{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"}],"units":"Participants"}],"description":"Number of patients with grades III-IV acute GVHD\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 w/ 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":"CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.\n\nTRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.\n\nIMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant\n\nSirolimus: Given PO\n\nTotal-Body Irradiation: Undergo total-body irradiation","id":"OG000","title":"Treatment (Fludarabine, Transplant, Immunosuppression)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One subject aborted transplant during conditioning and was counted towards accrual but not evaluated with respect to outcome measures.","reportingStatus":"POSTED","timeFrame":"100 days post-transplant","title":"Number of Patients With Grade III-IV Acute GVHD","type":"SECONDARY","unitOfMeasure":"Participants"}