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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT00464269
Description: Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
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: NCT00464269
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 0 98 32 98 View
BRV 5 mg/Day Brivaracetam 5 mg/day, 2.5 mg administered twice a day None None 1 97 49 97 View
BRV 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day None None 3 100 46 100 View
BRV 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day None None 4 101 51 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA9.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA9.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Grand mal convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Aspiration bronchial NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Brain hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA9.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA9.0 View