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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT02566369
Description: None
Frequency Threshold: 0
Time Frame: Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
Study: NCT02566369
Study Brief: Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in 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
Placebo Cream Placebo cream applied once daily for 12 weeks 0 None 2 596 74 596 View
CD5789 (Trifarotene) 50μg/g Cream CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. 0 None 4 612 177 612 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hereditary angioedema NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Procedural dizziness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infectious Mononucleosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atypical Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Facial Bones Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Application Site Irritation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Pruritis NON_SYSTEMATIC_ASSESSMENT General disorders None View