Viewing Study NCT02599402

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Ignite Creation Date: 2025-12-25 @ 3:53 AM
Ignite Modification Date: 2026-03-03 @ 4:48 PM
Study NCT ID: NCT02599402
Status: COMPLETED
Last Update Posted: 2021-06-15
First Post: 2015-11-05
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Nivolumab + Ipilimumab Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months', 'otherNumAtRisk': 533, 'deathsNumAtRisk': 533, 'otherNumAffected': 503, 'seriousNumAtRisk': 533, 'deathsNumAffected': 199, 'seriousNumAffected': 356}, {'id': 'EG001', 'title': 'Nivolumab + Ipilimumab ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup', 'otherNumAtRisk': 477, 'deathsNumAtRisk': 477, 'otherNumAffected': 453, 'seriousNumAtRisk': 477, 'deathsNumAffected': 169, 'seriousNumAffected': 324}, {'id': 'EG002', 'title': 'Nivolumab + Ipilimumab ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 49, 'seriousNumAtRisk': 55, 'deathsNumAffected': 29, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Nivolumab + Ipilimumab Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Brain Metastasis subgroup', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 37, 'seriousNumAtRisk': 42, 'deathsNumAffected': 13, 'seriousNumAffected': 31}, {'id': 'EG004', 'title': 'Nivolumab + Ipilimumab Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Mucosal', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 28, 'seriousNumAtRisk': 32, 'deathsNumAffected': 20, 'seriousNumAffected': 26}, {'id': 'EG005', 'title': 'Nivolumab + Ipilimumab Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Ocular/Uveal', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 61, 'seriousNumAtRisk': 64, 'deathsNumAffected': 41, 'seriousNumAffected': 40}, {'id': 'EG006', 'title': 'Nivolumab + Ipilimumab Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Cutaneous', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 347, 'seriousNumAtRisk': 365, 'deathsNumAffected': 107, 'seriousNumAffected': 238}, {'id': 'EG007', 'title': 'Nivolumab + Ipilimumab Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Acral', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 6, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'Nivolumab + Ipilimumab Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Other', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 57, 'seriousNumAtRisk': 62, 'deathsNumAffected': 25, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 35}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 69}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 25}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 73}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 16}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 52}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 22}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 61}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 224}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 209}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 154}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 37}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 105}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 60}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 63}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 173}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 129}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 31}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 91}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 29}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 69}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 29}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 59}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 24}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vein collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 365, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Ipilimumab Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months'}, {'id': 'OG001', 'title': 'Nivolumab + Ipilimumab ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup'}, {'id': 'OG002', 'title': 'Nivolumab + Ipilimumab ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup'}, {'id': 'OG003', 'title': 'Nivolumab + Ipilimumab Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Brain Metastasis subgroup'}, {'id': 'OG004', 'title': 'Nivolumab + Ipilimumab Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Mucosal'}, {'id': 'OG005', 'title': 'Nivolumab + Ipilimumab Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Ocular/Uveal'}, {'id': 'OG006', 'title': 'Nivolumab + Ipilimumab Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Cutaneous'}, {'id': 'OG007', 'title': 'Nivolumab + Ipilimumab Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Acral'}, {'id': 'OG008', 'title': 'Nivolumab + Ipilimumab Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months\n\nParticipants were grouped in to Disease Subtype subgroup Other'}], 'classes': [{'title': 'Pulmonary: Grade 3-4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Pulmonary: Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal: Grade 3-4', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal: Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Skin: Grade 3-4', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Skin: Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Renal: Grade 3-4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Renal: Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hepatic: