Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
NCT ID:
NCT03316950
Group ID:
EG002
Title:
Placebo Arm
Description:
Participants from the DiVa Sham Group and Intragen Sham Group combined DiVa Placebo: patients will undergo a three-part placebo treatment, spaced 1 month apart (+/- 10 days) of the vulvovaginal area. The vaginal HFL handpiece will be inserted into the vaginal canal but sub-therapeutic energy will not be delivered to the tissue.
IntraGen Placebo: patients will undergo a three-part placebo treatment, space 1 month apart (+/- 10 days) of the vulvovaginal area. This will be achieved through application of the probe, but with applying sub-therapeutic energy to the tissue.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
23
Other Number Affected:
6
Other Number At Risk:
23
Study:
NCT03316950
Results Section:
NCT03316950
Adverse Events Module:
NCT03316950