{"eventGroups":[{"description":"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0\n\nTherapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.\n\nBusulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.\n\nIV Busulfan is available and diluted and administered per package insert guidelines.\n\nCyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including","id":"EG000","otherNumAffected":52,"otherNumAtRisk":147,"seriousNumAffected":59,"seriousNumAtRisk":147,"title":"Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated to Regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":147}],"term":"Neutropenic fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":147}],"term":"Hyperbilirubinemia or transaminitis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Atrial fibrillation/flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Respiratory pulseless electrical activity (PEA) arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Event associated with CsA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Cryptogenic organizing pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Eosinophilic pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147}],"term":"CsA toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147}],"term":"Posterior-reversible encephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Veno-occlusive disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Steroid myopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"ABO incompatability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147}],"term":"Bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147}],"term":"Thrombosis/deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Thrombotic thrombocytopenic purpura (TTP)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Refractory ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Ogilvie's syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Related to regimen","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Fractures/musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Unrelated to regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":147}],"term":"Death Caused by Bacterial Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Unrelated to regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Death Caused by Fungal Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Unrelated to regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Death Caused by Sepsis/Septic Shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Unrelated to regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147}],"term":"Death Caused by Viral Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Unrelated to regimen","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147}],"term":"Death Caused by Nonspecified Pneumonia"}],"timeFrame":"Non-hematologic toxicities and adverse experiences ≥ Grade 3 will be assessed up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant."}