 (or with the next scheduled blood draw), as the last sample drawn, on randomized subjects only, or at a later date as soon as the informed consent is obtained. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment). Assign Baseline number when the study informed consent is signed. \\\\\n4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2. \\\\\n5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2. \\\\\n6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness. \\\\\n7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology). \\\\\n8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only. \\\\\n9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. Pregnancy tests (serum and/or urine tests) should be repeated if required by local guidelines. \\\\\n10 Coagulation factors (PT/INR and aPTT) should be monitored closely throughout the trial for any subject receiving anticoagulant therapy. \\\\\n11 Laboratory tests for screening are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests. \\\\\n12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. See Section 7.1.3 for details regarding laboratory tests. \\\\\n13 Perform every 4 cycles after Cycle 13; perform thyroid testing every other cycle. \\\\\n14 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service. \\\\\n15 Informed consent for future biomedical research samples must be obtained before the DNA sample. DNA sample for analysis should be obtained predose, on Cycle 1 (or with the next scheduled blood draw), as the last sample drawn, on randomized subjects only, or at a later date as soon as the informed consent is obtained. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.\n\\end{tabular}","cell_row":7,"cell_column":0,"cell_row_span":1,"cell_col_span":17,"confidence":0.49161701699426885,"confidence_rate":0.9998616280448719},{"cnt":[[268,800],[2485,800],[2485,837],[268,837]],"region":{"top_left_x":267,"top_left_y":800,"width":2219,"height":38},"line":106,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66a8b7a912134bc6be85855877f09cbb","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are","text_display":"1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are","confidence":1,"confidence_rate":1},{"cnt":[[313,837],[2485,837],[2485,874],[313,874]],"region":{"top_left_x":313,"top_left_y":837,"width":2173,"height":38},"line":107,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"975c6cc94c774c31876e12153efd28bc","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section","text_display":" 3 weeks (21-days); however the MK-3475 treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section","confidence":0.9946331977844238,"confidence_rate":0.9999675833252344},{"cnt":[[313,874],[2485,874],[2485,911],[313,911]],"region":{"top_left_x":313,"top_left_y":874,"width":2173,"height":37},"line":108,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f880ed3eb0842f8afa19f130c7d1d8e","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be","text_display":" 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be","confidence":1,"confidence_rate":1},{"cnt":[[313,911],[2396,911],[2396,950],[313,950]],"region":{"top_left_x":313,"top_left_y":910,"width":2084,"height":40},"line":109,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ad99cec2df747159b71ff231d8a2663","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays.","text_display":" performed every 9 weeks ( \\(\\pm 7\\) days) from the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) regardless of any treatment delays.","confidence":0.49161701699426885,"confidence_rate":0.9960630187209939},{"cnt":[[263,948],[1264,948],[1264,989],[263,989]],"region":{"top_left_x":263,"top_left_y":947,"width":1001,"height":42},"line":110,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"027fbe7012574f9888bfad29224c9698","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified.","text_display":"\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified.","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[266,987],[2485,987],[2485,1023],[266,1023]],"region":{"top_left_x":265,"top_left_y":986,"width":2221,"height":38},"line":111,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1e84df1062343a2ae44fa166ec4cfbc","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine","text_display":"\n3 Written consent must be obtained prior to performing any protocol specific procedure. Results of a test performed prior to the subject signing consent as part of routine","confidence":1,"confidence_rate":1},{"cnt":[[313,1023],[2485,1023],[2485,1062],[313,1062]],"region":{"top_left_x":313,"top_left_y":1023,"width":2173,"height":40},"line":112,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15917a8050a64418a5648be335a13bf3","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment).","text_display":" clinical management are acceptable in lieu of a screening test if performed within the specified time frame (e.g., within 42 days prior to the first dose of trial treatment).","confidence":1,"confidence_rate":1},{"cnt":[[313,1060],[1173,1060],[1173,1097],[313,1097]],"region":{"top_left_x":313,"top_left_y":1060,"width":860,"height":38},"line":113,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"848e9dbddc224192a93865bdaacdd225","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"Assign Baseline number when the study informed consent is signed.","text_display":" Assign Baseline number when the study informed consent is signed.","confidence":1,"confidence_rate":1},{"cnt":[[266,1095],[2485,1095],[2485,1132],[266,1132]],"region":{"top_left_x":265,"top_left_y":1094,"width":2221,"height":38},"line":114,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09e899e800d24b46b3982bceef68f347","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to","text_display":"\n4 Signing the informed consent for future biomedical research (FBR) samples is optional. Informed consent for future biomedical research (FBR) must be obtained prior to","confidence":0.99951171875,"confidence_rate":0.9999971604662518},{"cnt":[[313,1132],[2256,1132],[2256,1166],[313,1166]],"region":{"top_left_x":313,"top_left_y":1131,"width":1943,"height":36},"line":115,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ada4917cd8e4ddca1f3bb1c8b8e3c09","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.","text_display":" sample collection. Detailed instructions for the collection and management of specimens for FBR are provided in the Procedures manual and Section 12.2.","confidence":0.99951171875,"confidence_rate":0.9999968692324771},{"cnt":[[266,1169],[2485,1169],[2485,1205],[266,1205]],"region":{"top_left_x":265,"top_left_y":1168,"width":2221,"height":38},"line":116,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34d1454f2d1d41d7be9d022718af3f04","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to","text_display":"\n5 Prior medications - Record all medications taken within 30 days of Visit 1 and all treatments for a prior cancer other than NSCLC even if taken greater than 30 days prior to","confidence":1,"confidence_rate":1},{"cnt":[[313,1203],[2485,1203],[2485,1240],[313,1240]],"region":{"top_left_x":313,"top_left_y":1203,"width":2173,"height":37},"line":117,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03119b5529d54ac0814b9383459dd706","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up","text_display":" Visit 1 (prior treatments for NSCLC will be recorded separately). Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up","confidence":1,"confidence_rate":1},{"cnt":[[313,1238],[1740,1238],[1740,1275],[313,1275]],"region":{"top_left_x":313,"top_left_y":1237,"width":1428,"height":38},"line":118,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1e8668434ca431882710034ead05629","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2.","text_display":" Visit. After the Safety Follow-up Visit record all medications taken for SAEs and ECIs as defined in Section 7.2.","confidence":1,"confidence_rate":1},{"cnt":[[266,1275],[2464,1275],[2464,1311],[266,1311]],"region":{"top_left_x":265,"top_left_y":1274,"width":2199,"height":38},"line":119,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01904c7aede9435bb3bb785bc5435b10","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness.","text_display":"\n6 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness.","confidence":1,"confidence_rate":1},{"cnt":[[266,1311],[2485,1311],[2485,1348],[266,1348]],"region":{"top_left_x":265,"top_left_y":1311,"width":2221,"height":38},"line":120,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8fd63460aa94a55a9ba00529d048cf5","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the","text_display":"\n7 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the","confidence":1,"confidence_rate":1},{"cnt":[[313,1346],[1825,1346],[1825,1383],[313,1383]],"region":{"top_left_x":313,"top_left_y":1346,"width":1512,"height":37},"line":121,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ae3cb4cfd7e47299cd124f8533d4df1","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology).","text_display":" administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology).","confidence":1,"confidence_rate":1},{"cnt":[[266,1381],[1901,1381],[1901,1422],[266,1422]],"region":{"top_left_x":265,"top_left_y":1380,"width":1636,"height":42},"line":122,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f0325e272934b748e89ae7960a3f123","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only.","text_display":"\n8 Vital signs to include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at Visit 1 only.","confidence":1,"confidence_rate":1},{"cnt":[[266,1415],[2485,1415],[2485,1457],[266,1457]],"region":{"top_left_x":265,"top_left_y":1415,"width":2221,"height":42},"line":123,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"892f95e0a2e94778844c060e90bbb97b","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be","text_display":"\n9 For women of reproductive potential, a urine pregnancy test will be performed within 72 hours prior to first dose of trial treatment. If urine pregnancy results cannot be","confidence":0.99951171875,"confidence_rate":0.9999972715093195},{"cnt":[[313,1454],[2490,1454],[2490,1491],[313,1491]],"region":{"top_left_x":313,"top_left_y":1454,"width":2177,"height":38},"line":124,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4df1f47fce274f49b6b8889045f38462","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. Pregnancy tests (serum and/or urine tests) should be repeated if","text_display":" confirmed as negative, a serum pregnancy test, performed by the local study site laboratory, will be required. 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See Section 7.1.3 for details regarding laboratory tests.","text_display":"\n11 Laboratory tests for screening are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests.","confidence":1,"confidence_rate":1},{"cnt":[[268,1597],[2485,1597],[2485,1636],[268,1636]],"region":{"top_left_x":267,"top_left_y":1597,"width":2219,"height":40},"line":128,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4331bb615a0a4cc9893646efc2971b47","type":"text","conversion_output":false,"parent_id":"f7fb743b60134df4b20348bbcae11b43","text":"12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. See Section","text_display":"\n12 After Cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. Laboratory results must be known and acceptable prior to dosing. 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It is most relevant and strongly recommended that ePROs are administered prior to study drug administration, adverse event evaluation and","text_display":" lastly the EORTC LC-13. It is most relevant and strongly recommended that ePROs are administered prior to study drug administration, adverse event evaluation and","confidence":1,"confidence_rate":1},{"cnt":[[314,954],[1940,954],[1940,990],[314,990]],"region":{"top_left_x":313,"top_left_y":953,"width":1628,"height":38},"line":84,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"966cb53f2ca14c36bd37e6a3381fd3cd","type":"text","conversion_output":true,"text":"disease status notification. HEA will be completed by qualified site personnel after the subject completes all other questionnaires.","text_display":" disease status notification. HEA will be completed by qualified site personnel after the subject completes all other questionnaires.","confidence":0.9990234375,"confidence_rate":0.9999928683491688},{"cnt":[[266,990],[2486,990],[2486,1027],[266,1027]],"region":{"top_left_x":266,"top_left_y":990,"width":2220,"height":37},"line":85,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0e678c0477143d79f6f950581cacc8d","type":"text","conversion_output":true,"text":"19 Tumor tissue for biomarker analysis from an archival tissue sample (acceptable for EGFR and ALK testing) or newly obtained formalin fixed tumor tissue from a recent","text_display":"\n19 Tumor tissue for biomarker analysis from an archival tissue sample (acceptable for EGFR and ALK testing) or newly obtained formalin fixed tumor tissue from a recent","confidence":1,"confidence_rate":1},{"cnt":[[314,1027],[2486,1027],[2486,1063],[314,1063]],"region":{"top_left_x":313,"top_left_y":1026,"width":2173,"height":38},"line":86,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48afe2e0197b4a09810d1c349287aaa0","type":"text","conversion_output":true,"text":"biopsy of a tumor lesion not previously irradiated (required for PD-L1 determination; acceptable for EGFR and ALK testing) must be provided and received by the central","text_display":" biopsy of a tumor lesion not previously irradiated (required for PD-L1 determination; acceptable for EGFR and ALK testing) must be provided and received by the central","confidence":1,"confidence_rate":1},{"cnt":[[314,1061],[2486,1061],[2486,1100],[314,1100]],"region":{"top_left_x":313,"top_left_y":1061,"width":2173,"height":39},"line":87,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f4638dc0aae49ff99230b7eb8e8874e","type":"text","conversion_output":true,"text":"vendor before randomization. No systemic antineoplastic therapy may have been received by the patient between the time of the biopsy for PD-L1 testing and the first","text_display":" vendor before randomization. No systemic antineoplastic therapy may have been received by the patient between the time of the biopsy for PD-L1 testing and the first","confidence":1,"confidence_rate":1},{"cnt":[[314,1100],[2486,1100],[2486,1137],[314,1137]],"region":{"top_left_x":313,"top_left_y":1100,"width":2173,"height":37},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5038f154ee824d7f872e8736896bd2a6","type":"text","conversion_output":true,"text":"administration of study medication. Detailed instructions for tissue collection, processing and shipment are provided in the Procedures Manual. If the subject signs the","text_display":" administration of study medication. Detailed instructions for tissue collection, processing and shipment are provided in the Procedures Manual. If the subject signs the","confidence":1,"confidence_rate":1},{"cnt":[[314,1134],[2333,1134],[2333,1171],[314,1171]],"region":{"top_left_x":313,"top_left_y":1134,"width":2021,"height":37},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fdfed233a14c42d7906dcade2d23d8e7","type":"text","conversion_output":true,"text":"Future Biomedical Research (FBR) consent, any leftover tissue biopsies that would ordinarily be discarded at the end of the main study will be retained for FBR.","text_display":" Future Biomedical Research (FBR) consent, any leftover tissue biopsies that would ordinarily be discarded at the end of the main study will be retained for FBR.","confidence":1,"confidence_rate":1},{"cnt":[[264,1169],[2486,1169],[2486,1205],[264,1205]],"region":{"top_left_x":264,"top_left_y":1168,"width":2222,"height":38},"line":90,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e20b3cefeeb400da37519f66c29d2e5","type":"text","conversion_output":true,"text":"20 MK-3475 treated subjects in the Treatment Phase - Additional optional biopsies at approximately Week 6, Week 12 and Week 24 and at disease progression are highly","text_display":"\n20 MK-3475 treated subjects in the Treatment Phase - Additional optional biopsies at approximately Week 6, Week 12 and Week 24 and at disease progression are highly","confidence":1,"confidence_rate":1},{"cnt":[[314,1207],[2486,1207],[2486,1244],[314,1244]],"region":{"top_left_x":313,"top_left_y":1207,"width":2173,"height":37},"line":91,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1552bb972b2149918affcc43d6372225","type":"text","conversion_output":true,"text":"desired when feasible. Detailed instructions for tissue collection, processing and shipment are provided in the Procedures Manual. Patients who agree to undergo these","text_display":" desired when feasible. Detailed instructions for tissue collection, processing and shipment are provided in the Procedures Manual. Patients who agree to undergo these","confidence":1,"confidence_rate":1},{"cnt":[[314,1242],[1592,1242],[1592,1278],[314,1278]],"region":{"top_left_x":313,"top_left_y":1241,"width":1279,"height":38},"line":92,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1320811aa4b84523988c5f8913d52d80","type":"text","conversion_output":true,"text":"additional, optional tumor biopsies while receiving MK-3475 may not have them under CT-guidance.","text_display":" additional, optional tumor biopsies while receiving MK-3475 may not have them under CT-guidance.","confidence":1,"confidence_rate":1},{"cnt":[[266,1278],[2262,1278],[2262,1315],[266,1315]],"region":{"top_left_x":266,"top_left_y":1278,"width":1997,"height":37},"line":93,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"588c2d687da84dc88d2734c9562014f2","type":"text","conversion_output":true,"text":"21 Perform a full physical examination every 3 cycles after Cycle 12. Otherwise, perform a directed physical examination the day of the study treatment visit.","text_display":"\n21 Perform a full physical examination every 3 cycles after Cycle 12. Otherwise, perform a directed physical examination the day of the study treatment visit.","confidence":1,"confidence_rate":1},{"cnt":[[266,1323],[2486,1323],[2486,1360],[266,1360]],"region":{"top_left_x":266,"top_left_y":1323,"width":2220,"height":37},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a39d46e16ac4ff2891b747d5673b91c","type":"text","conversion_output":true,"text":"22 Pulmonary function tests should include an assessment of forced vital capacity, forced expiratory flow between 25 and 75 percent of FVC (FEF25-75), forced expiratory","text_display":"\n22 Pulmonary function tests should include an assessment of forced vital capacity, forced expiratory flow between 25 and 75 percent of FVC (FEF25-75), forced expiratory","confidence":1,"confidence_rate":1},{"cnt":[[312,1362],[2486,1362],[2486,1399],[312,1399]],"region":{"top_left_x":311,"top_left_y":1362,"width":2175,"height":37},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7c0912c5d8f4a76804c5cbd58b610d9","type":"text","conversion_output":true,"text":"volume in one second, peak expiratory flow (PEF) and diffusion capacity. Additionally, oxygen saturation as assessed by pulse oximetry is required. Perform at baseline","text_display":" volume in one second, peak expiratory flow (PEF) and diffusion capacity. Additionally, oxygen saturation as assessed by pulse oximetry is required. Perform at baseline","confidence":1,"confidence_rate":1},{"cnt":[[314,1399],[1936,1399],[1936,1433],[314,1433]],"region":{"top_left_x":313,"top_left_y":1398,"width":1623,"height":36},"line":96,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7cd57a9e2ec40e6905f7a25ef8d0420","type":"text","conversion_output":true,"text":"and subsequently at the discretion of the investigator. Hemoglobin must be obtained within 3 days of pulmonary function testing.","text_display":" and subsequently at the discretion of the investigator. Hemoglobin must be obtained within 3 days of pulmonary function testing.","confidence":1,"confidence_rate":1},{"cnt":[[266,1435],[2486,1435],[2486,1472],[266,1472]],"region":{"top_left_x":266,"top_left_y":1435,"width":2220,"height":37},"line":97,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"078d2a51cf7d49f18c1eac6eb1e5e5d1","type":"text","conversion_output":true,"text":"23 Site must be able to provide documentation of the subject's tumor EGFR mutation and ALK translocation status. If the site is unable to provide this source documentation,","text_display":"\n23 Site must be able to provide documentation of the subject's tumor EGFR mutation and ALK translocation status. If the site is unable to provide this source documentation,","confidence":1,"confidence_rate":1},{"cnt":[[314,1470],[1102,1470],[1102,1506],[314,1506]],"region":{"top_left_x":313,"top_left_y":1469,"width":790,"height":38},"line":98,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f7ed61c72fa492aa34f07ec4d21839c","type":"text","conversion_output":true,"text":"then the Sponsor will offer this molecular testing of the tumor.","text_display":" then the Sponsor will offer this molecular testing of the