Grade 3-4', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '56', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Hepatic: Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Endocrine: Grade 3-4', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Endocrine: Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction: Grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction: Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Pulmonary: Grade 3-4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal: Grade 3-4', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal: Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Skin: Grade 3-4', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Renal: Grade 3-4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Renal: Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hepatic: Grade 3-4', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '67', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}]}, {'title': 'Hepatic: Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction: Grade 3-4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Median Time to Onset (Grades 3-4) of Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '783'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '783'}, {'value': '51.0', 'groupId': 'OG005', 'lowerLimit': '51', 'upperLimit': '51'}, {'value': '52.0', 'groupId': 'OG006', 'lowerLimit': '12', 'upperLimit': '783'}]}]}, {'title': 'Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '582'}, {'value': '49.0', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '582'}, {'value': '61.0', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '91'}, {'value': '83.0', 'groupId': 'OG003', 'lowerLimit': '35', 'upperLimit': '543'}, {'value': '42.5', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '543'}, {'value': '39.0', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '95'}, {'value': '49.0', 'groupId': 'OG006', 'lowerLimit': '7', 'upperLimit': '582'}, {'value': '7.0', 'groupId': 'OG007', 'lowerLimit': '7', 'upperLimit': '7'}, {'value': '79.0', 'groupId': 'OG008', 'lowerLimit': '8', 'upperLimit': '281'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '670'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '404'}, {'value': '17.5', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '670'}, {'value': '14.0', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '48.0', 'groupId': 'OG004', 'lowerLimit': '8', 'upperLimit': '69'}, {'value': '36.5', 'groupId': 'OG005', 'lowerLimit': '14', 'upperLimit': '127'}, {'value': '17.5', 'groupId': 'OG006', 'lowerLimit': '4', 'upperLimit': '670'}, {'value': '89.0', 'groupId': 'OG007', 'lowerLimit': '89', 'upperLimit': '89'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '10', 'upperLimit': '338'}]}]}, {'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '540'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '223'}, {'value': '540.0', 'groupId': 'OG002', 'lowerLimit': '540', 'upperLimit': '540'}, {'value': '106.0', 'groupId': 'OG003', 'lowerLimit': '106', 'upperLimit': '106'}, {'value': '23.0', 'groupId': 'OG005', 'lowerLimit': '23', 'upperLimit': '23'}, {'value': '106.0', 'groupId': 'OG006', 'lowerLimit': '14', 'upperLimit': '540'}, {'value': '16.0', 'groupId': 'OG007', 'lowerLimit': '16', 'upperLimit': '16'}, {'value': '6.0', 'groupId': 'OG008', 'lowerLimit': '6', 'upperLimit': '6'}]}]}, {'title': 'Hepatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '67', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '724'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '724'}, {'value': '63.0', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '83'}, {'value': '64.0', 'groupId': 'OG003', 'lowerLimit': '41', 'upperLimit': '724'}, {'value': '139.0', 'groupId': 'OG004', 'lowerLimit': '22', 'upperLimit': '475'}, {'value': '64.0', 'groupId': 'OG005', 'lowerLimit': '16', 'upperLimit': '111'}, {'value': '62.0', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '588'}, {'value': '101.0', 'groupId': 'OG007', 'lowerLimit': '101', 'upperLimit': '101'}, {'value': '80.0', 'groupId': 'OG008', 'lowerLimit': '8', 'upperLimit': '724'}]}]}, {'title': 'Endocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '369'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '369'}, {'value': '67.0', 'groupId': 'OG003', 'lowerLimit': '25', 'upperLimit': '130'}, {'value': '153.0', 'groupId': 'OG004', 'lowerLimit': '102', 'upperLimit': '204'}, {'value': '70.0', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '98'}, {'value': '71.5', 'groupId': 'OG006', 'lowerLimit': '7', 'upperLimit': '369'}, {'value': '114.0', 'groupId': 'OG007', 'lowerLimit': '114', 'upperLimit': '114'}, {'value': '39.5', 'groupId': 'OG008', 'lowerLimit': '16', 'upperLimit': '115'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '291.5', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '561'}, {'value': '291.5', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '561'}, {'value': '22.0', 'groupId': 'OG006', 'lowerLimit': '22', 'upperLimit': '22'}, {'value': '561.0', 'groupId': 'OG008', 'lowerLimit': '561', 'upperLimit': '561'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category'}, {'type': 'SECONDARY', 'title': 'Median Time to Resolution (Grades 3-4) of Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '64'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '64'}, {'value': '6.0', 'groupId': 'OG005', 'lowerLimit': '6', 