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 @ 4:27 PM
Ignite Modification Date: 2025-12-25 @ 2:20 PM
NCT ID: NCT01629966
Description: The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
Frequency Threshold: 5
Time Frame: Adverse events were collected until week 8.
Study: NCT01629966
Study Brief: Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety 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
Vilazadone 20mg Vilazodone 20mg once per day, oral administration. 0 None 1 227 123 227 View
Placebo Dose-matched placebo one per day, oral administration 0 None 1 221 85 221 View
Vilazodone 40mg Vilazodone 40mg once per day, oral administration 0 None 0 225 121 225 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 16.1 View
left carpal canal hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 16.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.1 View