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 @ 4:16 AM
Ignite Modification Date: 2025-12-26 @ 3:16 AM
NCT ID: NCT02170220
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.
Frequency Threshold: 5
Time Frame: The first dose of study drug to within 32 days
Study: NCT02170220
Study Brief: Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
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 5 mg: Normal Hepatic Function Cohort Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function. None None 0 6 0 6 View
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment. None None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View