{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Grade II-IV Acute GVHD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Grade I-II Acute GVHD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Grade III-IV Acute GVHD"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.\n\nOverall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II","groups":[{"description":"Visilizumab, Tacrolimus and Methotrexate. All participants.","id":"OG000","title":"First Study Stage: Study Treatment"}],"paramType":"NUMBER","populationDescription":"All participants","reportingStatus":"POSTED","timeFrame":"100 days","title":"Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days","type":"PRIMARY","unitOfMeasure":"participants"}