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: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT02396420
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) occurring during the clinical trial and the protocol-defined 12-month follow-up period were recorded.
Study: NCT02396420
Study Brief: Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment This is a single arm study. All subjects with eligibility confirmed during the screening period and completing Visit 1 (Prostate Artery Embolization) within 4 weeks of screening are included in the arm. 1 None 1 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site burning SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 18.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 18.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 18.1 View
Bladder irritation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.0 View
Allergic Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 19.0 View