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 @ 4:38 PM
Ignite Modification Date:
2025-12-25 @ 2:28 PM
NCT ID:
NCT04544566
Group ID:
EG002
Title:
Comparator
Description:
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
12
Other Number Affected:
1
Other Number At Risk:
12
Study:
NCT04544566
Results Section:
NCT04544566
Adverse Events Module:
NCT04544566