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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT02752958
Description: None
Frequency Threshold: 1
Time Frame: Baseline to Week 24
Study: NCT02752958
Study Brief: Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stannous Fluoride Participants will brush with a full brush head of toothpaste for 1 timed minute (in their usual manner), twice daily (morning and evening) from baseline 0 None 1 75 47 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations None View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
HERPES VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
TONSILLITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations None View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
TOOTHACHE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ORAL MUCOSAL EXFOLIATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GINGIVAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP EXFOLIATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LIP ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ORAL MUCOSAL ERYTHEMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
APHTHOUS ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ORAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
TOOTH FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
TOOTH INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
EYELID INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FACE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HAND FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
POST-TRAUMATIC NECK SYNDROME SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ROAD TRAFFIC ACCIDENT 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
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DEVICE FAILURE SYSTEMATIC_ASSESSMENT Product Issues None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View