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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT02987205
Description: Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT02987205
Study Brief: Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Revanesse Ultra Revanesse Ultra in the NLF on one side of the face Revanesse Ultra: NLF correction 0 None 0 163 114 163 View
Restylane Restylane injection in the NLF on the other side of the face to optimal correction Restylane: NLF Correction 0 None 1 163 137 163 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Treatment emergent Injection site vascular complication NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INJECTION SITE SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
INJECTION SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
INJECTION SITE ERYTHEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
INJECTION SITE HAEMATOMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View