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 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT03299166
Description: Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
Frequency Threshold: 5
Time Frame: Randomization Phase: Maximum duration: 12 weeks
Study: NCT03299166
Study Brief: Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
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 - Randomization Phase Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase. 0 None 0 122 24 122 View
Troriluzole - Randomization Phase Randomization phase (Weeks 1 through 12): Participants received troriluzole 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks in the double-blind (DB) randomization phase. 0 None 0 122 35 122 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View