Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-04-22 @ 11:33 AM
Study NCT ID:
NCT02659059
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2016-01-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Chile', 'France', 'Germany', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C053518', 'term': 'CP protocol'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, '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': 'Part 1: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 72 months). Part 2: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 59 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 282, 'seriousNumAtRisk': 288, 'deathsNumAffected': 209, 'seriousNumAffected': 171}, {'id': 'EG001', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'deathsNumAffected': 28, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Neuropathy peripheral', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Influenza B virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Paraneoplastic encephalomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Unintended pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Laryngeal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Pulmonary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'PD-L1 ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000', 'lowerLimit': '33.0', 'upperLimit': '50.0'}]}]}, {'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '22.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to database lock (Up to 18 months)', 'description': 'Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \\<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All PD-L1 evaluable participants -Part 1'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 weeks after first dose', 'description': 'Dose limiting toxicities (DLTs) were defined as any of the items listed below.\n\n1. Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment.\n2. Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.\n3. Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days.\n4. Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting \\< 14 days and asymptomatic amylase/lipase elevation.\n5. Drug-related hepatic function laboratory abnormalities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants -Part 2'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Deaths due to Disease progression', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Deaths due to Study drug toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Deaths due to unknown causes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Deaths due to other causes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose', 'description': 'Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants -Part 2'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'title': 'ALT OR AST >3XULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALT OR AST >5XULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALT OR AST >10XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALT OR AST >20XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TOTAL BILIRUBIN >2XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 1 day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 30 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose', 'description': 'Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter -Part 2'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'TSH > ULN with TSH <= ULN at baseline', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'TSH > ULN with at least one FT3/FT4 test value < LLN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'TSH > ULN with all other FT3/FT4 test values ≥ LLN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TSH > ULN with FT3/FT4 test missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'TSH < LLN with TSH >= LLN at baseline', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'TSH < LLN with at least one FT3/FT4 test value > ULN', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'TSH < LLN with all other FT3/FT4 test values <= ULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'TSH < LLN with FT3/Ft4 test missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose', 'description': 'Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on-treatment TSH measurement -Part 2'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'categories': [{'measurements': [{'value': '20.83', 'groupId': 'OG000', 'lowerLimit': '14.46', 'upperLimit': '25.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. 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 in Part 1'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '19.35', 'groupId': 'OG000', 'lowerLimit': '6.54', 'upperLimit': '35.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 59 months)', 'description': 'Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. 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 in Part 2'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'groupId': 'OG000', 'lowerLimit': '3.06', 'upperLimit': '5.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '10.81', 'groupId': 'OG000', 'lowerLimit': '5.26', 'upperLimit': '16.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months)', 'description': 'Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '26.9', 'upperLimit': '38.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '64.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to approximately 59 months', 'description': 'Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by PD-L1 Expression Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'PD-L1 ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.51', 'groupId': 'OG000', 'lowerLimit': '17.12', 'upperLimit': '43.17'}]}]}, {'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.70', 'groupId': 'OG000', 'lowerLimit': '10.71', 'upperLimit': '21.91'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'PD-L1 ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.80', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '10.97'}]}]}, {'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '4.11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'PD-L1 ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '52.9'}]}]}, {'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '25.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All PD-L1 evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'High TMB (>=10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.31', 'comment': 'The 95% upper limit was not reached per the Kaplan-Meier method, as the probability of survival was still above 50%', 'groupId': 'OG000', 'lowerLimit': '14.46', 'upperLimit': 'NA'}]}]}, {'title': 'Low TMB (<10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.33', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '13.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'High TMB (>=10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.84', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '22.21'}]}]}, {'title': 'Low TMB (<10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '5.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}], 'classes': [{'title': 'High TMB (>=10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '66.7'}]}]}, {'title': 'Low TMB (<10 Mutations/MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '34.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All TMB evaluable participants in Part 1. Data was pre-specified to be collected only in Part 1 arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}, {'id': 'FG001', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Study Drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event unrelated to Study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '324 participants treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab+Ipilimumab', 'description': 'Part 1 Nivolumab IV 3 mg/kg Q2W + Ipilimumab IV 1 mg/kg Q6W'}, {'id': 'BG001', 'title': 'Nivolumab+Ipilimumab+Chemotherapy', 'description': 'Part 2 Nivolumab IV 360mg Q3W + Ipilimumab IV 1 mg/kg Q6W + 2 cycles Platinum Doublet Chemotherapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-11', 'size': 3635194, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-10T12:53', 'hasProtocol': True}, {'date': '2019-04-25', 'size': 8234137, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-10T12:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2019-06-21', 'completionDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2016-01-15', 'dispFirstSubmitQcDate': '2019-07-02', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2016-01-15', 'dispFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-01', 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1', 'timeFrame': 'From first dose to database lock (Up to 18 months)', 'description': 'Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \\<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.'}, {'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2', 'timeFrame': '9 weeks after first dose', 'description': 'Dose limiting toxicities (DLTs) were defined as any of the items listed below.\n\n1. Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment.\n2. Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.\n3. Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days.\n4. Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting \\< 14 days and asymptomatic amylase/lipase elevation.\n5. Drug-related hepatic function laboratory abnormalities.'}, {'measure': 'Number of Participants With Adverse Events (AEs) - Part 2', 'timeFrame': 'Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose', 'description': 'Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2', 'timeFrame': 'From first dose to 30 days post last dose', 'description': 'Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2', 'timeFrame': 'From first dose to 30 days post last dose', 'description': 'Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) - Part 1', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.'}, {'measure': 'Overall Survival (OS) - Part 2', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 59 months)', 'description': 'Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.'}, {'measure': 'Progression Free Survival (PFS) - Part 1', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Progression Free Survival (PFS) - Part 2', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months)', 'description': 'Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Objective Response Rate (ORR) - Part 1', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Objective Response Rate (ORR) - Part 2', 'timeFrame': 'From first dose up to approximately 59 months', 'description': 'Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Overall Survival (OS) by PD-L1 Expression Levels - Part 1', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)'}, {'measure': 'Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)'}, {'measure': 'Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nPD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \\<1% = PD-L1 negative (membranous staining in \\<1% tumor cells)'}, {'measure': 'Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1', 'timeFrame': 'From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)', 'description': 'Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase'}, {'measure': 'Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1', 'timeFrame': 'From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)', 'description': 'Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase'}, {'measure': 'Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1', 'timeFrame': 'From first dose up to approximately 72 months', 'description': 'Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.\n\nCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nHigh TMB = ≥ 10 mutations per megabase Low TMB = \\< 10 mutations per megabase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30785829', 'type': 'DERIVED', 'citation': "Ready N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS. First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers. J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20."}], '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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.\n\nThe purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women ≥ 18 years of age\n* Diagnosed with stage IV Non-Small Cell Lung Cancer\n* Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.\n\nExclusion Criteria:\n\n* Subjects with untreated CNS metastases are excluded.\n* Subjects with carcinomatous meningitis\n* Subjects with an active, known or suspected autoimmune disease.\n* Subjects with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.\n* Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02659059', 'acronym': 'CheckMate 568', 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