Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT00527735
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2007-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS 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': {'eventGroups': [{'id': 'EG000', 'title': 'Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC', 'description': 'During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.', 'otherNumAtRisk': 71, 'otherNumAffected': 63, 'seriousNumAtRisk': 71, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC', 'description': 'During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.', 'otherNumAtRisk': 67, 'otherNumAffected': 63, 'seriousNumAtRisk': 67, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Placebo + Paclitaxel/Carboplatin NSCLC', 'description': 'During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.', 'otherNumAtRisk': 65, 'otherNumAffected': 59, 'seriousNumAtRisk': 65, 'seriousNumAffected': 33}, {'id': 'EG003', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC', 'description': 'During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.', 'otherNumAtRisk': 42, 'otherNumAffected': 36, 'seriousNumAtRisk': 42, 'seriousNumAffected': 25}, {'id': 'EG004', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC', 'description': 'During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.', 'otherNumAtRisk': 42, 'otherNumAffected': 39, 'seriousNumAtRisk': 42, 'seriousNumAffected': 21}, {'id': 'EG005', 'title': 'Placebo + Paclitaxel/Carboplatin SCLC', 'description': 'During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.', 'otherNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 44, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 8}], 'organSystem': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERIPHERAL MOTOR NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'TRACHEO-OESOPHAGEAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DROWNING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GASTRITIS EROSIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 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0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ICHTHYOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, 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'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.52', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '6.74'}, {'value': '5.68', 'groupId': 'OG001', 'lowerLimit': '4.76', 'upperLimit': '7.79'}, {'value': '4.63', 'groupId': 'OG002', 'lowerLimit': '4.14', 'upperLimit': '5.52'}]}]}], 'analyses': [{'pValue': '0.1302', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.806', 'ciLowerLimit': '0.553', 'ciUpperLimit': '1.174', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0473', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.724', 'ciLowerLimit': '0.495', 'ciUpperLimit': '1.059', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)', 'description': 'irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.11', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '5.32'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '4.17', 'upperLimit': '5.72'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '2.76', 'upperLimit': '5.32'}]}]}], 'analyses': [{'pValue': '0.2502', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.882', 'ciLowerLimit': '0.612', 'ciUpperLimit': '1.271', 'statisticalMethod': 'One-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0240', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.691', 'ciLowerLimit': '0.478', 'ciUpperLimit': '0.999', 'statisticalMethod': 'One-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)', 'description': 'By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All NSCLC participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Participants With NSCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'groupId': 'OG000', 'lowerLimit': '7.59', 'upperLimit': '12.48'}, {'value': '12.22', 'groupId': 'OG001', 'lowerLimit': '9.26', 'upperLimit': '14.39'}, {'value': '8.28', 'groupId': 'OG002', 'lowerLimit': '6.80', 'upperLimit': '12.39'}]}]}], 'analyses': [{'pValue': '0.4759', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.988', 'ciLowerLimit': '0.669', 'ciUpperLimit': '1.460', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2340', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.866', 'ciLowerLimit': '0.587', 'ciUpperLimit': '1.278', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization date to date of death (of censored, maximum reached: 26.5 months)', 'description': 'Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All NSCLC participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '32.29'}, {'value': '32.4', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '44.8'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '6.4', 'upperLimit': '24.3'}]}]}, {'title': 'BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '48.5'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '72.3'}, {'value': '48.9', 'groupId': 'OG002', 'lowerLimit': '33.7', 'upperLimit': '64.