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 @ 4:51 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT03123250
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT03123250
Study Brief: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aquablation Procedure Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system. 0 None 18 101 82 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Scrotal edema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multi-system organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ejaculatory dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT General disorders None View