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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:43 PM
NCT ID: NCT02924350
Description: The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Frequency Threshold: 0
Time Frame: up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3)
Study: NCT02924350
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
Test Dentifrice Containing Stannous Fluoride All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). 0 None 0 102 9 102 View
Control Dentifrice Containing Sodium Monofluorophosphate All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). 0 None 0 102 11 102 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizzines SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View