{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.\n\nClinical Limited cGVHD\n\n1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.\n2. Mild liver test abnormalities (alkaline phosphatase \\<2 x upper limit of normal, AST or ALT \\<3 x upper limit of normal and total bilirubin \\<1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.\n3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving \\<20% of body surface area (BSA), dyspigmentation involving \\<20% BSA, or erythema involving \\<50% BSA, positive skin biopsy, and no other manifestations of cGVHD.\n4. Ocular sicca (Schirmer's test \\<5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.\n5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.","groups":[{"description":"Subjects with hematological malignancies with prior autologous transplant, \\>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.\n\n* Cyclophosphamide 50 mg/Kg Day -6\n* Fludarabine 40mg/m2 Days -6 to -2\n* TBI 200 cGy Day -1\n\nImmune suppression: begin Day -3 cyclosporine and mycophenolate mofetil","id":"OG000","title":"Cyclophosphamide/Fludarabine/TBI"},{"description":"Subjects with hematological malignancies with prior autologous transplant \\>12 mos or \\<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.\n\n* Cyclophosphamide 50 mg/Kg Day -6\n* Fludarabine 40mg/m2 Days -6 to -2\n* TBI 200 cGy Day -1\n* Equine ATG 30mg/Kg Days -6 to -4\n\nImmune suppression: begin Day -3 cyclosporine and mycophenolate mofetil","id":"OG001","title":"Cyclophosphamide/Fludarabine/TBI/ATG"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"1 year post transplant","title":"Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year","type":"SECONDARY","unitOfMeasure":"Participants"}