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NCT00719888 · ADVERSE EVENTS

Adverse events

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease · Source last updated 2025-03-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.
Other-event reporting threshold
0%

For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide

Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT

47 / 10873 / 10824 / 108
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa

Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV

7 / 2725 / 279 / 27

Group identifiers: EG000: Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide · EG001: Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage) and post-renal causes (ureteral or bladder outflow obstruction).
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute kidney injury (AKI)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chronic dialysis or renal transplant indicated.
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes fluid to build up in the lungs, making it difficult to breathe and get oxygen into the body. Graded on whether intubation is indicated.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute Respiratory Distress Syndrome (ARDS)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4 hyperbilirubinemia is bilirubin level raised by \>10.0 times the Upper Limit Number (ULN)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Bilirubin (hyperbilirubinemia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Loss of heart activity due to irregular heart rhythm. Life-threatening.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Inflammation of the gallbladder. Interventional radiology, endoscopic, or operative intervention indicated.
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cholecystitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Confusion or delirium interfering with activities of daily living (ADLs).
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hrs; hospitalization; severe increase in output compared to baseline; interfering with ADL.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cognitive disturbance; depressed level of consciousness. Grade 3= signs or symptoms interfering with ADL; hospitalization indicated. Grade 4= life-threatening or disabling.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Encephalopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A brief loss of consciousness that is followed by a quick and complete recovery.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Syncope (fainting)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 109/L, fever ≥38.5°C).
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Febrile neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Headache causing severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Pain - Select: Head/headache

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Allergic reaction/hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection; ANC \<1.0 x 109/L, fever ≥38.5°C.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      108
      num Events
      50
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      27
      num Events
      14
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    CD4 count \<50/mm3 \<0.05 x 109 /L.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    CD4 count
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Leukocyte (total WBC) count \<1000/mm3 \<1.0 x 109 /L.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    e.g., immune hemolytic anemia, drug-related hemolysis
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Iron overload
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Supraventricular and nodal arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Prolonged QTc interval
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac General - Other (Heart failure)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
      num Events
      15
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      27
      num Events
      13
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      5
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Cardiac ischemia/infarction
Complete source fields
description
For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
event Groups
  1. deaths Num Affected
    24
    deaths Num At Risk
    108
    description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT
    id
    EG000
    other Num Affected
    73
    other Num At Risk
    108
    serious Num Affected
    47
    serious Num At Risk
    108
    title
    Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide
  2. deaths Num Affected
    9
    deaths Num At Risk
    27
    description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    27
    serious Num Affected
    7
    serious Num At Risk
    27
    title
    Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Allergic reaction/hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection; ANC \<1.0 x 109/L, fever ≥38.5°C.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      108
      num Events
      50
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      27
      num Events
      14
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    CD4 count \<50/mm3 \<0.05 x 109 /L.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    CD4 count
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Leukocyte (total WBC) count \<1000/mm3 \<1.0 x 109 /L.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Leukocytes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    e.g., immune hemolytic anemia, drug-related hemolysis
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Hemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Iron overload
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Supraventricular and nodal arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Prolonged QTc interval
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac General - Other (Heart failure)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
      num Events
      15
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      27
      num Events
      13
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      5
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Cardiac ischemia/infarction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage) and post-renal causes (ureteral or bladder outflow obstruction).
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute kidney injury (AKI)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chronic dialysis or renal transplant indicated.
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes fluid to build up in the lungs, making it difficult to breathe and get oxygen into the body. Graded on whether intubation is indicated.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute Respiratory Distress Syndrome (ARDS)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4 hyperbilirubinemia is bilirubin level raised by \>10.0 times the Upper Limit Number (ULN)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Bilirubin (hyperbilirubinemia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Loss of heart activity due to irregular heart rhythm. Life-threatening.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Inflammation of the gallbladder. Interventional radiology, endoscopic, or operative intervention indicated.
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cholecystitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Confusion or delirium interfering with activities of daily living (ADLs).
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hrs; hospitalization; severe increase in output compared to baseline; interfering with ADL.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cognitive disturbance; depressed level of consciousness. Grade 3= signs or symptoms interfering with ADL; hospitalization indicated. Grade 4= life-threatening or disabling.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Encephalopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A brief loss of consciousness that is followed by a quick and complete recovery.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Syncope (fainting)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 109/L, fever ≥38.5°C).
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Febrile neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Headache causing severe pain; pain or analgesics severely interfering with ADL.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Pain - Select: Head/headache
time Frame
Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.

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