Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT03975920
Description: By definition, no Serious Adverse Events, All-Cause Mortality, and Other (Not Including Serious) Adverse Events occurred in this study.
Frequency Threshold: 0
Time Frame: Up to 6 months
Study: NCT03975920
Study Brief: Assessing a New Jaw Support Device During Third Molar Extractions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care (UC) The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block. 0 None 0 84 0 84 View
Experimental Care (EC) The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block. The Restful Jaw Device: The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures. 0 None 0 87 0 87 View
Serious Events(If Any):
Other Events(If Any):