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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT04601103
Description: None
Frequency Threshold: 0
Time Frame: Within 3 weeks of starting treatment
Study: NCT04601103
Study Brief: 3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comparator: No SLS Toothpaste 3M Oral Rinse in combination with no SLS toothpaste (A) No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth 0 None 0 18 15 18 View
Comparator: Medium SLS Toothpaste 3M Oral Rinse in combination with medium SLS toothpaste (B) Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth 0 None 0 18 15 18 View
Comparator: High SLS Toothpaste 3M Oral Rinse in combination with high SLS toothpaste (C) High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate Anti-plaque: Rinse prevents bacterial adherence to teeth 0 None 0 17 16 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Breath odor NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Buccal mucosal roughening NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Glossitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hyperaesthesia teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypoaesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth injury NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral mucosal exfoliation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Sensitivity of teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tongue biting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tongue exfoliation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Device failure NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA View