{"description":"Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":14,"description":"PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":9,"seriousNumAtRisk":14,"title":"Arm I"}],"frequencyThreshold":"5","seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":4}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Supraventricular and nodal arrhythmia - Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Death not associated with CTCAE term - Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hemorrhage, pulmonary/upper respiratory - Nose"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":14,"numEvents":5}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Death not associated with CTCAE term - Death NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Bone marrow cellularity - Primary graft failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Catheter related","organSystem":"Product Issues","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Colitis, infectious (e.g., Clostridium difficile)"}],"timeFrame":"Adverse Events were collected from participant start on study to going off study up to a period of 2 years."}