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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT01075256
Description: None
Frequency Threshold: 1
Time Frame: All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Study: NCT01075256
Study Brief: Dose Response of a Tubule Occlusion Agent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7.5% Sodium Calcium Phosphosilicate Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free. None None 0 63 3 63 View
5% Sodium Calcium Phosphosilicate Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free. None None 0 66 3 66 View
Placebo Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free. None None 0 66 3 66 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gingival Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mouth Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsilitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensitivity of teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View