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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT04206293
Description: All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
Frequency Threshold: 0
Time Frame: First dose of study treatment to end of the study (Up to 9 months)
Study: NCT04206293
Study Brief: A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Juvéderm® VOLITE Treated Zone Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated. 0 None 0 11 5 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin tightness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View