{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"6"}],"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":"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nTotal-Body Irradiation: Undergo TBI","id":"OG000","title":"Arm I (MMF and CSP)"},{"description":"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nSirolimus: Given PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG001","title":"Arm II (MMF, CSP, and Sirolimus)"},{"description":"Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011","id":"OG002","title":"Arm 0 (CSP and Sirolimus)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One subject on Arm II aborted transplant during conditioning 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":"Up to 100 days","title":"Number of Patients With Grades III-IV Acute GVHD","type":"SECONDARY","unitOfMeasure":"Participants"}