{"description":"Evaluation of toxicities will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTCAE version 4.03. The protocol pre-specifies that Adverse Events on this study are reported and evaluated by conditioning regimen arm (MAC or RIC).","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":40,"description":"Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan","id":"EG000","otherNumAffected":5,"otherNumAtRisk":40,"seriousNumAffected":12,"seriousNumAtRisk":40,"title":"Myeloablative Conditioning (MAC)"},{"deathsNumAffected":8,"deathsNumAtRisk":40,"description":"Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation","id":"EG001","otherNumAffected":0,"otherNumAtRisk":40,"seriousNumAffected":13,"seriousNumAtRisk":40,"title":"Reduced Intensity Conditioning (RIC)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Respiratory failure"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Recurrence, persistence, or progression of disease","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":40}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":40}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Leukemia secondary to oncology chemotherapy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One case of Acute Myeloid Leukemia under MAC, two cases of recurrence, persistence, or progression of disease under MAC, and two cases of recurrence, persistence, or progression of disease under RIC.","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":40}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":40}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":40}],"term":"Respiratory failure"}],"timeFrame":"Up to 1 year post transplant"}