{"description":"Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.\n\n3 patients from ARM III (Non-Randomized) were excluded due to ineligibility.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.\n\nTRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.\n\nPatients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT\n\nBusulfan: Given IV\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMelphalan: Given IV\n\nMycophenolate Mofetil: Given IV or PO\n\nPharmacological Study: Correlative studies\n\nTacrolimus: Given IV or PO","id":"EG000","otherNumAffected":5,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Arm I (Busulfan, Cyclophosphamide, Melphalan)"},{"deathsNumAffected":5,"deathsNumAtRisk":9,"description":"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.\n\nTRANSPLANT: Patients undergo allogeneic HCT as in Arm I.\n\nPatients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT\n\nBusulfan: Given IV\n\nFludarabine Phosphate: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nPharmacological Study: Correlative studies\n\nTacrolimus: Given IV or PO","id":"EG001","otherNumAffected":7,"otherNumAtRisk":9,"seriousNumAffected":1,"seriousNumAtRisk":9,"title":"Arm II (Busulfan, Fludarabine Phosphate)"},{"deathsNumAffected":1,"deathsNumAtRisk":12,"description":"Patients who have not met all protocol requirements to proceed to HCT","id":"EG002","otherNumAffected":0,"otherNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"title":"ARM III (Non-Randomized)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hoarseness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urine output decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Respiratory failure"}],"timeFrame":"Up to 1 year after completion of transplant."}