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NCT00361140 · ADVERSE EVENTS

Adverse events

Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT) · Source last updated 2017-03-03

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
Not reported
Other-event reporting threshold
5%

Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AUC Level 1

Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min

2 / 400 / 40Not reported / Not reported
AUC Level 2

Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min

13 / 290 / 29Not reported / Not reported
AUC Level 3

Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min

2 / 30 / 3Not reported / Not reported

Group identifiers: EG000: AUC Level 1 · EG001: AUC Level 2 · EG002: AUC Level 3

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
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unlikely to be related
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cardiac ischemia/infarction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unlikely to be related
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Hemorrhage, GI - Stomach
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unlikely to be related
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Death not associated with CTCAE term - Death NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cholecystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hepatobiliary/Pancreas - Other, VOD
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Liver dysfunction/failure (clinical)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    AST, SGOT - high

Other reported adverse events

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

    Complete source fields
    description
    Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.
    event Groups
    1. description
      Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      40
      serious Num Affected
      2
      serious Num At Risk
      40
      title
      AUC Level 1
    2. description
      Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      29
      serious Num Affected
      13
      serious Num At Risk
      29
      title
      AUC Level 2
    3. description
      Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      3
      serious Num Affected
      2
      serious Num At Risk
      3
      title
      AUC Level 3
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unlikely to be related
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Cardiac ischemia/infarction
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unlikely to be related
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Hemorrhage, GI - Stomach
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unlikely to be related
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Nausea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Death not associated with CTCAE term - Death NOS
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Cholecystitis
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Hepatobiliary/Pancreas - Other, VOD
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Liver dysfunction/failure (clinical)
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        29
        num Events
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        40
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        29
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Unrelated
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        29
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        3
        num Events
        0
      term
      AST, SGOT - high

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    Preserved source evidence · Not medical advice