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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT01660893
Description: None
Frequency Threshold: 0
Time Frame: 24 hours
Study: NCT01660893
Study Brief: Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kovacaine Mist, 3 Sprays Unilateral Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose None None 0 10 9 10 View
Tetracaine Only, 3 Sprays Unilateral Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose None None 0 10 10 10 View
Placebo, 3 Sprays Unilateral Placebo Placebo: 3 unilateral intranasal sprays per dose None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oral discomfort None Gastrointestinal disorders MedDRA (15.0) View
Nasal congestion None Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Rhinorrhea None Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Nasal discomfort None Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Rhinalgia None Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Dysgeusia None Nervous system disorders MedDRA (15.0) View
Headache None Nervous system disorders MedDRA (15.0) View
Dizziness None Nervous system disorders MedDRA (15.0) View
Lacrimation increased None Eye disorders MedDRA (15.0) View
Vision blurred None Eye disorders MedDRA (15.0) View
Hypoaesthesia eye None Eye disorders MedDRA (15.0) View
Ear discomfort None Ear and labyrinth disorders MedDRA (15.0) View
Pharyngeal Hypoaesthesia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Intranasal Hypoaesthesia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Anaesthetic Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.0) View