Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:28 PM
Ignite Modification Date: 2025-12-25 @ 3:02 PM
NCT ID: NCT03591068
Description: None
Frequency Threshold: 5
Time Frame: 24 weeks, and up to 30 days after the last dose
Study: NCT03591068
Study Brief: Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OPN-375 186 mcg BID Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system 0 None 0 11 1 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Tension Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vasomotor Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fungal Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal Discharge Discolouration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View