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:
EG000
Title:
DB: Cohort 1: Placebo
Description:
During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
20
Other Number Affected:
7
Other Number At Risk:
20
Study:
NCT04836559
Results Section:
NCT04836559
Adverse Events Module:
NCT04836559