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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
NCT ID: NCT01727258
Description: Adverse events were systematically collected at each study visit through Visit 4 (Day 28 -2 days/+4 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Frequency Threshold: 5
Time Frame: Day 28 -2 days/+4 days, +30 days for serious adverse events.
Study: NCT01727258
Study Brief: A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Colgate Regular Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007). None None 0 51 0 51 View
Sensodyne Toothpaste 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046). None None 0 51 0 51 View
Potassium Oxalate Mouthrinse Potassium Oxalate Mouthrinse (experimental group)(12027-033). None None 0 51 0 51 View
Serious Events(If Any):
Other Events(If Any):