'upperLimit': '6'}, {'value': '30.0', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '64'}]}]}, {'title': 'Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '684'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '684'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '437'}, {'value': '107.5', 'groupId': 'OG003', 'lowerLimit': '18', 'upperLimit': '666'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '6', 'upperLimit': '437'}, {'value': '14.0', 'groupId': 'OG005', 'lowerLimit': '6', 'upperLimit': '183'}, {'value': '23.0', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '684'}, {'value': '5.0', 'groupId': 'OG007', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '12.0', 'groupId': 'OG008', 'lowerLimit': '4', 'upperLimit': '214'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '690'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '690'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '186'}, {'value': '67.0', 'groupId': 'OG003', 'lowerLimit': '67', 'upperLimit': '67'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '44'}, {'value': '17.5', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '690'}, {'value': '24.0', 'groupId': 'OG006', 'lowerLimit': '8', 'upperLimit': '455'}, {'value': '15.0', 'groupId': 'OG007', 'lowerLimit': '15', 'upperLimit': '15'}, {'value': '28.0', 'groupId': 'OG008', 'lowerLimit': '4', 'upperLimit': '287'}]}]}, {'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '66'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '66'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '11'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '7'}, {'value': '23.0', 'groupId': 'OG005', 'lowerLimit': '23', 'upperLimit': '23'}, {'value': '11.0', 'groupId': 'OG006', 'lowerLimit': '3', 'upperLimit': '60'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG007', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': '66.0', 'groupId': 'OG008', 'lowerLimit': '66', 'upperLimit': '66'}]}]}, {'title': 'Hepatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '67', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '889'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '889'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '225'}, {'value': '17.5', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '285'}, {'value': '126.0', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '625'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '612'}, {'value': '30.0', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '889'}, {'value': '29.0', 'groupId': 'OG007', 'lowerLimit': '29', 'upperLimit': '29'}, {'value': '117.0', 'groupId': 'OG008', 'lowerLimit': '15', 'upperLimit': '285'}]}]}, {'title': 'Endocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '1223'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '1019'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '950'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '931'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG005', 'lowerLimit': '3', 'upperLimit': '670'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG006', 'lowerLimit': '4', 'upperLimit': '1019'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG007', 'lowerLimit': '514', 'upperLimit': '514'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG008', 'lowerLimit': '4', 'upperLimit': '627'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '7.0', 'groupId': 'OG008', 'lowerLimit': '7', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '738'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '738'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '8'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG003', 'lowerLimit': '55', 'upperLimit': '302'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG004', 'lowerLimit': '7', 'upperLimit': '371'}, {'value': '19.0', 'groupId': 'OG005', 'lowerLimit': '6', 'upperLimit': '62'}, {'value': '43.0', 'groupId': 'OG006', 'lowerLimit': '7', 'upperLimit': '738'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG008', 'lowerLimit': '24', 'upperLimit': '302'}]}]}, {'title': 'Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '175', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1016'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1016'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '468'}, {'value': '36.0', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '720'}, {'value': '14.0', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '527'}, {'value': '14.0', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '183'}, {'value': '19.0', 'groupId': 'OG006', 'lowerLimit': '1', 'upperLimit': '1016'}, {'value': '5.0', 'groupId': 'OG007', 'lowerLimit': '1', 'upperLimit': '22'}, {'value': '36.0', 'groupId': 'OG008', 'lowerLimit': '2', 'upperLimit': '645'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '228', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1175'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1175'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '1002'}, {'value': '257.0', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '1011'}, {'value': '84.0', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '1055'}, {'value': '33.5', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '775'}, {'value': '102.0', 'groupId': 'OG006', 'lowerLimit': '1', 'upperLimit': '1175'}, {'value': '46.0', 'groupId': 'OG007', 'lowerLimit': '15', 'upperLimit': '625'}, {'value': '59.5', 'groupId': 'OG008', 'lowerLimit': '2', 'upperLimit': '952'}]}]}, {'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '904'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '904'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '11'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '100'}, {'value': '9.5', 