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NCT00253513 · ADVERSE EVENTS

Adverse events

Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome · Source last updated 2012-06-01

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treosulfan and Fludarabine Conditioning

Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

5 / 600 / 60Not reported / Not reported

Group identifiers: EG000: Treosulfan and Fludarabine Conditioning

Serious adverse events

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

  1. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Grade 4 mucositis
  2. organ System
    Immune system disorders
    source Vocabulary
    NCI-CTCAE v 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Death - cGVHD
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v 2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Death - intracranial hemmorrage
  4. organ System
    Infections and infestations
    source Vocabulary
    NCI-CTCAE v 2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Death - fungal infection

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. description
      Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      60
      serious Num Affected
      5
      serious Num At Risk
      60
      title
      Treosulfan and Fludarabine Conditioning
    frequency Threshold
    5
    serious Events
    1. organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE v2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        60
        num Events
        1
      term
      Grade 4 mucositis
    2. organ System
      Immune system disorders
      source Vocabulary
      NCI-CTCAE v 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        60
        num Events
        2
      term
      Death - cGVHD
    3. organ System
      Blood and lymphatic system disorders
      source Vocabulary
      NCI-CTCAE v 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        60
        num Events
        1
      term
      Death - intracranial hemmorrage
    4. organ System
      Infections and infestations
      source Vocabulary
      NCI-CTCAE v 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        60
        num Events
        2
      term
      Death - fungal infection

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

    Preserved source evidence · Not medical advice