{"description":"One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.","eventGroups":[{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"EG000","otherNumAffected":10,"otherNumAtRisk":20,"seriousNumAffected":6,"seriousNumAtRisk":20,"title":"Group 1A (Pentostatin, DLI Dose Level 1)"},{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"EG001","otherNumAffected":2,"otherNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"title":"Group 1B (Pentostatin, DLI Dose Level 2)"},{"description":"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"EG002","otherNumAffected":2,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)"},{"description":"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Forced expiratory volume decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Ileal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Investigations - Other, (Pancytopenia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Small intestine infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fever"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"GVHD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hemolytic uremic syndrome"}],"timeFrame":"AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200"}