{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.09","pValueComment":"Overall test of homogeneity among arms, reflecting events over the entire period of follow-up","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.1","estimateComment":"HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\\[","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.10","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.0","estimateComment":"HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.04","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"32"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"68"}],"units":"Participants"}],"description":"Number of patients with grades II-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 tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.\n\nFludarabine Phosphate: Given IV\n\nTotal-Body Irradiation: Undergo total-body irradiation\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nTacrolimus: Given IV or PO\n\nMycophenolate Mofetil: Given PO","id":"OG000","title":"Arm I (MMF and Tacrolimus)"},{"description":"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.\n\nFludarabine Phosphate: Given IV\n\nTotal-Body Irradiation: Undergo total-body irradiation\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nTacrolimus: Given IV or PO\n\nMycophenolate Mofetil: Given PO","id":"OG001","title":"Arm II (MMF and Tacrolimus Alternate Schedule)"},{"description":"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.\n\nFludarabine Phosphate: Given IV\n\nTotal-Body Irradiation: Undergo total-body irradiation\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nTacrolimus: Given IV or PO\n\nMycophenolate Mofetil: Given PO\n\nSirolimus: Given PO","id":"OG002","title":"Arm III (MMF, Tacrolimus, and Sirolimus)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.","reportingStatus":"POSTED","timeFrame":"150 days after transplant","title":"Number of Participants With Grades II-IV Acute GVHD","type":"PRIMARY","unitOfMeasure":"Participants"}