tumor.","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[752,1912],[752,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1912,"width":508,"height":37},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1621eef2b7b4d5c825f321bb9e48d3b","type":"page_info","conversion_output":false,"text":"MK-3475-010-17 Final 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Trial Phase & Safety Follow-up \\({ }^{1}\\) & \\multicolumn{3}{|c|}{Follow-up \\({ }^{2}\\)} & Survival Follow-up \\({ }^{3}\\) \\\\\n\\hline Time from Last Dose of Trial Treatment & 30 Days & 3 Months & 6 Months & Every 9 weeks (63 days) after Month 6 & Every 12 Weeks ( ± 7 days) or as directed by the Sponsor \\\\\n\\hline Visit & Safety Follow-up Visit & Follow-up Visit 1 & Follow-up Visit 2 & Follow-up Visit 3 and beyond & Survival Follow-up Visit 1 and beyond \\\\\n\\hline Scheduling Window & \\(\\pm 3\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 14\\) days \\\\\n\\hline Administrative Procedures & & & & & \\\\\n\\hline Review Medications & X & & & & \\\\\n\\hline Subsequent antineoplastic therapy Status & X & X & X & X & X \\\\\n\\hline Survival Status \\({ }^{3}\\) & \\multicolumn{5}{|c|}{} \\\\\n\\hline Clinical Procedures/Assessments & & & & & \\\\\n\\hline Review Adverse Events \\({ }^{4}\\) & X & X & X & X & X \\\\\n\\hline ECOG Performance Status & X & X & X & & \\\\\n\\hline Directed Physical Examination & X & X & X & & \\\\\n\\hline Vital Signs and Weight \\({ }^{5}\\) & X & X & X & & \\\\\n\\hline Efficacy Measurement & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{6}\\) & \\(X ^{7}\\) & \\(X ^{7}\\) & \\(X ^{7}\\) & \\(X ^{7}\\) & \\\\\n\\hline \\multicolumn{3}{|l|}{Laboratory Procedures/Assessments: analysis performed by local laboratory} & & & \\\\\n\\hline CBC with Differential \\({ }^{8}\\) & X & & & & \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{8}\\) & X & & & & \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{9}\\) & X & & & & \\\\\n\\hline Patient Reported Outcomes & & & & & \\\\\n\\hline EuroQoL EQ-5D \\({ }^{10}\\) & X & & & & \\\\\n\\hline EORTC QLQ-C30 \\({ }^{{ }^{ 1 0 }}\\) & X & & & & \\\\\n\\hline EORTC QLQ LC-13 \\({ }^{10}\\) & X & & & & \\\\\n\\hline Health Economic Assessment \\({ }^{10}\\) & X & & & & \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\n1 The mandatory Safety Follow-Up Visit 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Subjects who enter the Second Course Phase will be assessed every","confidence":0.9990234375,"confidence_rate":0.9999944169318835},{"cnt":[[305,855],[1562,855],[1562,892],[305,892]],"region":{"top_left_x":305,"top_left_y":855,"width":1257,"height":37},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3afe08b14a384ca78d2bfee3fa0c7e88","type":"text","conversion_output":true,"text":"12 weeks ( \\(84 \\pm 7\\) days) by radiologic imaging as described in the Second Course Phase Flow Chart.","text_display":" 12 weeks ( \\(84 \\pm 7\\) days) by radiologic imaging as described in the Second Course Phase Flow Chart.","confidence":0.9595486841863021,"confidence_rate":0.999595256188719},{"cnt":[[262,889],[2486,889],[2486,930],[262,930]],"region":{"top_left_x":262,"top_left_y":889,"width":2224,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1612f94a5da4200b80c78c92aeaa1e2","type":"text","conversion_output":true,"text":"7 Subjects who discontinue trial treatment due to reasons other than disease progression should continue to be assessed every 9 weeks ( \\(63 \\pm 7\\) days) through Week 54 and then","text_display":"\n7 Subjects who discontinue trial treatment due to reasons other than disease progression should continue to be assessed every 9 weeks ( \\(63 \\pm 7\\) days) through Week 54 and then","confidence":0.994149920064956,"confidence_rate":0.9999681132329401},{"cnt":[[305,928],[1661,928],[1661,965],[305,965]],"region":{"top_left_x":305,"top_left_y":928,"width":1356,"height":37},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb3a9f4ed8c147cd9dd4ce5e6765f1f1","type":"text","conversion_output":true,"text":"every 12 weeks ( \\(84 \\pm 7\\) days) thereafter by radiologic imaging calculated from the study treatment start day.","text_display":" every 12 weeks ( \\(84 \\pm 7\\) days) thereafter by radiologic imaging calculated from the study treatment start day.","confidence":0.9970703125,"confidence_rate":0.9999751360088194},{"cnt":[[266,962],[866,962],[866,999],[266,999]],"region":{"top_left_x":266,"top_left_y":962,"width":600,"height":38},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2159ce98a2ac46188b652033630ead1e","type":"text","conversion_output":true,"text":"8 See Section 7.1.3 for list of laboratory tests.","text_display":"\n8 See Section 7.1.3 for list of laboratory tests.","confidence":1,"confidence_rate":1},{"cnt":[[262,999],[1704,999],[1704,1038],[262,1038]],"region":{"top_left_x":262,"top_left_y":999,"width":1442,"height":39},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4eb595d3d6244fd87fab928f645486d","type":"text","conversion_output":true,"text":"9 Analysis will be performed by a central laboratory only if the local laboratory is unable to perform this service.","text_display":"\n9 Analysis will be performed by a central laboratory only if the local laboratory is unable to perform this service.","confidence":1,"confidence_rate":1},{"cnt":[[266,1036],[2486,1036],[2486,1072],[266,1072]],"region":{"top_left_x":266,"top_left_y":1035,"width":2220,"height":38},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fa7d4127eeb472fa2dc7fe2d5da210e","type":"text","conversion_output":true,"text":"10 Patient reported outcomes (PROs) are to be administered by trained site personnel and completed electronically by subjects in the following order: EuroQol EQ-5D first,","text_display":"\n10 Patient reported outcomes (PROs) are to be administered by trained site personnel and completed electronically by subjects in the following order: EuroQol EQ-5D first,","confidence":1,"confidence_rate":1},{"cnt":[[309,1070],[2486,1070],[2486,1109],[309,1109]],"region":{"top_left_x":309,"top_left_y":1069,"width":2177,"height":40},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a0f02f0de9141b68e606cfe50046848","type":"text","conversion_output":true,"text":"then EORTC QLQ C-30, and lastly the EORTC LC-13. 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Trial Phase & \\multicolumn{14}{|c|}{Second Course Treatment Cycles \\({ }^{ 1 }\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 17 & \\multirow[b]{2}{*}{Discontinuat ion Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline \\multicolumn{16}{|l|}{Administrative Procedures} \\\\\n\\hline Eligibility Criteria \\({ }^{3}\\) & X & & & & & & & & & & & & & & \\\\\n\\hline Concomitant Medications \\({ }^{4}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Trial Treatment Administration & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline \\multicolumn{16}{|l|}{Clinical Procedures / Assessments} \\\\\n\\hline Review Adverse Events \\({ }^{5,6}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Full Physical Examination & X & & & X & & & X & & & X & & & X & \\(X ^{7}\\) & \\\\\n\\hline Directed Physical Examination & & X & X & & X & X & & X & X & & X & X & & \\(X ^{7}\\) & X \\\\\n\\hline Vital Signs and Weight \\({ }^{8}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline ECOG Performance Status & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline \\multicolumn{16}{|l|}{Laboratory Procedures / Assessments: analysis performed by local laboratory} \\\\\n\\hline Pregnancy Test - Urine or Serum \\(\\beta- HCG ^{9}\\) & X & & & & & & & & & & & & & & \\\\\n\\hline PT/INR and aPTT \\({ }^{10}\\) & X \\({ }^{11}\\) & & & & & & & & & & & & & & \\\\\n\\hline CBC with Differential \\({ }^{12}\\) & X \\({ }^{11}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{12}\\) & \\(X ^{11}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Urinalysis \\({ }^{12}\\) & X \\({ }^{11}\\) & & & & X & & & & X & & & & X & \\(X ^{13}\\) & X \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{12,14}\\) & X \\({ }^{11}\\) & X & & X & & X & & X & & X & & X & & X \\({ }^{13}\\) & X \\\\\n\\hline \\multicolumn{8}{|l|}{Efficacy Measurements} & & & & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{ 1 5 , 1 6 }\\) & X & & & X & & & X & & & X & & & X & \\(X ^{15}\\) & X \\\\\n\\hline \\multicolumn{16}{|c|}{\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. If treatment cycles are increased all procedures except imaging will be completed according to the Cycle number and not weeks on treatment, imaging will be performed every 12 weeks ( \\(84 \\pm 7\\) days) from the first dose of trial treatment regardless of any treatment delays. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Review Secord Course Phase eligibility criteria in Section 7.1.5.4 prior to administering the first dose of trial treatment.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline Trial Phase & \\multicolumn{14}{|c|}{Second Course Treatment Cycles \\({ }^{ 1 }\\)} & End of Treatment \\\\\n\\hline Treatment Cycle / Scheduled Time & 1 & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 to 17 & \\multirow[b]{2}{*}{Discontinuat ion Visit} \\\\\n\\hline Scheduling Window (Days): \\({ }^{2}\\) & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\\\\n\\hline \\multicolumn{16}{|l|}{Administrative Procedures} \\\\\n\\hline Eligibility Criteria \\({ }^{3}\\) & X & & & & & & & & & & & & & & \\\\\n\\hline Concomitant Medications \\({ }^{4}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Trial Treatment Administration & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline \\multicolumn{16}{|l|}{Clinical Procedures / Assessments} \\\\\n\\hline Review Adverse Events \\({ }^{5,6}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Full Physical Examination & X & & & X & & & X & & & X & & & X & \\(X ^{7}\\) & \\\\\n\\hline Directed Physical Examination & & X & X & & X & X & & X & X & & X & X & & \\(X ^{7}\\) & X \\\\\n\\hline Vital Signs and Weight \\({ }^{8}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline ECOG Performance Status & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline \\multicolumn{16}{|l|}{Laboratory Procedures / Assessments: analysis performed by local laboratory} \\\\\n\\hline Pregnancy Test - Urine or Serum \\(\\beta- HCG ^{9}\\) & X & & & & & & & & & & & & & & \\\\\n\\hline PT/INR and aPTT \\({ }^{10}\\) & X \\({ }^{11}\\) & & & & & & & & & & & & & & \\\\\n\\hline CBC with Differential \\({ }^{12}\\) & X \\({ }^{11}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{12}\\) & \\(X ^{11}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Urinalysis \\({ }^{12}\\) & X \\({ }^{11}\\) & & & & X & & & & X & & & & X & \\(X ^{13}\\) & X \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{12,14}\\) & X \\({ }^{11}\\) & X & & X & & X & & X & & X & & X & & X \\({ }^{13}\\) & X \\\\\n\\hline \\multicolumn{8}{|l|}{Efficacy Measurements} & & & & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{ 1 5 , 1 6 }\\) & X & & & X & & & X & & & X & & & X & \\(X ^{15}\\) & X \\\\\n\\hline \\multicolumn{16}{|c|}{\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 and prior to the first dose of trial treatment for each cycle unless otherwise specified. Treatment cycles are 3 weeks (21-days); however the treatment cycle interval may be increased due to toxicity according to the dose modification guidelines provided in Section 5.2.1.2. 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After the Safety Follow-up Visit record all medications taken","text_display":"\n\n4 Concomitant Medications - Enter new medications started during the trial through the Safety Follow-up Visit. After the Safety Follow-up Visit record all medications taken","confidence":1,"confidence_rate":1},{"cnt":[[305,352],[866,352],[866,385],[305,385]],"region":{"top_left_x":305,"top_left_y":352,"width":561,"height":33},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae03fef43a6a4a0e916f8b1cd841bf82","type":"text","conversion_output":true,"text":"for SAEs and ECI as defined in Section 7.2.","text_display":" for SAEs and ECI as defined in Section 7.2.","confidence":1,"confidence_rate":1},{"cnt":[[264,387],[2460,387],[2460,423],[264,423]],"region":{"top_left_x":264,"top_left_y":386,"width":2196,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e83fd799a8b044c19d3a675644074509","type":"text","conversion_output":true,"text":"5 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness.","text_display":"\n5 AEs and laboratory safety measurements will be graded per NCI CTCAE version 4.0. All AEs, whether gradable by CTCAE or not, will also be evaluated for seriousness.","confidence":1,"confidence_rate":1},{"cnt":[[264,421],[2486,421],[2486,462],[264,462]],"region":{"top_left_x":264,"top_left_y":421,"width":2222,"height":41},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c69416546b2c42d096bd109c83007198","type":"text","conversion_output":true,"text":"6 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the","text_display":"\n6 All AEs of unknown etiology associated with trial treatment exposure should be evaluated to determine if it is possibly an ECI. (See the separate guidance document in the","confidence":1,"confidence_rate":1},{"cnt":[[305,460],[1824,460],[1824,496],[305,496]],"region":{"top_left_x":305,"top_left_y":459,"width":1520,"height":38},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"550c5f894011451b851f209054b3574a","type":"text","conversion_output":true,"text":"administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology).","text_display":" administrative binder regarding identification, evaluation and management of AEs of a potential immunologic etiology).","confidence":1,"confidence_rate":1},{"cnt":[[264,494],[2258,494],[2258,535],[264,535]],"region":{"top_left_x":264,"top_left_y":494,"width":1995,"height":41},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d45fd9951c5d4c9b8e668802ec5f7aeb","type":"text","conversion_output":true,"text":"7 Perform a full physical examination every 3 cycles after Cycle 13. 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Trial Phase & Safety Follow-up \\({ }^{1}\\) & \\multicolumn{3}{|c|}{Follow-up \\({ }^{2}\\)} & Survival Follow-up \\({ }^{3}\\) \\\\\n\\hline Time from Last Dose of Trial Treatment & 30 Days & 3 Months & 6 Months & Every 12 weeks (84 days) after Month 6 & Every 12 Weeks \\\\\n\\hline Visit & Safety Follow-up Visit & Follow-up Visit 1 & Follow-up Visit 2 & Follow-up Visit 3 and beyond & Survival Follow-up Visit 1 and beyond \\\\\n\\hline Scheduling Window & \\(\\pm 3\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 14\\) days \\\\\n\\hline Administrative Procedures & & & & & \\\\\n\\hline Review Medications & X & & & & \\\\\n\\hline Subsequent antineoplastic therapy Status & X & X & X & X & X \\\\\n\\hline Survival Status \\({ }^{3}\\) & \\multicolumn{5}{|l|}{\\(\\longleftrightarrow\\)} \\\\\n\\hline Clinical Procedures/Assessments & & & & & \\\\\n\\hline Review Adverse Events \\({ }^{4}\\) & X & X & X & X & X \\\\\n\\hline ECOG Performance Status & X & X & X & & \\\\\n\\hline Directed Physical Examination & X & X & X & & \\\\\n\\hline Vital Signs and Weight \\({ }^{5}\\) & X & X & X & & \\\\\n\\hline Efficacy Measurement & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{6}\\) & X \\({ }^{6}\\) & X & X & X & \\\\\n\\hline \\multicolumn{3}{|l|}{Laboratory Procedures/Assessments: analysis performed by local laboratory} & & & \\\\\n\\hline CBC with Differential \\({ }^{7}\\) & X & & & & \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{7}\\) & X & & & & \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{8}\\) & X & & & & \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\n1 The mandatory Safety Follow-Up Visit should be conducted approximately 30 days after the last dose of trial treatment regardless of initiation of new antineoplastic treatment. Subjects who are eligible per the requirements in Section 7.1.5.4 for treatment with MK-3475 during the Second Course Phase may have up to two Safety Followup Visits, one after the Treatment Phase and the second after the Second Course Phase. \\\\\n2 Subjects who discontinue trial treatment for a reason other than disease progression will move into the Follow-up Phase and should be assessed by radiologic imaging to monitor disease status every 12 weeks ( \\(84 \\pm 7\\) days). Follow-up Visit 1 should be scheduled 3 months after the last dose of trial treatment. Follow-up Visit 2 should occur 6 months after the last dose of trial treatment. After Follow-up Visit 2 subjects only need to be assessed by radiologic imaging to monitor disease status, development of drug related SAEs and ECIs, and initiation of new antineoplastic therapy every 12 weeks ( \\(84 \\pm 7\\) days). Unless otherwise noted in the flow chart, every effort should be made to collect subject information until the start of new antineoplastic therapy, disease progression or death, whichever occurs first. \\\\\n3 Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by telephone every 12 weeks to assess for survival status and start of new antineoplastic therapy if applicable. Updated survival status may be requested by the Sponsor at any time during the course of the study. Upon Sponsor notification, all participants who do not/will not have a scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have withdrawn consent or have a death event previously recorded).\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline Trial Phase & Safety Follow-up \\({ }^{1}\\) & \\multicolumn{3}{|c|}{Follow-up \\({ }^{2}\\)} & Survival Follow-up \\({ }^{3}\\) \\\\\n\\hline Time from Last Dose of Trial Treatment & 30 Days & 3 Months & 6 Months & Every 12 weeks (84 days) after Month 6 & Every 12 Weeks \\\\\n\\hline Visit & Safety Follow-up Visit & Follow-up Visit 1 & Follow-up Visit 2 & Follow-up Visit 3 and beyond & Survival Follow-up Visit 1 and beyond \\\\\n\\hline Scheduling Window & \\(\\pm 3\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 7\\) days & \\(\\pm 14\\) days \\\\\n\\hline Administrative Procedures & & & & & \\\\\n\\hline Review Medications & X & & & & \\\\\n\\hline Subsequent antineoplastic therapy Status & X & X & X & X & X \\\\\n\\hline Survival Status \\({ }^{3}\\) & \\multicolumn{5}{|l|}{\\(\\longleftrightarrow\\)} \\\\\n\\hline Clinical Procedures/Assessments & & & & & \\\\\n\\hline Review Adverse Events \\({ }^{4}\\) & X & X & X & X & X \\\\\n\\hline ECOG Performance Status & X & X & X & & \\\\\n\\hline Directed Physical Examination & X & X & X & & \\\\\n\\hline Vital Signs and Weight \\({ }^{5}\\) & X & X & X & & \\\\\n\\hline Efficacy Measurement & & & & & \\\\\n\\hline Tumor Imaging \\({ }^{6}\\) & X \\({ }^{6}\\) & X & X & X & \\\\\n\\hline \\multicolumn{3}{|l|}{Laboratory Procedures/Assessments: analysis performed by local laboratory} & & & \\\\\n\\hline CBC with Differential \\({ }^{7}\\) & X & & & & \\\\\n\\hline Comprehensive Chemistry Panel \\({ }^{7}\\) & X & & & & \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{8}\\) & X & & & & \\\\\n\\hline \\multicolumn{6}{|c|}{\\begin{tabular}{l}\n1 The mandatory Safety Follow-Up Visit should be conducted approximately 30 days after the last dose of trial treatment regardless of initiation of new antineoplastic treatment. Subjects who are eligible per the requirements in Section 7.1.5.4 for treatment with MK-3475 during the Second Course Phase may have up to two Safety Followup Visits, one after the Treatment Phase and the second after the Second Course Phase. \\\\\n2 Subjects who discontinue trial treatment for a reason other than disease progression will move into the Follow-up Phase and should be assessed by radiologic imaging to monitor disease status every 12 weeks ( \\(84 \\pm 7\\) days). Follow-up Visit 1 should be scheduled 3 months after the last dose of trial treatment. Follow-up Visit 2 should occur 6 months after the last dose of trial treatment. After Follow-up Visit 2 subjects only need to be assessed by radiologic imaging to monitor disease status, development of drug related SAEs and ECIs, and initiation of new antineoplastic therapy every 12 weeks ( \\(84 \\pm 7\\) days). Unless otherwise noted in the flow chart, every effort should be made to collect subject information until the start of new antineoplastic therapy, disease progression or death, whichever occurs first. \\\\\n3 Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by telephone every 12 weeks to assess for survival status and start of new antineoplastic therapy if applicable. Updated survival status may be requested by the Sponsor at any time during the course of the study. 