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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT02548156
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT02548156
Study Brief: Intra Oral Kinetics of Fluoride Containing Dentifrices
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Dentifrice 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse None None 0 28 8 28 View
Reference Dentifrice 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse None None 0 29 3 29 View
Comparator Dentifrice 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse None None 0 28 5 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device failure None General disorders None View
Medical device complication None General disorders None View
Malaise None General disorders None View
Vaccination site pain None General disorders None View
Influenza None Infections and infestations None View
Oral herpes None Infections and infestations None View
Rhinitis None Infections and infestations None View
Mouth injury None Injury, poisoning and procedural complications None View
Thermal burn None Injury, poisoning and procedural complications None View
Headache None Nervous system disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Chapped Lips None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View