{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"description":"Number of patients who developed acute GVHD post allogeneic transplant.\n\naGVHD Stages\n\nSkin:\n\n1. a maculopapular eruption involving \\< 25% BSA\n2. a maculopapular eruption involving 25 - 50% BSA\n3. generalized erythroderma\n4. generalized erythroderma w/ bullous formation and often w/ desquamation\n\nLiver:\n\n1. bilirubin 2.0 - 3.0 mg/100 mL\n2. bilirubin 3 - 5.9 mg/100 mL\n3. bilirubin 6 - 14.9 mg/100 mL\n4. bilirubin \\> 15 mg/100 mL\n\nGut:\n\nDiarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.\n\naGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death","groups":[{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.\n\nTRANSPLANT: Patients undergo donor PBSC transplant on day 0.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG000","title":"Primary - Reg A (Flu/TBI)"},{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.\n\nTRANSPLANT: Patients undergo donor PBSC transplant on day 0.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG001","title":"Primary - Reg B (TBI Alone)"},{"description":"NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.\n\nPOST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.","id":"OG002","title":"Adjunct"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.","reportingStatus":"POSTED","timeFrame":"100 days post-transplant","title":"Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)","type":"SECONDARY","unitOfMeasure":"Participants"}