{"description":"Adverse event information was assessed by study investigators and entered into an internal Bone Marrow Transplant database.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Single arm combined bone marrow and kidney transplantation\n\nTacrolimus: Tacrolimus starting on Day -1\n\nEquine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3\n\nKidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques.\n\nBone marrow transplant from a related donor: Donor bone marrow (\\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed.\n\nTotal body irradiation 400 centigray (200 cGy X 2): On transplant day -1","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Bone Marrow and Kidney RECIPIENT"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques.\n\nBone marrow transplant from a related donor: Donor bone marrow (\\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Bone Marrow and Kidney DONOR"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A postoperative transient perinephric hematoma occurred, not requiring surgical intervention.","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAtRisk":1}],"term":"Perinephric hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Abdominal pain due to constipation occurred which was alleviated by a bowel regimen.","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAtRisk":1}],"term":"Abdominal pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Transient acute kidney injury due to tacrolimus and engraftment syndrome","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAtRisk":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Delayed (secondary) hematopoietic graft rejection. A second HLA-matched related stem cell transplant was performed from the same donor on 5/11/16 with successful and sustained engraftment.","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAtRisk":1}],"term":"Hematopoietic graft rejection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pulmonary aspergillosis following hematopoietic graft rejection, treated to resolution following a second hematopoietic cell transplant from the same donor and anti-fungal therapy","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAtRisk":1}],"term":"Aspergillosis"}],"timeFrame":"6 years"}