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NCT00448201 · ADVERSE EVENTS

Adverse events

Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease · Source last updated 2017-05-30

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
1 year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Trial Participants

All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).

7 / 710 / 044 / 71

Group identifiers: EG000: All Trial Participants

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    hypoxemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    graft failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    liver toxicity/hyperbilirubinemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
    term
    Graft vs host disease grade 4
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    CMV viremia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    subdural hematoma
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
    term
    Fever
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    Failure to thrive
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    elevated lipase
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    CMV pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    BK viruria
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
    term
    fungal pneumonia

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
    event Groups
    1. deaths Num Affected
      44
      deaths Num At Risk
      71
      description
      All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      7
      serious Num At Risk
      71
      title
      All Trial Participants
    frequency Threshold
    0
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      hypoxemia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      graft failure
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      liver toxicity/hyperbilirubinemia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        71
      term
      Graft vs host disease grade 4
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      CMV viremia
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      subdural hematoma
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        71
      term
      Fever
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      Failure to thrive
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      elevated lipase
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      CMV pneumonia
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      BK viruria
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        71
      term
      fungal pneumonia
    time Frame
    1 year

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice