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 @ 4:19 AM
Ignite Modification Date: 2025-12-26 @ 3:21 AM
NCT ID: NCT02228720
Description: None
Frequency Threshold: 5
Time Frame: Day 90
Study: NCT02228720
Study Brief: Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Propel Nova Sinus Implant Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time None None 1 15 9 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Squamous Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal polyps NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vasovagal Reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus Drainage, green NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Crusting in nares NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View