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NCT00899353 · ADVERSE EVENTS

Adverse events

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM) · Source last updated 2013-12-12

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
Adverse Effects

Serious adverse effects associated with omega 3 fatty acid consumption.

0 / 165 / 16Not reported / Not reported

Group identifiers: EG000: Adverse Effects

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
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Grade 1 and 2 Diarrhea in participants consuming 6 or 9 capsules per day (4.8 or 7.2g per day)
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        5
      term
      Diarrhea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Participants were consuming 6 or 9 capsules per day (4.8 or 7.2g per day)
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        3
      term
      Nausea
    Complete source fields
    event Groups
    1. description
      Serious adverse effects associated with omega 3 fatty acid consumption.
      id
      EG000
      other Num Affected
      5
      other Num At Risk
      16
      serious Num Affected
      0
      serious Num At Risk
      16
      title
      Adverse Effects
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Grade 1 and 2 Diarrhea in participants consuming 6 or 9 capsules per day (4.8 or 7.2g per day)
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        5
      term
      Diarrhea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Participants were consuming 6 or 9 capsules per day (4.8 or 7.2g per day)
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        3
      term
      Nausea

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

    Preserved source evidence · Not medical advice