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NCT03739983 · ADVERSE EVENTS

Adverse events

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention · Source last updated 2021-10-20

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 3 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
VRP Therapy

All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand.

0 / 22 / 20 / 2

Group identifiers: EG000: VRP 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
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Irritation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Vulvar Stinging
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Perineal Chaffing
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      2
      description
      All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand.
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      2
      serious Num Affected
      0
      serious Num At Risk
      2
      title
      VRP Therapy
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Irritation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Vulvar Stinging
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE V.4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Perineal Chaffing
    time Frame
    up to 3 months

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

    Preserved source evidence · Not medical advice