Viewing Study NCT01454102

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Ignite Creation Date: 2025-12-25 @ 3:49 AM
Ignite Modification Date: 2025-12-26 @ 2:37 AM
Study NCT ID: NCT01454102
Status: COMPLETED
Last Update Posted: 2021-10-12
First Post: 2011-09-16
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'Adverse event data was only collected by cohort and not by dose. All participants in "Arm C10: Nivolumab (10 mg/kg) + Paclitaxel + Carboplatin" and "Arm C5: Nivolumab (5 mg/kg) + Paclitaxel + Carboplatin" were monitored for adverse events under a single "Arm C" as a cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Arm J: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression', 'otherNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 12}, {'id': 'EG006', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity', 'otherNumAtRisk': 40, 'otherNumAffected': 33, 'seriousNumAtRisk': 40, 'seriousNumAffected': 21}, {'id': 'EG007', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity', 'otherNumAtRisk': 38, 'otherNumAffected': 35, 'seriousNumAtRisk': 38, 'seriousNumAffected': 25}, {'id': 'EG008', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity', 'otherNumAtRisk': 39, 'otherNumAffected': 33, 'seriousNumAtRisk': 39, 'seriousNumAffected': 25}, {'id': 'EG009', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 10}, {'id': 'EG010', 'title': 'Arm C: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 17}, {'id': 'EG011', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 3}, {'id': 'EG012', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'seriousNumAffected': 11}, {'id': 'EG013', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 52, 'otherNumAffected': 50, 'seriousNumAtRisk': 52, 'seriousNumAffected': 23}, {'id': 'EG014', 'title': 'Arm G: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 6}, {'id': 'EG015', 'title': 'Arm H: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 12}, {'id': 'EG016', 'title': 'Arm I: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial 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'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '31', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Selected Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '31', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'title': 'Endorcrine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '12', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '13', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}]}]}, {'title': 'Skin', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '20', 'groupId': 'OG012'}, {'value': '21', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}]}]}, {'title': 'Hypersensitivity/Infusion Reactions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and\n\nHypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles:\n\n* AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies\n* AEs that may require immunosuppression (eg, corticosteroids) as part of their management\n* AEs whose early recognition and management may mitigate severe toxicity\n* AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '29', 'groupId': 'OG011'}, {'value': '37', 'groupId': 'OG012'}, {'value': '37', 'groupId': 'OG013'}, {'value': '36', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}]}, {'title': 'ALT OR AST > 5XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'ALT OR AST > 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'AST or ALT>3XULN with Bilirubin>2XULN within 1 day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'AST or ALT>3XULN with Bilirubin>2XULN within 30day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of subjects with selected hepatic laboratory abnormalities is reported.\n\nAST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with baseline and post-baseline measurements'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '29', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}, {'value': '34', 'groupId': 'OG013'}, {'value': '28', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}]}]}, {'title': 'TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}]}, {'title': 'TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}]}]}, {'title': 'TSH < LLN WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}]}]}, {'title': 'TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}]}, {'title': 'TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date.