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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT00926367
Description: Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
Frequency Threshold: 0.1
Time Frame: 14 days
Study: NCT00926367
Study Brief: Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Duac Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide None None 0 25 13 25 View
Epiduo Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene None None 0 27 13 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stitches contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Joint stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Seaonal allergies NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Menstrual cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Earache NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Scratched cornea NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View