{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).","id":"EG000","otherNumAffected":2,"otherNumAtRisk":7,"seriousNumAffected":6,"seriousNumAtRisk":7,"title":"Phase I MTD Vosaroxin"},{"deathsNumAffected":7,"deathsNumAtRisk":59,"description":"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).\n\nFollowing the phase I portion, patients in phase II receive the following induction:\n\n1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.\n2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.\n\nVosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.\n\nPhase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.\n\nDecitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).","id":"EG001","otherNumAffected":19,"otherNumAtRisk":59,"seriousNumAffected":48,"seriousNumAtRisk":59,"title":"Vasoroxin + Decitabine"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Aspartate Aminotransferase Increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Blood Bilirubin Increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Dysartharia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":59,"numEvents":3}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hearing Impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Heart Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hoarsness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition 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(4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Soft Tissue Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Urine discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Wound Complication"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Bone Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":59,"numEvents":3}],"term":"Catheter Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Edema Face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Enterocolitis Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7,"numEvents":8},{"groupId":"EG001","numAffected":18,"numAtRisk":59,"numEvents":23}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Gastrointestinal Disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Generalized Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":59,"numEvents":10}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Intracranial Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":13,"numAtRisk":59,"numEvents":17}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":59,"numEvents":4}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Multi-Organ Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 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(4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Renal Calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":59,"numEvents":3}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Respiratory, thoracic and mediastinal disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":11,"numAtRisk":59,"numEvents":12}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Soft Tissue Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 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