{"description":"Attribution of adverse events when patients are co-enrolled on other trials: because abatacept's effects are strictly immunologic and because co-enrollment will only be allowed in trials testing agents without immunomodulatory effects, all adverse events stemming directly or indirectly from immune deficiency or immune dysregulation will be attributed (definite, probable or possible depending on the circumstances) to abatacept and not the agent being tested in the other trial.","eventGroups":[{"description":"In this trial, we will test the safety and tolerability of the addition of the CD28-B7 blockade agent, abatacept, as an adjunctive therapy for the prevention of GvHD in a high-risk BMT cohort. Four doses of abatacept will be given according to a dosing schedule based on previous trials using CD28-B7 blockade with belatacept in kidney transplantation. Pharmacokinetic and pharmakodynamic analysis of abatacept will be undertaken, as well as an evaluation of the incidence and severity of acute GvHD in this patient cohort.\n\nDosage: Abatacept is administered as an intravenous infusion under medically controlled conditions. Dose is 10mg/kg with a maximum dose of 1 gram. Abatacept should be administered as a 30-minute intravenous infusion. In this study, abatacept will be dosed on days -1, +5, +14, +28 post-transplant. Small adjustments in dose to accommodate abatacept vial size may be acceptable. These dose adjustments must be approved by the study PI.","id":"EG000","otherNumAffected":8,"otherNumAtRisk":10,"seriousNumAffected":7,"seriousNumAtRisk":10,"title":"Abatacept"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Renal toxicity grade 2","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10,"numEvents":4}],"term":"Renal toxicity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Mucositis oral grade 2","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":10,"numEvents":5}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"bladder grade 2","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Bladder toxicity"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10,"numEvents":4}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":2}],"term":"Bacteremia with coagulase negative staphylococcus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Upper Respiratory Infection - Parainfluenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"i","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Bacteremia with E. coli"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Upper Respiratory Infection - Rhinovirus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Perianal cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Hemorrhagic cystitis with BK virus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Polyclonal lymphoproliferative disorder"}],"timeFrame":"One year post-transplant."}