\n\nTSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with baseline and post-baseline measurements'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '31', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '72.3'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '73.4'}, {'value': '46.7', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '73.4'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '48.4'}, {'value': '19.0', 'groupId': 'OG004', 'lowerLimit': '5.4', 'upperLimit': '41.9'}, {'value': '23.1', 'groupId': 'OG005', 'lowerLimit': '12.5', 'upperLimit': '36.8'}, {'value': '20.8', 'groupId': 'OG006', 'lowerLimit': '7.1', 'upperLimit': '42.2'}, {'value': '24.0', 'groupId': 'OG007', 'lowerLimit': '9.4', 'upperLimit': '45.1'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '24.7'}, {'value': '15.4', 'groupId': 'OG009', 'lowerLimit': '1.9', 'upperLimit': '45.4'}, {'value': '8.3', 'groupId': 'OG010', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '22.6', 'groupId': 'OG011', 'lowerLimit': '9.6', 'upperLimit': '41.1'}, {'value': '32.5', 'groupId': 'OG012', 'lowerLimit': '18.6', 'upperLimit': '49.1'}, {'value': '47.4', 'groupId': 'OG013', 'lowerLimit': '31.0', 'upperLimit': '64.2'}, {'value': '38.5', 'groupId': 'OG014', 'lowerLimit': '23.4', 'upperLimit': '55.4'}, {'value': '50.0', 'groupId': 'OG015', 'lowerLimit': '23.0', 'upperLimit': '77.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months)', 'description': 'ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Rate (PFSR) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '31', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '38', 'groupId': 'OG013'}, {'value': '39', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'OG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'OG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'OG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'OG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'OG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'OG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '75.7'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '86.8'}, {'value': '34.3', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '59.2'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '27.0', 'upperLimit': '80.1'}, {'value': '50.6', 'groupId': 'OG004', 'lowerLimit': '27.7', 'upperLimit': '69.7'}, {'value': '39.7', 'groupId': 'OG005', 'lowerLimit': '26.0', 'upperLimit': '53.1'}, {'value': '42.8', 'groupId': 'OG006', 'lowerLimit': '22.4', 'upperLimit': '61.8'}, {'value': '37.3', 'groupId': 'OG007', 'lowerLimit': '18.1', 'upperLimit': '56.7'}, {'value': '50.0', 'groupId': 'OG008', 'lowerLimit': '20.8', 'upperLimit': '73.6'}, {'value': '20.5', 'groupId': 'OG009', 'lowerLimit': '3.3', 'upperLimit': '47.8'}, {'value': '8.3', 'groupId': 'OG010', 'lowerLimit': '0.5', 'upperLimit': '31.1'}, {'value': '49.1', 'groupId': 'OG011', 'lowerLimit': '30.3', 'upperLimit': '65.5'}, {'value': '48.0', 'groupId': 'OG012', 'lowerLimit': '31.6', 'upperLimit': '62.7'}, {'value': '72.4', 'groupId': 'OG013', 'lowerLimit': '54.7', 'upperLimit': '84.1'}, {'value': '39.5', 'groupId': 'OG014', 'lowerLimit': '24.2', 'upperLimit': '54.4'}, {'value': '59.3', 'groupId': 'OG015', 'lowerLimit': '27.5', 'upperLimit': '81.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy).\n\nPFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'FG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'FG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'FG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'FG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'FG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'FG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'FG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'FG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'FG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'FG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '24'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '13'}, {'groupId': 'FG009', 'numSubjects': '13'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '31'}, {'groupId': 'FG012', 'numSubjects': '40'}, {'groupId': 'FG013', 'numSubjects': '38'}, {'groupId': 'FG014', 'numSubjects': '39'}, {'groupId': 'FG015', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '22'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '13'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '27'}, {'groupId': 'FG012', 'numSubjects': '33'}, {'groupId': 'FG013', 'numSubjects': '34'}, {'groupId': 'FG014', 'numSubjects': '36'}, {'groupId': 'FG015', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Continuing in the treatment period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '472 participants were enrolled; 376 participants received at least one dose of study treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '31', 'groupId': 'BG011'}, {'value': '40', 'groupId': 'BG012'}, {'value': '38', 'groupId': 'BG013'}, {'value': '39', 'groupId': 'BG014'}, {'value': '14', 'groupId': 'BG015'}, {'value': '376', 'groupId': 'BG016'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'BG001', 'title': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'BG002', 'title': 'Arm C10: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4'}, {'id': 'BG003', 'title': 'Arm D: Nivolumab + Bevacizumab Maintenance', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression'}, {'id': 'BG004', 'title': 'Arm E: Nivolumab + Erlotinib', 'description': 'Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG005', 'title': 'Arm F: Nivolumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG006', 'title': 'Arm GH: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG007', 'title': 'Arm IJ: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG008', 'title': 'Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)', 'description': 'SQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'BG009', 'title': 'Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)', 'description': 'NSQ subjects who completed \\>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression'}, {'id': 'BG010', 'title': 'Arm M: Nivolumab', 'description': 'Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG011', 'title': 'Arm N: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression'}, {'id': 'BG012', 'title': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'BG013', 'title': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity'}, {'id': 'BG014', 'title': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity'}, {'id': 'BG015', 'title': 'Arm C5: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4'}, {'id': 'BG016', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '6.82', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '11.20', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '8.81', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '9.53', 'groupId': 'BG003'}, {'value': '62.8', 'spread': '9.41', 'groupId': 'BG004'}, {'value': '67.0', 'spread': '9.96', 'groupId': 'BG005'}, {'value': '60.5', 'spread': '6.99', 'groupId': 'BG006'}, {'value': '63.1', 'spread': '8.31', 'groupId': 'BG007'}, {'value': '63.6', 'spread': '10.15', 'groupId': 'BG008'}, {'value': '68.7', 'spread': '12.64', 'groupId': 'BG009'}, {'value': '62.6', 'spread': '12.65', 'groupId': 'BG010'}, {'value': '61.5', 'spread': '10.85', 'groupId': 'BG011'}, {'value': '64.9', 'spread': '11.25', 'groupId': 'BG012'}, {'value': '65.9', 'spread': '9.36', 'groupId': 'BG013'}, {'value': '64.4', 'spread': '9.95', 'groupId': 'BG014'}, {'value': '64.9', 'spread': '9.79', 'groupId': 'BG015'}, {'value': '64.0', 'spread': '9.95', 'groupId': 'BG016'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}, {'value': '22', 'groupId': 'BG012'}, {'value': '21', 'groupId': 'BG013'}, {'value': '15', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '188', 'groupId': 'BG016'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '18', 'groupId': 'BG012'}, {'value': '17', 'groupId': 'BG013'}, {'value': '24', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '188', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2011-09-16', 'resultsFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-02', 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death', 'timeFrame': 'From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.'}, {'measure': 'Number of Participants Who Experienced Selected Adverse Events', 'timeFrame': 'From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and\n\nHypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles:\n\n* AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies\n* AEs that may require immunosuppression (eg, corticosteroids) as part of their management\n* AEs whose early recognition and management may mitigate severe toxicity\n* AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization.'}, {'measure': 'Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests', 'timeFrame': 'From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of subjects with selected hepatic laboratory abnormalities is reported.\n\nAST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal.'}, {'measure': 'Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests', 'timeFrame': 'From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)', 'description': 'The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date.\n\nTSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months)', 'description': 'ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression.'}, {'measure': 'Progression-Free Survival Rate (PFSR) at Week 24', 'timeFrame': '24 weeks', 'description': 'Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy).\n\nPFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '27354485', 'type': 'BACKGROUND', 'citation': 'Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Sep 1;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929. Epub 2016 Jun 27.'}, {'pmid': '27354481', 'type': 'BACKGROUND', 'citation': 'Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S. Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Sep 1;34(25):2969-79. doi: 10.1200/JCO.2016.66.9861. Epub 2016 Jun 27.'}, {'pmid': '27932067', 'type': 'BACKGROUND', 'citation': 'Hellmann MD, Rizvi NA, Goldman JW, Gettinger SN, Borghaei H, Brahmer JR, Ready NE, Gerber DE, Chow LQ, Juergens RA, Shepherd FA, Laurie SA, Geese WJ, Agrawal S, Young TC, Li X, Antonia SJ. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. Lancet Oncol. 2017 Jan;18(1):31-41. doi: 10.1016/S1470-2045(16)30624-6. Epub 2016 Dec 5.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': '* The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC.