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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT01622569
Description: The Safety Analysis Set (SAS) included all ITT subjects who received at least 1 dose of study drug. The SAS was used for the analysis of safety. The treatment group classification in the SAS was according to the treatment actually received.
Frequency Threshold: 2
Time Frame: None
Study: NCT01622569
Study Brief: Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo (Double-Blind Phase) 100 μg BID or 200 μg BID or 400 μg Matching Placebo BID x 16 weeks 0 None 0 82 42 82 View
OPN-375 100 μg BID (Double-Blind Phase) OPN-375 100 μg BID x 16 weeks 0 None 1 81 40 81 View
OPN-375 200 μg BID (Double-Blind Phase) OPN-375 200 μg BID x 16 weeks 0 None 0 80 45 80 View
OPN-375 400 μg BID (Double-Blind Phase) OPN-375 400 μg BID x 16 weeks 0 None 1 79 50 79 View
OPN-375 400 μg (Open-Label Phase) OPN-375 400 μg BID x 8 weeks 0 None 2 282 38 282 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pneumonia None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear Pain None Ear and labyrinth disorders None View
Cataract Nuclear None Eye disorders None View
Abdominal Discomfort None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Acute Sinusitis None Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Influenza None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Otitis Media None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Weight Increased None Investigations None View
Intraocular Pressure Increased None Investigations None View
Headache None Nervous system disorders None View
Epistaxis (Spontaneously Reported by Subject) None Respiratory, thoracic and mediastinal disorders None View
Nasal Mucosal Disorder None Respiratory, thoracic and mediastinal disorders None View
Nasal Septal Ulceration None Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion None Respiratory, thoracic and mediastinal disorders None View
Nasal Septum Disorder None Respiratory, thoracic and mediastinal disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea None Respiratory, thoracic and mediastinal disorders None View
Epistaxis (Found on Nasoendoscopy) None Respiratory, thoracic and mediastinal disorders None View