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NCT00981305 · ADVERSE EVENTS

Adverse events

Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors · Source last updated 2017-08-07

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
8 weeks
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lactate-containing Vaginal Lubricant

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

0 / 507 / 50Not reported / Not reported
Placebo

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

0 / 577 / 57Not reported / Not reported

Group identifiers: EG000: Lactate-containing Vaginal Lubricant · EG001: Placebo

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
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        57
      term
      Vaginal itching
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        57
      term
      Vaginal irritation
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        57
      term
      Both
    Complete source fields
    event Groups
    1. description
      apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
      id
      EG000
      other Num Affected
      7
      other Num At Risk
      50
      serious Num Affected
      0
      serious Num At Risk
      50
      title
      Lactate-containing Vaginal Lubricant
    2. description
      apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
      id
      EG001
      other Num Affected
      7
      other Num At Risk
      57
      serious Num Affected
      0
      serious Num At Risk
      57
      title
      Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        57
      term
      Vaginal itching
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        57
      term
      Vaginal irritation
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        50
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        57
      term
      Both
    time Frame
    8 weeks

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

    Preserved source evidence · Not medical advice