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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:50 PM
NCT ID: NCT02651467
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02651467
Study Brief: A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. 0 None 0 74 4 74 View
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. 0 None 0 74 2 74 View
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. 0 None 0 73 5 73 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
OEDEMA MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SENSITIVITY OF TEETH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BURN ORAL CAVITY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
TRAUMATIC ULCER SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View