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Unless otherwise noted in the flow chart, every effort should be made to","confidence":0.99169921875,"confidence_rate":0.9999536931578671},{"cnt":[[307,1674],[1866,1674],[1866,1713],[307,1713]],"region":{"top_left_x":306,"top_left_y":1674,"width":1560,"height":40},"line":123,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"959f30416b4840a8bc1adf89830ed7f6","type":"text","conversion_output":false,"parent_id":"e782998d05b944619a6a679e147a1374","text":"collect subject information until the start of new antineoplastic therapy, disease progression or death, whichever occurs first.","text_display":" collect subject information until the start of new antineoplastic therapy, disease progression or death, whichever occurs first.","confidence":1,"confidence_rate":1},{"cnt":[[266,1711],[2503,1711],[2503,1748],[266,1748]],"region":{"top_left_x":265,"top_left_y":1711,"width":2238,"height":38},"line":124,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b518665b896e49c1a5b0af81613e7555","type":"text","conversion_output":false,"parent_id":"e782998d05b944619a6a679e147a1374","text":"3 Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by","text_display":"\n3 Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by","confidence":1,"confidence_rate":1},{"cnt":[[307,1746],[2503,1746],[2503,1785],[307,1785]],"region":{"top_left_x":306,"top_left_y":1745,"width":2197,"height":40},"line":125,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bb0803853ee4649a350ec0bfbc44831","type":"text","conversion_output":false,"parent_id":"e782998d05b944619a6a679e147a1374","text":"telephone every 12 weeks to assess for survival status and start of new antineoplastic therapy if applicable. 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Report all SAEs (related and unrelated to trial treatment), ECIs, and irAEs occurring within","text_display":"\n\n4 Record all AEs occurring within 30 days after the last dose of trial treatment.. Report all SAEs (related and unrelated to trial treatment), ECIs, and irAEs occurring within","confidence":1,"confidence_rate":1},{"cnt":[[305,352],[2505,352],[2505,389],[305,389]],"region":{"top_left_x":305,"top_left_y":352,"width":2201,"height":37},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ead27f68b834b4199fc187d3ccf6004","type":"text","conversion_output":true,"text":"90 days of the last dose of trial treatment or the start of new anti-cancer treatment, whichever comes first. After this time, report only SAEs and ECIs that are considered","text_display":" 90 days of the last dose of trial treatment or the start of new anti-cancer treatment, whichever comes first. After this time, report only SAEs and ECIs that are considered","confidence":1,"confidence_rate":1},{"cnt":[[305,389],[623,389],[623,423],[305,423]],"region":{"top_left_x":305,"top_left_y":388,"width":319,"height":36},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0196921df14b4c97a2e54e621828757f","type":"text","conversion_output":true,"text":"related to trial treatment.","text_display":" related to trial treatment.","confidence":1,"confidence_rate":1},{"cnt":[[264,423],[1377,423],[1377,462],[264,462]],"region":{"top_left_x":264,"top_left_y":423,"width":1114,"height":39},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db91c48ba93b4d0badbaf040599af37b","type":"text","conversion_output":true,"text":"5 Vital signs to include temperature, pulse, respiratory rate, blood pressure and weight.","text_display":"\n5 Vital signs to include temperature, pulse, respiratory rate, blood pressure and weight.","confidence":1,"confidence_rate":1},{"cnt":[[264,460],[2503,460],[2503,501],[264,501]],"region":{"top_left_x":264,"top_left_y":459,"width":2239,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0ba342def1a4a7eb0dad3ec0eab01b1","type":"text","conversion_output":true,"text":"6 The same imaging technique should be used in a subject as was used earlier in the trial. 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same Post-Treatment Follow-up Phase Flow Chart.","text_display":"\n\nSubjects who discontinue study treatment of the Crossover Phase will follow the same Post-Treatment Follow-up Phase Flow 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& \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment & Survival Follow-up \\\\\n\\hline Treatment Cycle / Scheduled Time & \\(1^{7}\\) & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 through 35 & \\multirow{2}{*}{Discontinuation Visit} & \\multirow{2}{*}{Every 12 Weeks} \\\\\n\\hline Scheduling Window (Days): \\({ }^{ 2 }\\) & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & ± 3 & ± 3 & ± 3 & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & & \\\\\n\\hline Administrative Procedures & & & & & & & & & & & & & & & & \\\\\n\\hline Informed Consent & X & & & & & & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion Criteria & X & & & & & & & & & & & & & & & \\\\\n\\hline Previous Anti-Cancer Therapy \\({ }^{10}\\) & & & & & & & & & & & & & & & X & \\\\\n\\hline Prior and Concomitant Medications & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline Clinical Procedures Assessments & / & & & & & & & & & & & & & & & \\\\\n\\hline Review Adverse Events & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline Full Physical Examination & X & & & X & & & X & & & X & & & X & \\(X ^{12}\\) & X & \\\\\n\\hline Directed Physical Examination & & X & X & X & X & X & X & X & X & X & X & X & X & X & & \\\\\n\\hline Vital Signs and Weight & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline ECOG Performance Status & X & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline \\multicolumn{7}{|c|}{Laboratory Procedures / Assessments: analysis performed by local laboratory} & & & & & & & & & & \\\\\n\\hline CBC with Differential \\({ }^{9}\\) & \\(X ^{3}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline PT/INR and aPTT & \\(X ^{3}\\) & & & & & & & & & & & & & & & \\\\\n\\hline Comprehensive Serum Chemistry Panel & \\(X ^{3}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & X & \\\\\n\\hline Urinalysis & \\(X ^{3}\\) & & & & X & & & & X & & & & X & \\(X ^{11}\\) & X & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment & Survival Follow-up \\\\\n\\hline Treatment Cycle / Scheduled Time & \\(1^{7}\\) & 2 & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 through 35 & \\multirow{2}{*}{Discontinuation Visit} & \\multirow{2}{*}{Every 12 Weeks} \\\\\n\\hline Scheduling Window (Days): \\({ }^{ 2 }\\) & & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & ± 3 & ± 3 & ± 3 & ± 3 & \\(\\pm 3\\) & \\(\\pm 3\\) & & \\\\\n\\hline Administrative Procedures & & & & & & & & & & & & & & & & \\\\\n\\hline Informed Consent & X & & & & & & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion Criteria & X & & & & & & & & & & & & & & & \\\\\n\\hline Previous Anti-Cancer Therapy \\({ }^{10}\\) & & & & & & & & & & & & & & & X & \\\\\n\\hline Prior and 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Progressive disease from docetaxel or subsequent anti-cancer therapies based on investigator's assessment (either radiographic or clinical) is required. Treatment cycles are 3 weeks ( 21 -days). Imaging will be performed every 9 weeks ( \\(63 \\pm 7\\) days) from the first dose of trial treatment regardless of any treatment delays through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter. \\\\\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified. \\\\\n3 Laboratory tests are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests. \\\\\n4 Perform thyroid testing every other cycle. \\\\\n5 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service. \\\\\n6 Baseline imaging for the crossover phase should be done within 30 days of the first dose of crossover study medication. On study imaging will be performed every 9 weeks ( \\(63 \\pm 7\\) days) after the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter, or more frequently if clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts or extension of MK-3475 cycle frequencies. The same imaging technique should be used in a subject throughout the trial. Local reading (investigator assessment with site radiology reading) will be used to determine eligibility and for subject management. Images done in the study including baseline scan should be submitted to a central imaging vendor. The processes for image collection and transmission to the central vendor are in the investigator Imaging Operations Manual (IIOM). \\\\\n7 Screening can initiate when investigator decides subjects meet inclusion and exclusion criteria for the crossover phase. Wash out period from last dose of docetaxel or anticancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any AEs of the previous anti-cancer therapies. \\\\\n8 Wash out period from last dose of docetaxel or anti-cancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any AEs of the previous anti-cancer therapies. 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Upon Sponsor notification, all participants who do not/will not have a scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have a death event previously recorded)\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{14}{|c|}{Treatment Cycles \\({ }^{1}\\)} & End of Treatment & Survival Follow-up \\\\\n\\hline Treatment Cycle / Scheduled Time & \\(1^{7}\\) & 3 & 4 & 5 & 6 & 7 & 8 & 9 & 10 & 11 & 12 & 13 & 14 through 35 & & \\multirow{2}{*}{Every 12 Weeks} \\\\\n\\hline Scheduling Window (Days): \\({ }^{ 2 }\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & \\(\\pm 3\\) & ± 3 & \\(\\pm 3\\) & \\begin{tabular}{l}\n± \\\\\n3\n\\end{tabular} & \\(\\pm 3\\) & \\begin{tabular}{l}\n± \\\\\n3\n\\end{tabular} & \\begin{tabular}{l}\n± \\\\\n3\n\\end{tabular} & \\begin{tabular}{l}\n± \\\\\n3\n\\end{tabular} & \\begin{tabular}{l}\n± \\\\\n3\n\\end{tabular} & \\(\\pm 3\\) & \\(\\pm 3\\) & \\begin{tabular}{l}\nDiscontinuation \\\\\nVisit\n\\end{tabular} & \\\\\n\\hline T3/FT3, FT4 and TSH \\({ }^{4,5}\\) & \\(X ^{3}\\) & & X & & X & & X & & X & & X & & X \\({ }^{4}\\) & X & \\\\\n\\hline Efficacy Measurements & & & & & & & & & & & & \\multicolumn{4}{|c|}{} \\\\\n\\hline Survival Status & \\multicolumn{14}{|l|}{←} & \\(X ^{13}\\) \\\\\n\\hline Tumor Imaging \\({ }^{6}\\) & X & & & X & & & & X & & & X & & \\(X ^{6}\\) & X & \\\\\n\\hline \\multicolumn{16}{|l|}{Study Drug Administration} \\\\\n\\hline MK-3475 \\({ }^{8}\\) & X & X & X & X & X & X & X & X & X & X & X & X & X & & \\\\\n\\hline \\multicolumn{16}{|c|}{\\begin{tabular}{l}\n1 In general, assessments/procedures are to be performed on Day 1 of crossover study and prior to the first dose of study medication and for each dose of following cycle unless otherwise specified. 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Subjects will continue in trial until progressive disease is confirmed as assessed by irRC as determined by the investigators or up to two years from initiation of a new anti-cancer therapy, whichever comes first. \\\\\n9 After cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. \\\\\n10 If patient is entering the Crossover Phase after experiencing an anti-cancer therapy, the previous anti-cancer therapy must be recorded in the EDC system. \\\\\n11 Perform every 4 cycles after cycle 13. \\\\\n12 Perform every 3 cycles after cycle 13. \\\\\n13. Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by telephone approximately every 12 weeks to assess for survival status and start of new antineoplastic therapy, if applicable. Updated survival status may be requested by the Sponsor at any time during the course of the study. Upon Sponsor notification, all participants who do not/will not have a scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have a death event previously recorded)\n\\end{tabular}} 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Subjects will continue in trial until progressive disease is confirmed as assessed by irRC as determined by the investigators or up to two years from initiation of a new anti-cancer therapy, whichever comes first. \\\\\n9 After cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point. \\\\\n10 If patient is entering the Crossover Phase after experiencing an anti-cancer therapy, the previous anti-cancer therapy must be recorded in the EDC system. \\\\\n11 Perform every 4 cycles after cycle 13. \\\\\n12 Perform every 3 cycles after cycle 13. \\\\\n13. Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be contacted by telephone approximately every 12 weeks to assess for survival status and start of new antineoplastic therapy, if applicable. Updated survival status may be requested by the Sponsor at any time during the course of the study. Upon Sponsor notification, all participants who do not/will not have a scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have a death event previously recorded)\n\\end{tabular}","cell_row":9,"cell_column":0,"cell_row_span":1,"cell_col_span":16,"confidence":0.5927734375,"confidence_rate":0.9998182405551034},{"cnt":[[384,894],[2370,894],[2370,926],[384,926]],"region":{"top_left_x":383,"top_left_y":893,"width":1987,"height":34},"line":133,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48119681eb204272926c8f017f460ac0","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"1 In general, assessments/procedures are to be performed on Day 1 of crossover study and prior to the first dose of study medication and for each dose of following cycle","text_display":"1 In general, assessments/procedures are to be performed on Day 1 of crossover study and prior to the first dose of study medication and for each dose of following cycle","confidence":1,"confidence_rate":1},{"cnt":[[427,926],[2370,926],[2370,959],[427,959]],"region":{"top_left_x":427,"top_left_y":926,"width":1943,"height":33},"line":134,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34ca795ca1cf495c923a09b5efc8fe38","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"unless otherwise specified. Progressive disease from docetaxel or subsequent anti-cancer therapies based on investigator's assessment (either radiographic or clinical) is","text_display":" unless otherwise specified. Progressive disease from docetaxel or subsequent anti-cancer therapies based on investigator's assessment (either radiographic or clinical) is","confidence":1,"confidence_rate":1},{"cnt":[[427,959],[2370,959],[2370,991],[427,991]],"region":{"top_left_x":427,"top_left_y":958,"width":1943,"height":34},"line":135,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d24c6044fe6547cd95c6779775f7cece","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"required. Treatment cycles are 3 weeks ( 21 -days). Imaging will be performed every 9 weeks ( \\(63 \\pm 7\\) days) from the first dose of trial treatment regardless of any treatment","text_display":" required. Treatment cycles are 3 weeks ( 21 -days). Imaging will be performed every 9 weeks ( \\(63 \\pm 7\\) days) from the first dose of trial treatment regardless of any treatment","confidence":0.9565844535827637,"confidence_rate":0.9997639310622168},{"cnt":[[427,989],[1272,989],[1272,1021],[427,1021]],"region":{"top_left_x":427,"top_left_y":988,"width":845,"height":34},"line":136,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28e276559a974ecfbb388f40dd3269e0","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"delays through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter.","text_display":" delays through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter.","confidence":0.9820051193237305,"confidence_rate":0.999781243720035},{"cnt":[[380,1024],[1274,1024],[1274,1056],[380,1056]],"region":{"top_left_x":379,"top_left_y":1023,"width":896,"height":34},"line":137,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b28c8dcd7bfb45baa0df7343cb472c6e","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified.","text_display":"\n2 In general, the window for each visit is \\(\\pm 3\\) days unless otherwise specified.","confidence":1,"confidence_rate":1},{"cnt":[[380,1054],[2064,1054],[2064,1086],[380,1086]],"region":{"top_left_x":379,"top_left_y":1053,"width":1686,"height":34},"line":138,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"234a025c6bf9426f858793a0f333f521","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"3 Laboratory tests are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests.","text_display":"\n3 Laboratory tests are to be performed within 10 days prior to the first dose of trial treatment. See Section 7.1.3 for details regarding laboratory tests.","confidence":0.99951171875,"confidence_rate":0.999996985186655},{"cnt":[[380,1089],[897,1089],[897,1121],[380,1121]],"region":{"top_left_x":379,"top_left_y":1088,"width":519,"height":34},"line":139,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7979656ca43e4567bfa80bdb349ede8e","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"4 Perform thyroid testing every other cycle.","text_display":"\n4 Perform thyroid testing every other cycle.","confidence":1,"confidence_rate":1},{"cnt":[[380,1119],[1815,1119],[1815,1151],[380,1151]],"region":{"top_left_x":379,"top_left_y":1118,"width":1437,"height":34},"line":140,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"536e206d1a0040b0aa10abde00c082b7","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"5 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service.","text_display":"\n5 Thyroid function tests will be performed by a central laboratory only if the local laboratory is unable to perform this service.","confidence":0.99951171875,"confidence_rate":0.9999963552268055},{"cnt":[[382,1154],[2370,1151],[2370,1185],[382,1188]],"region":{"top_left_x":381,"top_left_y":1151,"width":1989,"height":37},"line":141,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3177860dea7b42e7b1591442cdb0e10c","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"6 Baseline imaging for the crossover phase should be done within 30 days of the first dose of crossover study medication. On study imaging will be performed every 9 weeks","text_display":"\n6 Baseline imaging for the crossover phase should be done within 30 days of the first dose of crossover study medication. On study imaging will be performed every 9 weeks","confidence":1,"confidence_rate":1},{"cnt":[[427,1184],[2370,1184],[2370,1216],[427,1216]],"region":{"top_left_x":427,"top_left_y":1183,"width":1943,"height":34},"line":142,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"231190d800ac453db923f29f24bb99c3","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"( \\(63 \\pm 7\\) days) after the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter, or more frequently if clinically indicated. The timing","text_display":" ( \\(63 \\pm 7\\) days) after the first dose of trial treatment through Week 54, and then every 12 weeks ( \\(84 \\pm 7\\) days) thereafter, or more frequently if clinically indicated. The timing","confidence":0.7773041163500238,"confidence_rate":0.9986537219819581},{"cnt":[[427,1214],[2370,1214],[2370,1249],[427,1249]],"region":{"top_left_x":427,"top_left_y":1214,"width":1943,"height":35},"line":143,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7911862a546c476bbe66220c692204ed","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts or extension of MK-3475 cycle frequencies. The same imaging","text_display":" for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts or extension of MK-3475 cycle frequencies. The same imaging","confidence":0.5927734375,"confidence_rate":0.9968546977360416},{"cnt":[[427,1249],[2370,1249],[2370,1281],[427,1281]],"region":{"top_left_x":427,"top_left_y":1248,"width":1943,"height":34},"line":144,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9193652ba0084c48899cce01c5f1d107","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"technique should be used in a subject throughout the trial. Local reading (investigator assessment with site radiology reading) will be used to determine eligibility and for","text_display":" technique should be used in a subject throughout the trial. Local reading (investigator assessment with site radiology reading) will be used to determine eligibility and for","confidence":1,"confidence_rate":1},{"cnt":[[427,1279],[2370,1279],[2370,1312],[427,1312]],"region":{"top_left_x":427,"top_left_y":1279,"width":1943,"height":33},"line":145,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e64dd2fe57c1451c9fed232a1f8d8e8f","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"subject management. Images done in the study including baseline scan should be submitted to a central imaging vendor. The processes for image collection and transmission","text_display":" subject management. Images done in the study including baseline scan should be submitted to a central imaging vendor. The processes for image collection and transmission","confidence":1,"confidence_rate":1},{"cnt":[[427,1312],[1326,1312],[1326,1344],[427,1344]],"region":{"top_left_x":427,"top_left_y":1311,"width":899,"height":34},"line":146,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c30bbc5d3eed48ce83f259d70aa7e3af","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"to the central vendor are in the investigator Imaging Operations Manual (IIOM).","text_display":" to the central vendor are in the investigator Imaging Operations Manual (IIOM).","confidence":1,"confidence_rate":1},{"cnt":[[380,1344],[2370,1344],[2370,1377],[380,1377]],"region":{"top_left_x":379,"top_left_y":1344,"width":1991,"height":33},"line":147,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"643160fb47e74e21b1e9828b5b44b549","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"7 Screening can initiate when investigator decides subjects meet inclusion and exclusion criteria for the crossover phase. Wash out period from last dose of docetaxel or anti-","text_display":"\n7 Screening can initiate when investigator decides subjects meet inclusion and exclusion criteria