{"eventGroups":[{"description":"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nTotal-Body Irradiation: Undergo TBI","id":"EG000","otherNumAffected":27,"otherNumAtRisk":77,"seriousNumAffected":0,"seriousNumAtRisk":77,"title":"Arm I (MMF and CSP)"},{"description":"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nSirolimus: Given PO\n\nTotal-Body Irradiation: Undergo TBI","id":"EG001","otherNumAffected":26,"otherNumAtRisk":90,"seriousNumAffected":0,"seriousNumAtRisk":90,"title":"Arm II (MMF, CSP, and Sirolimus)"},{"description":"Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011","id":"EG002","otherNumAffected":3,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Arm 0 (CSP and Sirolimus)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":77,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"\"Adult respiratory distress syndrome\""},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":77,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":77,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":90,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bronchopulmonary hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Colonic hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":77,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":90,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":77,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Encephalitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":77,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fecal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":77,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":90,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":77,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":77,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":90,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Laryngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":77,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":90,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":77,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pleural infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Renal and urinary disorders - Other (Hemorrhagic cystitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":77,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":90,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system 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disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":77,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":90,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Weight loss"}],"timeFrame":"AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200"}