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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT00883233
Description: None
Frequency Threshold: 2
Time Frame: 12 weeks
Study: NCT00883233
Study Brief: Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 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
Adapalene-BPO Gel 3h Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks None None 0 32 8 32 View
Adapalene-BPO Gel EoD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks None None 0 32 5 32 View
Adapalene-BPO Gel Cetaphil Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks None None 0 29 8 29 View
Adapalene-BPO Gel StD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week None None 0 30 6 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
sunburn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
impetigo SYSTEMATIC_ASSESSMENT Infections and infestations None View
upper track respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations None View
tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
skin oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
face oedema SYSTEMATIC_ASSESSMENT General disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View