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 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT05109234
Group ID:
EG000
Title:
Childhood Absence Epilepsy (CAE): Brivaracetam
Description:
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
64
Other Number Affected:
15
Other Number At Risk:
64
Study:
NCT05109234
Results Section:
NCT05109234
Adverse Events Module:
NCT05109234