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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT00791934
Description: Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting
Frequency Threshold: 3
Time Frame: Up to 10 weeks
Study: NCT00791934
Study Brief: Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stratus Microflow Ethmoid Spacer Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days None None 2 63 19 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wing Detachment from device SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Stuffiness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View