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 @ 2:13 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT03943095
Description: Safety population: all participants who were eligible to participate in the study and received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
Frequency Threshold: 0
Time Frame: From screening up to Day 56
Study: NCT03943095
Study Brief: Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin 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
Test Dentifrice Participants were instructed to apply a strip of dentifrice (a full brush head) containing 5 percent (%) weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing.Participants received test dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily. 0 None 0 52 2 52 View
Control Dentifrice Participants were instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants brushed their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and were permitted to rinse with water post-brushing. Participants received control dentifrice via a manual toothbrush throughout the study duration (8 weeks i.e. till Day 56) twice daily. 0 None 0 52 1 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oral mucosal exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 22.0 View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 22.0 View