'groupId': 'OG004', 'lowerLimit': '4', 'upperLimit': '15'}, {'value': '27.5', 'groupId': 'OG005', 'lowerLimit': '23', 'upperLimit': '32'}, {'value': '56.0', 'groupId': 'OG006', 'lowerLimit': '2', 'upperLimit': '904'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG007', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG008', 'lowerLimit': '66', 'upperLimit': '603'}]}]}, {'title': 'Hepatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '128', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1008'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1008'}, {'value': '80.5', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '225'}, {'value': '20.5', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '1008'}, {'value': '97.0', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '650'}, {'value': '34.0', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '612'}, {'value': '37.0', 'groupId': 'OG006', 'lowerLimit': '3', 'upperLimit': '912'}, {'value': '129.0', 'groupId': 'OG007', 'lowerLimit': '31', 'upperLimit': '129'}, {'value': '29.0', 'groupId': 'OG008', 'lowerLimit': '8', 'upperLimit': '1008'}]}]}, {'title': 'Endocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '166', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '1223'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '1223'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '917'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '950'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '1139'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '759'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG006', 'lowerLimit': '4', 'upperLimit': '1223'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG007', 'lowerLimit': '40', 'upperLimit': '938'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG008', 'lowerLimit': '6', 'upperLimit': '1060'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG008', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG000', 'lowerLimit': '33.91', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG001', 'lowerLimit': '34.76', 'upperLimit': 'NA'}, {'value': '11.01', 'comment': 'Insufficient data due to insufficient participant follow up.', 'groupId': 'OG002', 'lowerLimit': '7.23', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.55', 'groupId': 'OG004', 'lowerLimit': '3.78', 'upperLimit': '33.91'}, {'value': '15.21', 'groupId': 'OG005', 'lowerLimit': '10.41', 'upperLimit': '21.42'}, {'value': 'NA', 'comment': 'KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '20.83', 'comment': 'Insufficient data due to insufficient participant follow up.', 'groupId': 'OG007', 'lowerLimit': '1.15', 'upperLimit': 'NA'}, {'value': '34.76', 'comment': 'Insufficient data due to insufficient participant follow up.', 'groupId': 'OG008', 'lowerLimit': '16.69', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 37 months', 'description': 'Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Incidence of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}]}, {'title': 'Treatment-Related AEs', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}, {'value': '332', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '35', 'groupId': 'OG008'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '238', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Incidence of Participants With Select Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '175', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}]}, {'title': 'Skin', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '228', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '128', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '166', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}]}, {'title': 'Hypersensitivity/Infusion Reaction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Incidence of Participants With Laboratory Abnormalities - Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'ALT OR AST > 5XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}]}, {'title': 'ALT OR AST > 10XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'ALT OR AST > 20XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 1 DAY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3XULN; TOTAL BILIRUBIN > 2XULN IN 30 DAYS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '338', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '57', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment measurement of the corresponding laboratory parameter'}, {'type': 'SECONDARY', 'title': 'Incidence of Participants With Laboratory Abnormalities - Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '313', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '91', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '79', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '124', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}]}, {'title': 'TSH <LLN WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '116', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment TSH measurement'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '48.8'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '50.7'}, {'value': '30.9', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '44.8'}, {'value': '52.4', 'groupId': 'OG003', 'lowerLimit': '36.4', 'upperLimit': '68.0'}, {'value': '43.8', 'groupId': 'OG004', 'lowerLimit': '26.4', 'upperLimit': '62.3'}, {'value': '9.4', 'groupId': 'OG005', 'lowerLimit': '3.5', 'upperLimit': '19.3'}, {'value': '51.2', 'groupId': 'OG006', 'lowerLimit': '46.0', 'upperLimit': '56.5'}, {'value': '30.0', 'groupId': 'OG007', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '43.5', 'groupId': 'OG008', 'lowerLimit': '31.0', 'upperLimit': '56.