{"description":"Patients were monitored for local and systemic adverse reactions with weekly to twice weekly examinations and laboratory studies during the study period. Acute graft-versus host disease (GVHD) was graded according to Keystone criteria.19 Non-GVHD adverse events were reported according to the National Cancer Institute Common Toxicity Criteria v.4 guidelines.","eventGroups":[{"deathsNumAffected":14,"deathsNumAtRisk":30,"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":"EG000","otherNumAffected":10,"otherNumAtRisk":30,"seriousNumAffected":1,"seriousNumAtRisk":30,"title":"GVAX"},{"deathsNumAffected":13,"deathsNumAtRisk":27,"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":"EG001","otherNumAffected":4,"otherNumAtRisk":27,"seriousNumAffected":2,"seriousNumAtRisk":27,"title":"Placebo"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Erythema Multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Skin Induration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Ventricular tachycardia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Alanine aminotransferase increased"}],"timeFrame":"18 Months"}