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 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT04839692
Description: Minimal-risk study with healthy participants. Two subjects from the young arm presented lip asymmetry as an adverse event.
Frequency Threshold: 0
Time Frame: 21 days
Study: NCT04839692
Study Brief: Assessment and Augmentation of Lip Appearance in Specific Study Populations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Post Menopausal Females post menopausal females from all phototypes who have thin or moderately thick lips Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. 0 None 0 11 0 11 View
Young Females (21-30 Years Old) young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. 0 None 0 22 2 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asymmetry NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View