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 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
NCT ID:
NCT03978832
Group ID:
EG000
Title:
Oral Risperidone Followed by PERSERIS
Description:
All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm.
PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly
Risperidone: Oral risperidone
Outcome measures and adverse events were not reported by intervention, but by number of participants who experienced the adverse event. Based on narrative, it was possible to determine the timing of the serious adverse event. By nature of the adverse event, any injection site reported adverse events or outcome data occurred in participants who had received PERSERIS
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
23
Other Number Affected:
9
Other Number At Risk:
23
Study:
NCT03978832
Results Section:
NCT03978832
Adverse Events Module:
NCT03978832