Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-09 @ 6:15 PM
Study NCT ID:
NCT02596035
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}], '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': 'Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 91, 'seriousNumAtRisk': 97, 'deathsNumAffected': 63, 'seriousNumAffected': 54}, {'id': 'EG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 44, 'deathsNumAffected': 29, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Total', 'description': 'Total Participants', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 133, 'seriousNumAtRisk': 142, 'deathsNumAffected': 93, 'seriousNumAffected': 73}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}], 'classes': [{'title': 'Hepatitis (Grade 3-4)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hepatitis (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adrenal Insufficiency (Grade 3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adrenal Insufficiency (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nephritis And Renal Dysfunction (Grade 3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nephritis And Renal Dysfunction (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash (Grade 3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diabetes mellitus (Grade 3-4)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diabetes mellitus (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypothyroidism (Grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypothyroidism (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypophysitis (Grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypophysitis (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis (Grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity (Grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypersensitivity (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea/Colitis (Grade 3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea/Colitis (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperthyroidism (Grade 3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperthyroidism (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days of the last dose of study drug (Approximately 2 years)', 'description': 'IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed in all treated participants who received any dose of nivolumab.'}, {'type': 'SECONDARY', 'title': 'Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}], 'classes': [{'title': 'Adrenal Insufficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '76'}]}]}, {'title': 'Diabetes Mellitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '805'}]}]}, {'title': 'Hepatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '448'}]}]}, {'title': 'Nephritis And Renal Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '43'}]}]}, {'title': 'Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '7'}]}]}, {'title': 'Diarrhea/Colitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '645.0', 'groupId': 'OG000', 'lowerLimit': '645.0', 'upperLimit': '645.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)', 'description': 'Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories."}, {'type': 'SECONDARY', 'title': 'Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}], 'classes': [{'title': 'Hepatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '75'}]}]}, {'title': 'Nephritis And Renal Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '54'}]}]}, {'title': 'Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '23'}]}]}, {'title': 'Diarrhea/Colitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '154.0', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '154'}]}]}, {'title': 'Adrenal Insufficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': '0 Participants Resolved', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)', 'description': 'Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}], 'classes': [{'title': 'Participants with Pneumonitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Diarrhea/Colitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hepatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Adrenal Insufficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Nephritis And Renal Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hypersensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Hyperthyroidism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hypophysitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)', 'description': 'Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Cell Histology', 'description': 'Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG001', 'title': 'Non-Clear Cell Histology', 'description': 'Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}, {'id': 'OG002', 'title': 'Brain Metastasis', 'description': 'Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.'}], 'classes': [{'title': 'Participants with Pneumonitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Diarrhea/Colitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hepatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Adrenal Insufficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Nephritis And Renal Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hypersensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Hyperthyroidism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Hypophysitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)', 'description': 'Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in all treated participants who received any dose of nivolumab. 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