for the crossover phase. Wash out period from last dose of docetaxel or anti","confidence":1,"confidence_rate":1},{"cnt":[[427,1374],[2222,1374],[2222,1407],[427,1407]],"region":{"top_left_x":427,"top_left_y":1374,"width":1796,"height":33},"line":148,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93c8c2ae272f409bb103aff17e69c3e5","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"cancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any AEs of the previous anti-cancer therapies.","text_display":"cancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any AEs of the previous anti-cancer therapies.","confidence":1,"confidence_rate":1},{"cnt":[[380,1407],[2370,1407],[2370,1439],[380,1439]],"region":{"top_left_x":379,"top_left_y":1406,"width":1991,"height":34},"line":149,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c74fa5d56f34d91874c726fccb869f2","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"8 Wash out period from last dose of docetaxel or anti-cancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any","text_display":"\n8 Wash out period from last dose of docetaxel or anti-cancer therapy is left to investigator discretion while ensuring that patient will have adequate time to recover from any","confidence":1,"confidence_rate":1},{"cnt":[[427,1439],[2370,1439],[2370,1472],[427,1472]],"region":{"top_left_x":427,"top_left_y":1439,"width":1943,"height":33},"line":150,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"299875343c684a7bb2b8972077eeabe2","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"AEs of the previous anti-cancer therapies. Subjects will continue in trial until progressive disease is confirmed as assessed by irRC as determined by the investigators or up","text_display":" AEs of the previous anti-cancer therapies. Subjects will continue in trial until progressive disease is confirmed as assessed by irRC as determined by the investigators or up","confidence":0.99951171875,"confidence_rate":0.9999972715093195},{"cnt":[[427,1470],[1326,1470],[1326,1502],[427,1502]],"region":{"top_left_x":427,"top_left_y":1469,"width":899,"height":34},"line":151,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f09e63f4b3c349ca84f38f6d5cd9e472","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"to two years from initiation of a new anti-cancer therapy, whichever comes first.","text_display":" to two years from initiation of a new anti-cancer therapy, whichever comes first.","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[380,1504],[1452,1504],[1452,1537],[380,1537]],"region":{"top_left_x":379,"top_left_y":1504,"width":1073,"height":33},"line":152,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4c6ee52cf0c4cd4bab49a0fd2034069","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"9 After cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point.","text_display":"\n9 After cycle 1, lab samples can be collected up to 48 hours prior to the scheduled time point.","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[382,1535],[2145,1535],[2145,1567],[382,1567]],"region":{"top_left_x":381,"top_left_y":1534,"width":1764,"height":34},"line":153,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24d62fb5d0414bccad40e7992e010a72","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"10 If patient is entering the Crossover Phase after experiencing an anti-cancer therapy, the previous anti-cancer therapy must be recorded in the EDC system.","text_display":"\n10 If patient is entering the Crossover Phase after experiencing an anti-cancer therapy, the previous anti-cancer therapy must be recorded in the EDC system.","confidence":1,"confidence_rate":1},{"cnt":[[384,1567],[850,1567],[850,1600],[384,1600]],"region":{"top_left_x":383,"top_left_y":1567,"width":467,"height":33},"line":154,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6fd26ce82164a8c86394cb401c107d5","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"11 Perform every 4 cycles after cycle 13.","text_display":"\n11 Perform every 4 cycles after cycle 13.","confidence":0.994631290435791,"confidence_rate":0.999885470965869},{"cnt":[[384,1600],[850,1600],[850,1632],[384,1632]],"region":{"top_left_x":383,"top_left_y":1599,"width":467,"height":34},"line":155,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbe41cefc8954cfe9baadd1643319960","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"12 Perform every 3 cycles after cycle 13.","text_display":"\n12 Perform every 3 cycles after cycle 13.","confidence":1,"confidence_rate":1},{"cnt":[[382,1632],[2370,1632],[2370,1667],[382,1667]],"region":{"top_left_x":381,"top_left_y":1632,"width":1989,"height":35},"line":156,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9636c41f390744ae962405d56c72bcc7","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"13. Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be","text_display":"\n13. Once a subject experiences disease progression or starts a new antineoplastic therapy, the subject moves into the Survival Follow-up Phase and should be","confidence":1,"confidence_rate":1},{"cnt":[[427,1669],[2370,1669],[2370,1706],[427,1706]],"region":{"top_left_x":427,"top_left_y":1668,"width":1943,"height":38},"line":157,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46de187c80c4454f893fc9f37e0950f5","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"contacted by telephone approximately every 12 weeks to assess for survival status and start of new antineoplastic therapy, if applicable. Updated survival","text_display":" contacted by telephone approximately every 12 weeks to assess for survival status and start of new antineoplastic therapy, if applicable. Updated survival","confidence":1,"confidence_rate":1},{"cnt":[[427,1704],[2370,1704],[2370,1740],[427,1740]],"region":{"top_left_x":427,"top_left_y":1703,"width":1943,"height":38},"line":158,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffe846d1d4d1435a952bd32a6b3facff","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"status may be requested by the Sponsor at any time during the course of the study. Upon Sponsor notification, all participants who do not/will not have a","text_display":" status may be requested by the Sponsor at any time during the course of the study. Upon Sponsor notification, all participants who do not/will not have a","confidence":1,"confidence_rate":1},{"cnt":[[427,1738],[2372,1738],[2372,1775],[427,1775]],"region":{"top_left_x":427,"top_left_y":1738,"width":1945,"height":38},"line":159,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94f13a5108134946bba1976c4d41de84","type":"text","conversion_output":false,"parent_id":"46b3c738b742492387f9fcbe87cee86d","text":"scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have a","text_display":" scheduled study visit or study contact during the Sponsor defined time period will be contacted for their survival status (excluding participants that have 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Hematology & Chemistry & Urinalysis & Other \\\\\n\\hline Hematocrit & Albumin & Blood & PT (INR) \\\\\n\\hline Hemoglobin & Alkaline phosphatase & Glucose & aPTT \\\\\n\\hline Platelet count & Alanine aminotransferase (ALT) & Protein & Triiodothyronine (T3) or Free Triiodothyronine \\\\\n\\hline WBC (total and differential) & Aspartate aminotransferase (AST) & Specific gravity & Free thyroxine (FT4) \\\\\n\\hline Red Blood Cell Count & Lactate dehydrogenase (LDH) & Microscopic exam, if abnormal results are noted & Thyroid stimulating hormone (TSH) \\\\\n\\hline Absolute Neutrophil Count & Carbon Dioxide ( \\(CO _{2}\\) or bicarbonate)*** & Urine pregnancy test* & Serum \\(\\beta\\)-human chorionic gonadotropin \\((\\beta- hCG )\\) * \\\\\n\\hline Absolute Lymphocyte Count & Creatinine or calculated creatinine clearance (CrCl) & & Anti-MK-3475 Antibodies \\\\\n\\hline & Uric acid & & PK \\\\\n\\hline & Calcium & & Blood for FBR \\\\\n\\hline & Chloride & & GFR \\\\\n\\hline & Glucose & 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If urine pregnancy results cannot be confirmed as negative, a serum pregnancy test will be required. \\\\\n** White Blood Cell Differential (Absolute) is required. White Blood Cell Differential (\\%) is required only if customarily reported in your region. If White Blood Cell Differential (\\%) is not normally done then these fields can be left blank and no comment is required. \\\\\n*** If this test is not done as part of local standard of care, this test does not need to be performed.\n\\end{tabular}} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5 Laboratory Tests}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Hematology & Chemistry & Urinalysis & Other \\\\\n\\hline Hematocrit & Albumin & Blood & PT (INR) \\\\\n\\hline Hemoglobin & Alkaline phosphatase & Glucose & aPTT \\\\\n\\hline Platelet count & Alanine aminotransferase (ALT) & Protein & Triiodothyronine (T3) or Free Triiodothyronine \\\\\n\\hline WBC (total and differential) & Aspartate aminotransferase (AST) & Specific gravity & Free thyroxine (FT4) \\\\\n\\hline Red Blood Cell Count & Lactate dehydrogenase (LDH) & Microscopic exam, if abnormal results are noted & Thyroid stimulating hormone (TSH) \\\\\n\\hline Absolute Neutrophil Count & Carbon Dioxide ( \\(CO _{2}\\) or bicarbonate)*** & Urine pregnancy test* & Serum \\(\\beta\\)-human chorionic gonadotropin \\((\\beta- hCG )\\) * \\\\\n\\hline Absolute Lymphocyte Count & Creatinine or calculated creatinine clearance (CrCl) & & Anti-MK-3475 Antibodies \\\\\n\\hline & Uric acid & & PK \\\\\n\\hline & Calcium & & Blood for FBR \\\\\n\\hline & Chloride & & GFR \\\\\n\\hline & Glucose & & \\\\\n\\hline & Phosphorus & & \\\\\n\\hline & Potassium & & \\\\\n\\hline & Sodium & & \\\\\n\\hline & Magnesium & & \\\\\n\\hline & Total Bilirubin & & \\\\\n\\hline & Direct and indirect Bilirubin & & \\\\\n\\hline & Total protein & & \\\\\n\\hline & Blood Urea Nitrogen & & \\\\\n\\hline & Total Cholesterol & & \\\\\n\\hline & Triglycerides & & \\\\\n\\hline \\multicolumn{4}{|c|}{\\begin{tabular}{l}\n* Perform on women of child bearing potential only. 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Imaging may be performed more frequently if clinically indicated. CT timing","text_display":" onward. Imaging may be performed more frequently if clinically indicated. 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Subjects","text_display":" experiences confirmed disease progression or starts a new antineoplastic therapy. 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Any adverse event","text_display":" NCI Common Terminology for Adverse Events (CTCAE), version 4.0. Any adverse event","confidence":1,"confidence_rate":1},{"cnt":[[305,761],[1880,761],[1880,814],[305,814]],"region":{"top_left_x":305,"top_left_y":760,"width":1575,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af1dab74fe9441d1a5ca582e9bd2c4f0","type":"text","conversion_output":true,"text":"which changes CTCAE grade over the course of a given episode will have each change of","text_display":" which changes CTCAE grade over the course of a given episode will have each change of","confidence":1,"confidence_rate":1},{"cnt":[[305,810],[1422,810],[1422,862],[305,862]],"region":{"top_left_x":305,"top_left_y":809,"width":1118,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9dd4605c2a84f0c9efc1167bcdc04a4","type":"text","conversion_output":true,"text":"grade recorded on the adverse event case report forms/worksheets.","text_display":" grade recorded on the adverse event case report 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V4.0 CTCAE Grading & Grade 1 & Mild; asymptomatic or mid symptoms; clinical or diagnostic observations only; intervention not indicated. \\\\\n\\hline & Grade 2 & Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. \\\\\n\\hline & Grade 3 & Severe or medically significant but not immediately life-threatening; hospitalization or prolongation or hospitalization indicated; disabling; limiting self-care ADL. \\\\\n\\hline & Grade 4 & Life threatening consequences; urgent intervention indicated. \\\\\n\\hline & Grade 5 & Death related to AE \\\\\n\\hline \\multirow[t]{9}{*}{Seriousness} & \\multicolumn{2}{|l|}{A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that:} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Results in death; or} \\\\\n\\hline & \\multicolumn{2}{|c|}{†Is life threatening; or places the subject, in the view of the investigator, at immediate risk of death from the event as it occurred (Note: This does not include an adverse event that, had it occurred in a more severe form, might have caused death.); or} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Results in a persistent or significant disability/incapacity (substantial disruption of one's ability to conduct normal life functions); or} \\\\\n\\hline & \\multicolumn{2}{|c|}{† Results in or prolongs an existing inpatient hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay, even if the hospitalization is a precautionary measure for continued observation. (Note: Hospitalization [including hospitalization for an elective procedure] for a preexisting condition which has not worsened does not constitute a serious adverse event.); or} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Is a congenital anomaly/birth defect (in offspring of subject taking the product regardless of time to diagnosis);or} \\\\\n\\hline & \\multicolumn{2}{|c|}{Is a new cancer (that is not a condition of the study) (although not serious per ICH definition, is reportable to the Sponsor within 24 hours to meet certain local requirements); or} \\\\\n\\hline & \\multicolumn{2}{|c|}{Is an overdose (whether accidental or intentional). Any adverse event associated with an overdose is considered a serious adverse event for collection purposes. An overdose that is not associated with an adverse event is considered a non-serious event of clinical interest and must be reported within 24 hours.} \\\\\n\\hline & \\multicolumn{2}{|c|}{Other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, the event may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed previously (designated above by a † ).} \\\\\n\\hline Duration & \\multicolumn{2}{|l|}{Record the start and stop dates of the adverse event. If less than 1 day, indicate the appropriate length of time and units} \\\\\n\\hline Action taken & \\multicolumn{2}{|l|}{Did the adverse event cause the Sponsor's product to be discontinued?} \\\\\n\\hline \\multirow[t]{4}{*}{Relationship to Sponsor's Product} & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nDid the Sponsor's product cause the adverse event? The determination of the likelihood that the Sponsor's product caused the adverse event will be provided by an investigator who is a qualified physician. The investigator's signed/dated initials on the source document or worksheet that supports the causality noted on the AE form, ensures that a medically qualified assessment of causality was done. This initialed document must be retained for the required regulatory time frame. The criteria below are intended as reference guidelines to assist the investigator in assessing the likelihood of a relationship between the test drug and the adverse event based upon the available information. \\\\\nThe following components are to be used to assess the relationship between the Sponsor's product and the AE; the greater the correlation with the components and their respective elements (in number and/or intensity), the more likely the Sponsor's product caused the adverse event (AE):\n\\end{tabular}} \\\\\n\\hline & Exposure & Is there evidence that the subject was actually exposed to the Sponsor's product such as: reliable history, acceptable compliance assessment (pill count, diary, etc.), expected pharmacologic effect, or measurement of drug/metabolite in bodily specimen? \\\\\n\\hline & Time Course & Did the AE follow in a reasonable temporal sequence from administration of the Sponsor's product? Is the time of onset of the AE compatible with a drug-induced effect (applies to trials with investigational medicinal product)? \\\\\n\\hline & Likely Cause & Is the AE not reasonably explained by another etiology such as underlying disease, other drug(s)/vaccine(s), or other host or environmental factors \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline V4.0 CTCAE Grading & Grade 1 & Mild; asymptomatic or mid symptoms; clinical or diagnostic observations only; intervention not indicated. \\\\\n\\hline & Grade 2 & Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. \\\\\n\\hline & Grade 3 & Severe or medically significant but not immediately life-threatening; hospitalization or prolongation or hospitalization indicated; disabling; limiting self-care ADL. \\\\\n\\hline & Grade 4 & Life threatening consequences; urgent intervention indicated. \\\\\n\\hline & Grade 5 & Death related to AE \\\\\n\\hline \\multirow[t]{9}{*}{Seriousness} & \\multicolumn{2}{|l|}{A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that:} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Results in death; or} \\\\\n\\hline & \\multicolumn{2}{|c|}{†Is life threatening; or places the subject, in the view of the investigator, at immediate risk of death from the event as it occurred (Note: This does not include an adverse event that, had it occurred in a more severe form, might have caused death.); or} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Results in a persistent or significant disability/incapacity (substantial disruption of one's ability to conduct normal life functions); or} \\\\\n\\hline & \\multicolumn{2}{|c|}{† Results in or prolongs an existing inpatient hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay, even if the hospitalization is a precautionary measure for continued observation. (Note: Hospitalization [including hospitalization for an elective procedure] for a preexisting condition which has not worsened does not constitute a serious adverse event.); or} \\\\\n\\hline & \\multicolumn{2}{|l|}{† Is a congenital anomaly/birth defect (in offspring of subject taking the product regardless of time to diagnosis);or} \\\\\n\\hline & \\multicolumn{2}{|c|}{Is a new cancer (that is not a condition of the study) (although not serious per ICH definition, is reportable to the Sponsor within 24 hours to meet certain local requirements); or} \\\\\n\\hline & \\multicolumn{2}{|c|}{Is an overdose (whether accidental or intentional). Any adverse event associated with an overdose is considered a serious adverse event for collection purposes. An overdose that is not associated with an adverse event is considered a non-serious event of clinical interest and must be reported within 24 hours.} \\\\\n\\hline & \\multicolumn{2}{|c|}{Other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, the event may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed previously (designated above by a † ).} \\\\\n\\hline Duration & \\multicolumn{2}{|l|}{Record the start and stop dates of the adverse event. If less than 1 day, indicate the appropriate length of time and units} \\\\\n\\hline Action taken & \\multicolumn{2}{|l|}{Did the adverse event cause the Sponsor's product to be discontinued?} \\\\\n\\hline \\multirow[t]{4}{*}{Relationship to Sponsor's Product} & \\multicolumn{2}{|c|}{\\begin{tabular}{l}\nDid the Sponsor's product cause the adverse event? The determination of the likelihood that the Sponsor's product caused the adverse event will be provided by an investigator who is a qualified physician. The investigator's signed/dated initials on the source document or worksheet that supports the causality noted on the AE form, ensures that a medically qualified assessment of causality was done. This initialed document must be retained for the required regulatory time frame. 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The temporal sequence of the AE onset relative to the administration of the Sponsor's product is reasonable. The AE is more likely explained by the Sponsor's product than by another cause. \\\\\n\\hline & No, there is not a reasonable possibility of Sponsor's product relationship & Subject did not receive the Sponsor's product OR temporal sequence of the AE onset relative to administration of the Sponsor's product is not reasonable OR the AE is more likely explained by another cause than the Sponsor's product. 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If no, this is a negative rechallenge. \\\\\n(Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent disability, or (2) the trial is a single-dose drug trial); or (3) Sponsor's product(s) is/are used only one time). \\\\\nNOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN CAUSED BY THE SPONSOR'S PRODUCT, OR IF REEXPOSURE TO THE SPONSOR'S PRODUCT POSES ADDITIONAL POTENTIAL SIGNIFICANT RISK TO THE SUBJECT, THEN THE RECHALLENGE MUST BE APPROVED IN ADVANCE BY THE U.S. CLINICAL MONITOR AS PER DOSE MODIFICATION GUIDELINES IN THE PROTOCOL.\n\\end{tabular} \\\\\n\\hline & Consistency with Trial Treatment Profile & Is the clinical/pathological presentation of the AE consistent with previous knowledge regarding the Sponsor's product or drug class pharmacology or toxicology? \\\\\n\\hline \\multicolumn{3}{|c|}{The assessment of relationship will be reported on the case report forms /worksheets by an investigator who is a qualified physician according to his/her best clinical judgment, including consideration of the above elements.