Viewing Study NCT04349267

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Ignite Creation Date: 2025-12-25 @ 12:45 AM
Ignite Modification Date: 2026-01-05 @ 2:45 PM
Study NCT ID: NCT04349267
Status: COMPLETED
Last Update Posted: 2025-12-17
First Post: 2020-04-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Chile'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], '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': 'All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).', 'description': 'All-cause mortality, serious and other adverse events were collected for all the treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 7, 'seriousNumAffected': 8}, {'id': 'EG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 14, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Detachment of retinal pigment epithelium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oral dysaesthesia', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ludwig angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastases to spinal cord', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'VIth nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pharyngeal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'title': 'Any adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)', 'description': 'An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose (Day 1) untill Day 28', 'description': 'A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '7.1', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '21.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)', 'description': 'ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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 treated participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not reached due to insufficient number of participants with events" and "95% CI not calculable for a single participant', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)', 'description': 'DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest 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. Only confirmed responders (CR or PR) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of BMS-986315', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8519', 'spread': '40', 'groupId': 'OG000'}, {'value': '51.9309', 'spread': '13', 'groupId': 'OG001'}, {'value': '168.2658', 'spread': '3', 'groupId': 'OG002'}, {'value': '283.6735', 'spread': '66', 'groupId': 'OG003'}, {'value': '63.1812', 'spread': '15', 'groupId': 'OG004'}, {'value': '160.8894', 'spread': '35', 'groupId': 'OG005'}, {'value': '309.0469', 'spread': '24', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of BMS-986315', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1916', 'spread': '168', 'groupId': 'OG000'}, {'value': '2.5151', 'spread': '84', 'groupId': 'OG001'}, {'value': '1.0747', 'spread': '10', 'groupId': 'OG002'}, {'value': '1.8572', 'spread': '104', 'groupId': 'OG003'}, {'value': '1.4213', 'spread': '63', 'groupId': 'OG004'}, {'value': '3.5165', 'spread': '249', 'groupId': 'OG005'}, {'value': '1.9030', 'spread': '78', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '6885.1959', 'spread': '33', 'groupId': 'OG000'}, {'value': '12122.1650', 'spread': '18', 'groupId': 'OG001'}, {'value': '41381.3449', 'spread': '12', 'groupId': 'OG002'}, {'value': '62500.0455', 'spread': '56', 'groupId': 'OG003'}, {'value': '12885.5705', 'spread': '20', 'groupId': 'OG004'}, {'value': '36893.5416', 'spread': '32', 'groupId': 'OG005'}, {'value': '62110.3402', 'spread': '33', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '6345.4606', 'spread': '21', 'groupId': 'OG000'}, {'value': '13113.1903', 'spread': '6', 'groupId': 'OG001'}, {'value': '41381.3449', 'spread': '12', 'groupId': 'OG002'}, {'value': '62500.0455', 'spread': '56', 'groupId': 'OG003'}, {'value': '12885.5705', 'spread': '20', 'groupId': 'OG004'}, {'value': '36893.5416', 'spread': '32', 'groupId': 'OG005'}, {'value': '70405.3800', 'spread': '29', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Concentration in a Dosing Interval (Ctau) of BMS-986315', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4119', 'spread': '20', 'groupId': 'OG000'}, {'value': '10.7013', 'spread': '23', 'groupId': 'OG001'}, {'value': '33.1011', 'spread': '4', 'groupId': 'OG002'}, {'value': '51.1321', 'spread': '66', 'groupId': 'OG003'}, {'value': '10.5418', 'spread': '26', 'groupId': 'OG004'}, {'value': '28.3387', 'spread': '40', 'groupId': 'OG005'}, {'value': '49.2124', 'spread': '48', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable PK Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'OG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'OG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'classes': [{'title': 'BMS986315 ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Nivolumab ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1', 'description': 'An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\\>=) than baseline positive titer) at any time after initiation of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with baseline and at least one post-baseline evaluable ADA assessment. Participants in Part 1A did not have at least one post-baseline evaluable assessment, hence no participants are included in analysis of Part1A.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'FG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'FG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'FG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'FG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'FG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'FG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'No participants were enrolled in Part 1C.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1A BMS-986315-80 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'BG001', 'title': 'Part 1A BMS-986315-200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'BG002', 'title': 'Part 1A BMS-986315-600 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'BG003', 'title': 'Part 1A BMS-986315-1200 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.'}, {'id': 'BG004', 'title': 'Part 1B BMS-986315-200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'BG005', 'title': 'Part 1B BMS-986315-600 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'BG006', 'title': 'Part 1B BMS-986315-1200 mg + Nivolumab 480 mg', 'description': 'Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '18.38', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '2.12', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '9.00', 'groupId': 'BG002'}, {'value': '63.0', 'spread': '13.00', 'groupId': 'BG003'}, {'value': '70.8', 'spread': '6.91', 'groupId': 'BG004'}, {'value': '67.4', 'spread': '9.71', 'groupId': 'BG005'}, {'value': '61.1', 'spread': '8.93', 'groupId': 'BG006'}, {'value': '64.9', 'spread': '9.55', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-11', 'size': 25183688, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-18T00:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-04-15', 'resultsFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-02', 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events and Deaths', 'timeFrame': 'From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)', 'description': 'An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.'}, {'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From first dose (Day 1) untill Day 28', 'description': 'A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)', 'description': 'ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)', 'description': 'DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest 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) Rate', 'timeFrame': 'At 6 months', 'description': 'Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of BMS-986315', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of BMS-986315', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.'}, {'measure': 'Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.'}, {'measure': 'Concentration in a Dosing Interval (Ctau) of BMS-986315', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Blood samples were collected to assess pharmacokinetic (PK) parameters.'}, {'measure': 'Number of Participants With Anti-Drug Antibody (ADA)', 'timeFrame': 'Cycle 1 Day 1', 'description': 'An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\\>=) than baseline positive titer) at any time after initiation of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC (Non-small cell lung cancer)', 'RCC (Renal cell carcinoma)', 'SCCHN (Squamous cell carcinoma of the head and neck)'], 'conditions': ['Advanced Solid Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/home', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1\n* Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor\n* Eastern cooperative oncology group performance status of 0 or 1\n* Women of childbearing potential must agree to follow methods of contraception\n\nExclusion Criteria:\n\n* Participants with active, known or suspected autoimmune disease\n* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications\n* Uncontrolled or significant cardiovascular disease\n* History of or with active interstitial lung disease or pulmonary fibrosis\n* Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study\n* History of allergy or hypersensitivity to study drug components\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04349267', 'briefTitle': 'Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CA047-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986315', 'interventionNames': ['Biological: BMS-986315']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986315 + nivolumab', 'interventionNames': ['Biological: BMS-986315', 'Biological: nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986315 + cetuximab', 'interventionNames': ['Biological: BMS-986315', 'Biological: cetuximab']}], 'interventions': [{'name': 'BMS-986315', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986315', 'BMS-986315 + cetuximab', 'BMS-986315 + nivolumab']}, {'name': 'nivolumab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986315 + nivolumab']}, {'name': 'cetuximab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986315 + cetuximab']}]}, 'contactsLocationsModule': 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Institution - 0005', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Local Institution - 0013', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '06100', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}