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 @ 1:50 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT02923895
Description: None
Frequency Threshold: 1
Time Frame: Approximately 64 days (from Screening Visit to till 5 days following last administration of study product on Visit 3)
Study: NCT02923895
Study Brief: To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)
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 Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. 0 None 0 97 1 97 View
Control Dentifrice Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then brushed the whole mouth thoroughly for at least 1 minute twice daily. 0 None 0 95 0 95 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View