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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT02751450
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02751450
Study Brief: The Efficacy of an Occluding Dentifrice in Providing Relief From 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
Stannous Fluoride Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing. 0 None 1 117 1 117 View
Sodium Monofluorophosphate Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing. 0 None 0 116 3 116 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PROSTATE CANCER None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
MYALGIA None Musculoskeletal and connective tissue disorders None View
HEADACHE None Nervous system disorders None View
BACK PAIN None Musculoskeletal and connective tissue disorders None View