\n* The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of platinum doublet chemotherapy.\n* The study is evaluating the safety and tolerability of Nivolumab in combination with Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous NSCLC subjects and as monotherapy in subjects with NSCLC.\n* The study is evaluating the safety and tolerability of Nivolumab in combination with Ipilimumab in subjects with squamous and non-squamous NSCLC.\n* The study is evaluating the safety and tolerability of Nivolumab as switch maintenance therapy in subjects with squamous and non-squamous NSCLC.\n* The study is evaluating the safety and tolerability of Nivolumab as monotherapy among subjects with untreated, asymptomatic brain metastases and no evidence of cerebral edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Newly diagnosed and confirmed Stage IIIB/IV NSCLC\n* Previously treated NSCLC with asymptomatic brain metastases (eligible for Arm M) See additional details below\n* Men and women aged ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Subject must be chemotherapy naive (except Arm D, K, L and M). Prior use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is acceptable. For Arms D, K, and L, subjects must be non-progressors within 42 days after completion of first-line treatment with ≥4 cycles of Platinum Doublet chemotherapy with or without Bevacizumab. See below for Arm M\n* Either a formalin fixed tissue block or a minimum of 10 slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling)\n* Life expectancy of at least 3 months\n* Prior radiotherapy must have been completed at least 2 weeks prior to study entry\n\nFor Arm M:\n\n* No more than 4 brain metastases\n* Each brain metastases ≤3 cm in size\n* No evidence of cerebral edema\n* Subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ≥10 days prior to initiation of study treatment\n* At least 1 measurable target brain lesion \\>0.5 cm and no larger than 3 cm in diameter and/or 2 measurable brain target lesions \\>0.3 cm\n* No prior radiation therapy, surgery, or other local therapy for target brain lesions\n* Must have received at least one prior systemic anticancer therapy for NSCLC\n\nExclusion Criteria:\n\n* Subjects with symptomatic brain metastases, spinal cord compression, or intractable back pain due to a compressive or destructive mass\n* Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy\n* Any active or history of a known autoimmune disease\n* Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric, or colon cancers or cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period\n* History of Grade ≥2 neuropathy\n* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity'}, 'identificationModule': {'nctId': 'NCT01454102', 'briefTitle': 'Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CA209-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab + Gemcitabine + Cisplatin', 'description': 'Nivolumab solution intravenously every 3 weeks until progressive disease (PD) or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle\n\nGemcitabine solution intravenously on Day 1 and Day 8 of every cycle for 4 cycles\n\nCisplatin solution intravenously on Day 1 of each cycle for 4 cycles', 'interventionNames': ['Biological: Nivolumab', 'Drug: Gemcitabine', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'description': 'Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle\n\nPemetrexed solution intravenously on Day 1 of every cycle for 4 cycles\n\nCisplatin solution intravenously on Day 1 of each cycle for 4 cycles', 'interventionNames': ['Biological: Nivolumab', 'Drug: Cisplatin', 'Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Nivolumab + Paclitaxel + Carboplatin', 'description': 'Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle\n\nPaclitaxel solution intravenously on Day 1 of every cycle for 4 cycles\n\nCarboplatin area under curve (AUC) 6 solution intravenously on Day 1 of every cycle for 4 cycles', 'interventionNames': ['Biological: Nivolumab', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: Nivolumab + Bevacizumab maintenance', 'description': 'Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle\n\nBevacizumab administered prior to intravenous infusion on Cycle 1 Day 1 followed by intravenous infusion every 3 weeks on Cycle 2 onwards and until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E: Nivolumab + Erlotinib', 'description': 'Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle\n\nErlotinib tablet by mouth daily until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F: Nivolumab', 'description': 'Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G: Nivolumab + Ipilimumab', 'description': 'In Squamous histology subjects (NSCLC)\n\nNivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles\n\nIpilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles\n\nFollowed by Nivolumab administered until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm