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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT03781804
Description: None
Frequency Threshold: 2
Time Frame: Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
Study: NCT03781804
Study Brief: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
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 μg BID OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID 0 None 1 111 37 111 View
OPN-375 372 μg BID OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID 0 None 2 109 37 109 View
Placebo Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID 0 None 3 112 14 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alcoholic pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cataract nuclear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract cortical SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View