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 @ 3:53 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT04421092
Description: This is a routine procedure done by laryngologists.
Frequency Threshold: 5
Time Frame: 1 year and 6 months
Study: NCT04421092
Study Brief: Efficacy of SLN Block for Chronic Cough
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Steroid-Lidocaine Mixture Will receive numbing injection, which is a mixture of steroid and lidocaine Superior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic. Injection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. 0 None 0 10 3 10 View
Placebo Will receive saline injection as a placebo Superior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic. Injection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection. 0 None 0 7 1 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild transient soreness at injection site SYSTEMATIC_ASSESSMENT Investigations None View