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 @ 9:48 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT06010732
Description: None
Frequency Threshold: 0
Time Frame: 5 months
Study: NCT06010732
Study Brief: In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1100 Ppm F as Sodium Fluoride Test Product Each subject used this product during one of the three treatment periods in the crossover study design. 0 None 1 52 19 52 View
0 Ppm F (Placebo) Each subject used this product during one of the three treatment periods in the crossover study design. 0 None 1 52 23 52 View
1100 Ppm F as Sodium Fluoride (Positive Control) Each subject used this product during one of the three treatment periods in the crossover study design. 0 None 0 52 16 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bowel Obstructiion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Migraine vestibulaire SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Cold Sweats SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Lack of balance SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Common cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Erythema Mandibular Ridge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Dehydration SYSTEMATIC_ASSESSMENT General disorders Table View
Prolonged Post Operative Lleus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Dry, cracked lower lip SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Table View
Burning Sensation Oral Cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Transient Sour Sensation in Oral Cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
COVID-19 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Sciatica Nerve Pain SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Kidney Infection SYSTEMATIC_ASSESSMENT Infections and infestations Table View
Fractured Metal Frame of the Mandibular Partial SYSTEMATIC_ASSESSMENT Product Issues Table View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Table View
Oral ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Herpetic Lesion Upper Lip SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Table View
Sore throat SYSTEMATIC_ASSESSMENT Infections and infestations Table View
Dry and Chapped Lower Lip SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Table View
Swollen Lower Lip SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Table View
Tenderness Oral Cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Table View
Basel cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Table View
Bladder Infection SYSTEMATIC_ASSESSMENT Infections and infestations Table View
Worsening of the lower back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Table View
Erythema, Hard palate SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Pain anterior gingiva SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Erythema buccal mucosa due to cheek bite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Table View
Body ache from shingle vaccine SYSTEMATIC_ASSESSMENT General disorders Table View
Worsening of COPD symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Worsening of Asthma symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Muscle Strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Table View
Worsening of Chest Pain SYSTEMATIC_ASSESSMENT General disorders Table View
Stuffy nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Table View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Table View