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance', 'description': 'mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of \\>=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'irBORR ( irRC) NSCLC cohort (n=70, 68, 66)', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '32.29'}, {'value': '32.4', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '44.8'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '29.6'}]}]}, {'title': 'irBORR (irRC) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '64.5'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '84.3'}, {'value': '53.3', 'groupId': 'OG002', 'lowerLimit': '37.9', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance', 'description': 'irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'irDCR (irRC) NSCLC cohort (n=70, 68, 66)', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '80.4'}, {'value': '86.8', 'groupId': 'OG001', 'lowerLimit': '76.4', 'upperLimit': '93.8'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '70.4', 'upperLimit': '90.2'}]}]}, {'title': 'DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '68.9'}, {'value': '77.9', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '87.1'}, {'value': '72.7', 'groupId': 'OG002', 'lowerLimit': '60.4', 'upperLimit': '83.0'}]}]}, {'title': 'rDCR (irRC) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '91.6'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '98.5'}, {'value': '95.6', 'groupId': 'OG002', 'lowerLimit': '84.9', 'upperLimit': '99.5'}]}]}, {'title': 'DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '53.9', 'upperLimit': '82.8'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '91.4'}, {'value': '93.3', 'groupId': 'OG002', 'lowerLimit': '81.7', 'upperLimit': '98.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)', 'description': 'irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'irDoR (irRC) NSCLC cohort (n=70, 63, 62)', 'categories': [{'measurements': [{'value': '6.70', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '8.51'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': '6.74'}, {'value': '4.01', 'groupId': 'OG002', 'lowerLimit': '4.01', 'upperLimit': '5.72'}]}]}, {'title': 'DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)', 'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '7.43'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': '6.74'}, {'value': '4.01', 'groupId': 'OG002', 'lowerLimit': '3.94', 'upperLimit': '5.59'}]}]}, {'title': 'irDoR (irRC) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '5.95', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '10.8'}, {'value': '5.78', 'groupId': 'OG001', 'lowerLimit': '4.44', 'upperLimit': '6.67'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '3.91', 'upperLimit': '6.41'}]}]}, {'title': 'DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)', 'categories': [{'measurements': [{'value': '7.62', 'groupId': 'OG000', 'lowerLimit': '4.90', 'upperLimit': '11.1'}, {'value': '5.78', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '6.57'}, {'value': '4.21', 'groupId': 'OG002', 'lowerLimit': '3.91', 'upperLimit': '5.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)', 'description': 'irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Deaths (total)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Deaths within 30 days of last dose of study drug', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Deaths within 70 days of last dose of study drug', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'SAEs (total)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Drug-related', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Drug-related Grade 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to discontinuation (disc) (total)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related (all)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AEs (total)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Grades 3 and 4', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related Any Grade', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related Grades 3 and 4', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related Grade 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)', '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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'White blood cell count, Grades 3 and 4', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Any grade', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}, {'value': '98.5', 'groupId': 'OG001'}, {'value': '90.2', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Grades 3 and 4', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'ANC, Grades 3 and 4', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, Grades 3 and 4', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\\<LLN to 3.0\\*10\\^9/L, Gr 2:\\<3.0 to 2.0\\*10\\^9/L, Gr 3:\\<2.0 to 1.0\\*10\\^9/L, Gr 4:\\<1.0\\*10\\^9/L. ANC Gr 1:\\<LLN to 1.5\\*10\\^9/L, Gr 2:\\<1.5 to 1.0\\*10\\^9/L, Gr 3:\\<1.0 to 0.5\\*10\\^9/L, Gr 4:\\<0.5\\*10\\^9/L. Platelet count Gr 1:LLN to 75.0\\*10\\^9/L, Gr 2:\\<75.0 to 50.0\\*10\\^9/L, Gr 3:\\<50.0 to 25.0\\*10\\^9/L, Gr 4:\\<25.0 to 10\\^9/L. Hemoglobin Gr 1:\\<LLN to 10.0 g/dL, Gr 2:\\<10.0 to 8.0 g/dL, Gr 3:\\<8.0 to 6.5 g/dL, Gr 4:\\<6.5 g/dL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.'}, {'type': 'SECONDARY', 'title': 'irPFS in Participants With SCLC Per irRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'groupId': 'OG000', 'lowerLimit': '5.19', 'upperLimit': '6.87'}, {'value': '6.44', 'groupId': 'OG001', 'lowerLimit': '5.29', 'upperLimit': '7.75'}, {'value': '5.26', 'groupId': 'OG002', 'lowerLimit': '4.67', 'upperLimit': '5.72'}]}]}], 'analyses': [{'pValue': '0.1098', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.751', 'ciLowerLimit': '0.475', 'ciUpperLimit': '1.188', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0282', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.640', 'ciLowerLimit': '0.403', 'ciUpperLimit': '1.1016', 'statisticalMethod': '1-sided log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization date to date of irPD or death (maximum reached: 22 months)', 'description': 'IRC performed TA.