H: Nivolumab + Ipilimumab', 'description': 'In non-squamous histology subjects (NSCLC)\n\nNivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles\n\nIpilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles\n\nFollowed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm I: Nivolumab + Ipilimumab', 'description': 'In squamous histology subjects (NSCLC)\n\nNivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles\n\nIpilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles\n\nFollowed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm J: Nivolumab + Ipilimumab', 'description': 'In non-squamous histology subjects (NSCLC)\n\nNivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles\n\nIpilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles\n\nFollowed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm K: Nivolumab', 'description': 'In squamous histology subjects (NSCLC)\n\nNivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered as switch maintenance therapy. A cycle is 2 weeks', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm L: Nivolumab', 'description': 'In non-squamous histology subjects (NSCLC)\n\nNivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes as switch maintenance therapy. A cycle is 2 weeks', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm M: Nivolumab', 'description': 'NSCLC subjects with untreated, asymptomatic brain metastases and have no evidence of cerebral edema\n\nNivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered for up to an hour as monotherapy. A cycle is 2 weeks', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm N: Nivolumab + Ipilimumab', 'description': 'In subjects with any histology (NSCLC)\n\nNivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles\n\nIpilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles\n\nFollowed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm O: Nivolumab + Ipilimumab', 'description': 'Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity\n\nIpilimumab at specified dose/schedule until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm P: Nivolumab + Ipilimumab', 'description': 'Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity\n\nIpilimumab at specified dose/schedule until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Q: Nivolumab + Ipilimumab', 'description': 'Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity\n\nIpilimumab at specified dose/schedule until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm R: Nivolumab + Ipilimumab', 'description': 'Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity\n\nIpilimumab at specified dose/schedule until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm S: Nivolumab + Ipilimumab', 'description': 'Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity\n\nIpilimumab at specified dose/schedule until PD or discontinuation due to toxicity', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558'], 'armGroupLabels': ['Arm A: Nivolumab + Gemcitabine + Cisplatin', 'Arm B: Nivolumab + Pemetrexed + Cisplatin', 'Arm C: Nivolumab + Paclitaxel + Carboplatin', 'Arm D: Nivolumab + Bevacizumab maintenance', 'Arm E: Nivolumab + Erlotinib', 'Arm F: Nivolumab', 'Arm G: Nivolumab + Ipilimumab', 'Arm H: Nivolumab + Ipilimumab', 'Arm I: Nivolumab + Ipilimumab', 'Arm J: Nivolumab + Ipilimumab', 'Arm K: Nivolumab', 'Arm L: Nivolumab', 'Arm M: Nivolumab', 'Arm N: Nivolumab + Ipilimumab', 'Arm O: Nivolumab + Ipilimumab', 'Arm P: Nivolumab + Ipilimumab', 'Arm Q: Nivolumab + Ipilimumab', 'Arm R: Nivolumab + Ipilimumab', 'Arm S: Nivolumab + Ipilimumab']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['Arm A: Nivolumab + Gemcitabine + Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm A: Nivolumab + Gemcitabine + Cisplatin', 'Arm B: Nivolumab + Pemetrexed + Cisplatin']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'armGroupLabels': ['Arm B: Nivolumab + Pemetrexed + Cisplatin']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Arm C: Nivolumab + Paclitaxel + Carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm C: Nivolumab + Paclitaxel + Carboplatin']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'armGroupLabels': ['Arm D: Nivolumab + Bevacizumab maintenance']}, {'name': 'Erlotinib', 'type': 'DRUG', 'armGroupLabels': ['Arm E: Nivolumab + Erlotinib']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Arm G: Nivolumab + Ipilimumab', 'Arm H: Nivolumab + Ipilimumab', 'Arm I: Nivolumab + Ipilimumab', 'Arm J: Nivolumab + Ipilimumab', 'Arm N: Nivolumab + Ipilimumab', 'Arm O: Nivolumab + Ipilimumab', 'Arm P: Nivolumab + Ipilimumab', 'Arm Q: Nivolumab + Ipilimumab', 'Arm R: Nivolumab + Ipilimumab', 'Arm S: Nivolumab + Ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ucla', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390-8852', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ut Southwestern Medical Center At Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington - Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}