{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.33"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Percentage of participants experiencing grade 3 or higher non-hematologic or grade or higher hematologic adverse events evaluated by CTCAE v5.0.","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":"18 Months","title":"Percentage of Participants Experiencing Grade 3 or Higher Non-Hematologic or Grade 4 or Higher Hematologic Adverse Events","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}