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: 2025-12-24 @ 5:46 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT03310268
Description: None
Frequency Threshold: 0
Time Frame: From screening up to Week 8
Study: NCT03310268
Study Brief: A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Negative Control (1400 Ppm Fluoride as SMFP) Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated. 0 None 0 62 3 62 View
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride]) Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated. 0 None 0 61 4 61 View
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride]) Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated. 0 None 0 62 7 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lip Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non infective Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Angular Chelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Pulpitis Dental SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View