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 @ 4:17 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT04398966
Description: None
Frequency Threshold: 0
Time Frame: From the time of the PAE procedure through 12-Month Follow-Up.
Study: NCT04398966
Study Brief: Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PAE Procedure This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH) Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material 1 None 1 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Failure to Thrive SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heaviness in distal left penis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heaviness in left lower buttock SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heat sensation in pelvic area SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Strong urinary smell SYSTEMATIC_ASSESSMENT Infections and infestations None View
Strong yellow urine color SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in Groin (Post Embolization Syndrome) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue (Post Embolization Syndrome) SYSTEMATIC_ASSESSMENT General disorders None View
Blotches on Penis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Exacerbation of Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retrograde ejaculation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Straining SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View