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 @ 3:54 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT02940392
Description: AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC). 51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Study: NCT02940392
Study Brief: Rezum FIM Optimization Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rezum Treatment Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. 2 None 3 15 14 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subject was surgically treated for a pre-existing hernia. SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adenocarcinoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Poor Stream SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection (non UTI) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Terminal Dribbling SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatic Urethral Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ureteral Calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria with Clots and Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
UTI - Prophylaxis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Incontinence - Urge SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection (UTI) - Suspected SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View