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 @ 12:12 PM
Ignite Modification Date: 2025-12-25 @ 12:00 PM
NCT ID: NCT04399161
Description: The intervention was carried out for a period of 14 days. A record log was maintained to document regular usage of the mouth rinse and also to record other (not so serious) adverse events like burning sensation in the mouth as a result of using the mouth rinses.
Frequency Threshold: 5
Time Frame: 14 days
Study: NCT04399161
Study Brief: Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A (Chlorhexidine Mouthrinse) Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention. 0 None 0 20 2 20 View
Group B (Xylitol Mouth Rinse) Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention. 0 None 0 20 0 20 View
Group C (Probiotic Mouth Rinse) Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention. 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
irritation of oral mucosa (burning sensation in the mouth and tongue) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View