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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT02285634
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for the duration of the study protocol. Total observation time was 30 minutes and after completion of the study protocol any adverse effects were recorded.
Study: NCT02285634
Study Brief: The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lidocaine 1% Plus Epinephrine 1:100,000 Lidocaine 1% plus epinephrine 1:100,000 Lidocaine 1% plus epinephrine 1:100,000: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. 0 None 0 11 0 11 View
Bacteriostatic 0.9% NaCL Bacteriostatic 0.9% sodium chloride (NaCL) Bacteriostatic 0.9% sodium chloride (NaCL): sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. 0 None 0 17 2 17 View
Oxymetazoline 0.05% Oxymetazoline 0.05% Oxymetazoline 0.05%: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. 0 None 0 15 4 15 View
Phenylephrine 0.25% Phenylephrine 0.25% Phenylephrine 0.25%: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. 0 None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Eye watering SYSTEMATIC_ASSESSMENT Eye disorders None View
Diziness SYSTEMATIC_ASSESSMENT General disorders None View
Unpleasant aftertaste SYSTEMATIC_ASSESSMENT General disorders None View