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NCT04148651 · ADVERSE EVENTS

Adverse events

The CO2RE® System for Vulvar Lichen Sclerosus · Source last updated 2022-03-22

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
The period of time over which adverse event data were collected is from treatment visit until 12-month follow-up (16 month post last treatment).
Other-event reporting threshold
0%

The number and severity of adverse events following each treatment were evaluated at each treatment visit and at the follow-up visit up to 12 months after the last treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Subjects Treated With CO2RE® Treatment

All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.

0 / 120 / 120 / 12

Group identifiers: EG000: Subjects Treated With CO2RE® Treatment

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.

      Complete source fields
      description
      The number and severity of adverse events following each treatment were evaluated at each treatment visit and at the follow-up visit up to 12 months after the last treatment.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        12
        description
        All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        12
        serious Num Affected
        0
        serious Num At Risk
        12
        title
        Subjects Treated With CO2RE® Treatment
      frequency Threshold
      0
      time Frame
      The period of time over which adverse event data were collected is from treatment visit until 12-month follow-up (16 month post last treatment).

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

      Preserved source evidence · Not medical advice