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NCT01894477 · ADVERSE EVENTS

Adverse events

Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2021-06-03

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
Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Other-event reporting threshold
0%

Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Treosulfan, Fludarabine Phosphate)

Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.

6 / 3528 / 3515 / 35
Arm B (Treosulfan, Fludarabine Phosphate, TBI)

Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.

9 / 6751 / 6720 / 67

Group identifiers: EG000: Arm A (Treosulfan, Fludarabine Phosphate) · EG001: Arm B (Treosulfan, Fludarabine Phosphate, TBI)

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
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    GI bleed
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Cardiac tamponade
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    pericardial effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    CMV Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    loss of vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    Engraftment syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    mental status changes
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    Pulmonary edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    Respiratory failure

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
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    Atrial fibrillation/flutter
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Decreased LVEF
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Elevated BNP
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Deconditioned
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Fluid overload
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
      num Events
      4
    term
    Weakness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      67
      num Events
      14
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      67
      num Events
      9
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Diarrhea
Complete source fields
description
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    35
    description
    Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    35
    serious Num Affected
    6
    serious Num At Risk
    35
    title
    Arm A (Treosulfan, Fludarabine Phosphate)
  2. deaths Num Affected
    20
    deaths Num At Risk
    67
    description
    Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    67
    serious Num Affected
    9
    serious Num At Risk
    67
    title
    Arm B (Treosulfan, Fludarabine Phosphate, TBI)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    Atrial fibrillation/flutter
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Decreased LVEF
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Elevated BNP
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Deconditioned
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Edema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Fluid overload
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
      num Events
      4
    term
    Weakness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      67
      num Events
      14
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      67
      num Events
      9
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
      num Events
      2
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    GI bleed
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Cardiac tamponade
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    pericardial effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    CMV Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    loss of vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    Engraftment syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
      num Events
      1
    term
    mental status changes
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
      num Events
      0
    term
    Pulmonary edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      67
      num Events
      3
    term
    Respiratory failure
time Frame
Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.

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