} \\\\\n\\hline \\multicolumn{2}{|l|}{Record one of the following} & Use the following scale of criteria as guidance (not all criteria must be present to be indicative of a Sponsor's product relationship). \\\\\n\\hline & Yes, there is a reasonable possibility of Sponsor's product relationship. & There is evidence of exposure to the Sponsor's product. 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If no, this is a negative dechallenge. \\\\\n(Note: This criterion is not applicable if: (1) the AE resulted in death or permanent disability; (2) the AE resolved/improved despite continuation of the Sponsor's product; or (3) the trial is a single-dose drug trial); or (4) Sponsor's product(s) is/are only used one time.)\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.5846753120422363,"confidence_rate":0.9992256712038462},{"cnt":[[736,353],[1665,353],[1665,385],[736,385]],"region":{"top_left_x":736,"top_left_y":352,"width":930,"height":34},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e5d78824f524751a7e4d030d3451b9a","type":"text","conversion_output":false,"parent_id":"ebee8b78f9a440968de9276a1ac0459b","text":"Was the Sponsor's product discontinued or dose/exposure/frequency reduced?","text_display":"Was the Sponsor's product discontinued or dose/exposure/frequency reduced?","confidence":1,"confidence_rate":1},{"cnt":[[788,383],[1249,383],[1249,420],[788,420]],"region":{"top_left_x":788,"top_left_y":382,"width":462,"height":38},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f012b66226344b5e8d757bef97365cfc","type":"text","conversion_output":false,"parent_id":"ebee8b78f9a440968de9276a1ac0459b","text":"If yes, did the AE resolve or improve?","text_display":"\nIf yes, did the AE resolve or improve?","confidence":0.98876953125,"confidence_rate":0.9997373831731221},{"cnt":[[851,418],[1717,418],[1717,454],[851,454]],"region":{"top_left_x":850,"top_left_y":417,"width":868,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89c34318c40b457382f9bac3563e8867","type":"text","conversion_output":false,"parent_id":"ebee8b78f9a440968de9276a1ac0459b","text":"If yes, this is a positive dechallenge. If no, this is a negative dechallenge.","text_display":"\nIf yes, this is a positive dechallenge. If no, this is a negative dechallenge.","confidence":0.99462890625,"confidence_rate":0.9999351157203459},{"cnt":[[736,452],[2453,452],[2453,489],[736,489]],"region":{"top_left_x":736,"top_left_y":452,"width":1718,"height":38},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7bbffdfa93a4487a688d3f10ad7cc3e","type":"text","conversion_output":false,"parent_id":"ebee8b78f9a440968de9276a1ac0459b","text":"(Note: This criterion is not applicable if: (1) the AE resulted in death or permanent disability; (2) the AE resolved/improved despite continuation","text_display":"\n(Note: This criterion is not applicable if: (1) the AE resulted in death or permanent disability; (2) the AE resolved/improved despite continuation","confidence":0.5846753120422363,"confidence_rate":0.9964753144444106},{"cnt":[[736,487],[2185,487],[2185,524],[736,524]],"region":{"top_left_x":736,"top_left_y":486,"width":1449,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ceeed8399aa4f238f34c193944738e6","type":"text","conversion_output":false,"parent_id":"ebee8b78f9a440968de9276a1ac0459b","text":"of the Sponsor's product; or (3) the trial is a single-dose drug trial); or (4) Sponsor's product(s) is/are only used one time.)","text_display":" of the Sponsor's product; or (3) the trial is a single-dose drug trial); or (4) Sponsor's product(s) is/are only used one time.)","confidence":0.9980475902557373,"confidence_rate":0.9999853059862994},{"cnt":[[485,522],[643,522],[643,558],[485,558]],"region":{"top_left_x":484,"top_left_y":521,"width":159,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea162489a4344a0fb2c36b83b058b39e","type":"simple_cell","conversion_output":false,"parent_id":"e27f00b7447c4968b6b6428a680c942c","text":"Rechallenge","text_display":"Rechallenge","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[732,522],[2455,522],[2455,827],[732,827]],"region":{"top_left_x":731,"top_left_y":521,"width":1725,"height":306},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1afd5542fa294d58960bace3c08d1058","type":"complex_cell","conversion_output":false,"parent_id":"e27f00b7447c4968b6b6428a680c942c","children_ids":["d707d5cfbe684f8c89dc5dd174e9582a","927eb4149d324428b21ce59fd1ab8cda","35a6037f3ad54c4b8ddfc5f351ee9225","a454c1e5eb7747dd8ace33ba7c19cd85","7fa6561f1a394df0aa4fc419564248da","27e104d8da944ce984afa2f9d24da996","9126bc9d72874d8fa38d6b9020362578","2e1abdb740da4bfb972e80ed1eb7beb5","692da86bb4b048c9b04c3801950c4eb0"],"text":"\\begin{tabular}{l}\nWas the subject re-exposed to the Sponsor's product in this study? \\\\\nIf yes, did the AE recur or worsen? \\\\\nIf yes, this is a positive rechallenge. If no, this is a negative rechallenge. \\\\\n(Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent disability, or (2) the trial is a single-dose drug trial); or (3) Sponsor's product(s) is/are used only one time). \\\\\nNOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN CAUSED BY THE SPONSOR'S PRODUCT, OR IF REEXPOSURE TO THE SPONSOR'S PRODUCT POSES ADDITIONAL POTENTIAL SIGNIFICANT RISK TO THE SUBJECT, THEN THE RECHALLENGE MUST BE APPROVED IN ADVANCE BY THE U.S. CLINICAL MONITOR AS PER DOSE MODIFICATION GUIDELINES IN THE PROTOCOL.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nWas the subject re-exposed to the Sponsor's product in this study? \\\\\nIf yes, did the AE recur or worsen? \\\\\nIf yes, this is a positive rechallenge. If no, this is a negative rechallenge. \\\\\n(Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent disability, or (2) the trial is a single-dose drug trial); or (3) Sponsor's product(s) is/are used only one time). \\\\\nNOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN CAUSED BY THE SPONSOR'S PRODUCT, OR IF REEXPOSURE TO THE SPONSOR'S PRODUCT POSES ADDITIONAL POTENTIAL SIGNIFICANT RISK TO THE SUBJECT, THEN THE RECHALLENGE MUST BE APPROVED IN ADVANCE BY THE U.S. CLINICAL MONITOR AS PER DOSE MODIFICATION GUIDELINES IN THE PROTOCOL.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999968238731621},{"cnt":[[736,522],[1526,522],[1526,558],[736,558]],"region":{"top_left_x":736,"top_left_y":521,"width":791,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d707d5cfbe684f8c89dc5dd174e9582a","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"Was the subject re-exposed to the Sponsor's product in this study?","text_display":"Was the subject re-exposed to the Sponsor's product in this study?","confidence":0.9990234375,"confidence_rate":0.9999862389728834},{"cnt":[[788,556],[1210,556],[1210,593],[788,593]],"region":{"top_left_x":788,"top_left_y":556,"width":423,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"927eb4149d324428b21ce59fd1ab8cda","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"If yes, did the AE recur or worsen?","text_display":"\nIf yes, did the AE recur or worsen?","confidence":1,"confidence_rate":1},{"cnt":[[851,591],[1706,591],[1706,625],[851,625]],"region":{"top_left_x":850,"top_left_y":590,"width":857,"height":36},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35a6037f3ad54c4b8ddfc5f351ee9225","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"If yes, this is a positive rechallenge. If no, this is a negative rechallenge.","text_display":"\nIf yes, this is a positive rechallenge. 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or","confidence":0.99951171875,"confidence_rate":0.9999969475015457},{"cnt":[[736,660],[1345,660],[1345,693],[736,693]],"region":{"top_left_x":736,"top_left_y":660,"width":609,"height":33},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7fa6561f1a394df0aa4fc419564248da","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"(3) Sponsor's product(s) is/are used only one time).","text_display":" (3) Sponsor's product(s) is/are used only one time).","confidence":1,"confidence_rate":1},{"cnt":[[736,690],[2453,690],[2453,723],[736,723]],"region":{"top_left_x":736,"top_left_y":690,"width":1718,"height":33},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27e104d8da944ce984afa2f9d24da996","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"NOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN","text_display":"\nNOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN","confidence":1,"confidence_rate":1},{"cnt":[[736,725],[2453,725],[2453,758],[736,758]],"region":{"top_left_x":736,"top_left_y":725,"width":1718,"height":33},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9126bc9d72874d8fa38d6b9020362578","type":"text","conversion_output":false,"parent_id":"1afd5542fa294d58960bace3c08d1058","text":"CAUSED BY THE SPONSOR'S PRODUCT, OR IF REEXPOSURE TO THE SPONSOR'S PRODUCT POSES ADDITIONAL POTENTIAL","text_display":" CAUSED BY THE SPONSOR'S PRODUCT, OR IF REEXPOSURE TO THE SPONSOR'S PRODUCT POSES ADDITIONAL 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toxicology?","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9980475902557373,"confidence_rate":0.9999928674773322},{"cnt":[[736,829],[2453,829],[2453,866],[736,866]],"region":{"top_left_x":736,"top_left_y":829,"width":1718,"height":37},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9419dd12a27342ed8162b679569605d4","type":"text","conversion_output":false,"parent_id":"d1eb36d91df845ac9ecc230e1309b21d","text":"Is the clinical/pathological presentation of the AE consistent with previous knowledge regarding the Sponsor's product or drug class","text_display":"Is the clinical/pathological presentation of the AE consistent with previous knowledge regarding the Sponsor's product or drug 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report forms /worksheets by an investigator who is a qualified physician according to his/her best clinical judgment, including consideration of the above elements.","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[244,965],[2455,965],[2455,1035],[244,1035]],"region":{"top_left_x":244,"top_left_y":965,"width":2212,"height":70},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9bb07a8a900e43fe962f584740a6ebf9","type":"complex_cell","conversion_output":false,"parent_id":"4e419e21d0a144178a6127eec04fe7f9","children_ids":["e07253ec3a224558b2c63d415c925b33","60b45049f7a0483f93cbae5c8094998d"],"text":"The assessment of relationship will be reported on the case report forms /worksheets by an investigator who is a qualified physician according to his/her best clinical judgment, including consideration of the above elements.","text_display":"The assessment of relationship will be reported on the case report forms /worksheets by an 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following","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[247,1037],[600,1037],[600,1074],[247,1074]],"region":{"top_left_x":246,"top_left_y":1036,"width":354,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"855ae45c382941929683bb15b780bf6a","type":"simple_cell","conversion_output":false,"parent_id":"eec7570736474474883ed3db857fa9da","text":"Record one of the following","text_display":"Record one of the following","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[736,1037],[2384,1037],[2384,1074],[736,1074]],"region":{"top_left_x":736,"top_left_y":1036,"width":1648,"height":38},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42c08151993e444c946596c94d700e89","type":"simple_cell","conversion_output":false,"parent_id":"e27f00b7447c4968b6b6428a680c942c","text":"Use the following scale of criteria as guidance (not all 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Full detail is in","confidence":1,"confidence_rate":1},{"cnt":[[305,1351],[1068,1351],[1068,1403],[305,1403]],"region":{"top_left_x":305,"top_left_y":1351,"width":763,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b504b23653394fe2ad2f949ee0a158f5","type":"text","conversion_output":true,"text":"Section 8.2 - Statistical Analysis Plan (SAP).","text_display":" Section 8.2 - Statistical Analysis Plan (SAP).","confidence":1,"confidence_rate":1},{"cnt":[[301,1439],[763,1439],[763,1497],[301,1497]],"region":{"top_left_x":300,"top_left_y":1439,"width":463,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0a006bf25734c79958823145fcbfbda","type":"section_header","conversion_output":false,"children_ids":["d76a151bb1974619825ca0feda0caddf"],"text":"","text_display":""},{"cnt":[[305,1444],[758,1444],[758,1493],[305,1493]],"region":{"top_left_x":305,"top_left_y":1443,"width":454,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d76a151bb1974619825ca0feda0caddf","type":"text","conversion_output":true,"parent_id":"c0a006bf25734c79958823145fcbfbda","text":"8.1.1 Efficacy Analyses","text_display":"\n\n\\subsection*{8.1.1 Efficacy Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,1532],[1880,1532],[1880,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1531,"width":1575,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ec2a735622e4c1989795bf0edd140f1","type":"text","conversion_output":true,"text":"The intention-to-treat (ITT) population in the strongly positive PD-L1 stratum and the overall","text_display":"\n\nThe intention-to-treat (ITT) population in the strongly positive PD-L1 stratum and the overall","confidence":1,"confidence_rate":1},{"cnt":[[305,1577],[1880,1577],[1880,1631],[305,1631]],"region":{"top_left_x":305,"top_left_y":1576,"width":1575,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b328d9459a664ba9b60ee8bc7272f19f","type":"text","conversion_output":true,"text":"positive PD-L1 population will serve as the primary population for the analyses of efficacy","text_display":" positive PD-L1 population will serve as the primary population for the analyses of efficacy","confidence":1,"confidence_rate":1},{"cnt":[[305,1629],[1880,1629],[1880,1678],[305,1678]],"region":{"top_left_x":305,"top_left_y":1628,"width":1575,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9efc3c383954728a85fdf6cc6589c36","type":"text","conversion_output":true,"text":"data in this trial. The primary efficacy endpoints are overall survival (OS) (i.e., the time from","text_display":" data in this trial. The primary efficacy endpoints are overall survival (OS) (i.e., the time from","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[305,1676],[1880,1676],[1880,1725],[305,1725]],"region":{"top_left_x":305,"top_left_y":1675,"width":1575,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88a78cf7554041dc8a153f428dc7119b","type":"text","conversion_output":true,"text":"randomization to death due to any cause) and progression-free survival (PFS) (i.e., time from","text_display":" randomization to death due to any cause) and progression-free survival (PFS) (i.e., time from","confidence":0.994145393371582,"confidence_rate":0.9999400853457244},{"cnt":[[305,1723],[1880,1723],[1880,1772],[305,1772]],"region":{"top_left_x":305,"top_left_y":1723,"width":1575,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22195c564c494a949db8f6f82a948dbb","type":"text","conversion_output":true,"text":"randomization to documented progressive disease or death due to any cause, whichever","text_display":" randomization to documented progressive disease or death due to any cause, whichever","confidence":1,"confidence_rate":1},{"cnt":[[305,1770],[1882,1770],[1882,1824],[305,1824]],"region":{"top_left_x":305,"top_left_y":1770,"width":1578,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab682c5e634b437aa9669a474650e263","type":"text","conversion_output":true,"text":"occurs first) per RECIST 1.1 based on blinded independent radiologists' review. Type I error","text_display":" occurs first) per RECIST 1.1 based on blinded independent radiologists' review. Type I error","confidence":1,"confidence_rate":1},{"cnt":[[305,1818],[1880,1818],[1880,1869],[305,1869]],"region":{"top_left_x":305,"top_left_y":1817,"width":1575,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eaebdaa70ff747208d9b98cfa1567a69","type":"text","conversion_output":true,"text":"is strongly controlled at \\(2.5 \\%\\) (one-sided) for tests of PFS and OS in both the strongly","text_display":" is strongly controlled at \\(2.5 \\%\\) (one-sided) for tests of PFS and OS in both the strongly","confidence":1,"confidence_rate":1},{"cnt":[[305,1867],[1880,1867],[1880,1919],[305,1919]],"region":{"top_left_x":305,"top_left_y":1866,"width":1575,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42570e90236f467d80abdc47732db353","type":"text","conversion_output":true,"text":"positive PD-L1 stratum and the overall PD-L1 positive population. The secondary objectives","text_display":" positive PD-L1 stratum and the overall PD-L1 positive population. The secondary objectives","confidence":1,"confidence_rate":1},{"cnt":[[305,1916],[1880,1916],[1880,1966],[305,1966]],"region":{"top_left_x":305,"top_left_y":1916,"width":1575,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3acbdc5ad904642b9d987187d5878a6","type":"text","conversion_output":true,"text":"for this trial are overall response rate (ORR) and response duration per RECIST 1.1 based on","text_display":" for this trial are overall response rate (ORR) and response duration per RECIST 1.1 based on","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,1962],[1880,1962],[1880,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1961,"width":1575,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c5aa32fa0774af88285791fb945cfd8","type":"text","conversion_output":true,"text":"blinded independent radiologists' review. The same endpoints will be applied to analyses of","text_display":" blinded independent radiologists' review. The same endpoints will be applied to analyses of","confidence":1,"confidence_rate":1},{"cnt":[[305,2011],[1880,2011],[1880,2065],[305,2065]],"region":{"top_left_x":305,"top_left_y":2010,"width":1575,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a34830373e7c4a7c9ddf9863f3b35198","type":"text","conversion_output":true,"text":"the overall population. In addition, PFS, ORR and response duration per irRC based on","text_display":" the overall population. In addition, PFS, ORR and response duration per irRC based on","confidence":1,"confidence_rate":1},{"cnt":[[305,2058],[1880,2058],[1880,2110],[305,2110]],"region":{"top_left_x":305,"top_left_y":2058,"width":1575,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5360aecce3ce4546b605cb2873b89117","type":"text","conversion_output":true,"text":"investigators' reviews will also be provided for both populations. An outline of the analysis","text_display":" investigators' reviews will also be provided for both populations. An outline of the analysis","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,2105],[1405,2105],[1405,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2105,"width":1101,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7581d14eedb4c3ba2409f5ab212e216","type":"text","conversion_output":true,"text":"strategy for key efficacy endpoints is presented in Table 7 below.","text_display":" strategy for key efficacy endpoints is presented in Table 7 below.","confidence":0.9187240600585938,"confidence_rate":0.9988551225916553},{"cnt":[[305,2535],[819,2535],[819,2580],[305,2580]],"region":{"top_left_x":305,"top_left_y":2535,"width":514,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b025b4d967ef43af83dd8426e110c818","type":"page_info","conversion_output":false,"text":"MK-3475-010-17 Final 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MK-3475 (SCH 900475)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1762,129],[1888,129],[1888,174],[1762,174]],"region":{"top_left_x":1761,"top_left_y":128,"width":128,"height":47},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba9cb7fdfd57439abaeeaae891b09d02","type":"page_info","conversion_output":false,"text":"Page 91","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,172],[849,172],[849,211],[309,211]],"region":{"top_left_x":309,"top_left_y":171,"width":540,"height":40},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46d6519017c64a679298e5392e120cb3","type":"page_info","conversion_output":false,"text":"Protocol/Amendment No.: 010-17","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[309,301],[1876,301],[1876,350],[309,350]],"region":{"top_left_x":309,"top_left_y":300,"width":1567,"height":51},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"766fc2a21b40486cb6850a704eeb503f","type":"text","conversion_output":true,"text":"dose of study drug) will be calculated using the stratified Miettinen and Nurminen method","text_display":"\ndose of study drug) will be calculated using the stratified Miettinen and Nurminen method","confidence":1,"confidence_rate":1},{"cnt":[[309,350],[397,350],[397,397],[309,397]],"region":{"top_left_x":309,"top_left_y":350,"width":89,"height":48},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd62792d7852439daa9462f62c114754","type":"text","conversion_output":true,"text":"[30].","text_display":" 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to be immune-related by the investigator: 1) Grade \\(\\geq 3\\) diarrhea 2) Grade \\(\\geq 2\\)","confidence":0.9892923366553474,"confidence_rate":0.9998829915969708},{"cnt":[[305,535],[1880,535],[1880,587],[305,587]],"region":{"top_left_x":305,"top_left_y":534,"width":1575,"height":53},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acf601e1bb914fff92fb33e7b9c154da","type":"text","conversion_output":true,"text":"colitis, 3) Grade \\(\\geq 2\\) pneumonitis, 4) Grade \\(\\geq 3\\) hypo- or hyperthyroidism. P-values and \\(95 \\%\\)","text_display":" colitis, 3) Grade \\(\\geq 2\\) pneumonitis, 4) Grade \\(\\geq 3\\) hypo- or hyperthyroidism. P-values and \\(95 \\%\\)","confidence":0.9563652744645879,"confidence_rate":0.9995448449140374},{"cnt":[[305,584],[1884,584],[1884,634],[305,634]],"region":{"top_left_x":305,"top_left_y":584,"width":1580,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc01cdb7e8d44678883f79fe2af0f7fe","type":"text","conversion_output":true,"text":"confidence intervals will be provided for between-treatment differences in the percentage of","text_display":" confidence intervals will be provided for between-treatment differences in the percentage of","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,632],[752,632],[752,681],[305,681]],"region":{"top_left_x":305,"top_left_y":631,"width":447,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ed85fdcaa4e41d98c29c278ec64e1ea","type":"text","conversion_output":true,"text":"patients with these events.","text_display":" patients with these events.","confidence":1,"confidence_rate":1},{"cnt":[[303,718],[862,718],[862,776],[303,776]],"region":{"top_left_x":302,"top_left_y":717,"width":560,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5c4b121d1d44a7eb89033119124e10d","type":"section_header","conversion_output":false,"children_ids":["b8e6320259624332bb90ccd3bd0d6a08"],"text":"","text_display":""},{"cnt":[[305,722],[857,722],[857,771],[305,771]],"region":{"top_left_x":305,"top_left_y":721,"width":553,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8e6320259624332bb90ccd3bd0d6a08","type":"text","conversion_output":true,"parent_id":"c5c4b121d1d44a7eb89033119124e10d","text":"8.1.3 Power and Sample Size","text_display":"\n\n\\subsection*{8.1.3 Power and Sample Size}","confidence":1,"confidence_rate":1},{"cnt":[[305,812],[1880,812],[1880,862],[305,862]],"region":{"top_left_x":305,"top_left_y":812,"width":1575,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"80a7204592dd40989914bdda54c06de4","type":"text","conversion_output":true,"text":"The study will randomize subjects in a 1:1:1 ratio into two MK-3475 arms and one docetaxel","text_display":"\n\nThe study will randomize subjects in a 1:1:1 ratio into two MK-3475 arms and one docetaxel","confidence":0.986328125,"confidence_rate":0.999855103174726},{"cnt":[[305,859],[1880,859],[1880,909],[305,909]],"region":{"top_left_x":305,"top_left_y":859,"width":1575,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91bb0158b04543778bb4674864275fc2","type":"text","conversion_output":true,"text":"arm. The sample size for subjects with strongly positive PD-L1 is targeted at approximately","text_display":" arm. 