Viewing Study NCT03130959

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Ignite Creation Date: 2025-12-24 @ 2:25 PM
Ignite Modification Date: 2026-03-31 @ 8:51 PM
Study NCT ID: NCT03130959
Status: COMPLETED
Last Update Posted: 2022-08-09
First Post: 2017-04-05
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months).', 'description': 'Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'deathsNumAffected': 18, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 18, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 12, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 13, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 12, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 11, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 9, 'seriousNumAffected': 11}, {'id': 'EG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 7, 'seriousNumAffected': 6}, {'id': 'EG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 18, 'seriousNumAffected': 14}, {'id': 'EG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 15, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': "Von Willebrand's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 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'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bladder dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1, Safety Lead-in', 'description': 'Module A, Cohort 1'}, {'id': 'OG001', 'title': 'Arms A2-A5, Safety Lead-in', 'description': 'Module A, Cohorts 2 through 5'}, {'id': 'OG002', 'title': 'Arms B2-B5, Safety Lead-in', 'description': 'Module B, Cohorts 2 through 5'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 weeks post-dosing', 'description': 'A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \\> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1, Safety Lead-in', 'description': 'Module A, Cohort 1'}, {'id': 'OG001', 'title': 'Arms A2-A5, Safety Lead-in', 'description': 'Module A, Cohorts 2 through 5'}, {'id': 'OG002', 'title': 'Arms B2-B5, Safety Lead-in', 'description': 'Module B, Cohorts 2 through 5'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 weeks post-dosing', 'description': 'The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1, Safety Lead-in', 'description': 'Module A, Cohort 1'}, {'id': 'OG001', 'title': 'Arms A2-A5, Safety Lead-in', 'description': 'Module A, Cohorts 2 through 5'}, {'id': 'OG002', 'title': 'Arms B2-B5, Safety Lead-in', 'description': 'Module B, Cohorts 2 through 5'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately 6 weeks)', 'description': 'The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS), Cohort 1 Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.66', 'groupId': 'OG000', 'lowerLimit': '10.32', 'upperLimit': '16.46'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '9.13', 'upperLimit': '15.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to approximately 42 months', 'description': 'Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.', 'unitOfMeasure': 'months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS), Cohorts 2-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG001', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG002', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG003', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG004', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG005', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '2.73'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.45'}, {'value': '1.38', 'groupId': 'OG002', 'lowerLimit': '1.22', 'upperLimit': '1.38'}, {'value': '2.76', 'groupId': 'OG003', 'lowerLimit': '1.48', 'upperLimit': '4.53'}, {'value': '1.41', 'groupId': 'OG004', 'lowerLimit': '1.41', 'upperLimit': '2.60'}, {'value': '4.60', 'groupId': 'OG005', 'lowerLimit': '1.41', 'upperLimit': '5.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to approximately 42 months', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS), Cohort 5 Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG001', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.31'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '3.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to approximately 42 months', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS), Cohort 1 Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '6.54'}, {'value': '4.53', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '6.44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 12 Months (OS12), Cohorts 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '66.5'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '62.3'}, {'value': '37.5', 'groupId': 'OG002', 'lowerLimit': '15.4', 'upperLimit': '59.8'}, {'value': '32.8', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '57.6'}, {'value': '38.9', 'groupId': 'OG004', 'lowerLimit': '14.3', 'upperLimit': '63.2'}, {'value': '86.7', 'groupId': 'OG005', 'lowerLimit': '56.4', 'upperLimit': '96.5'}, {'value': '41.7', 'groupId': 'OG006', 'lowerLimit': '15.2', 'upperLimit': '66.5'}, {'value': '44.4', 'groupId': 'OG007', 'lowerLimit': '13.6', 'upperLimit': '71.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to up to 12 months after first dose', 'description': 'Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts 1-4'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG001', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG002', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG003', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG004', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG005', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG006', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG007', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '31.8'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '36.6'}, {'value': '0', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': '42.4'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '47.5'}, {'value': '11.4', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '39.5'}, {'value': '5.3', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '21.4'}, {'value': '14.0', 'groupId': 'OG007', 'lowerLimit': '2.8', 'upperLimit': '34.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to up to 6 months after first dose', 'description': 'Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free.\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts 2-5'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS), Cohorts 2-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG001', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG002', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG003', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG004', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG005', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG006', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG007', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000', 'lowerLimit': '2.99', 'upperLimit': '14.62'}, {'value': '6.47', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '13.17'}, {'value': '7.36', 'groupId': 'OG002', 'lowerLimit': '2.46', 'upperLimit': '30.23'}, {'value': '22.21', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '13.77', 'upperLimit': 'NA'}, {'value': '5.70', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '1.81', 'upperLimit': 'NA'}, {'value': '9.82', 'comment': 'Insufficient number of participants with events..', 'groupId': 'OG005', 'lowerLimit': '2.50', 'upperLimit': 'NA'}, {'value': '5.91', 'groupId': 'OG006', 'lowerLimit': '1.97', 'upperLimit': '7.98'}, {'value': '8.48', 'groupId': 'OG007', 'lowerLimit': '3.45', 'upperLimit': '17.