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NCT00134017 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer · Source last updated 2018-08-31

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
Up to one year
Other-event reporting threshold
5%

Adverse events were tracked systematically for 30-60 days depending on exact discharge date from the initial hospitalization. Only the following adverse events were collected: all graft failures; deaths in the first sixty days; unexpected grade 4-5 events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bone Marrow Transplant

Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis

20 / 1420 / 14266 / 142

Group identifiers: EG000: Bone Marrow Transplant

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
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Aspergillus pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      142
      num Events
      6
    term
    Graft failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Graft versus host disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Multiorgan failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      142
      num Events
      7
    term
    Pulmonary failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Pulmonary hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Septic shock
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    Veno-occlusive disease

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
    Adverse events were tracked systematically for 30-60 days depending on exact discharge date from the initial hospitalization. Only the following adverse events were collected: all graft failures; deaths in the first sixty days; unexpected grade 4-5 events.
    event Groups
    1. deaths Num Affected
      66
      deaths Num At Risk
      142
      description
      Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      142
      serious Num Affected
      20
      serious Num At Risk
      142
      title
      Bone Marrow Transplant
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
        num Events
        1
      term
      Aspergillus pneumonia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        142
        num Events
        6
      term
      Graft failure
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
        num Events
        1
      term
      Graft versus host disease
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
        num Events
        1
      term
      Multiorgan failure
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        142
        num Events
        7
      term
      Pulmonary failure
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
        num Events
        1
      term
      Pulmonary hemorrhage
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        142
        num Events
        1
      term
      Septic shock
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        142
        num Events
        4
      term
      Veno-occlusive disease
    time Frame
    Up to one year

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

    Preserved source evidence · Not medical advice