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The assumptions for the","text_display":" MK-3475 vs. docetaxel comparisons using Hochberg procedure. The assumptions for the","confidence":1,"confidence_rate":1},{"cnt":[[305,1332],[1405,1332],[1405,1381],[305,1381]],"region":{"top_left_x":305,"top_left_y":1332,"width":1101,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc61b4500fae4890aafb3a79d3789f09","type":"text","conversion_output":true,"text":"sample size and power calculations are specified in Section 8.2.7.","text_display":" sample size and power calculations are specified in Section 8.2.7.","confidence":1,"confidence_rate":1},{"cnt":[[303,1418],[879,1418],[879,1476],[303,1476]],"region":{"top_left_x":302,"top_left_y":1417,"width":577,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f4fe3d730124b0cb0a7c21cef93fef1","type":"section_header","conversion_output":false,"children_ids":["8a9c85b5ee254ced968adcb9324031a7"],"text":"","text_display":""},{"cnt":[[305,1422],[874,1422],[874,1472],[305,1472]],"region":{"top_left_x":305,"top_left_y":1422,"width":570,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a9c85b5ee254ced968adcb9324031a7","type":"text","conversion_output":true,"parent_id":"5f4fe3d730124b0cb0a7c21cef93fef1","text":"8.1.4 Multiplicity Adjustment","text_display":"\n\n\\subsection*{8.1.4 Multiplicity Adjustment}","confidence":1,"confidence_rate":1},{"cnt":[[305,1512],[1880,1512],[1880,1560],[305,1560]],"region":{"top_left_x":305,"top_left_y":1512,"width":1575,"height":48},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ca502f541664ceaa8886f065ee2cf84","type":"text","conversion_output":true,"text":"The multiplicity strategy specified in this section will be applied to the strongly positive PD-","text_display":"\n\nThe multiplicity strategy specified in this section will be applied to the strongly positive PD","confidence":0.966796875,"confidence_rate":0.999665730509501},{"cnt":[[305,1560],[1876,1560],[1876,1609],[305,1609]],"region":{"top_left_x":305,"top_left_y":1559,"width":1571,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b546a47998a44fbbc4dae438cde4edb","type":"text","conversion_output":true,"text":"L1 stratum and the overall positive PD-L1 population for the testing of primary hypotheses.","text_display":"L1 stratum and the overall positive PD-L1 population for the testing of primary hypotheses.","confidence":1,"confidence_rate":1},{"cnt":[[305,1607],[1880,1607],[1880,1656],[305,1656]],"region":{"top_left_x":305,"top_left_y":1607,"width":1575,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ad172558ac54754be6ad6f04dc19695","type":"text","conversion_output":true,"text":"The Hochberg step-up procedure will be used for multiple comparisons on an efficacy","text_display":" The Hochberg step-up procedure will be used for multiple comparisons on an efficacy","confidence":0.9990236759185791,"confidence_rate":0.9999889000502842},{"cnt":[[305,1654],[1880,1654],[1880,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1575,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ab90abe6c4d4bd3a22e6da6cd2df010","type":"text","conversion_output":true,"text":"endpoint if both MK-3475 arms continue to study completion. The type I error rates are all","text_display":" endpoint if both MK-3475 arms continue to study completion. The type I error rates are all","confidence":1,"confidence_rate":1},{"cnt":[[305,1702],[488,1702],[488,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1701,"width":183,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f2f0dd4107e44f1874f5cb80b4b7364","type":"text","conversion_output":true,"text":"one-sided.","text_display":" one-sided.","confidence":1,"confidence_rate":1},{"cnt":[[305,1792],[1878,1792],[1878,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1791,"width":1573,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1e97b8519514522a4f153cee640bb9d","type":"text","conversion_output":true,"text":"The overall type I error is strongly controlled at \\(2.5 \\%\\) (one-sided) with \\(0.35 \\%\\) allocated to","text_display":"\n\nThe overall type I error is strongly controlled at \\(2.5 \\%\\) (one-sided) with \\(0.35 \\%\\) allocated to","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1841],[1880,1841],[1880,1888],[305,1888]],"region":{"top_left_x":305,"top_left_y":1841,"width":1575,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78f31d159b0a4e0f8f8dc942501ef20b","type":"text","conversion_output":true,"text":"PFS and \\(2.15 \\%\\) allocated to OS hypothesis. 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At each analysis, if both MK-3475 arms","text_display":" the final analysis for long-term PFS effect. 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At the second interim analysis, only if both","text_display":" analysis, and at \\(\\geq 0.825 \\%\\) at the final analysis. At the second interim analysis, only if both","confidence":1,"confidence_rate":1},{"cnt":[[305,2217],[1880,2217],[1880,2267],[305,2267]],"region":{"top_left_x":305,"top_left_y":2217,"width":1575,"height":50},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf45cb33dd594e29ae8e590e46c64356","type":"text","conversion_output":true,"text":"MK-3475 arms demonstrate superior OS in the strongly positive PD-L1 stratum, will OS in","text_display":" MK-3475 arms demonstrate superior OS in the strongly positive PD-L1 stratum, will OS in","confidence":1,"confidence_rate":1},{"cnt":[[305,2264],[1880,2264],[1880,2314],[305,2314]],"region":{"top_left_x":305,"top_left_y":2264,"width":1575,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db29327bd33b4c8789003d81923ca808","type":"text","conversion_output":true,"text":"the overall positive PD-L1 population be sequentially tested at the same alpha level. At the","text_display":" the overall positive PD-L1 population be sequentially tested at the same alpha level. At the","confidence":1,"confidence_rate":1},{"cnt":[[305,2312],[1876,2312],[1876,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2311,"width":1571,"height":51},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd6906f27bc7439cb88ef3156b7bf4c2","type":"text","conversion_output":true,"text":"final analysis, OS in the strongly positive PD-L1 stratum and the overall positive PD-L1","text_display":" final analysis, OS in the strongly positive PD-L1 stratum and the overall positive PD-L1","confidence":0.50390625,"confidence_rate":0.9926575717433465},{"cnt":[[305,2361],[1876,2361],[1876,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2361,"width":1571,"height":52},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cadd1988b8e5460fa1ee7c0c1c948391","type":"text","conversion_output":true,"text":"population will be tested simultaneously, with available alpha split evenly between the two","text_display":" population will be tested simultaneously, with available alpha split evenly between the two","confidence":1,"confidence_rate":1},{"cnt":[[305,2411],[896,2411],[896,2460],[305,2460]],"region":{"top_left_x":305,"top_left_y":2410,"width":591,"height":50},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ddd300fb2494041884ae802c4895834","type":"text","conversion_output":true,"text":"tests (see Section 8.2.6 for details).","text_display":" tests (see Section 8.2.6 for details).","confidence":1,"confidence_rate":1},{"cnt":[[305,2535],[814,2535],[814,2576],[305,2576]],"region":{"top_left_x":305,"top_left_y":2535,"width":510,"height":41},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7863d47cac3640fdb24a5e47b9481952","type":"page_info","conversion_output":false,"text":"MK-3475-010-17 Final 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010-17","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999720849711223},{"cnt":[[309,301],[1876,301],[1876,350],[309,350]],"region":{"top_left_x":309,"top_left_y":300,"width":1567,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cffb14d99bd144fca7f12fe9e2230941","type":"text","conversion_output":true,"text":"Since the above alpha allocation strategy does not depend on number of events, it remains","text_display":"\n\nSince the above alpha allocation strategy does not depend on number of events, it remains","confidence":1,"confidence_rate":1},{"cnt":[[309,350],[1876,350],[1876,397],[309,397]],"region":{"top_left_x":309,"top_left_y":350,"width":1567,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13fab50a5f0047058f8c2ffa7578fc10","type":"text","conversion_output":true,"text":"valid in case actual number of events at an interim analysis or final analysis differs from","text_display":" valid in case actual number of events at an interim analysis or final analysis differs from","confidence":1,"confidence_rate":1},{"cnt":[[309,400],[1876,400],[1876,449],[309,449]],"region":{"top_left_x":309,"top_left_y":399,"width":1567,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfb1a6da16b74b4bad35de906ff16376","type":"text","conversion_output":true,"text":"planned number of events. Based on emerging external data, this testing strategy on PD-L1","text_display":" planned number of events. Based on emerging external data, this testing strategy on PD-L1","confidence":1,"confidence_rate":1},{"cnt":[[309,447],[1876,447],[1876,494],[309,494]],"region":{"top_left_x":309,"top_left_y":446,"width":1567,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a4c64a77f3b4a81945e04c758da4287","type":"text","conversion_output":true,"text":"may be modified to improve the efficiency of the design before unblinding the biomarker","text_display":" may be modified to improve the efficiency of the design before unblinding the biomarker","confidence":1,"confidence_rate":1},{"cnt":[[309,494],[1876,494],[1876,544],[309,544]],"region":{"top_left_x":309,"top_left_y":494,"width":1567,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2863544d9da4aca9f9e7d738663641c","type":"text","conversion_output":true,"text":"data. Should it happen, a protocol amendment will be issued to document the change which","text_display":" data. Should it happen, a protocol amendment will be issued to document the change which","confidence":1,"confidence_rate":1},{"cnt":[[309,541],[1128,541],[1128,591],[309,591]],"region":{"top_left_x":309,"top_left_y":541,"width":819,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0574352076ab40b49d1b461f25cfcdf9","type":"text","conversion_output":true,"text":"is not expected to impact the conduct of the trial.","text_display":" is not expected to impact the conduct of the trial.","confidence":1,"confidence_rate":1},{"cnt":[[305,629],[750,629],[750,685],[305,685]],"region":{"top_left_x":305,"top_left_y":629,"width":445,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e2797f05c4e4d72909c81638f325399","type":"section_header","conversion_output":false,"children_ids":["d669b6a123604d2aaac7e76dceb30ef5"],"text":"","text_display":""},{"cnt":[[309,632],[746,632],[746,681],[309,681]],"region":{"top_left_x":309,"top_left_y":631,"width":437,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d669b6a123604d2aaac7e76dceb30ef5","type":"text","conversion_output":true,"parent_id":"4e2797f05c4e4d72909c81638f325399","text":"8.1.5 Interim Analyses","text_display":"\n\n\\subsection*{8.1.5 Interim Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[309,722],[1171,722],[1171,771],[309,771]],"region":{"top_left_x":309,"top_left_y":721,"width":862,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8556da919ce4cb78a1d352ae05595a3","type":"text","conversion_output":true,"text":"There are two planned interim analyses in this trial.","text_display":"\n\nThere are two planned interim analyses in this trial.","confidence":1,"confidence_rate":1},{"cnt":[[309,812],[1876,812],[1876,862],[309,862]],"region":{"top_left_x":309,"top_left_y":812,"width":1567,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33fe32dae6fb4cdfac09b86cfab0789e","type":"text","conversion_output":true,"text":"Table 8 summaries the strategy and timing of each interim analysis. 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The EORTC","text_display":" and tumor volumetric changes will be assessed in the exploratory analysis. The EORTC","confidence":1,"confidence_rate":1},{"cnt":[[305,1036],[1880,1036],[1880,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1035,"width":1575,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86a3b84221bf4c80918eb0c95f156b0f","type":"text","conversion_output":true,"text":"QLQ-C30, EORTC QLQ-LC13, and EQ5D are not pure efficacy or safety endpoints because","text_display":" QLQ-C30, EORTC QLQ-LC13, and EQ5D are not pure efficacy or safety endpoints because","confidence":1,"confidence_rate":1},{"cnt":[[305,1087],[1506,1087],[1506,1137],[305,1137]],"region":{"top_left_x":305,"top_left_y":1087,"width":1202,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"154ac33eb7404fb1bd628539f26e6628","type":"text","conversion_output":true,"text":"they are affected by both disease progression and treatment tolerability.","text_display":" they are affected by both disease progression and treatment tolerability.","confidence":1,"confidence_rate":1},{"cnt":[[301,1169],[821,1169],[821,1233],[301,1233]],"region":{"top_left_x":300,"top_left_y":1168,"width":521,"height":66},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e2a4e0263ce4ae5abb1842424b5a941","type":"section_header","conversion_output":false,"children_ids":["c62e5855c9cd4f53b74ca7b43cbf2db5"],"text":"","text_display":""},{"cnt":[[305,1175],[814,1175],[814,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1175,"width":510,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c62e5855c9cd4f53b74ca7b43cbf2db5","type":"text","conversion_output":true,"parent_id":"4e2a4e0263ce4ae5abb1842424b5a941","text":"8.2.4 Analysis Populations","text_display":"\n\n\\subsection*{8.2.4 Analysis Populations}","confidence":1,"confidence_rate":1},{"cnt":[[301,1259],[1001,1259],[1001,1326],[301,1326]],"region":{"top_left_x":300,"top_left_y":1258,"width":702,"height":68},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"354c9144ab44402d906a75c251dbb81a","type":"section_header","conversion_output":false,"children_ids":["3c6683ea6e1746499640290a3fc6ec14"],"text":"","text_display":""},{"cnt":[[305,1263],[995,1263],[995,1317],[305,1317]],"region":{"top_left_x":305,"top_left_y":1263,"width":690,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c6683ea6e1746499640290a3fc6ec14","type":"text","conversion_output":true,"parent_id":"354c9144ab44402d906a75c251dbb81a","text":"8.2.4.1 Efficacy Analysis Populations","text_display":"\n\n\\subsection*{8.2.4.1 Efficacy Analysis Populations}","confidence":0.99365234375,"confidence_rate":0.9998483951055003},{"cnt":[[305,1354],[1880,1354],[1880,1405],[305,1405]],"region":{"top_left_x":305,"top_left_y":1353,"width":1575,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dfe675446564d8a9baafe96ea67e89f","type":"text","conversion_output":true,"text":"The analysis of primary efficacy endpoints are based on the intention-to-treat (ITT)","text_display":"\n\nThe analysis of primary efficacy endpoints are based on the intention-to-treat (ITT)","confidence":1,"confidence_rate":1},{"cnt":[[305,1401],[1880,1401],[1880,1452],[305,1452]],"region":{"top_left_x":305,"top_left_y":1400,"width":1575,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f18844e7f1149638555c627f6a485db","type":"text","conversion_output":true,"text":"population, i.e., subjects will be included in the treatment group to which they are","text_display":" population, i.e., subjects will be included in the treatment group to which they are","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[305,1448],[1880,1448],[1880,1502],[305,1502]],"region":{"top_left_x":305,"top_left_y":1448,"width":1575,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eefde9d7ad4b4dcf9b2d52d66db9ce44","type":"text","conversion_output":true,"text":"randomized. 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In case","text_display":" initiation of new therapy as a time-dependent binary covariate will also be conducted. In case","confidence":1,"confidence_rate":1},{"cnt":[[305,397],[1880,397],[1880,449],[305,449]],"region":{"top_left_x":305,"top_left_y":397,"width":1575,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beb5393bac9f4f39bc66dc3e033d1a56","type":"text","conversion_output":true,"text":"the proportional hazards assumption doesn't hold, Fleming and Harrington's weighted log-","text_display":" the proportional hazards assumption doesn't hold, Fleming and Harrington's weighted log","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1880,443],[1880,496],[305,496]],"region":{"top_left_x":305,"top_left_y":442,"width":1575,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf5ca6c905044415996dde26abca372c","type":"text","conversion_output":true,"text":"rank test or other methods, as appropriate, will be conducted, after proper adjustment of the","text_display":"rank test or other methods, as appropriate, will be conducted, after proper adjustment of the","confidence":1,"confidence_rate":1},{"cnt":[[305,492],[761,492],[761,539],[305,539]],"region":{"top_left_x":305,"top_left_y":491,"width":456,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4586cb58b7514910b174e79b093762b5","type":"text","conversion_output":true,"text":"crossover effect over time.","text_display":" crossover effect over time.","confidence":1,"confidence_rate":1},{"cnt":[[296,576],[1886,576],[1886,692],[296,692]],"region":{"top_left_x":296,"top_left_y":575,"width":1591,"height":117},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d8858d4aa854457affcaf2e08a5c9ba","type":"section_header","conversion_output":false,"children_ids":["ce5730d8581749d084d0138b6902fb9a","2e111971483d43b49990934bcbe6cde3"],"text":"","text_display":""},{"cnt":[[305,580],[1880,580],[1880,634],[305,634]],"region":{"top_left_x":305,"top_left_y":580,"width":1575,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce5730d8581749d084d0138b6902fb9a","type":"text","conversion_output":true,"parent_id":"1d8858d4aa854457affcaf2e08a5c9ba","text":"Restricted mean survival time (RMST) estimate of OS over time may be calculated as","text_display":"\n\n\\section*{Restricted mean survival time (RMST) estimate of OS over time may be calculated as","confidence":1,"confidence_rate":1},{"cnt":[[305,632],[743,632],[743,683],[305,683]],"region":{"top_left_x":305,"top_left_y":631,"width":439,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e111971483d43b49990934bcbe6cde3","type":"text","conversion_output":true,"parent_id":"1d8858d4aa854457affcaf2e08a5c9ba","text":"an exploratory analysis.","text_display":" an exploratory analysis.}","confidence":1,"confidence_rate":1},{"cnt":[[301,713],[1059,713],[1059,780],[301,780]],"region":{"top_left_x":300,"top_left_y":713,"width":760,"height":67},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af2a4f6eff34cacb24a0d09fb55d480","type":"section_header","conversion_output":false,"children_ids":["a716d898ab1249a8b0b6b1c0c3818527"],"text":"","text_display":""},{"cnt":[[305,718],[1055,718],[1055,776],[305,776]],"region":{"top_left_x":305,"top_left_y":717,"width":750,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a716d898ab1249a8b0b6b1c0c3818527","type":"text","conversion_output":true,"parent_id":"0af2a4f6eff34cacb24a0d09fb55d480","text":"8.2.5.1.2 Progression-free-survival (PFS)","text_display":"\n\n\\subsection*{8.2.5.1.2 Progression-free-survival (PFS)}","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[305,808],[1880,808],[1880,862],[305,862]],"region":{"top_left_x":305,"top_left_y":807,"width":1575,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23e34479d5014c9384ec6c43ad69aede","type":"text","conversion_output":true,"text":"The non-parametric Kaplan-Meier method will be used to estimate the PFS curve in each","text_display":"\n\nThe non-parametric Kaplan-Meier method will be used to estimate the PFS curve in each","confidence":1,"confidence_rate":1},{"cnt":[[305,855],[1882,855],[1882,909],[305,909]],"region":{"top_left_x":305,"top_left_y":855,"width":1578,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9058be163ec24232b14a0634e51acf30","type":"text","conversion_output":true,"text":"treatment group. 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For the primary analysis, for the subjects who have PD,","text_display":" assessment when PD is documented. For the primary analysis, for the subjects who have PD,","confidence":1,"confidence_rate":1},{"cnt":[[305,1379],[1880,1379],[1880,1429],[305,1429]],"region":{"top_left_x":305,"top_left_y":1379,"width":1575,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da812551866438a8421e20687c0ebb6","type":"text","conversion_output":true,"text":"the true date of disease progression will be approximated by the date of first assessment at","text_display":" the true date of disease progression will be approximated by the date of first assessment at","confidence":1,"confidence_rate":1},{"cnt":[[305,1422],[1880,1422],[1880,1476],[305,1476]],"region":{"top_left_x":305,"top_left_y":1422,"width":1575,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41e9b67235904533bccc7d17014078fa","type":"text","conversion_output":true,"text":"which PD is objectively documented, regardless of discontinuation of trial treatment. Death","text_display":" which PD is objectively documented, regardless of discontinuation of trial treatment. Death","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[1880,1474],[1880,1525],[305,1525]],"region":{"top_left_x":305,"top_left_y":1473,"width":1575,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6c32e3d01a4bb6b86a6e2dddc016f6","type":"text","conversion_output":true,"text":"is always considered as a confirmed PD event. Subjects without documented PD/death will","text_display":" is always considered as a confirmed PD event. Subjects without documented PD/death will","confidence":1,"confidence_rate":1},{"cnt":[[305,1521],[1102,1521],[1102,1571],[305,1571]],"region":{"top_left_x":305,"top_left_y":1521,"width":798,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"649d6b4453054f4aa4e199c186c3fe33","type":"text","conversion_output":true,"text":"be censored at the last disease assessment date.","text_display":" be censored at the last disease assessment date.","confidence":1,"confidence_rate":1},{"cnt":[[305,1609],[1880,1609],[1880,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1609,"width":1575,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53593599b0b045858881255c3f4f2ddc","type":"text","conversion_output":true,"text":"There are three sensitivity analyses with a different set of censoring rules and PD event","text_display":"\n\nThere are three sensitivity analyses with a different set of censoring rules and PD event","confidence":1,"confidence_rate":1},{"cnt":[[305,1659],[1880,1659],[1880,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1658,"width":1575,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c0bb0dec37d43c39458b8aee83d0642","type":"text","conversion_output":true,"text":"definitions under various scenarios. The first sensitivity analysis is the same as the primary","text_display":" definitions under various scenarios. 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The second sensitivity analysis","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[305,1800],[1882,1800],[1882,1854],[305,1854]],"region":{"top_left_x":305,"top_left_y":1800,"width":1578,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a259afd299ad4aadba6b72717567f1fd","type":"text","conversion_output":true,"text":"is the same as the primary analysis except that it considers discontinuation of treatment or","text_display":" is the same as the primary analysis except that it considers discontinuation of treatment or","confidence":1,"confidence_rate":1},{"cnt":[[305,1850],[1880,1850],[1880,1901],[305,1901]],"region":{"top_left_x":305,"top_left_y":1849,"width":1575,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b8c62bed3ab4ef484e2f0008d5134da","type":"text","conversion_output":true,"text":"initiation of new anticancer treatment, whichever occurs later, to be a PD event for subjects","text_display":" initiation of new anticancer treatment, whichever occurs later, to be a PD event for subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,1899],[1880,1899],[1880,1949],[305,1949]],"region":{"top_left_x":305,"top_left_y":1899,"width":1575,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11b39c7d56164ceebbbcfe3271c38e8a","type":"text","conversion_output":true,"text":"without documented PD or death. The third sensitivity analysis is the same as the second","text_display":" without documented PD or death. 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Details","text_display":" and tumor volumetric changes will be summarized as part of the exploratory analysis. Details","confidence":1,"confidence_rate":1},{"cnt":[[305,1139],[1652,1139],[1652,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1138,"width":1348,"height":53},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02b8cfa4b4034a17a82897aa1564270e","type":"text","conversion_output":true,"text":"will be provided in a separate document on analysis plan before any unblinding.","text_display":" will be provided in a separate document on analysis plan before any unblinding.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[305,1229],[1880,1229],[1880,1278],[305,1278]],"region":{"top_left_x":305,"top_left_y":1228,"width":1575,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5bdbbd607baf4b7e8194c0624fbc3f7d","type":"text","conversion_output":true,"text":"The correlation of tumor volumetric changes with OS will be explored by appropriate","text_display":"\n\nThe correlation of tumor volumetric changes with OS will be explored by appropriate","confidence":1,"confidence_rate":1},{"cnt":[[305,1276],[1880,1276],[1880,1326],[305,1326]],"region":{"top_left_x":305,"top_left_y":1276,"width":1575,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ccfb349ac61f4300a050c9bd7fcfbab3","type":"text","conversion_output":true,"text":"methods such as the Cox model with the time-dependent covariate of tumor volumetric","text_display":" methods such as the Cox model with the time-dependent covariate of tumor volumetric","confidence":1,"confidence_rate":1},{"cnt":[[305,1323],[462,1323],[462,1377],[305,1377]],"region":{"top_left_x":305,"top_left_y":1323,"width":157,"height":55},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cda186c0dd614cdcb4e52d20d9d5a3d3","type":"text","conversion_output":true,"text":"changes.","text_display":" changes.","confidence":0.99755859375,"confidence_rate":0.9998119875733383},{"cnt":[[301,1409],[1167,1409],[1167,1472],[301,1472]],"region":{"top_left_x":300,"top_left_y":1409,"width":867,"height":63},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22507f63103d48ada6fc98b726299bfb","type":"section_header","conversion_output":false,"children_ids":["cb1cd5431ea74b58abdbb6ceb4d0608b"],"text":"","text_display":""},{"cnt":[[305,1414],[1162,1414],[1162,1467],[305,1467]],"region":{"top_left_x":305,"top_left_y":1413,"width":858,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb1cd5431ea74b58abdbb6ceb4d0608b","type":"text","conversion_output":true,"parent_id":"22507f63103d48ada6fc98b726299bfb","text":"8.2.5.2 Statistical Methods for Safety Analyses","text_display":"\n\n\\subsection*{8.2.5.2 Statistical Methods for Safety Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,1502],[1882,1502],[1882,1553],[305,1553]],"region":{"top_left_x":305,"top_left_y":1501,"width":1578,"height":53},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c41ba947b814bc9b59126e8a063f30d","type":"text","conversion_output":true,"text":"Safety and tolerability will be assessed by clinical review of all relevant parameters including","text_display":"\n\nSafety and tolerability will be assessed by clinical review of all relevant parameters including","confidence":1,"confidence_rate":1},{"cnt":[[305,1551],[1661,1551],[1661,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1551,"width":1356,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af0a27c642234a90bf190c83a1386d47","type":"text","conversion_output":true,"text":"adverse experiences (AEs), laboratory tests, vital signs, and ECG measurements.","text_display":" adverse experiences (AEs), laboratory tests, vital signs, and ECG measurements.","confidence":1,"confidence_rate":1},{"cnt":[[305,1641],[1880,1641],[1880,1691],[305,1691]],"region":{"top_left_x":305,"top_left_y":1641,"width":1575,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1b13f666bde4b3bbbaa0a07d15136df","type":"text","conversion_output":true,"text":"The analysis of safety results will follow a tiered approach (Table 10). 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Summary statistics for baseline, on-treatment, and change from baseline values","text_display":" parameters. Summary statistics for baseline, on-treatment, and change from baseline values","confidence":1,"confidence_rate":1},{"cnt":[[305,773],[1880,773],[1880,827],[305,827]],"region":{"top_left_x":305,"top_left_y":773,"width":1575,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b8fe83c1d4e41878edf89b5eb377456","type":"text","conversion_output":true,"text":"will be provided by treatment group in table format. In addition, summary statistics for the","text_display":" will be provided by treatment group in table format. In addition, summary statistics for the","confidence":1,"confidence_rate":1},{"cnt":[[305,821],[1882,821],[1882,874],[305,874]],"region":{"top_left_x":305,"top_left_y":820,"width":1578,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f06ddf38dde34f2b887777145fac44a6","type":"text","conversion_output":true,"text":"difference between treatment groups will also be provided, along with nominal p -values for","text_display":" difference between treatment groups will also be provided, along with nominal p -values for","confidence":0.708984375,"confidence_rate":0.9966338958117801},{"cnt":[[305,868],[1880,868],[1880,922],[305,922]],"region":{"top_left_x":305,"top_left_y":867,"width":1575,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"718a69c8922445c49233a08ec8edf73f","type":"text","conversion_output":true,"text":"between-group differences. Mean change from baseline over time will be plotted with the","text_display":" between-group differences. Mean change from baseline over time will be plotted with the","confidence":1,"confidence_rate":1},{"cnt":[[305,920],[823,920],[823,969],[305,969]],"region":{"top_left_x":305,"top_left_y":919,"width":518,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a772654150974edd895e12728e7eeb63","type":"text","conversion_output":true,"text":"corresponding standard errors.","text_display":" corresponding standard errors.","confidence":1,"confidence_rate":1},{"cnt":[[305,1005],[1880,1005],[1880,1059],[305,1059]],"region":{"top_left_x":305,"top_left_y":1005,"width":1575,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"545314dcb0a741bcaa0abde947b62617","type":"text","conversion_output":true,"text":"To properly account for the potential difference in follow-up time between the study arms,","text_display":"\n\nTo properly account for the potential difference in follow-up time between the study arms,","confidence":1,"confidence_rate":1},{"cnt":[[305,1055],[1880,1055],[1880,1106],[305,1106]],"region":{"top_left_x":305,"top_left_y":1054,"width":1575,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abd9a791bf694aaeb514be6b11334dd3","type":"text","conversion_output":true,"text":"which is expected to be longer in the MK-3475 arm, an important analysis of Tier 1 AE and","text_display":" which is expected to be longer in the MK-3475 arm, an important analysis of Tier 1 AE and","confidence":0.88720703125,"confidence_rate":0.9987669781395517},{"cnt":[[305,1104],[1880,1104],[1880,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1104,"width":1575,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd9215805db443b1b50f81a3291f7a01","type":"text","conversion_output":true,"text":"Grade 3-5 AE will be based on the time to first event using the same time-to-event analysis","text_display":" Grade 3-5 AE will be based on the time to first event using the same time-to-event analysis","confidence":0.9833984375,"confidence_rate":0.9998256306949188},{"cnt":[[305,1152],[1880,1152],[1880,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1151,"width":1575,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59e6e438e66844f59e093ba5857f682f","type":"text","conversion_output":true,"text":"methods as for OS (i.e., the stratified log-rank test will be used for testing the time to AEs,","text_display":" methods as for OS (i.e., the stratified log-rank test will be used for testing the time to AEs,","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[305,1199],[1880,1199],[1880,1250],[305,1250]],"region":{"top_left_x":305,"top_left_y":1198,"width":1575,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"583ba1dc9db949939ec28cb516187f37","type":"text","conversion_output":true,"text":"and the stratified Cox model with Efron's tie handling method will be used for estimating the","text_display":" and the stratified Cox model with Efron's tie handling method will be used for estimating the","confidence":1,"confidence_rate":1},{"cnt":[[305,1246],[1880,1246],[1880,1300],[305,1300]],"region":{"top_left_x":305,"top_left_y":1246,"width":1575,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57349d3e3f8c4cb882467d9dd94f4f2b","type":"text","conversion_output":true,"text":"hazard ratio and its \\(95 \\%\\) confidence interval). For other AEs with potentially differential","text_display":" hazard ratio and its \\(95 \\%\\) confidence interval). For other AEs with potentially differential","confidence":1,"confidence_rate":1},{"cnt":[[305,1296],[1182,1296],[1182,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":1295,"width":877,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f32d1d5e2024e718d2b2c51ef4aba9f","type":"text","conversion_output":true,"text":"follow-up time, such analysis may also be explored.","text_display":" follow-up time, such analysis may also be explored.","confidence":1,"confidence_rate":1},{"cnt":[[305,1384],[1880,1384],[1880,1437],[305,1437]],"region":{"top_left_x":305,"top_left_y":1383,"width":1575,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54a811c313c547579b5efd5ade3d6650","type":"text","conversion_output":true,"text":"In addition, the p-value and \\(95 \\%\\) confidence interval for between-treatment difference in the","text_display":"\n\nIn addition, the p-value and \\(95 \\%\\) confidence interval for between-treatment difference in the","confidence":0.6278729438781738,"confidence_rate":0.9953566393706531},{"cnt":[[305,1433],[1880,1433],[1880,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1433,"width":1575,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da78f9aa9f4412abca176dc670d3943","type":"text","conversion_output":true,"text":"percentage of subjects with Grade 3-5 AE overall as well as per cycle for the first four cycles,","text_display":" percentage of subjects with Grade 3-5 AE overall as well as per cycle for the first four cycles,","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[305,1482],[1880,1482],[1880,1532],[305,1532]],"region":{"top_left_x":305,"top_left_y":1482,"width":1575,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e3076ebfe8d48c8bcc729f365cad4c4","type":"text","conversion_output":true,"text":"and the between-treatment difference in the Grade 3-5 AE incidence density adjusted for","text_display":" and the between-treatment difference in the Grade 3-5 AE incidence density adjusted for","confidence":0.97705078125,"confidence_rate":0.9997476769303905},{"cnt":[[305,1525],[1880,1525],[1880,1579],[305,1579]],"region":{"top_left_x":305,"top_left_y":1525,"width":1575,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b0707e6b6784764b377364001d9d8f9","type":"text","conversion_output":true,"text":"treatment exposure (AE duration is defined as from first dose of study drug to 30 days after","text_display":" treatment exposure (AE duration is defined as from first dose of study drug to 30 days 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determined to be immune-related by the investigator: 1) Grade \\(\\geq 3\\) diarrhea 2) Grade \\(\\geq 2\\)","confidence":0.9980475902557373,"confidence_rate":0.9999787576367025},{"cnt":[[305,1809],[1880,1809],[1880,1858],[305,1858]],"region":{"top_left_x":305,"top_left_y":1808,"width":1575,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"580ff8d43de149e9814cb5a2d587efaf","type":"text","conversion_output":true,"text":"colitis, 3) Grade \\(\\geq 2\\) pneumonitis, 4) Grade \\(\\geq 3\\) hypo- or hyperthyroidism will be collected as","text_display":" colitis, 3) Grade \\(\\geq 2\\) pneumonitis, 4) Grade \\(\\geq 3\\) hypo- or hyperthyroidism will be collected 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P-values and \\(95 \\%\\) confidence intervals will be provided for between-treatment","text_display":" Tier 1 events. 