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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 2:49 PM

Ignite Modification Date: 2025-12-26 @ 12:51 PM

Study NCT ID: NCT03662659

Status: COMPLETED

Last Update Posted: 2025-02-05

First Post: 2018-09-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C519688', 'term': 'XELOX'}, {'id': 'C410216', 'term': 'Folfox protocol'}], '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': 'Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 63 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 63 months).', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 138, 'otherNumAffected': 130, 'seriousNumAtRisk': 136, 'deathsNumAffected': 122, 'seriousNumAffected': 110}, {'id': 'EG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 136, 'otherNumAffected': 133, 'seriousNumAtRisk': 135, 'deathsNumAffected': 118, 'seriousNumAffected': 100}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 18}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cold dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal wall neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphangiosis carcinomatosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 26}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastases to skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastatic gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tumour perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Axonal neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Encephalitis autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '38.2', 'upperLimit': '58.8'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '70.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 25 months', 'description': 'The number of LAG-3 Positive (\\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized LAG-3 positive (\\>=1%) participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'BICR-assessed with LAG-3 expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '42.9'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '54.0'}]}]}, {'title': 'BICR-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '35.8'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '33.5', 'upperLimit': '50.7'}]}]}, {'title': 'Investigator-assessed with LAG-3 expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '43.2', 'upperLimit': '63.8'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '43.7', 'upperLimit': '64.2'}]}]}, {'title': 'Investigator-assessed with LAG-3 expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '53.1'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '59.2'}]}]}, {'title': 'Investigator-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '57.2'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '59.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized LAG-3 positive (\\>=1%) participants, and all randomized LAG-3 negative (\\<1%) participants, and all randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'BICR-assessed with LAG-3 expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.72', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '9.95'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '5.85', 'upperLimit': '20.67'}]}]}, {'title': 'BICR-assessed with LAG-3 expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.44', 'groupId': 'OG000', 'lowerLimit': '3.06', 'upperLimit': '7.00'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '9.95'}]}]}, {'title': 'BICR-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.68', 'groupId': 'OG000', 'lowerLimit': '5.32', 'upperLimit': '9.63'}, {'value': '6.93', 'groupId': 'OG001', 'lowerLimit': '5.55', 'upperLimit': '12.25'}]}]}, {'title': 'Investigator-assessed with LAG-3 expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '4.47', 'upperLimit': '7.82'}, {'value': '10.28', 'groupId': 'OG001', 'lowerLimit': '7.06', 'upperLimit': '15.61'}]}]}, {'title': 'Investigator-assessed with LAG-3 expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.54', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '7.43'}, {'value': '8.31', 'groupId': 'OG001', 'lowerLimit': '6.28', 'upperLimit': '14.13'}]}]}, {'title': 'Investigator-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000', 'lowerLimit': '4.47', 'upperLimit': '6.93'}, {'value': '9.92', 'groupId': 'OG001', 'lowerLimit': '7.13', 'upperLimit': '13.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented complete response (CR) or partial response (PR) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized responders with LAG-3 positive (\\>=1%), and all randomized responders with LAG-3 negative (\\<1%), and all randomized responders'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'LAG-3 Expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.19', 'groupId': 'OG000', 'lowerLimit': '11.89', 'upperLimit': '18.56'}, {'value': '14.98', 'groupId': 'OG001', 'lowerLimit': '10.02', 'upperLimit': '21.98'}]}]}, {'title': 'LAG-3 Expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.72', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '12.75'}, {'value': '15.51', 'groupId': 'OG001', 'lowerLimit': '11.43', 'upperLimit': '17.61'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.65', 'groupId': 'OG000', 'lowerLimit': '10.91', 'upperLimit': '14.49'}, {'value': '15.15', 'groupId': 'OG001', 'lowerLimit': '11.50', 'upperLimit': '17.61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of death due to any cause (Up to 63 months)', 'description': 'Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized LAG-3 positive (\\>=1%) participants, and all randomized LAG-3 negative (\\<1%) participants, and all randomized participants'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'BICR-assessed LAG-3 Expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.26', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '11.07'}, {'value': '10.84', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': '15.70'}]}]}, {'title': 'BICR-assessed LAG-3 Expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.80', 'groupId': 'OG000', 'lowerLimit': '5.98', 'upperLimit': '8.80'}, {'value': '10.45', 'groupId': 'OG001', 'lowerLimit': '6.11', 'upperLimit': '13.70'}]}]}, {'title': 'BICR-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.13', 'groupId': 'OG000', 'lowerLimit': '6.74', 'upperLimit': '9.82'}, {'value': '10.45', 'groupId': 'OG001', 'lowerLimit': '7.13', 'upperLimit': '12.65'}]}]}, {'title': 'Investigator-assessed LAG-3 Expression >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.97', 'groupId': 'OG000', 'lowerLimit': '5.78', 'upperLimit': '8.34'}, {'value': '8.31', 'groupId': 'OG001', 'lowerLimit': '5.88', 'upperLimit': '9.72'}]}]}, {'title': 'Investigator-assessed LAG-3 Expression <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '7.98'}, {'value': '9.69', 'groupId': 'OG001', 'lowerLimit': '6.87', 'upperLimit': '13.70'}]}]}, {'title': 'Investigator-assessed Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.64', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '7.62'}, {'value': '8.31', 'groupId': 'OG001', 'lowerLimit': '6.90', 'upperLimit': '11.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.