{"description":"SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).","eventGroups":[{"description":"Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \\& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \\& -4) \\& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \\& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \\& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \\& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.","id":"EG000","otherNumAffected":38,"otherNumAtRisk":72,"seriousNumAffected":9,"seriousNumAtRisk":72,"title":"Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen"},{"description":"Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \\& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \\& -4) \\& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \\& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \\& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \\& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).","id":"EG001","otherNumAffected":30,"otherNumAtRisk":70,"seriousNumAffected":5,"seriousNumAtRisk":70,"title":"Tacro-MTX GVHD Prophylaxis"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Abdominal pain"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Acute kidney injury"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Adult respiratory distress syndrome"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Alanine aminotransferase increased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Anal pain"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Anaphylaxis"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":70}],"term":"Anemia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Ascites"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":70}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Ataxia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Atelectasis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Bladder infection"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Blood and lymphatic system disorders - Other, specify"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Blood bilirubin increased"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Capillary leak syndrome"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Confusion"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Death NOS"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Diarrhea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Dyspnea"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Encephalopathy"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Gastrointestinal disorders - Other, specify"},{"organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hepatic failure"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hypercalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":70}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":70}],"term":"Hyperkalemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Hypertension"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hyponatremia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hypoxia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Laryngeal edema"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Localized edema"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":70}],"term":"Lymphocyte count decreased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Mucositis oral"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":72},{"groupId":"EG001","numAffected":21,"numAtRisk":70}],"term":"Neutrophil count decreased"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Pericardial effusion"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":72},{"groupId":"EG001","numAffected":20,"numAtRisk":70}],"term":"Platelet count decreased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Pleural effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Pneumonitis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Seizure"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Sepsis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Stevens-Johnson syndrome"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Tremor"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":72},{"groupId":"EG001","numAffected":21,"numAtRisk":70}],"term":"White blood cell decreased"}],"seriousEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":70}],"term":"Acute kidney injury"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Adult respiratory distress syndrome"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Ascites"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Blood bilirubin increased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Bronchopulmonary hemorrhage"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Cardiac disorders - Other, specify"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Death NOS"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Disseminated intravascular coagulation"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Encephalopathy"},{"organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":70}],"term":"Hepatic failure"},{"organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Hepatobiliary disorders - Other, specify"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Hypotension"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Multi-organ failure"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Pericardial effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Pneumonitis"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Renal and urinary disorders - Other, specify"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":70}],"term":"Seizure"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Thromboembolic event"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":70}],"term":"Vascular disorders - Other, specify"}]}