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 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
NCT ID:
NCT05737069
Group ID:
EG003
Title:
Fed Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference)
Description:
Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
50
Other Number Affected:
10
Other Number At Risk:
50
Study:
NCT05737069
Results Section:
NCT05737069
Adverse Events Module:
NCT05737069