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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT02780661
Description: None
Frequency Threshold: 1
Time Frame: up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Study: NCT02780661
Study Brief: Frequency of Denture Cleanser Use and Denture Cleanliness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Denture Cleanser Tablet: Daily Use Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening. 0 None 0 19 8 19 View
Denture Cleanser Tablet: Weekly Use Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening. 0 None 0 19 8 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue coated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oedema mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injury associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Chronic fatigue syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View