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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT02319668
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02319668
Study Brief: Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
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 and Reference Product Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash). None None 0 19 17 19 View
Reference Product Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing. None None 0 19 18 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingue bitting SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Angular cheilitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Implant site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Implant site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders None View
Implant site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain prophylaxis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urine ordour abnormal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oropharyngal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View