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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT00647556
Description: Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT00647556
Study Brief: Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Differin® Gel, 0.3% adapalene gel 0.3% - apply once daily in the evening for 24 weeks None None 0 15 7 15 View
Tretinoin Emollient Cream Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks None None 0 15 14 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site bleeding NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Application site burn NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Application site dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Application site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Application site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastrointestinal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Chlamydial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gonorrhea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Streptococcal postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Face injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Open wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Terminal dribbling NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Actinic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View