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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT02589405
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT02589405
Study Brief: Benzac 5% Gel in Combination With Cosmetic Products 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
Three-part Treatment Regimen Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 0 None 1 50 13 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View