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Alanine aminotransferase (ALT), Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Grades 3 and 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase (AST), Grade 1', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'AST, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Grades 3 and 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grades 3 and 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase, Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase, Grades 3 and 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. AST Grade 1: \\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. Total bilirubin Grade 1: \\>ULN to 1.5\\*ULN; Grade 2: \\>1.5 to 3.0\\*ULN; Grade 3: \\>3.0 to 10.0\\*ULN; Grade 4: \\>10.0\\*ULN. ALK (U/L) G1:\\>ULN to 2.5\\*ULN, G2:\\>2.5 to 5.0\\*ULN, G3:\\>5.0 to 20.0\\*ULN, G4:\\>20.0\\*ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Vital sign measurements', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Physical examination findings', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Lipase, Grades 3 and 4', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Amylase, Grades 3 and 4', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39\\*ULN; Gr 2: \\>1.5 to 2.0\\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\\*ULN. Amylase (U/L) Gr 1: \\>ULN to 1.5\\*ULN; Grade 2 \\>1.5 to 2.0\\*ULN, Grade 3 \\>2.0 to 5.0\\*ULN, Grade 4 \\>5.0\\*ULN. Creatine (mg/dL) Grade 1: \\>ULN to 1.5\\*ULN, Gr 2: 1.5 to 3.0\\*ULN, Gr 3: \\>3.0 to 6.0\\*ULN, Gr 4: \\>6.0\\*ULN.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Deaths (total)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Deaths within 30 days of last dose of study drug', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Deaths within 70 days of last dose of study drug', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'SAEs (total)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Grade 5', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Drug-related', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'SAEs, Drug-related Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to discontinuation (disc) (total)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related (all)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to disc, Drug-related Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs (total)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Grades 3 and 4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Grade 5', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related (all)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related,Grades 3 and 4', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'AEs, Drug-related, Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)', '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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'White blood cells, Grade 1 (n=39, 42, 43)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'White blood cells, Grade 2 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'White blood cells, Grades 3 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cells, Grade 4 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Absolute neutrophil count, Grade 1 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Absolute neutrophil count, Grade 2 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Absolute neutrophil count, Grade 3 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Absolute neutrophil count, Grade 4 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, Grade 1 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, Grade 2 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, Grade 3 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, Grade 4 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Grade 1 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Grade 2 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Grade 3 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, Grade 4 (n= 39, 42, 43)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment', 'description': 'CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\\<LLN to 3.0\\*10\\^9/L, Gr 2:\\<3.0 to 2.0\\*10\\^9/L, Gr 3:\\<2.0 to 1.0\\*10\\^9/L, Gr 4:\\<1.0\\*10\\^9/L. ANC Gr 1:\\<LLN to 1.5\\*10\\^9/L, Gr 2:\\<1.5 to 1.0\\*10\\^9/L, Gr 3:\\<1.0 to 0.5\\*10\\^9/L, Gr 4:\\<0.5\\*10\\^9/L. Platelet count Gr 1:LLN to 75.0\\*10\\^9/L, Gr 2:\\<75.0 to 50.0\\*10\\^9/L, Gr 3:\\<50.0 to 25.0\\*10\\^9/L, Gr 4:\\<25.0 to 10\\^9/L. Hemoglobin Gr 1:\\<LLN to 10.0 g/dL, Gr 2:\\<10.0 to 8.0 g/dL, Gr 3:\\<8.0 to 6.5 g/dL, Gr 4:\\<6.5 g/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'ALT, Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Grades 3 & 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'AST, Grade 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST, Grades 3 & 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, Grades 3 & 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALK, Grade 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'ALK, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ALK, Grades 3 & 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:\\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. AST