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: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT03686033
Description: None
Frequency Threshold: 0
Time Frame: Up to 28 days after the last dose of study treatment on Day 1 in Treatment Period 4 (approximately Day 71)
Study: NCT03686033
Study Brief: A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive 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
Treatment C: E2082 25 mg Participants received, E2082 25 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3. 0 None 0 4 1 4 View
Treatment A: Placebo Participants received, E2082-matched placebo tablet, orally, once on Day 1 as per assigned Treatment sequence in Treatment Period 1, 2, or 3. 0 None 1 5 2 5 View
Treatment B: E2082 2.5 mg Participants received, E2082 2.5 mg tablet, orally, once on Day 1 as per assigned treatment sequence in Treatment Period 1, 2, or 3. 0 None 0 5 2 5 View
Open-label Treatment: E2082 40 mg Participants received, E2082 40 mg tablet, orally, once on Day 1 of Treatment Period 4 in all the sequences. 0 None 0 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eye movement disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Anger SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View