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: 2025-12-24 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT05248204
Description: None
Frequency Threshold: 0
Time Frame: All device-related and serious adverse events were collected from the time of restoration through the 24-month follow-up visit. Non-serious, non-device related adverse events were collected from the time of restoration through the 6-month follow-up visit.
Study: NCT05248204
Study Brief: Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Scotchbond Universal Plus Treatment Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative 0 None 0 51 8 51 View
Scotchbond Universal Comparator Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative 0 None 0 51 8 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental Restoration Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Hyperaesthesia teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Gingival Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Periodontal Inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Tooth Fracture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View