{"eventGroups":[{"deathsNumAffected":44,"deathsNumAtRisk":71,"description":"All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":7,"seriousNumAtRisk":71,"title":"All Trial Participants"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"hypoxemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"graft failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"liver toxicity/hyperbilirubinemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":71}],"term":"Graft vs host disease grade 4"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"CMV viremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"subdural hematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"Failure to thrive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"elevated lipase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"CMV pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"BK viruria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"fungal pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"bronchiolitis obliterans organizing pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"EBV viremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"nocardia pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}],"term":"toxic epidermal nectrolysis"}],"timeFrame":"1 year"}