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: 2025-12-25 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT02151058
Description: Adverse events were systematically collected at each study visit through Visit 5 (Day 15 ± 2 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 15 ± 2 days, +30 days for serious adverse events.
Study: NCT02151058
Study Brief: A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
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 Colgate® Regular Cavity Protection Toothpaste (Brushing Only) None None 0 45 0 45 View
Crest 3D Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse) None None 0 91 0 91 View
Investigative Mouth Rinse Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse) None None 0 91 0 91 View
Serious Events(If Any):
Other Events(If Any):