Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05168202
Status:
TERMINATED
Last Update Posted:
2025-09-25
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': '1-855-907-3286', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Due to a strategic re-evaluation and prioritization of the company's portfolio, this study was terminated early during dose escalation (Part A) and prior to the start of dose expansion (Parts B, C, and D) with no relation to any safety issues associated with the use of CC-95251. Due to this termination, secondary efficacy endpoints, which were for these dose expansion cohorts, were not presented."}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy : CC-95251 20mg/kg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 7, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 6, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 6, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 8, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 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{'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 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27.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Meningorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nail bed bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash morbilliform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With DLTs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'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': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days)', 'description': "A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include:\n\n* Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash).\n* Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \\>2× ULN without cholestasis).\n* Hematologic toxicities: Grade 4 neutropenia/thrombocytopenia persisting at Day 28 without active AML/MDS; febrile neutropenia or Grade ≥3 thrombocytopenia with severe bleeding and prolonged myelosuppression (\\>42 days) without active leukemia.\n* Any adverse event requiring dose reduction in Cycle 1 unless clearly unrelated to the drug.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': "An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With With Grade 3 or Higher Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'hemoglobin', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'platelet count', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'leukocytes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'lymphocytes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'neutrophils', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'alkaline phosphatase', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'asparatate aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'bilirubin, total', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'albumin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'calcium, total', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'hyperkalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'hypocalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'hypokalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'hyponatremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'potassium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'sodium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': 'Clinical laboratory values from laboratories will be graded according to CTCAE Version 5 for applicable tests programmatically. For laboratory values that fall outside of the grade criteria of CTCAE Version 5, a Grade of 0 will be assigned. In addition, normal ranges will be used to determine the categories of High, Low, and Normal for laboratory tests that have no severity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Sinus Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Atrial Fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sinus Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening to 56 days post last dose (Approximately 29 months)', 'description': 'A single ECG will be performed in Screening, Cycle 1 Day 1 and 15, and Day 1 of Cycles ≥ 2. Investigators will make immediate clinical decisions based on their interpretation of the ECG results and provide their overall assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of ECOG Evaluations With Shift of ECOG Score of 3 or Greater.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'units': 'ECOG Evaluation', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening to 56 days post last dose (Approximately 29 months)', 'description': 'ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without estriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline.', 'unitOfMeasure': 'ECOG Evaluations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ECOG Evaluation', 'denomUnitsSelected': 'ECOG Evaluation', 'populationDescription': 'Safety Population - Multiple ECOG evaluations were done throughout the study at different timepoints'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'hypothermia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': 'Vital sign measurements include: Weight (kg), Temperature (°C), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Pulse (beats/min), Respiration Rate (breaths/min).