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 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
NCT ID:
NCT03467932
Group ID:
EG000
Title:
Combined Cohort A + Cohort B: Matched Placebo
Description:
Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)
Placebo oral capsule: Placebo provided QHS, BID, TID
Per FDA, the sub-Cohort A, excipient-matched placebo TID is an exploratory arm and is not part of the primary analysis.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
82
Other Number Affected:
11
Other Number At Risk:
82
Study:
NCT03467932
Results Section:
NCT03467932
Adverse Events Module:
NCT03467932