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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT05479604
Description: None
Frequency Threshold: 0
Time Frame: Through study completion, an average of 8 weeks
Study: NCT05479604
Study Brief: Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SinuSonic Group Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks SinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. 0 None 0 9 1 9 View
Sham Group Subjects will use the sham device for 2 minutes twice daily for 8 weeks Sham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other specified disorders of nose and nasal sinuses SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View