{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"Number of patients with grades II-IV acute GVHD aGVHD Stages\n\nSkin:\n\na maculopapular eruption involving \\< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma w/ bullous formation and often w/ desquamation\n\nLiver:\n\nbilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL 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 undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT\n\nCyclosporine: Given PO\n\nMycophenolate Mofetil: Given PO\n\nSirolimus: Given PO","id":"OG000","title":"Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)"},{"description":"Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT\n\nCyclophosphamide: Given IV\n\nCyclosporine: Given PO\n\nSirolimus: Given PO","id":"OG001","title":"Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"At day 100 post-HCT","title":"Number of Patients With Grades III-IV Acute Graft Versus Host Disease (GVHD)","type":"SECONDARY","unitOfMeasure":"Participants"}