{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"12"}]}],"title":"Grade 2-4 aGVHD @1yr"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 3-4 aGVHD @1yr"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"59"}]}],"title":"Chronic GVHD @3yrs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"33"}]}],"title":"Mod-severe cGVHD @3yrs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Percentage of participants with acute and chronic graft-versus-host disease (GVHD). The time frame for the acute incidence is 1 year and for chronic is 3 years.Grading of aGVHD was derived by consensus grading (Przepiorka 1995). The aGVHD algorithm calculates the grade based on the organ (skin, GI and liver) stage and etiology/biopsy reported. Skin staging: Stage 1. \\<25% rash; 2. 25-50%; 3. \\>50%; 4. generalized erythroderma with bullae. GI staging: Stage 1. Diarrhea\\>500ml/d or persistent nausea; 2. \\>1000ml/d; 3. \\>1500ml/d; 4. Large volume diarrhea and severe abdominal pain +- ileus. Liver staging: Stage 1. bilirubin 2-3mg/dl; 2. bili 3-6 mg/dl; 3. bili 6-15 mg/dl; 4. bili\\>15mg/dl. Grade 4 is the worst outcome.\n\nChronic GVHD is classified using the NIH Consensus Criteria. 8 organs will be scored on a 0-3 scale to reflect degree of cGVHD involvement 0 being none, 1 mild, 2 moderate 3 severe. Liver and pulmonary function test results will also be recorded. Severe is the worst outcome","groups":[{"description":"GVAX vaccine\n\nParticipants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.\n\nConditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.\n\nAllogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.\n\nGVHD Prevention:\n\n* Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.\n* Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.\n\nGVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.","id":"OG000","title":"GVAX"},{"description":"Placebo vaccine\n\nParticipants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.\n\nConditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.\n\nAllogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.\n\nGVHD Prevention:\n\n* Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.\n* Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.\n\nPlacebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"1 and 3 years","title":"Percentage of Participants Experiencing Acute and Chronic Graft-Versus-Host Disease","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}