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '371.59', 'spread': '25.14', 'groupId': 'OG000'}, {'value': '510.58', 'spread': '33.39', 'groupId': 'OG001'}, {'value': '209.40', 'spread': '14.13', 'groupId': 'OG002'}, {'value': '428.72', 'spread': '22.78', 'groupId': 'OG003'}, {'value': '636.93', 'spread': '7.80', 'groupId': 'OG004'}, {'value': '418.39', 'spread': '42.61', 'groupId': 'OG005'}, {'value': '653.88', 'spread': '10.36', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '514.05', 'spread': '25.01', 'groupId': 'OG000'}, {'value': '773.08', 'spread': '30.58', 'groupId': 'OG001'}, {'value': '314.49', 'spread': '16.76', 'groupId': 'OG002'}, {'value': '641.78', 'spread': '21.60', 'groupId': 'OG003'}, {'value': '1055.99', 'spread': '18.62', 'groupId': 'OG004'}, {'value': '592.41', 'spread': '50.25', 'groupId': 'OG005'}, {'value': '1036.14', 'spread': '28.08', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '568.25', 'spread': '32.29', 'groupId': 'OG000'}, {'value': '1217.78', 'spread': '19.11', 'groupId': 'OG001'}, {'value': '318.09', 'spread': '21.12', 'groupId': 'OG002'}, {'value': '637.76', 'spread': '21.01', 'groupId': 'OG003'}, {'value': '1468.00', 'spread': '18.85', 'groupId': 'OG004'}, {'value': '833.06', 'spread': '38.61', 'groupId': 'OG005'}, {'value': '1470.00', 'spread': 'NA', 'comment': 'GCV not calculable due to only 1 participant analyzed', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Maximum plasma concentration of drug', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.9'}, {'value': '4.87', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '7.2'}, {'value': '1.80', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '5.6'}, {'value': '4.02', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '6.0'}, {'value': '5.47', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '8.3'}, {'value': '4.61', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '22.3'}, {'value': '4.78', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '5.8'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.1'}, {'value': '6.80', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '7.6'}, {'value': '3.17', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '3.6'}, {'value': '3.87', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '22.6'}, {'value': '5.88', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '23.8'}, {'value': '3.42', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '23.9'}, {'value': '6.75', 'groupId': 'OG006', 'lowerLimit': '3.0', 'upperLimit': '26.1'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.78', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.0'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '7.1'}, {'value': '3.51', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '5.3'}, {'value': '12.27', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '69.6'}, {'value': '3.28', 'groupId': 'OG004', 'lowerLimit': '2.8', 'upperLimit': '5.7'}, {'value': '2.14', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '3.8'}, {'value': '3.37', 'groupId': 'OG006', 'lowerLimit': '3.37', 'upperLimit': '3.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Time to maximum plasma concentration (Tmax)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'AUC(0-T)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '27915.38', 'spread': '25.74', 'groupId': 'OG000'}, {'value': '37242.17', 'spread': '41.18', 'groupId': 'OG001'}, {'value': '13125.85', 'spread': '48.00', 'groupId': 'OG002'}, {'value': '23850.09', 'spread': '50.97', 'groupId': 'OG003'}, {'value': '49377.47', 'spread': '10.90', 'groupId': 'OG004'}, {'value': '28557.98', 'spread': '61.21', 'groupId': 'OG005'}, {'value': '42273.81', 'spread': '28.09', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '25766.21', 'spread': '366.57', 'groupId': 'OG000'}, {'value': '53952.86', 'spread': '105.79', 'groupId': 'OG001'}, {'value': '38363.45', 'spread': '34.52', 'groupId': 'OG002'}, {'value': '46250.05', 'spread': '55.29', 'groupId': 'OG003'}, {'value': '84673.85', 'spread': '80.82', 'groupId': 'OG004'}, {'value': '63857.81', 'spread': '83.67', 'groupId': 'OG005'}, {'value': '186843.83', 'spread': '120.44', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '42891.42', 'spread': '38.09', 'groupId': 'OG000'}, {'value': '54797.36', 'spread': '205.65', 'groupId': 'OG001'}, {'value': '37672.97', 'spread': '30.69', 'groupId': 'OG002'}, {'value': '54425.19', 'spread': '131.05', 'groupId': 'OG003'}, {'value': '116229.58', 'spread': '23.27', 'groupId': 'OG004'}, {'value': '74865.57', 'spread': '104.46', 'groupId': 'OG005'}, {'value': '137581.5', 'spread': 'NA', 'comment': 'GCV not calculable due to only 1 participant analyzed', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Area under the plasma concentration time-curve up to the last measurable concentration (AUC0-t)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'AUC(TAU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '27915.38', 'spread': '25.74', 'groupId': 'OG000'}, {'value': '39145.67', 'spread': '33.39', 'groupId': 'OG001'}, {'value': '15987.61', 'spread': '16.16', 'groupId': 'OG002'}, {'value': '28817.51', 'spread': '27.62', 'groupId': 