{"description":"For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.","eventGroups":[{"deathsNumAffected":24,"deathsNumAtRisk":108,"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0.\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclophosphamide: Given IV\n\nCyclosporine: Given IV and PO\n\nDouble-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT\n\nFludarabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV and PO\n\nTotal-Body Irradiation: Undergo high-dose or moderate-intensity TBI\n\nUmbilical Cord Blood Transplantation: Undergo UCBT","id":"EG000","otherNumAffected":73,"otherNumAtRisk":108,"seriousNumAffected":47,"seriousNumAtRisk":108,"title":"Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide"},{"deathsNumAffected":9,"deathsNumAtRisk":27,"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0.\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclophosphamide: Given IV\n\nCyclosporine: Given IV and PO\n\nDouble-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT\n\nFludarabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV and PO\n\nTotal-Body Irradiation: Undergo high-dose or moderate-intensity TBI\n\nUmbilical Cord Blood Transplantation: Undergo UCBT\n\nThiotepa: Given IV","id":"EG001","otherNumAffected":25,"otherNumAtRisk":27,"seriousNumAffected":7,"seriousNumAtRisk":27,"title":"Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Allergic reaction/hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fever of unknown origin without clinically or microbiologically documented infection; ANC \\<1.0 x 109/L, fever ≥38.5°C.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":108,"numEvents":50},{"groupId":"EG001","numAffected":14,"numAtRisk":27,"numEvents":14}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"CD4 count \\<50/mm3 \\<0.05 x 109 /L.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"CD4 count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Leukocyte (total WBC) count \\<1000/mm3 \\<1.0 x 109 /L.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Leukocytes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g., immune hemolytic anemia, drug-related hemolysis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":3}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":3}],"term":"Prolonged QTc interval"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Cardiac General - Other (Heart failure)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":15},{"groupId":"EG001","numAffected":11,"numAtRisk":27,"numEvents":13}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":5}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Cardiac ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Cardiac troponin I (cTnI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Coagulation, Other (Coagulopathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g., thrombotic thrombocytopenic purpura \\[TTP\\] or hemolytic uremic syndrome \\[HUS\\]","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Thrombotic microangiopathy (TMA)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":108,"numEvents":77},{"groupId":"EG001","numAffected":11,"numAtRisk":27,"numEvents":13}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":108,"numEvents":55},{"groupId":"EG001","numAffected":9,"numAtRisk":27,"numEvents":9}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":4}],"term":"Acute kidney injury (AKI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Alanine aminotransferase (ALT) increased, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Adult respiratory distress syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Aspartate aminotransferase increased (AST)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Osteonecrosis (avascular necrosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3}],"term":"Hyperbilirubinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4}],"term":"Cytomegalovirus virus (CMV) reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g. Deep vein thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Thrombosis/thrombus/ embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Mood alteration - Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":18},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":5}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Disseminated Adenovirus (ADV)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Renal/Genitourinary, Other (Veno-occlusive disease [VOD])"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hemorrhage/bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":17},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":5}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":108,"numEvents":70},{"groupId":"EG001","numAffected":7,"numAtRisk":27,"numEvents":10}],"term":"Infection in blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":108,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infection in urinary tract (urinary tract infection; UTI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g. pneumonia, RSV, etc.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":18},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4}],"term":"Infection in respiratory tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g. colitis infectious, enterocolitis infectious, C. Diff, etc.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3}],"term":"Infection in gastrointestinal tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"e.g. skin/cellulitis, cerebral spinal fluid (CSF), mucosal (mouth, perianal, etc.), sinus/sinusitis, etc.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Infection, Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Distention/bloating, abdominal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Irritable bowel syndrome (IBS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Multi-organ failure (MOF)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Captured when occurring after post-transplant engraftment after post-transplant engraftment","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":4}],"term":"Neutrophil count (ANC) decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Pain, Other - Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Somnolence/depressed level of consciousness"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage) and post-renal causes (ureteral or bladder outflow obstruction).","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Acute kidney injury (AKI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Chronic dialysis or renal transplant indicated.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes fluid to build up in the lungs, making it difficult to breathe and get oxygen into the body. Graded on whether intubation is indicated.