Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00795769 · ADVERSE EVENTS

Adverse events

Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant · Source last updated 2017-05-23

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
11 months between August 2008-June 2009
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ondansteron Therapy

Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. ondansetron: Given IV survey administration: Correlative studies management of therapy complications: Ondansetron IV

0 / 4918 / 490 / 49

Group identifiers: EG000: Ondansteron Therapy

Serious adverse events

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

    Other reported 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
      notes
      post stem cell infusion
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        49
      term
      nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      post stem cell infusion. Also had \> two point increase from baseline on MAT nausea score
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        49
      term
      nausea and vomiting
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      post stem cell infusion
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        49
      term
      vomiting
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      49
      description
      Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. ondansetron: Given IV survey administration: Correlative studies management of therapy complications: Ondansetron IV
      id
      EG000
      other Num Affected
      18
      other Num At Risk
      49
      serious Num Affected
      0
      serious Num At Risk
      49
      title
      Ondansteron Therapy
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      post stem cell infusion
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        49
      term
      nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      post stem cell infusion. Also had \> two point increase from baseline on MAT nausea score
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        49
      term
      nausea and vomiting
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      post stem cell infusion
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        49
      term
      vomiting
    time Frame
    11 months between August 2008-June 2009

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

    Preserved source evidence · Not medical advice