'OG003'}, {'value': '49377.47', 'spread': '10.90', 'groupId': 'OG004'}, {'value': '29931.17', 'spread': '64.80', 'groupId': 'OG005'}, {'value': '46778.93', 'spread': '18.30', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '48306.42', 'spread': '48.94', 'groupId': 'OG000'}, {'value': '87419.67', 'spread': '68.23', 'groupId': 'OG001'}, {'value': '34295.76', 'spread': '16.51', 'groupId': 'OG002'}, {'value': '64776.31', 'spread': '16.33', 'groupId': 'OG003'}, {'value': '120818.65', 'spread': '32.18', 'groupId': 'OG004'}, {'value': '57119.56', 'spread': '67.28', 'groupId': 'OG005'}, {'value': '109428.93', 'spread': '41.91', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '48436.92', 'spread': '44.72', 'groupId': 'OG000'}, {'value': '128864.45', 'spread': '8.24', 'groupId': 'OG001'}, {'value': '37672.97', 'spread': '30.69', 'groupId': 'OG002'}, {'value': '89459.57', 'spread': '19.99', 'groupId': 'OG003'}, {'value': '119737.08', 'spread': '25.79', 'groupId': 'OG004'}, {'value': '114221.87', 'spread': '19.11', 'groupId': 'OG005'}, {'value': '137581.85', 'spread': 'NA', 'comment': 'GCV not calculable due to only 1 participant analyzed', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Area under the plasma concentration time-curve during a dosing interval (AUCtau)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Cmin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'OG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'OG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'OG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'OG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG000'}, {'value': '1.96', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG002'}, {'value': '140.00', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG005'}, {'value': '0.47', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '149.97', 'spread': '50.58', 'groupId': 'OG000'}, {'value': '213.59', 'spread': '104.90', 'groupId': 'OG001'}, {'value': '109.90', 'spread': '40.52', 'groupId': 'OG002'}, {'value': '153.17', 'spread': '97.33', 'groupId': 'OG003'}, {'value': '342.42', 'spread': '39.35', 'groupId': 'OG004'}, {'value': '167.12', 'spread': '89.50', 'groupId': 'OG005'}, {'value': '336.79', 'spread': '54.07', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '171.28', 'spread': '48.96', 'groupId': 'OG000'}, {'value': '588.04', 'spread': '36.19', 'groupId': 'OG001'}, {'value': '135.10', 'spread': '44.61', 'groupId': 'OG002'}, {'value': '225.45', 'spread': '37.09', 'groupId': 'OG003'}, {'value': '573.75', 'spread': '46.78', 'groupId': 'OG004'}, {'value': '291.15', 'spread': '94.88', 'groupId': 'OG005'}, {'value': '545.00', 'spread': 'NA', 'comment': 'Below the limit of quantification', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Minimum serum concentration', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'FG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'FG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'FG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'FG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'FG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'FG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'comment': '= Completed Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'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': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Due to a strategic re-evaluation and prioritization of the company's portfolio, this study was terminated early during dose escalation (Part A).\n\nNo participants were enrolled in Parts B, C, and D because the study was terminated prior to the start of dose expansion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '56', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Treatment 1', 'description': 'Monotherapy: CC-95251 20mg/kg'}, {'id': 'BG001', 'title': 'Part A: Treatment 2', 'description': 'Monotherapy : CC-95251 30mg/kg'}, {'id': 'BG002', 'title': 'Part A: Treatment 3', 'description': 'Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2'}, {'id': 'BG003', 'title': 'Part A: Treatment 4', 'description': 'Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2'}, {'id': 'BG004', 'title': 'Part A: Treatment 5', 'description': 'Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2'}, {'id': 'BG005', 'title': 'Part A: Treatment 6', 'description': 'Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'BG006', 'title': 'Part A: Treatment 7', 'description': 'Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '69.4', 'spread': '10.82', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '8.59', 'groupId': 'BG002'}, {'value': '70.6', 'spread': '4.25', 'groupId': 'BG003'}, {'value': '67.5', 'spread': '14.09', 'groupId': 'BG004'}, {'value': '56.6', 'spread': '16.53', 'groupId': 'BG005'}, {'value': '65.4', 'spread': '13.37', 'groupId': 'BG006'}, {'value': '66.3', 'spread': '12.31', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'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'}]}, {'title': 'Black or African American', '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': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '37', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-19', 'size': 11061264, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-30T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2021-12-08', 'resultsFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-05', 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With DLTs', 'timeFrame': 'From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days)', 'description': "A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include:\n\n* Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash).