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 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 1:14 PM
NCT ID:
NCT04836559
Group ID:
EG005
Title:
OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813
Description:
During OLE period, cohort 1 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg BID, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg BID. The dose could be increased at the second visit (Month1) to 200 mg JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg JNJ-40411813 BID for non-induced participants (without EIAEDs).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
23
Other Number Affected:
12
Other Number At Risk:
23
Study:
NCT04836559
Results Section:
NCT04836559
Adverse Events Module:
NCT04836559