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 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT02972632
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: Baseline up to Day 113
Study: NCT02972632
Study Brief: Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive 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
Vortioxetine Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion. 0 None 1 122 46 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View