Grade 1: \\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. Total bilirubin Grade 1: \\>ULN to 1.5\\*ULN; Grade 2: \\>1.5 to 3.0\\*ULN; Grade 3: \\>3.0 to 10.0\\*ULN; Grade 4: \\>10.0\\*ULN. ALK (U/L) G1:\\>ULN to 2.5\\*ULN, G2:\\>2.5 to 5.0\\*ULN, G3:\\>5.0 to 20.0\\*ULN, G4:\\>20.0\\*ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Lipase, Grades 3 and 4', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '11.6', 'groupId': 'OG002'}]}]}, {'title': 'Amylase, Grades 3 and 4', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, Grades 3 and 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment', 'description': 'ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39\\*ULN; Gr 2: \\>1.5 to 2.0\\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\\*ULN. Amylase (U/L) Gr 1: \\>ULN to 1.5\\*ULN; Gr 2 \\>1.5 to 2.0\\*ULN, Gr 3 \\>2.0 to 5.0\\*ULN, Gr 4 \\>5.0\\*ULN. Creatine (mg/dL) Gr 1: \\>ULN to 1.5\\*ULN, Gr 2: 1.5 to 3.0\\*ULN, Gr 3: \\>3.0 to 6.0\\*ULN, Gr 4: \\>6.0\\*ULN.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '2.89', 'upperLimit': '5.85'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '6.57'}, {'value': '5.19', 'groupId': 'OG002', 'lowerLimit': '4.40', 'upperLimit': '5.59'}]}]}], 'analyses': [{'pValue': '0.3846', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.933', 'ciLowerLimit': '0.588', 'ciUpperLimit': '1.481', 'statisticalMethod': '1-sided Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3700', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.927', 'ciLowerLimit': '0.591', 'ciUpperLimit': '1.453', 'statisticalMethod': '1-sided Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization date to date of progression or death (of censored, maximum reached: 22 months)', 'description': 'By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who were randomized to a treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'title': 'Vital sign measurements', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Physical examination findings', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment', 'description': 'Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}], 'classes': [{'title': 'Positive at any timepoint (n=42, 42)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Positive postbaseline (n=38, 41)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Participants With SCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'OG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '2.89', 'upperLimit': '5.85'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '6.57'}, {'value': '5.19', 'groupId': 'OG002', 'lowerLimit': '4.40', 'upperLimit': '5.59'}]}]}], 'analyses': [{'pValue': '0.4132', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.947', 'ciLowerLimit': '0.585', 'ciUpperLimit': '1.536', 'statisticalMethod': '1-sided Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1287', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.753', 'ciLowerLimit': '0.461', 'ciUpperLimit': '1.232', 'statisticalMethod': '1-sided Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization date to date of death (of censored, maximum reached: 22 months)', 'description': 'Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with SCLC who were randomized to a treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'FG001', 'title': 'Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'FG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treated', 'groupId': 'FG000', 'numSubjects': '113'}, {'comment': 'Treated', 'groupId': 'FG001', 'numSubjects': '109'}, {'comment': 'Treated', 'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Still on treatment', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': 'Still on treatment', 'groupId': 'FG001', 'numSubjects': '2'}, {'comment': 'Still on treatment', 'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '107'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Completed treatment in treatment phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Not identified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'No longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Poor compliance or noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Completed treatment during maintenance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '334', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'BG001', 'title': 'Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)', 'description': 'During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.'}, {'id': 'BG002', 'title': 'Placebo + Paclitaxel/Carboplatin', 'description': 'During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Younger than 65 years', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}, {'title': '65 years and older', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Age of participants who received treatment.