\n\nProgression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized LAG-3 positive (\\>=1%) participants, and all randomized LAG-3 negative (\\<1%) participants, and all randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Events leading to discontinuation', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60 months', 'description': 'Number of participants who died in each arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities in Specific Liver Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'ALT or AST > 3xULN', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 5xULN', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 10xULN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 20xULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 2xULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALP > 1.5xULN', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN ONE DAY', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN 30 DAYS', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN ONE DAY', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN 30 DAYS', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* ALT or AST \\> 3 x ULN, \\> 5 x ULN, \\> 10 x ULN and \\> 20 x ULN\n* Total bilirubin \\> 2 x ULN\n* ALP \\> 1.5 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 1.5 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 1.5 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'title': 'TSH > ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN WITH TSH >= LLN AT BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* TSH value \\> ULN and\n* with baseline TSH value \\<= ULN\n* with at least one FT3/FT4 test value \\< LLN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\>= LLN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test.\n* TSH \\< LLN and\n* with baseline TSH value \\>= LLN\n* with at least one FT3/FT4 test value \\> ULN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\<= ULN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with thyroid stimulating hormone (TSH) abnormality measurement'}, {'type': 'PRIMARY', 'title': 'BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'OG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '37.9'}, {'value': '43.9', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '54.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'The number of LAG-3 Positive (\\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized LAG-3 positive (\\>=1%) participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'FG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}], 'periods': [{'title': 'Pre-treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Participant no longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Continuing treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '134'}]}], 'dropWithdraws': [{'type': 'Completed Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Adverse Event unrelated to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Administrative reasons by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '274 participants randomized and 271 treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BMS986213 + Chemotherapy', 'description': 'BMS986213 Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'BG001', 'title': 'Nivolumab + Chemotherapy', 'description': 'Nivolumab Q3W + Investigator Choice (IC) Chemotherapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-24', 'size': 3607607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-13T11:38', 'hasProtocol': True}, {'date': '2020-07-27', 'size': 900259, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-13T11:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2021-08-26', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2018-09-06', 'dispFirstSubmitQcDate': '2021-08-26', 'resultsFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2018-09-06', 'dispFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-13', 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants', 'timeFrame': 'Up to 25 months', 'description': 'The number of LAG-3 Positive (\\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions'}, {'measure': 'BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection', 'timeFrame': 'From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'The number of LAG-3 Positive (\\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression \\[per RECISIT 1.1\\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented complete response (CR) or partial response (PR) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.\n\nCR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization to the date of death due to any cause (Up to 63 months)', 'description': 'Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)', 'description': 'Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.\n\nProgression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Up to 60 months', 'description': 'Number of participants who died in each arm.'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Liver Tests', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* ALT or AST \\> 3 x ULN, \\> 5 x ULN, \\> 10 x ULN and \\> 20 x ULN\n* Total bilirubin \\> 2 x ULN\n* ALP \\> 1.5 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 1.5 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 1.5 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'timeFrame': 'From first dose to 30 days post last dose (Up to 60 months)', 'description': 'Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* TSH value \\> ULN and\n* with baseline TSH value \\<= ULN\n* with at least one FT3/FT4 test value \\< LLN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\>= LLN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test.\n* TSH \\< LLN and\n* with baseline TSH value \\>= LLN\n* with at least one FT3/FT4 test value \\> ULN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\<= ULN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Cancer of the Stomach', 'Esophagogastric Junction']}, 'referencesModule': {'references': [{'pmid': '38723227', 'type': 'DERIVED', 'citation': 'Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.'}, {'pmid': '35623069', 'type': 'DERIVED', 'citation': 'Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma\n* No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma\n* Tumor tissue must be provided for biomarker analyses\n\nExclusion Criteria:\n\n* Participants with HER2 positive status\n* Participants with known untreated central nervous system (CNS) metastases\n* Uncontrolled or significant cardiovascular disease\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03662659', 'briefTitle': 'An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CA224-060'}, 'secondaryIdInfos': [{'id': '2018-001069-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "BMS-986213 + investigator's choice chemotherapy", 'description': 'BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX', 'interventionNames': ['Biological: BMS-986213', 'Biological: Nivolumab', 'Drug: XELOX', 'Drug: FOLFOX', 'Drug: SOX']}, {'type': 'EXPERIMENTAL', 'label': "Nivolumab + investigator's choice chemotherapy", 'description': 'Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX', 'interventionNames': ['Biological: Nivolumab', 'Drug: XELOX', 'Drug: FOLFOX', 'Drug: SOX']}], 'interventions': [{'name': 'BMS-986213', 'type': 'BIOLOGICAL', 'description': 'Relatlimab + Nivolumab specified dose on specified days', 'armGroupLabels': ["BMS-986213 + investigator's choice chemotherapy"]}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo', 'BMS-936558'], 'description': 'Specified dose on specified days', 'armGroupLabels': ["BMS-986213 + investigator's choice chemotherapy", "Nivolumab + investigator's choice chemotherapy"]}, {'name': 'XELOX', 'type': 'DRUG', 'description': 'Oxaliplatin + capecitabine', 'armGroupLabels': ["BMS-986213 + investigator's choice chemotherapy", "Nivolumab + investigator's choice chemotherapy"]}, {'name': 'FOLFOX', 'type': 'DRUG', 'description': 'Oxaliplatin + leucovorin + fluorouracil', 'armGroupLabels': ["BMS-986213 + investigator's choice chemotherapy", "Nivolumab + investigator's choice chemotherapy"]}, {'name': 'SOX', 'type': 'DRUG', 'description': 'Oxaliplatin + tegafur/gimeracil/oteracil potassium', 'armGroupLabels': ["BMS-986213 + investigator's choice chemotherapy", "Nivolumab + investigator's choice chemotherapy"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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