Adverse Events Module

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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: 2025-12-24 @ 10:38 PM
Ignite Modification Date: 2025-12-25 @ 8:09 PM
NCT ID: NCT00490035
Description: Adverse Events (AEs) refer to the Safety Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Study: NCT00490035
Study Brief: Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching Placebo tablets administered twice a day None None 6 100 22 100 View
Brivaracetam 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day None None 2 99 31 99 View
Brivaracetam 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day None None 4 99 35 99 View
Brivaracetam 100 mg/Day Brivaracetam 100 mg/day, 50 mg administered twice a day None None 2 100 37 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (9.0) View
Amnesia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Gastritis erosive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Grand mal convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.0) View
Jaw fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.0) View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (9.0) View
Psychotic Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (9.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (9.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View