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Acute Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 4 hyperbilirubinemia is bilirubin level raised by \\>10.0 times the Upper Limit Number (ULN)","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Loss of heart activity due to irregular heart rhythm. Life-threatening.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Cardiopulmonary arrest, cause unknown (non-fatal)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Inflammation of the gallbladder. Interventional radiology, endoscopic, or operative intervention indicated.","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Confusion or delirium interfering with activities of daily living (ADLs).","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hrs; hospitalization; severe increase in output compared to baseline; interfering with ADL.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Cognitive disturbance; depressed level of consciousness. Grade 3= signs or symptoms interfering with ADL; hospitalization indicated. Grade 4= life-threatening or disabling.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A brief loss of consciousness that is followed by a quick and complete recovery.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Syncope (fainting)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fever of unknown origin without clinically or microbiologically documented infection (ANC \\<1.0 x 109/L, fever ≥38.5°C).","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Headache causing severe pain; pain or analgesics severely interfering with ADL.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Pain - Select: Head/headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Bronchopulmonary hemorrhage. Grade 3=Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy. Grade 4=Life-threatening consequences; major urgent intervention indicated.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hemorrhage, pulmonary/ upper respiratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 4= Potassium at a level \\>7.0 mmol/L.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Potassium, serum-high (hyperkalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3=Raised blood pressure with symptoms, requiring more than one drug or more intensive therapy than previously. Grade 4=Life-threatening consequences (e.g., hypertensive crisis).","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Low blood pressure, symptomatic; Grade 3=Sustained (≥24 hrs) therapy, resolves without persisting physiologic consequences. Grade 4=Shock (e.g., acidemia; impairment of vital organ function).","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by a decrease in the level of oxygen in the body. Grade 3=Decreased O2 saturation at rest; continuous oxygen indicated. Grade 4=Life-threatening; intubation or ventilation indicated. Grade 5=respiratory failure/death.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":8}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by an infectious process involving the lungs, including pneumonia. IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Also called sepsis; disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock. Blood culture positive with signs or symptoms; treatment indicated.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infection documented clinically or microbiologically with ANC \\<1.0 x 10\\^9/L. A disorder characterized by an infectious process involving the bladder or urinary tract.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infection with Grade 3 or 4 neutrophils - Bladder or urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infection documented clinically or microbiologically with ANC \\<1.0 x 10\\^9/L. Sepsis; disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infection with Grade 3 or 4 neutrophils - Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Acute infusion reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy. Life-threatening consequences; major urgent intervention indicated.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Hemorrhage, GI - Abdominal NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues. Grade 4=pH \\<7.3 with life-threatening consequences.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Acidosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by new or increased apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Mood alteration - Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A serious medical emergency that occurs when two or more organ systems in the body are no longer working properly. Grade 5 is the only appropriate grade.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Death not associated with CTCAE term - Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by inflammation involving the spinal cord. Symptoms include weakness, paresthesia, sensory loss, marked discomfort and incontinence.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Myelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic changes result in the collapse and the destruction of the bone structure.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Osteonecrosis (avascular necrosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Death resulting from a recurrence of disease in sites other than the bone marrow. Grade 5 is the only appropriate grade.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Death not associated with CTCAE term - Disease progression NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A retropharyngeal abscess is a pus-filled collection in the back of the throat that can be life-threatening. It's caused by a bacterial infection in the lymph nodes behind the throat, which are part of the immune system.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Infection with normal ANC - Throat/lymph nodes (retropharyngeal abscess)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":3}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Liver dysfunction/failure (clinical)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node. Symptomatic; intervention indicated.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia - Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include weight loss, abdominal marked discomfort, bloating and diarrhea.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Malabsorption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as seizures, hemiplegia, and visual disturbances. An acute or subacute condition.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0}],"term":"Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP]"}],"timeFrame":"Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death."}