{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":5,"description":"INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given IV or SC\n\nTrametinib: Given PO\n\nVenetoclax: Given PO","id":"EG000","otherNumAffected":3,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Cohort A (Newly Diagnosed AML Patients)"},{"deathsNumAffected":1,"deathsNumAtRisk":16,"description":"INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.\n\nAzacitidine: Given IV or SC\n\nTrametinib: Given PO\n\nVenetoclax: Given PO","id":"EG001","otherNumAffected":15,"otherNumAtRisk":16,"seriousNumAffected":4,"seriousNumAtRisk":16,"title":"Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Cardiac-General Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":12,"numAtRisk":16,"numEvents":12}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Edema limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":10,"numAtRisk":16,"numEvents":10}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":16,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Infection-Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":16,"numEvents":5}],"term":"Mucositis/stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Muscle weakness, generalized or specific area"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":8,"numAtRisk":16,"numEvents":8}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Retinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":16,"numEvents":4}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hip pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Oral ulcers"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Subdural Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Urinary tract infection"}],"timeFrame":"All-Cause Mortality monitored/assessed up to 3.5 years, Adverse Events monitored/assessed up to 2.5 years"}