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 @ 4:36 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT04389866
Description: Adverse events were monitored at every patient visit and through patient safety diaries completed daily for 1 month following treatment.
Frequency Threshold: 0
Time Frame: 12 months after last treatment
Study: NCT04389866
Study Brief: Jowl Improvement With Injectable 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
Jawline Injections JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) JUVÉDERM VOLUMA™ XC: Injectable gel 0 None 0 7 7 7 View
Both Jawline and Lateral (Zygomatic) Cheek Area Injections JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) 0 None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mild discomfort with chewing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild jaw ache SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Moderate jaw ache SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Moderate discomfort with chewing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lumps/bumps mass or nodule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Firmness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cheek pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear ache NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Inability to fully extend jaw SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bilateral eyelid droop SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Basal Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Moderate bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
arm or leg numbness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View