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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT01299805
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: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug.
Study: NCT01299805
Study Brief: Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults
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 20 mg, encapsulated tablet, orally, once daily for up to 14 days. None None 0 12 11 12 View
Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days. None None 0 5 4 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View