Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT05109234
Description:
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
Frequency Threshold:
5
Time Frame:
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Study:
NCT05109234
Study Brief:
A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Childhood Absence Epilepsy (CAE): Brivaracetam | 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. | 0 | None | 2 | 64 | 15 | 64 | View |
| Juvenile Absence Epilepsy (JAE): Brivaracetam | Participants with JAE 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 50 kg). 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 JAE was obtained for pediatric participants in their age range, until a 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 FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case. | 0 | None | 2 | 20 | 8 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 18.1 | View |
| Measles | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.1 | View |
| Generalised tonic-clonic seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.1 | View |
| Status epilepticus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.1 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 18.1 | View |
Other Events(If Any):