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NCT00609739 · ADVERSE EVENTS

Adverse events

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation · Source last updated 2017-12-28

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 30 days post study treatment.
Other-event reporting threshold
5%

Regimen related toxicity (RRT) is a concern, but because of the seriousness of relapsed JMML, a high incidence of grade III and IV RRT will be considered acceptable. No other adverse events were collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cytarabine + Mitoxantrone

Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.

1 / 10 / 1Not reported / Not reported

Group identifiers: EG000: Cytarabine + Mitoxantrone

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
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Death

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
    Regimen related toxicity (RRT) is a concern, but because of the seriousness of relapsed JMML, a high incidence of grade III and IV RRT will be considered acceptable. No other adverse events were collected.
    event Groups
    1. description
      Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      1
      serious Num Affected
      1
      serious Num At Risk
      1
      title
      Cytarabine + Mitoxantrone
    frequency Threshold
    5
    serious Events
    1. 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
        1
        num Events
        1
      term
      Death
    time Frame
    Up to 30 days post study treatment.

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

    Preserved source evidence · Not medical advice