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of death (up to approximately 55 months)', 'description': 'Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts 2-5'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced an Adverse Event (AE) during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study.\n\nSAE is defined as any untoward medical occurrence that, at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or causes prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event\n\nNote: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the AE section of the results form (first dose to 100 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participants With Drug-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a Drug-Related Adverse Event during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participants With Adverse Events Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced an Adverse Event leading to discontinuation during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participant Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to the date of death (up to approximately 55 months)', 'description': 'The number of treated participants who died during the course of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participant With Laboratory Abnormalities - Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'ALT OR AST > 5XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'ALT OR AST > 10XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'ALT OR AST > 20XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'ALP > 1.5XULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'ALT or AST > 3xULN w/ Tbili > 1.5*ULN within 1 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'ALT or AST > 3xULN w/ Tbili > 1.5*ULN within 30 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'ALT or AST > 3xULN w/ Tbili > 2*ULN within 1 day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'ALT or AST > 3xULN w/ Tbili > 2*ULN within 30 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.\n\nAspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Units per Liter (U/L) Results reported in International System of Units (SI)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Treated Participant With Laboratory Abnormalities - Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}, {'title': 'TSH > ULN, WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'TSH > ULN, WITH AT LEAST ONE FT3/FT4 TEST < LLN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'TSH > ULN, WITH ALL OTHER FT3/FT4 TEST >= LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'TSH > ULN, WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'TSH < LLN, WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'TSH<LLN, LLN WITH AT LEAST ONE FT3/FT4 TEST>ULN', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'TSH < LLN, WITH ALL OTHER FT3/FT4 TEST <= ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'TSH < LLN, WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.\n\nFree T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Milliunits per Liter (mlU/L) Results reported in International System of Units (SI)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on-treatment TSH measurement'}, {'type': 'POST_HOC', 'title': 'Overall Survival (OS), Cohort 1 Only - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'OG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.66', 'groupId': 'OG000', 'lowerLimit': '10.32', 'upperLimit': '23.49'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '9.13', 'upperLimit': '15.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of death (up to approximately 55 months)', 'description': 'Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1'}, {'type': 'POST_HOC', 'title': 'Progression-Free Survival (PFS), Cohorts 2-4 - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG001', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'OG002', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG003', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'OG004', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'OG005', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '2.73'}, {'value': '1.38', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '1.48'}, {'value': '1.38', 'groupId': 'OG002', 'lowerLimit': '1.22', 'upperLimit': '1.38'}, {'value': '2.69', 'groupId': 'OG003', 'lowerLimit': '1.48', 'upperLimit': '4.53'}, {'value': '1.41', 'groupId': 'OG004', 'lowerLimit': '1.38', 'upperLimit': '2.60'}, {'value': '4.60', 'groupId': 'OG005', 'lowerLimit': '1.41', 'upperLimit': '5.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohorts 2-4'}, {'type': 'POST_HOC', 'title': 'Progression-Free Survival (PFS), Cohort 5 Only - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'OG001', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.31'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '3.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 5'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'FG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'FG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'FG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'FG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'FG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'FG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'FG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'FG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'FG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started = initiated treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '19'}, {'groupId': 'FG009', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'comment': 'Completed = completed treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '19'}, {'groupId': 'FG009', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '8'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Other reasons', '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': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Subject request to discontinue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Adverse Event unrelated to drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '166 participants were treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '166', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A1', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'BG001', 'title': 'Arm B1', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.'}, {'id': 'BG002', 'title': 'Arm A2', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'BG003', 'title': 'Arm B2', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.'}, {'id': 'BG004', 'title': 'Arm A3', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'BG005', 'title': 'Arm B3', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 3: participants with relapsed or resistant medulloblastoma.'}, {'id': 'BG006', 'title': 'Arm A4', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'BG007', 'title': 'Arm B4', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 4: participants with relapsed or resistant ependymoma.'}, {'id': 'BG008', 'title': 'Arm A5', 'description': 'Module A: nivolumab 3 mg/kg every 2 weeks.