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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT02768194
Description: None
Frequency Threshold: 1
Time Frame: Baseline to Day 10
Study: NCT02768194
Study Brief: Dentine Tubule Occlusion Assessment in a Modified in Situ Model
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 Product Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. 0 None 0 23 2 23 View
Reference Product Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. 0 None 0 22 4 22 View
Negative Control Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. 0 None 0 24 3 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sensitivity of Teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
TOOTH FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
GROIN PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DYSMENORRHOEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View