{"description":"There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given SC or IV\n\nNivolumab: Given IV","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":6,"seriousNumAtRisk":6,"title":"Arm 1 A Lead-In (Azacitidine, Nivolumab)"},{"deathsNumAffected":16,"deathsNumAtRisk":85,"description":"Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given SC or IV\n\nNivolumab: Given IV","id":"EG001","otherNumAffected":62,"otherNumAtRisk":85,"seriousNumAffected":57,"seriousNumAtRisk":85,"title":"Arm 1 B (Azacitidine, Nivolumab)"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given SC or IV\n\nIpilimumab\n\nNivolumab: Given IV","id":"EG002","otherNumAffected":5,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)"},{"deathsNumAffected":5,"deathsNumAtRisk":47,"description":"Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given SC or IV\n\nIpilimumab\n\nNivolumab: Given IV","id":"EG003","otherNumAffected":25,"otherNumAtRisk":47,"seriousNumAffected":33,"seriousNumAtRisk":47,"title":"Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles.\n\nAzacitidine: Given SC or IV\n\nVenetoclax: Given Orally\n\nNivolumab: Given IV","id":"EG004","otherNumAffected":4,"otherNumAtRisk":6,"seriousNumAffected":5,"seriousNumAtRisk":6,"title":"Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles.\n\nAzacitidine: Given SC or IV\n\nVenetoclax: Given Orally\n\nNivolumab: Given IV","id":"EG005","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm 3 B (Azacitidine, Nivolumab, Venetoclax)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Abdominal Distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":47,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Benign Prostatic Hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Myelosuppression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":85,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":17,"numAtRisk":85,"numEvents":22},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":85,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":85,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":18,"numAtRisk":85,"numEvents":28},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":47,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":85,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dry 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