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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT02932904
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: From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7
Study: NCT02932904
Study Brief: Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
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 Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. 0 None 0 91 36 91 View
Paroxetine 20 mg Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. 0 None 0 84 59 84 View
Vortioxetine 10 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. 0 None 0 91 52 91 View
Vortioxetine 20 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. 0 None 0 91 40 91 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Orgasm abnormal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Ejaculation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 20.0 View