Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT03915860
Description: Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once.
Frequency Threshold: 5
Time Frame: From start of the study drug administration up to end of the study (Week 24).
Study: NCT03915860
Study Brief: Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trifarotene Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. 0 None 0 46 9 46 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1. View
Application site dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1. View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1. View