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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:07 AM
NCT ID: NCT01701505
Description: None
Frequency Threshold: 5
Time Frame: 24 hours post-dosing
Study: NCT01701505
Study Brief: Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each None None 0 8 6 8 View
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each None None 0 8 5 8 View
Cohort A: 12-17 High Dose (400uL Kovacaine Mist) 400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each None None 0 8 8 8 View
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each None None 0 8 6 8 View
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each None None 0 8 7 8 View
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each None None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Rhinalgia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Pharyngeal Hypoaesthesia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Nasal Dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA15.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA15.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA15.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA15.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA15.0 View
Sensory Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA15.0 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA15.0 View
Facial Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA15.0 View
Intranasal Hypoaesthesia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA15.0 View