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 @ 10:19 PM
Ignite Modification Date: 2025-12-25 @ 7:52 PM
NCT ID: NCT01138735
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01138735
Study Brief: Epiduo Pediatric Acne Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Topical Gel Vehicle Topical Gel Vehicle applied topically once daily for 12 weeks None None 1 143 18 143 View
Adapalene/Benzoyl Peroxide Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks None None 0 142 37 142 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
RIGHT FRONTAL ARTERIOVENOUS MALFORMATION NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin burning sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View