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Customized, by Disease Type', 'classes': [{'title': 'Younger than 65 years (NSCLC patients)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}, {'title': '65 years and older (NSCLC patients)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Younger than 65 years (SCLC patients)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': '65 years and older (SCLC patients)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer', 'unitOfMeasure': 'Participants'}, {'title': 'Gender, by Disease Type', 'classes': [{'title': 'Female (NSCLC patients)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'Male (NSCLC patients)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}, {'title': 'Female (SCLC patients)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Male (SCLC patients)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Stage at Study Entry', 'classes': [{'title': 'Stage IIIB (NSCLC patients)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Stage IV (NSCLC patients)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}]}, {'title': 'Extensive (SCLC patients)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}, {'title': 'Recurrent disease (SCLC patients)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer. Staging of NSCLC is based on the findings of several clinical tests, including magnetic resonance imaging scans and fine needle biopsy. Stages range from 1 (best prognosis) to IV (worst prognosis). Stage I cancer is confined to the lung. Stages II and III cancers are locally advanced. Stage IV cancer has spread outside the lung to other organs. SCLC is staged using a 2-tiered system: Limited stage SCLC is confined to its area of origin in the lung and lumph nodes. Extensive-stage SCLC has spread beyond the lung to other organs.', 'unitOfMeasure': 'Participants'}, {'title': 'Cell Type', 'classes': [{'title': 'Adenocarcinoma (NSCLC patients)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}]}, {'title': 'Bronchoalveolar carcinoma (NSCLC patients)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Large-cell carcinoma (NSCLC patients)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Other (NSCLC patients)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Squamous-cell carcinoma (NSCLC patients)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Unknown (NSCLC patients)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Other (SCLC patients)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Small-cell carcinoma (SCLC patients)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}, {'title': 'Unknown (SCLC patients)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Not reported (SCLC patients)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'NSCLC=nonsmall-cell lung cancer; SCLC=small-cell lung cancer', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'dispFirstSubmitDate': '2011-01-29', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2007-09-07', 'dispFirstSubmitQcDate': '2011-01-29', 'resultsFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2007-09-10', 'dispFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-06-11', 'studyFirstPostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)', 'timeFrame': 'Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)', 'description': 'irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria', 'timeFrame': 'Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)', 'description': 'By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.'}, {'measure': 'Overall Survival in Participants With NSCLC', 'timeFrame': 'Randomization date to date of death (of censored, maximum reached: 26.5 months)', 'description': 'Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.'}, {'measure': 'Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance', 'description': 'mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of \\>=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.'}, {'measure': 'Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance', 'description': 'irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.'}, {'measure': 'Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC', 'timeFrame': 'Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)', 'description': 'irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.'}, {'measure': 'Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC', 'timeFrame': 'Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)', 'description': 'irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.'}, {'measure': 'Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade', 'timeFrame': 'Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)', '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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.'}, {'measure': 'Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade', 'timeFrame': 'At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\\<LLN to 3.0\\*10\\^9/L, Gr 2:\\<3.0 to 2.0\\*10\\^9/L, Gr 3:\\<2.0 to 1.0\\*10\\^9/L, Gr 4:\\<1.0\\*10\\^9/L. ANC Gr 1:\\<LLN to 1.5\\*10\\^9/L, Gr 2:\\<1.5 to 1.0\\*10\\^9/L, Gr 3:\\<1.0 to 0.5\\*10\\^9/L, Gr 4:\\<0.5\\*10\\^9/L. Platelet count Gr 1:LLN to 75.0\\*10\\^9/L, Gr 2:\\<75.0 to 50.0\\*10\\^9/L, Gr 3:\\<50.0 to 25.0\\*10\\^9/L, Gr 4:\\<25.0 to 10\\^9/L. Hemoglobin Gr 1:\\<LLN to 10.0 g/dL, Gr 2:\\<10.0 to 8.0 g/dL, Gr 3:\\<8.0 to 6.5 g/dL, Gr 4:\\<6.5 g/dL.'}, {'measure': 'irPFS in Participants With SCLC Per irRC', 'timeFrame': 'Randomization date to date of irPD or death (maximum reached: 22 months)', 'description': 'IRC performed TA.'}, {'measure': 'Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. AST Grade 1: \\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. Total bilirubin Grade 1: \\>ULN to 1.5\\*ULN; Grade 2: \\>1.5 to 3.0\\*ULN; Grade 3: \\>3.0 to 10.0\\*ULN; Grade 4: \\>10.0\\*ULN. ALK (U/L) G1:\\>ULN to 2.5\\*ULN, G2:\\>2.5 to 5.0\\*ULN, G3:\\>5.0 to 20.0\\*ULN, G4:\\>20.0\\*ULN.'}, {'measure': 'Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings', 'timeFrame': 'At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent', 'description': 'Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.'