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 37 months', 'description': 'Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '365', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG001', 'title': 'ECOG PS0-1', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG002', 'title': 'ECOG PS2', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG003', 'title': 'Brain Metastasis', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG004', 'title': 'Mucosal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG005', 'title': 'Ocular/Uveal', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG006', 'title': 'Cutaneous', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG007', 'title': 'Acral', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}, {'id': 'OG008', 'title': 'Other', 'description': 'Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240mg) IV Q2W'}], 'classes': [{'categories': [{'measurements': [{'value': '4.96', 'groupId': 'OG000', 'lowerLimit': '3.45', 'upperLimit': '6.77'}, {'value': '5.45', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '7.69'}, {'value': '2.46', 'groupId': 'OG002', 'lowerLimit': '1.77', 'upperLimit': '3.75'}, {'value': '3.35', 'comment': 'Insufficient data due to insufficient participant follow up.', 'groupId': 'OG003', 'lowerLimit': '1.81', 'upperLimit': 'NA'}, {'value': '2.94', 'groupId': 'OG004', 'lowerLimit': '2.53', 'upperLimit': '8.74'}, {'value': '2.83', 'groupId': 'OG005', 'lowerLimit': '2.73', 'upperLimit': '4.63'}, {'value': '6.77', 'groupId': 'OG006', 'lowerLimit': '4.67', 'upperLimit': '10.45'}, {'value': '2.56', 'groupId': 'OG007', 'lowerLimit': '1.15', 'upperLimit': '8.48'}, {'value': '5.22', 'groupId': 'OG008', 'lowerLimit': '2.76', 'upperLimit': '27.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 37 months', 'description': 'Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab + Ipilimumab Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '533'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '533'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '153'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Adverse Event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Maximum Clinical Benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant no longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '95'}]}]}], 'preAssignmentDetails': '533 participants treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab + Ipilimumab Total', 'description': 'Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months\n\nThen\n\nPart 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'spread': '13.55', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '316', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '515', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '521', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-31', 'size': 2732600, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-23T15:43', 'hasProtocol': True}, {'date': '2020-02-25', 'size': 10639973, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-23T15:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2015-11-05', 'resultsFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-20', 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity'}], 'secondaryOutcomes': [{'measure': 'Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity'}, {'measure': 'Median Time to Onset (Grades 3-4) of Select Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity'}, {'measure': 'Median Time to Resolution (Grades 3-4) of Select Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity'}, {'measure': 'Time to Resolution of an Adverse Event (AE)', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 37 months', 'description': 'Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive'}, {'measure': 'Incidence of Participants With Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths'}, {'measure': 'Incidence of Participants With Select Adverse Events', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity'}, {'measure': 'Incidence of Participants With Laboratory Abnormalities - Liver', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)'}, {'measure': 'Incidence of Participants With Laboratory Abnormalities - Thyroid', 'timeFrame': 'From first dose to 30 days after last dose (up to approximately 37 months)', 'description': 'Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 37 months', 'description': 'Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 37 months', 'description': 'Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '37307514', 'type': 'DERIVED', 'citation': 'Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.\n* Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.\n\nNOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.\n\n* Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (\\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.\n\nExclusion Criteria:\n\n* Leptomenigeal metastases\n* Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.'}, 'identificationModule': {'nctId': 'NCT02599402', 'acronym': 'CheckMate 401', 'briefTitle': 'Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma 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