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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:15 PM
NCT ID: NCT03402893
Description: None
Frequency Threshold: 0
Time Frame: screening to week 16
Study: NCT03402893
Study Brief: The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Onexton Gel Application Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face 0 None 0 20 10 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
intermittent mid back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
group A beta hemolytic strep pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cellulitis right knee SYSTEMATIC_ASSESSMENT Infections and infestations None View
rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pharyngitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
unexpected menses SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
facial tattoo tightening SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
chest soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
serous otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
bacterial vaginosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
maxillary fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View