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NCT01370551 · ADVERSE EVENTS

Adverse events

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients · Source last updated 2024-10-15

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
12 weeks
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gynoflor

Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks

0 / 1614 / 160 / 16

Group identifiers: EG000: Gynoflor

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
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        16
        num Events
        7
      term
      Vaginal discharge
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
        num Events
        3
      term
      cystitis
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
        num Events
        5
      term
      Gastro-intestinal disorders
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Influenza-like ilness
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Ear and Labyrinth disorders
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      16
      description
      Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks
      id
      EG000
      other Num Affected
      14
      other Num At Risk
      16
      serious Num Affected
      0
      serious Num At Risk
      16
      title
      Gynoflor
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        16
        num Events
        7
      term
      Vaginal discharge
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
        num Events
        3
      term
      cystitis
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        16
        num Events
        5
      term
      Gastro-intestinal disorders
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Influenza-like ilness
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Ear and Labyrinth disorders
    time Frame
    12 weeks

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

    Preserved source evidence · Not medical advice