{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.009","pValueComment":"Overall test of homogeneity among arms, reflecting events over the entire period of follow-up","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.4","estimateComment":"HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.51","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.8","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":"0.004","paramType":"Hazard Ratio (HR)","paramValue":"0.47","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"68"}],"units":"Participants"}],"description":"Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.\n\nCumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)\" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198","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 Utilizing High-Dose Corticosteroids","type":"SECONDARY","unitOfMeasure":"Participants"}