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:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
NCT ID:
NCT02834793
Group ID:
EG002
Title:
Extension Phase: Perampanel
Description:
Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period; and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks).
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
58
Other Number Affected:
50
Other Number At Risk:
58
Study:
NCT02834793
Results Section:
NCT02834793
Adverse Events Module:
NCT02834793