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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT05320393
Description: Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
Frequency Threshold: 5
Time Frame: Adverse event data were collected over a period of up 12 months post treatment.
Study: NCT05320393
Study Brief: Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PrabotulinumtoxinA-xvfs 20U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 20 units 0 None 0 53 3 52 View
OnabotulinumtoxinA 20U of OnabotulinumtoxinA OnabotulinumtoxinA: One treatment of 20 units 0 None 0 50 5 50 View
Study Drug 40U of PrabotulinumtoxinA-xvfs PrabotulinumtoxinA-Xvfs: One treatment of 40 units 0 None 0 51 2 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View