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At \\(0.5 \\%\\) alpha, both MK arms are","text_display":"\n\n3475 and docetaxel arm under the alternative hypothesis. At \\(0.5 \\%\\) alpha, both MK arms are","confidence":1,"confidence_rate":1},{"cnt":[[305,348],[1880,348],[1880,402],[305,402]],"region":{"top_left_x":305,"top_left_y":348,"width":1575,"height":54},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a2cd36ff4174cd1a36cc4def04ed9ac","type":"text","conversion_output":true,"text":"superior to docetaxel in OS if both MK arms have an observed hazard ratio of approximately","text_display":" superior to docetaxel in OS if both MK arms have an observed hazard ratio of approximately","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,397],[1880,397],[1880,449],[305,449]],"region":{"top_left_x":305,"top_left_y":397,"width":1575,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed8db39bc8be46dbabd57d55600546a9","type":"text","conversion_output":true,"text":"0.570 or less (> 6.8 months of improvement when the median OS in docetaxel is 9 months);","text_display":" 0.570 or less (> 6.8 months of improvement when the median OS in docetaxel is 9 months);","confidence":0.9506721668876708,"confidence_rate":0.9994839495214409},{"cnt":[[305,443],[1884,443],[1884,496],[305,496]],"region":{"top_left_x":305,"top_left_y":442,"width":1580,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e96996bac9749c6a2877f4a586894f9","type":"text","conversion_output":true,"text":"only one MK arm is superior to docetaxel in OS if one MK arm has an observed HR of","text_display":" only one MK arm is superior to docetaxel in OS if one MK arm has an observed HR of","confidence":1,"confidence_rate":1},{"cnt":[[305,492],[1880,492],[1880,544],[305,544]],"region":{"top_left_x":305,"top_left_y":491,"width":1575,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d86605796744fa6aea8a2476d658e5b","type":"text","conversion_output":true,"text":"approximately 0.542 or less ( \\(>7.6\\) months of improvement when median OS in docetaxel is 9","text_display":" approximately 0.542 or less ( \\(>7.6\\) months of improvement when median OS in docetaxel is 9","confidence":0.8141899108886719,"confidence_rate":0.9979257740402584},{"cnt":[[305,541],[1880,541],[1880,591],[305,591]],"region":{"top_left_x":305,"top_left_y":541,"width":1575,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb406cb7e2984b6590334c5f7230e8b9","type":"text","conversion_output":true,"text":"months) but the other MK arm has an observed HR of \\(>0.570\\). If both MK-3475 arms","text_display":" months) but the other MK arm has an observed HR of \\(>0.570\\). If both MK-3475 arms","confidence":0.78271484375,"confidence_rate":0.9972199302806394},{"cnt":[[305,589],[1880,589],[1880,638],[305,638]],"region":{"top_left_x":305,"top_left_y":588,"width":1575,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"097d5060c5b64af6b6529d003987f46b","type":"text","conversion_output":true,"text":"demonstrate superior OS in the strongly positive stratum, OS will be tested in the overall PD-","text_display":" demonstrate superior OS in the strongly positive stratum, OS will be tested in the overall PD","confidence":0.99755859375,"confidence_rate":0.9999753094831817},{"cnt":[[305,636],[1848,636],[1848,690],[305,690]],"region":{"top_left_x":305,"top_left_y":635,"width":1543,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82698556a72b4c2481ca18b15d4095d4","type":"text","conversion_output":true,"text":"L1 positive population at the same alpha level, using the same Hochberg step-up procedure.","text_display":"L1 positive population at the same alpha level, using the same Hochberg step-up procedure.","confidence":1,"confidence_rate":1},{"cnt":[[301,722],[578,722],[578,784],[301,784]],"region":{"top_left_x":300,"top_left_y":721,"width":278,"height":64},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47006f0d3cd5474599fa0c28c28a6770","type":"section_header","conversion_output":false,"children_ids":["db3245d97e7e413db3dd3eafb0e8fb0b"],"text":"","text_display":""},{"cnt":[[305,726],[574,726],[574,780],[305,780]],"region":{"top_left_x":305,"top_left_y":726,"width":269,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db3245d97e7e413db3dd3eafb0e8fb0b","type":"text","conversion_output":true,"parent_id":"47006f0d3cd5474599fa0c28c28a6770","text":"Final Analysis","text_display":"\n\n\\section*{Final Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[305,816],[1880,816],[1880,866],[305,866]],"region":{"top_left_x":305,"top_left_y":816,"width":1575,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70bc787600a946d0b7053a7a94040810","type":"text","conversion_output":true,"text":"The final analysis will be carried out when approximately 200 deaths have occurred across","text_display":"\n\nThe final analysis will be carried out when approximately 200 deaths have occurred across","confidence":1,"confidence_rate":1},{"cnt":[[305,864],[1880,864],[1880,913],[305,913]],"region":{"top_left_x":305,"top_left_y":863,"width":1575,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b53b17a1d8b740f19ee815ae6574ad31","type":"text","conversion_output":true,"text":"three arms in the strongly PD-L1 positive stratum (approximately 140 deaths between one","text_display":" three arms in the strongly PD-L1 positive stratum (approximately 140 deaths between one","confidence":1,"confidence_rate":1},{"cnt":[[305,911],[1497,911],[1497,965],[305,965]],"region":{"top_left_x":305,"top_left_y":910,"width":1193,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fac7c84c90f413697871d0dc4344a49","type":"text","conversion_output":true,"text":"MK-3475 arm and the docetaxel arm under the alternative hypothesis).","text_display":" MK-3475 arm and the docetaxel arm under the alternative hypothesis).","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[305,1001],[1880,1001],[1880,1053],[305,1053]],"region":{"top_left_x":305,"top_left_y":1001,"width":1575,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79195d63ae204923930a0bdd9c486b0d","type":"text","conversion_output":true,"text":"If both MK-3475 arms proceed to study completion, the Hochberg step-up procedure will be","text_display":"\n\nIf both MK-3475 arms proceed to study completion, the Hochberg step-up procedure will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1048],[1880,1048],[1880,1102],[305,1102]],"region":{"top_left_x":305,"top_left_y":1048,"width":1575,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88efd0787ab548b99a14104b0396716a","type":"text","conversion_output":true,"text":"used for OS and PFS testing (MK vs. docetaxel) at the final analysis, giving equal weights to","text_display":" used for OS and PFS testing (MK vs. docetaxel) at the final analysis, giving equal weights to","confidence":1,"confidence_rate":1},{"cnt":[[305,1096],[726,1096],[726,1145],[305,1145]],"region":{"top_left_x":305,"top_left_y":1095,"width":422,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73e44f0122414d669ddf5f46a4ac7025","type":"text","conversion_output":true,"text":"the two MK- 3475 arms.","text_display":" the two MK- 3475 arms.","confidence":0.9208984375,"confidence_rate":0.9972569183771502},{"cnt":[[305,1186],[1880,1186],[1880,1240],[305,1240]],"region":{"top_left_x":305,"top_left_y":1185,"width":1575,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca3bdb0bd8994a14abb1b8456c3bb24d","type":"text","conversion_output":true,"text":"Alpha for OS at the final analysis ( \\(\\alpha_{o s}\\) ) will be between \\(1.65 \\%\\) and \\(2.00 \\%\\), and the actual","text_display":"\n\nAlpha for OS at the final analysis ( \\(\\alpha_{o s}\\) ) will be between \\(1.65 \\%\\) and \\(2.00 \\%\\), and the 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A Bonferroni procedure will be used for the adjustment over the strongly positive","text_display":" analysis. A Bonferroni procedure will be used for the adjustment over the strongly positive","confidence":1,"confidence_rate":1},{"cnt":[[305,1379],[1876,1379],[1876,1429],[305,1429]],"region":{"top_left_x":305,"top_left_y":1379,"width":1571,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35e3b28d532149cc94c61153b53e29c2","type":"text","conversion_output":true,"text":"PD-L1 stratum and the overall PD-L1 positive population. OS will be tested in the PD-L1","text_display":" PD-L1 stratum and the overall PD-L1 positive population. OS will be tested in the PD-L1","confidence":1,"confidence_rate":1},{"cnt":[[305,1427],[1880,1427],[1880,1480],[305,1480]],"region":{"top_left_x":305,"top_left_y":1426,"width":1575,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cde08e0751464263bfbde586227cfdcd","type":"text","conversion_output":true,"text":"strongly positive stratum and the overall PD-L1 positive population each at the same adjusted","text_display":" strongly positive stratum and the overall PD-L1 positive population each at the same adjusted","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[625,1474],[625,1525],[305,1525]],"region":{"top_left_x":305,"top_left_y":1473,"width":321,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bab6fa3b6209460fbc0fa819c7a15fde","type":"text","conversion_output":true,"text":"alpha level ( \\(\\alpha_{ os } / 2\\) ).","text_display":" alpha level ( \\(\\alpha_{ os } / 2\\) ).","confidence":0.9348767773701638,"confidence_rate":0.9983179026320705},{"cnt":[[305,1564],[1880,1564],[1880,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1564,"width":1575,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea71cd35cef647659d79a88726a4c590","type":"text","conversion_output":true,"text":"Based on the Hochberg procedure, if the p -value for both MK arms is \\(<\\alpha_{ os } / 2\\), both MK arms","text_display":"\n\nBased on the Hochberg procedure, if the p -value for both MK arms is \\(<\\alpha_{ os } / 2\\), both MK arms","confidence":0.5651752213220789,"confidence_rate":0.9950070723647129},{"cnt":[[305,1611],[1880,1611],[1880,1663],[305,1663]],"region":{"top_left_x":305,"top_left_y":1611,"width":1575,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7108f759685a4a6faa99fc6294d26837","type":"text","conversion_output":true,"text":"are superior to docetaxel in OS; if the least significant (larger) p -value is \\(>\\alpha_{ os } / 2\\) then the","text_display":" are superior to docetaxel in OS; if the least significant (larger) p -value is \\(>\\alpha_{ os } / 2\\) then the","confidence":0.4899568744003773,"confidence_rate":0.9939721568598868},{"cnt":[[305,1659],[1880,1659],[1880,1710],[305,1710]],"region":{"top_left_x":305,"top_left_y":1658,"width":1575,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"945276a38f0d486b81a431d854230f9e","type":"text","conversion_output":true,"text":"most significant (smaller) p -value needs to be compared with \\(\\alpha_{ os } / 4\\). With \\(0.825 \\%\\) alpha for","text_display":" most significant (smaller) p -value needs to be compared with \\(\\alpha_{ os } / 4\\). With \\(0.825 \\%\\) alpha for","confidence":0.9235335861030574,"confidence_rate":0.9993260906389171},{"cnt":[[305,1706],[1880,1706],[1880,1760],[305,1760]],"region":{"top_left_x":305,"top_left_y":1705,"width":1575,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f84471a53efc4fc3aa207efa24d30466","type":"text","conversion_output":true,"text":"OS in PD-L1 strongly positive stratum at the final analysis, both MK-3475 arms are superior","text_display":" OS in PD-L1 strongly positive stratum at the final analysis, both MK-3475 arms are superior","confidence":1,"confidence_rate":1},{"cnt":[[305,1755],[1880,1755],[1880,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1755,"width":1575,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec687abf11404520bd001cb95242c624","type":"text","conversion_output":true,"text":"to docetaxel if both MK-3475 arms have an observed HR of approximately 0.667 or less for","text_display":" to docetaxel if both MK-3475 arms have an observed HR of approximately 0.667 or less for","confidence":1,"confidence_rate":1},{"cnt":[[305,1800],[1880,1800],[1880,1854],[305,1854]],"region":{"top_left_x":305,"top_left_y":1800,"width":1575,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ad000f055824f4fb2c4b2c5573ecebf","type":"text","conversion_output":true,"text":"both MK arms (> 4.5 months of improvement in OS); only one MK arm is superior to","text_display":" both MK arms (> 4.5 months of improvement in OS); only one MK arm is superior to","confidence":0.83544921875,"confidence_rate":0.9979590660861596},{"cnt":[[305,1852],[1884,1852],[1884,1901],[305,1901]],"region":{"top_left_x":305,"top_left_y":1851,"width":1580,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1457a2b6ce84de4a30863c71aa46e30","type":"text","conversion_output":true,"text":"docetaxel if one MK arm has an observed HR of approximately 0.640 or less (>5.1 months of","text_display":" docetaxel if one MK arm has an observed HR of approximately 0.640 or less (>5.1 months of","confidence":1,"confidence_rate":1},{"cnt":[[305,1899],[1880,1899],[1880,1949],[305,1949]],"region":{"top_left_x":305,"top_left_y":1899,"width":1575,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61cdb1bb8d9947b489df183395326f53","type":"text","conversion_output":true,"text":"improvement in OS) but the other MK arm has an observed HR of \\(>0.667\\). Table 12 shows","text_display":" improvement in OS) but the other MK arm has an observed HR of \\(>0.667\\). Table 12 shows","confidence":0.8782777786254883,"confidence_rate":0.9986489098076252},{"cnt":[[305,1946],[1878,1946],[1878,2000],[305,2000]],"region":{"top_left_x":305,"top_left_y":1946,"width":1573,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"695040460cdd4e4bb637908ac2a983f6","type":"text","conversion_output":true,"text":"the empirical bars for a positive OS in PD-L1 strongly positive stratum at the final analysis.","text_display":" the empirical bars for a positive OS in PD-L1 strongly positive stratum at the final analysis.","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,1996],[1880,1996],[1880,2047],[305,2047]],"region":{"top_left_x":305,"top_left_y":1995,"width":1575,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f8e6fd0ed3e46d68c65a851ca7215e9","type":"text","conversion_output":true,"text":"Similarly, Table 13 shows the empirical bars for a positive OS in the Overall PD-L1 positive","text_display":" Similarly, Table 13 shows the empirical bars for a positive OS in the Overall PD-L1 positive","confidence":1,"confidence_rate":1},{"cnt":[[305,2041],[836,2041],[836,2095],[305,2095]],"region":{"top_left_x":305,"top_left_y":2041,"width":531,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33d0226252fb49a2b472c0799b752b41","type":"text","conversion_output":true,"text":"population at the final analysis.","text_display":" population at the final analysis.","confidence":1,"confidence_rate":1},{"cnt":[[305,2533],[819,2533],[819,2580],[305,2580]],"region":{"top_left_x":305,"top_left_y":2533,"width":514,"height":48},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73d03ecdae124af3ad7d2c5e0e62faf2","type":"page_info","conversion_output":false,"text":"MK-3475-010-17 Final 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MK-3475 (SCH 900475)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1742,129],[1893,129],[1893,174],[1742,174]],"region":{"top_left_x":1742,"top_left_y":128,"width":151,"height":47},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"daa93bd26efe4701ba3fc5f17c9f0d25","type":"page_info","conversion_output":false,"text":"Page 110","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,172],[849,172],[849,213],[305,213]],"region":{"top_left_x":305,"top_left_y":171,"width":544,"height":42},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"115b583cc69848e2b0a361ac5f63ec4a","type":"page_info","conversion_output":false,"text":"Protocol/Amendment No.: 010-17","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[296,294],[1886,294],[1886,458],[296,458]],"region":{"top_left_x":296,"top_left_y":294,"width":1591,"height":164},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afe34d850d8a4747802e58047cad5bfe","type":"figure_label","conversion_output":false,"children_ids":["74eccfd76e624274be1e7d8a58429b84","a98de26cf83e47ada5152d8213290e60","91f38107269243079c808e2c3bdd5870"],"text":"","text_display":""},{"cnt":[[305,301],[1880,301],[1880,352],[305,352]],"region":{"top_left_x":305,"top_left_y":300,"width":1575,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74eccfd76e624274be1e7d8a58429b84","type":"text","conversion_output":false,"parent_id":"afe34d850d8a4747802e58047cad5bfe","text":"Table 12 Approximate empirical bars for a positive OS in the PD-L1 strongly positive","text_display":"","confidence":0.9951193332672119,"confidence_rate":0.9999468208044652},{"cnt":[[481,348],[1880,348],[1880,400],[481,400]],"region":{"top_left_x":481,"top_left_y":348,"width":1399,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a98de26cf83e47ada5152d8213290e60","type":"text","conversion_output":false,"parent_id":"afe34d850d8a4747802e58047cad5bfe","text":"stratum at the final analysis based on outcomes in PFS for the overall PD-L1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[481,397],[814,397],[814,449],[481,449]],"region":{"top_left_x":481,"top_left_y":397,"width":334,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91f38107269243079c808e2c3bdd5870","type":"text","conversion_output":false,"parent_id":"afe34d850d8a4747802e58047cad5bfe","text":"positive population","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[294,477],[1893,477],[1893,1317],[294,1317]],"region":{"top_left_x":294,"top_left_y":476,"width":1599,"height":841},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ffc364012b04eeb982eef7c6b890ee8","type":"table","conversion_output":true,"children_ids":["35a749e4262d491c9b99c25309c81cbb","11931e025d6242608cdafa9b54654bb5","9aa852ade3eb4ee3911bc9d555b28b90","791efd435e6d4956b56a36fa170dd3ca","c094d89ce2bc4f6c8fc766b4892aaa03","ce99bc36623b4b8e8b1ae51ed792c5e8","b2cf1069b4f546c586096058898af915","342c2eb58da34c6483fb2ce592590035","4c46df4a6a5948feb7ea1a324fe64f0e","eb4b4683e4764266b7a92e04c85510a8","47f4dede95824d5188d2ea4bff60e8c6","807bed1ceb3b45aebd5d844b9f9838f8","943f7e27c517454a9086b77baf95a525","df15827550fa403a89a93387a716800e","682fa86aefde49a4913df84782c63046","c329b307382d416a8f127f08d983d5de","9a98a8c0c06e4195837c0329bed310c4","6d9ba5640c644981acc8ad3a0154f7fa","7572bcd9b8eb447b81eadffa77c1df9d","495183fcd1b34737b527dafaf217a2c2","ac1dbbcc993d4ba49eb045c14a2a7b8b","75864143d31c4f9bbe70168ec4acfedb","740e30bc30bc4f048f1595e102d389af","236fc4d230db4ab6a5f86c47da324531","6069d5c4d4b04328b4e19db8c3fd8dfb","1dbb9698f3a44b5088eb181e32950d29","36967ebb6d264a2c9a10962c3465e6b2","a2e479e61e1046138aaf7df4aa901c0a","6099e1f4e895443492f06b77d777a04d","9d203e2e9bc0477c8e61dc97e208bc66","305e81a95afd4de79f2c518b6847490c","078bc837b888482390b345ef9c4d787c","4d61adc04a6f40f1ad07c1e22485302c","d3d7a31357ff4df4b3ce941fbfc927f7","80a68f7749c14e138f7dce43b4dca578","8bfa7c2342c04654b432152fc684c0a8","76250f4b33e04f9f9143159ce5c0fb28"],"selected_labels":["afe34d850d8a4747802e58047cad5bfe"],"text":"\\begin{tabular}{|l|l|l|l|l|}\n\\hline IA2 (alpha \\(=0.25 \\%\\) for PFS) & Final analysis (alpha \\(=0.1 \\%\\) for PFS) & Nominal alpha for OS in PDL1 strong positive & \\begin{tabular}{l}\nBoth MK arms are superior in OS at FA \\\\\nEmpirical hazard ratio \\({ }^{1}\\) (empirical median improvement in month \\({ }^{2}\\) )\n\\end{tabular} & \\begin{tabular}{l}\nOnly One MK arm is superior in OS at FA \\\\\nEmpirical hazard ratio \\({ }^{1}\\) (empirical median improvement in month \\({ }^{2}\\) )\n\\end{tabular} \\\\\n\\hline At least one MK arm does not have superior PFS & At least one MK arm does not have superior PFS & 0.825\\% & 0.667 ( 4.5 m .) & 0.640 (5.1 m.) \\\\\n\\hline At least one MK arm does not have superior PFS & Both MK arms have superior PFS & 0.875\\% & 0.669 (4.4 m.) & 0.642 ( 5.0 m .) \\\\\n\\hline Both MK arms have superior PFS & At least one MK arm does not have superior PFS & 0.95\\% & 0.673 (4.4 m.) & \\(0.645(5.0 m\\). \\\\\n\\hline Both MK arms have superior PFS & Both MK arms have superior PFS & 1.00\\% & \\(0.675(4.3 m)\\) & 0.647 (4.9 m.) \\\\\n\\hline \\multicolumn{5}{|l|}{Observed treatment effect which may lead to statistical significance based on 140 deaths between one MK arm and docetaxel arm in the PD-L1 strongly positive stratum, and half of allocated alpha as a conservative estimate under Hochberg procedure \\({ }^{2}\\) Median survival for docetaxel is assumed to be 9 months} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 12 Approximate empirical bars for a positive OS in the PD-L1 strongly positive stratum at the final analysis based on outcomes in PFS for the overall PD-L1 positive population}\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline IA2 (alpha \\(=0.25 \\%\\) for PFS) & Final analysis (alpha \\(=0.1 \\%\\) for PFS) & Nominal alpha for OS in PDL1 strong positive & \\begin{tabular}{l}\nBoth MK arms are superior in OS at FA \\\\\nEmpirical hazard ratio \\({ }^{1}\\) (empirical median improvement 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Gender, Ethnicity and Minorities}","confidence":1,"confidence_rate":1},{"cnt":[[370,1457],[1880,1457],[1880,1510],[370,1510]],"region":{"top_left_x":369,"top_left_y":1456,"width":1511,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afdcd3d3e3064c4894005256c201a656","type":"text","conversion_output":true,"text":"Although many diagnoses differ in terms of frequency by ethnic population and gender,","text_display":"\n\nAlthough many diagnoses differ in terms of frequency by ethnic population and gender,","confidence":1,"confidence_rate":1},{"cnt":[[370,1508],[1880,1508],[1880,1558],[370,1558]],"region":{"top_left_x":369,"top_left_y":1508,"width":1511,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31cc7d418dff4cf48ef9378d7c4258fe","type":"text","conversion_output":true,"text":"every effort will be made to recruit all subjects diagnosed and treated on Merck clinical","text_display":" every effort will be made to recruit all subjects diagnosed and treated on Merck clinical","confidence":1,"confidence_rate":1},{"cnt":[[370,1555],[1880,1555],[1880,1605],[370,1605]],"region":{"top_left_x":369,"top_left_y":1555,"width":1511,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83e96f4a25514cb78e2994a31c8b5252","type":"text","conversion_output":true,"text":"trials for future biomedical research. 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CR must be confirmed by repeated,","text_display":" measureable or not, and no new lesions). CR must be confirmed by repeated,","confidence":1,"confidence_rate":1},{"cnt":[[430,490],[1880,490],[1880,541],[430,541]],"region":{"top_left_x":429,"top_left_y":489,"width":1451,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b74410fcb4a642a1a2bd515b7a2f5548","type":"text","conversion_output":true,"text":"consecutive assessments performed at the next scheduled time point (i.e., every \\(63+/-\\)","text_display":" consecutive assessments performed at the next scheduled time point (i.e., every \\(63+/-\\)","confidence":0.7947529710121554,"confidence_rate":0.9974221604742223},{"cnt":[[430,537],[571,537],[571,591],[430,591]],"region":{"top_left_x":429,"top_left_y":537,"width":143,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"918e133ca4b3422aafe9ccb8564e42fb","type":"text","conversion_output":true,"text":"7 days).","text_display":" 7 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