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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT05459558
Description: An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device).
Frequency Threshold: 0
Time Frame: From screening (visit 1) until 5 days following last administration of the study product or last procedure (for approximately 64 days).
Study: NCT05459558
Study Brief: Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Dentifrice 1 Randomized participants were instructed to brush their teeth with the experimental dentifrice 1 (5 % KNO3 dentifrice with 1% alumina and 5% STP), twice daily (morning and evening) for 2 minutes for 8 weeks. 0 None 0 93 6 93 View
Reference Dentifrice Randomized participants were instructed to brush their teeth with the reference dentifrice (Regular Fluoride Dentifrice), twice daily (morning and evening) for 2 minutes for 8 weeks. 0 None 0 94 2 94 View
Experimental Dentifrice 2 Randomized participants were instructed to brush their teeth with the experimental dentifrice 2 (5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica), twice daily (morning and evening) for 2 minutes for 8 weeks. 0 None 0 92 8 92 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANGULAR CHEILITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CHAPPED LIPS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GINGIVAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GINGIVAL SWELLING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP DRY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP EXFOLIATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ORAL MUCOSAL EXFOLIATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
SEASONAL ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders None View
TRAUMATIC ULCER SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SKIN FISSURES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View