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'BG009', 'title': 'Arm B5', 'description': 'Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter.\n\nCohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 2 years old', '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': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': '>= 2 and < 12 years old', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '87', 'groupId': 'BG010'}]}, {'title': '>= 12 and < 18 years old', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '61', 'groupId': 'BG010'}]}, {'title': '>= 18 years old', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '70', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '96', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '60', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '92', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '132', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-11', 'size': 5490039, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-03T16:40', 'hasProtocol': True}, {'date': '2022-03-02', 'size': 526028, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-14T16:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03126643', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2017-04-05', 'resultsFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-29', 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'up to 6 weeks post-dosing', 'description': 'A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \\> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).'}, {'measure': 'Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'up to 6 weeks post-dosing', 'description': 'The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.'}, {'measure': 'Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately 6 weeks)', 'description': 'The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.'}, {'measure': 'Overall Survival (OS), Cohort 1 Only', 'timeFrame': 'up to approximately 42 months', 'description': 'Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.'}, {'measure': 'Progression-Free Survival (PFS), Cohorts 2-4', 'timeFrame': 'up to approximately 42 months', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.'}, {'measure': 'Progression-Free Survival (PFS), Cohort 5 Only', 'timeFrame': 'up to approximately 42 months', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS), Cohort 1 Only', 'timeFrame': 'From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)', 'description': 'Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease'}, {'measure': 'Overall Survival at 12 Months (OS12), Cohorts 1-4', 'timeFrame': 'From first dose to up to 12 months after first dose', 'description': 'Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.'}, {'measure': 'Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5', 'timeFrame': 'From first dose to up to 6 months after first dose', 'description': 'Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free.\n\nProgression is defined as:\n\n* ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement\n* Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids\n* Any new lesion\n* Clear clinical deterioration not attributable to other causes apart from the tumor\n* Failure to return for evaluation as a result of death or deteriorating condition\n* Clear progression of non-measurable disease'}, {'measure': 'Overall Survival (OS), Cohorts 2-5', 'timeFrame': 'From first dose to the date of death (up to approximately 55 months)', 'description': 'Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.'}, {'measure': 'Number of Treated Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced an Adverse Event (AE) during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.'}, {'measure': 'Number of Treated Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study.\n\nSAE is defined as any untoward medical occurrence that, at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or causes prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event\n\nNote: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the AE section of the results form (first dose to 100 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.'}, {'measure': 'Number of Treated Participants With Drug-Related Adverse Events', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a Drug-Related Adverse Event during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.'}, {'measure': 'Number of Treated Participants With Adverse Events Leading to Discontinuation', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced an Adverse Event leading to discontinuation during the course of the study.\n\nAn AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.'}, {'measure': 'Number of Treated Participant Deaths', 'timeFrame': 'From first dose to the date of death (up to approximately 55 months)', 'description': 'The number of treated participants who died during the course of the study.'}, {'measure': 'Number of Treated Participant With Laboratory Abnormalities - Liver', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.\n\nAspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Units per Liter (U/L) Results reported in International System of Units (SI)'}, {'measure': 'Number of Treated Participant With Laboratory Abnormalities - Thyroid', 'timeFrame': 'From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)', 'description': 'The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.\n\nFree T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Milliunits per Liter (mlU/L) Results reported in International System of Units (SI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Various Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '36808285', 'type': 'DERIVED', 'citation': 'Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, Andre N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K. Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908. Neuro Oncol. 2023 Aug 3;25(8):1530-1545. doi: 10.1093/neuonc/noad031.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:\n* A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy\n* A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT\n* A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy\n* A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT\n* A histologically-confirmed high grade CNS malignancy "other than above" which is recurrent or progressive after at least one line of prior therapy\n* Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for \\> 16 years of age assessed within two weeks of enrollment must be \\>= 60\n* A tumor sample must be available for submission to central laboratory (not required for DIPG)\n\nExclusion Criteria:\n\n* An active, known, or suspected autoimmune disease\n* A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment\n* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03130959', 'acronym': 'CheckMate 908', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies', 'orgStudyIdInfo': {'id': 'CA209-908'}, 'secondaryIdInfos': [{'id': '2016-004441-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Module A', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Module B', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo, BMS-936558'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Module A', 'Module B']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy, BMS-734016'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Module B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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