{"description":"Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.","eventGroups":[{"deathsNumAffected":6,"deathsNumAtRisk":15,"description":"All subjects in this cohort will receive a minimal cell dose of 2 x 10\\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.\n\nHaplo-cord transplantation:\n\nAll subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.\n\nFor the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.\n\nIn addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":15,"seriousNumAffected":7,"seriousNumAtRisk":15,"title":"Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg"},{"deathsNumAffected":6,"deathsNumAtRisk":20,"description":"All subjects in this cohort will receive a minimal cell dose of 1 x 10\\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.\n\nHaplo-cord transplantation:\n\nAll subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.\n\nFor the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.\n\nIn addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.","id":"EG001","otherNumAffected":6,"otherNumAtRisk":20,"seriousNumAffected":9,"seriousNumAtRisk":20,"title":"Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg"},{"deathsNumAffected":11,"deathsNumAtRisk":25,"description":"All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.\n\nHaplo-cord transplantation:\n\nAll subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.\n\nFor the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.\n\nIn addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.","id":"EG002","otherNumAffected":12,"otherNumAtRisk":25,"seriousNumAffected":14,"seriousNumAtRisk":25,"title":"Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg"},{"deathsNumAffected":79,"deathsNumAtRisk":210,"description":"All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3)\n\nHaplo-cord transplantation:\n\nAll subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.\n\nFor the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.\n\nIn addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.","id":"EG003","otherNumAffected":93,"otherNumAtRisk":210,"seriousNumAffected":156,"seriousNumAtRisk":210,"title":"Cohort 4"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG003","numAffected":30,"numAtRisk":210,"numEvents":31}],"term":"Cytomegalovirus viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":25,"numEvents":3},{"groupId":"EG003","numAffected":30,"numAtRisk":210,"numEvents":33}],"term":"C. difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":210,"numEvents":3}],"term":"Candida esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Catheter Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":210,"numEvents":4}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Cytomegalovirus colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":210,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":210,"numEvents":0}],"term":"Hepatitis B Reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":210,"numEvents":3}],"term":"Human Herpes Virus 6 Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":210,"numEvents":4}],"term":"Herpes Simplex Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":14,"numAtRisk":210,"numEvents":14}],"term":"Infectious Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":11,"numAtRisk":210,"numEvents":11}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Vaginal yeast infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":9,"numAtRisk":210,"numEvents":9}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":15,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":25,"numEvents":6},{"groupId":"EG003","numAffected":26,"numAtRisk":210,"numEvents":33}],"term":"Upper Respiratory Infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":210,"numEvents":7}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Acute Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":210,"numEvents":6}],"term":"Infectious Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":8,"numAtRisk":210,"numEvents":9}],"term":"Adenovirus Viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Adult Respiratory Distress Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Altered Mental Status"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Anal Fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":210,"numEvents":3}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":210,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Asthma Exacerbation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":210,"numEvents":2}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":1}],"term":"Atrioventricular block complete"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":210,"numEvents":2}],"term":"Atypical hemolytic uremic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 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