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:
EG001
Title:
Fasted 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 fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours 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:
34
Other Number Affected:
5
Other Number At Risk:
34
Study:
NCT05737069
Results Section:
NCT05737069
Adverse Events Module:
NCT05737069