{"eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":43,"description":"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.\n\nTRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.\n\nGVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.\n\ncyclophosphamide: Given IV\n\ncyclosporine: Given IV\n\nperipheral blood stem cell transplantation: Undergo allogeneic PBSCT\n\ntotal-body irradiation: Undergo TBI\n\nfludarabine phosphate: Given IV\n\nbusulfan: Given IV\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT","id":"EG000","otherNumAffected":40,"otherNumAtRisk":43,"seriousNumAffected":22,"seriousNumAtRisk":43,"title":"Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":43,"numEvents":3}],"term":"Failure to engraft by day 28"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":43,"numEvents":3}],"term":"Persistent n/v thru day 28 and not related to GVHD"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":43,"numEvents":0}],"term":"Heart failure or LV dysfunction (grade 3-5)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":43,"numEvents":40}],"term":"Mucositis (grade 3-5; requiring TPN)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Cystitis or hematuria (grade 2-5; not infection)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":43,"numEvents":0}],"term":"Other (grade 3-5)"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Various organs (blood, pulmonary, bladder, etc)","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":43,"numEvents":18}],"term":"Infection/Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":43,"numEvents":4}],"term":"Disease recurrence/MRD"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Delayed engraftment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":2}],"term":"Graft failure/poor graft function"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":43,"numEvents":7}],"term":"GVHD"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Respiratory (not infection)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Myositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":43,"numEvents":2}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"RS3PE (rheumatologic)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Orthastic hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43,"numEvents":1}],"term":"Syncope"}],"timeFrame":"For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center"}