{"description":"Adverse events reported at each visit during time at transplant center and up to 180 days post-transplantation.","eventGroups":[{"deathsNumAffected":8,"deathsNumAtRisk":32,"description":"Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS):\n\nDays -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV\n\nFor patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma:\n\nDays -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered","id":"EG000","otherNumAffected":13,"otherNumAtRisk":32,"seriousNumAffected":14,"seriousNumAtRisk":32,"title":"Haploidentical BMT With PTCy for Acute Leukemias and MDS"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":20}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":4}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32,"numEvents":10}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":6}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":4}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":5}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":32,"numEvents":13}],"term":"Oral Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":8}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":27}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32,"numEvents":11}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":19}],"term":"White Blood cells decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":4}],"term":"Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"Graft Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Acute GVHD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Broviac Cather Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Intracranial Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"NCI CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Cystitis"}],"timeFrame":"Adverse event data was collected up to 180 days after transplantation. Mortality was observed for up to 2 year post-intervention."}