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 @ 4:57 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT03869450
Description: None
Frequency Threshold: 5
Time Frame: 24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.
Study: NCT03869450
Study Brief: A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Restylane Defyne According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Defyne: Hyaluronic based filler 0 None 0 25 0 25 View
Restylane Lyft Lidocaine According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Lyft Lidocaine: Hyaluronic based filler 0 None 0 34 0 34 View
Restylane Volyme According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency. Restylane Volyme: Hyaluronic based filler 0 None 0 31 3 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View