}, {'measure': 'Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39\\*ULN; Gr 2: \\>1.5 to 2.0\\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\\*ULN. Amylase (U/L) Gr 1: \\>ULN to 1.5\\*ULN; Grade 2 \\>1.5 to 2.0\\*ULN, Grade 3 \\>2.0 to 5.0\\*ULN, Grade 4 \\>5.0\\*ULN. Creatine (mg/dL) Grade 1: \\>ULN to 1.5\\*ULN, Gr 2: 1.5 to 3.0\\*ULN, Gr 3: \\>3.0 to 6.0\\*ULN, Gr 4: \\>6.0\\*ULN.'}, {'measure': 'Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline', 'timeFrame': 'Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.'}, {'measure': 'Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade', 'timeFrame': 'Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)', '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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.'}, {'measure': 'Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade', 'timeFrame': 'At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment', 'description': 'CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\\<LLN to 3.0\\*10\\^9/L, Gr 2:\\<3.0 to 2.0\\*10\\^9/L, Gr 3:\\<2.0 to 1.0\\*10\\^9/L, Gr 4:\\<1.0\\*10\\^9/L. ANC Gr 1:\\<LLN to 1.5\\*10\\^9/L, Gr 2:\\<1.5 to 1.0\\*10\\^9/L, Gr 3:\\<1.0 to 0.5\\*10\\^9/L, Gr 4:\\<0.5\\*10\\^9/L. Platelet count Gr 1:LLN to 75.0\\*10\\^9/L, Gr 2:\\<75.0 to 50.0\\*10\\^9/L, Gr 3:\\<50.0 to 25.0\\*10\\^9/L, Gr 4:\\<25.0 to 10\\^9/L. Hemoglobin Gr 1:\\<LLN to 10.0 g/dL, Gr 2:\\<10.0 to 8.0 g/dL, Gr 3:\\<8.0 to 6.5 g/dL, Gr 4:\\<6.5 g/dL.'}, {'measure': 'Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade', 'timeFrame': 'At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:\\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. AST Grade 1: \\>ULN to 2.5\\*ULN; Grade 2: \\>2.5 to 5.0\\*ULN; Grade 3: \\>5.0 to 20.0\\*ULN; Grade 4: \\>20.0\\*ULN. Total bilirubin Grade 1: \\>ULN to 1.5\\*ULN; Grade 2: \\>1.5 to 3.0\\*ULN; Grade 3: \\>3.0 to 10.0\\*ULN; Grade 4: \\>10.0\\*ULN. ALK (U/L) G1:\\>ULN to 2.5\\*ULN, G2:\\>2.5 to 5.0\\*ULN, G3:\\>5.0 to 20.0\\*ULN, G4:\\>20.0\\*ULN.'}, {'measure': 'Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade', 'timeFrame': 'At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment', 'description': 'ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39\\*ULN; Gr 2: \\>1.5 to 2.0\\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\\*ULN. Amylase (U/L) Gr 1: \\>ULN to 1.5\\*ULN; Gr 2 \\>1.5 to 2.0\\*ULN, Gr 3 \\>2.0 to 5.0\\*ULN, Gr 4 \\>5.0\\*ULN. Creatine (mg/dL) Gr 1: \\>ULN to 1.5\\*ULN, Gr 2: 1.5 to 3.0\\*ULN, Gr 3: \\>3.0 to 6.0\\*ULN, Gr 4: \\>6.0\\*ULN.'}, {'measure': 'Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria', 'timeFrame': 'Randomization date to date of progression or death (of censored, maximum reached: 22 months)', 'description': 'By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.'}, {'measure': 'Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings', 'timeFrame': 'Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment', 'description': 'Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.'}, {'measure': 'Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline', 'timeFrame': 'Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment', 'description': 'An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.'}, {'measure': 'Overall Survival in Participants With SCLC', 'timeFrame': 'Randomization date to date of death (of censored, maximum reached: 22 months)', 'description': 'Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer (NSCLC)', 'Small Cell Lung Cancer (SCLC)'], 'conditions': ['Lung Cancer', 'Small Cell Lung Cancer', 'Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \\[SCLC\\])\n* Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria\n* Eastern Cooperative Oncology Group performance status of ≤1 at study entry\n* Accessible for treatment and follow-up\n\nExclusion Criteria:\n\n* Brain metastases\n* Malignant pleural effusion\n* Autoimmune disease\n* Motor neuropathy of autoimmune origin\n* SCLC-related paraneoplastic syndromes\n* Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)\n* Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.\n\n * Grade 2 peripheral neuropathy (motor or sensory)\n* Known HIV or hepatitis B or C infection\n* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.\n* Inadequate hematologic function defined by an absolute neutrophil count \\<1,500/mm\\^3, a platelet count \\<100,000/mm\\^3, or hemoglobin level \\<9 g/dL.\n* Inadequate hepatic function defined by a total bilirubin level \\>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.\n* Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN\n* Inadequate creatinine clearance defined as less than 50 mL/min.'}, 'identificationModule': {'nctId': 'NCT00527735', 'briefTitle': 'Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer', 'orgStudyIdInfo': {'id': 'CA184-041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)', 'interventionNames': ['Drug: Ipilimumab', 'Drug: Placebo', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)', 'interventionNames': ['Drug: Ipilimumab', 'Drug: Placebo', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ipilimumab placebo + paclitaxel + carboplatin', 'interventionNames': ['Drug: Placebo', 'Drug: Paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Ipilimumab', 'type': 'DRUG', 'description': 'Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). 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