\n* Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \\>2× ULN without cholestasis).\n* Hematologic toxicities: Grade 4 neutropenia/thrombocytopenia persisting at Day 28 without active AML/MDS; febrile neutropenia or Grade ≥3 thrombocytopenia with severe bleeding and prolonged myelosuppression (\\>42 days) without active leukemia.\n* Any adverse event requiring dose reduction in Cycle 1 unless clearly unrelated to the drug."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': "An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE."}, {'measure': 'Number of Participants With With Grade 3 or Higher Laboratory Abnormalities', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': 'Clinical laboratory values from laboratories will be graded according to CTCAE Version 5 for applicable tests programmatically. For laboratory values that fall outside of the grade criteria of CTCAE Version 5, a Grade of 0 will be assigned. In addition, normal ranges will be used to determine the categories of High, Low, and Normal for laboratory tests that have no severity grade.'}, {'measure': 'Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events', 'timeFrame': 'From screening to 56 days post last dose (Approximately 29 months)', 'description': 'A single ECG will be performed in Screening, Cycle 1 Day 1 and 15, and Day 1 of Cycles ≥ 2. Investigators will make immediate clinical decisions based on their interpretation of the ECG results and provide their overall assessment.'}, {'measure': 'Number of ECOG Evaluations With Shift of ECOG Score of 3 or Greater.', 'timeFrame': 'From screening to 56 days post last dose (Approximately 29 months)', 'description': 'ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without estriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs', 'timeFrame': 'From signing informed consent to 56 days post last dose (Approximately 30 months)', 'description': 'Vital sign measurements include: Weight (kg), Temperature (°C), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Pulse (beats/min), Respiration Rate (breaths/min).'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Maximum plasma concentration of drug'}, {'measure': 'Tmax', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Time to maximum plasma concentration (Tmax)'}, {'measure': 'AUC(0-T)', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Area under the plasma concentration time-curve up to the last measurable concentration (AUC0-t)'}, {'measure': 'AUC(TAU)', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Area under the plasma concentration time-curve during a dosing interval (AUCtau)'}, {'measure': 'Cmin', 'timeFrame': 'On Cycle 1 Day 1, C1D22 and C2D22.', 'description': 'Minimum serum concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes', 'Acute Myeloid Leukemia', 'AML', 'MDS', 'Hematologic Cancers', 'Leukemia', 'Anti-SIRPa antibody', 'CC-95251'], 'conditions': ['Leukemia, Myeloid, Acute', 'Myelodysplastic Syndromes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Eastern Cooperative Oncology Group Performance Status of 0 to 2\n\nFor Parts A \\& B:\n\n* Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification\n* R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R)\n\nFor Part C:\n\n• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R\n\nFor Part D:\n\n• TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia\n* Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation\n* Participants who have received prior treatment with a CD47 or SIRPα targeting agent\n* Participant is on chronic systemic immunosuppressive therapy or corticosteroids\n* Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only).\n* Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study\n* Pregnant or nursing participants.\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05168202', 'briefTitle': 'A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'CA059-001'}, 'secondaryIdInfos': [{'id': '2021-002799-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-95251 monotherapy', 'interventionNames': ['Drug: CC-95251']}, {'type': 'EXPERIMENTAL', 'label': 'CC-95251 + azacitidine', 'interventionNames': ['Drug: CC-95251', 'Drug: Azacitidine']}, {'type': 'EXPERIMENTAL', 'label': 'CC-95251 + azacitidine + venetoclax', 'interventionNames': ['Drug: Venetoclax']}], 'interventions': [{'name': 'CC-95251', 'type': 'DRUG', 'otherNames': ['BMS-986351'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251 + azacitidine', 'CC-95251 monotherapy']}, {'name': 'Azacitidine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251 + azacitidine']}, {'name': 'Venetoclax', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251 + azacitidine + venetoclax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 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