{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"Cumulative incidence methods are compared using the Gray test with a p-value \\<0.05","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.05","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23","upperLimit":"50","value":"37"},{"groupId":"OG001","lowerLimit":"32","upperLimit":"60","value":"47"}]}],"title":"Grade 1-4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15","upperLimit":"39","value":"27"},{"groupId":"OG001","lowerLimit":"16","upperLimit":"41","value":"28"}]}],"title":"Grade 2-4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"12","value":"4"},{"groupId":"OG001","lowerLimit":"5","upperLimit":"24","value":"13"}]}],"title":"Grade 3-4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"description":"Acute GVHD by grade will be estimated using cumulative incidence methods and compared using the Gray test.\n\nA lower clinical grade and/or stage of GVHD corresponds to a better participant outcome and a higher grade corresponds to a worse participant outcome. Grading is as follows:\n\nGrade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade 2: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI.\n\nGrade 3: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI.\n\nGrade 4: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI.\n\nA greater stage of GVHD involves worsening end-organ involvement and worse participant outcomes based on the skin, liver, lower GI, and upper GI.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.\n\ntacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL\n\nmethotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \\< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.","id":"OG000","title":"Group A (Tacrolimus, Methotrexate)"},{"description":"Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).\n\ntacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL\n\nMycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \\>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \\< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol\n\nMethotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.","id":"OG001","title":"Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)"}],"paramType":"NUMBER","populationDescription":"participants who completed the study","reportingStatus":"POSTED","timeFrame":"Day 7- Day 100","title":"Cumulative Incidence of Participants With Acute GVHD","type":"PRIMARY","unitOfMeasure":"percentage of participants"}