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: 2025-12-25 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT00894933
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up
Study: NCT00894933
Study Brief: Performance Evaluation of the AMS CONTINUUM™ Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Continuum Device Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy None None 3 31 30 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Excessive bleeding None Surgical and medical procedures None View
Bladder Neck Contracture/Outlet Obstruct None Renal and urinary disorders None View
Separation/Disruption of Anastomosis None Renal and urinary disorders None View
Syncope None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Incontinence - De Novo None Renal and urinary disorders None View
Pain/Discomfort None General disorders None View
Pain/Discomfort - Other None General disorders None View
Hematuria None Renal and urinary disorders None View
Erectile Dysfunction - De Novo None Reproductive system and breast disorders None View
Pain/Discomfort - Abdominal None Gastrointestinal disorders None View
Erectile Dysfunction - Worsening None Reproductive system and breast disorders None View
Infection None Infections and infestations None View
Urinary Tract Infection (UTI) None Infections and infestations None View
Urinary Retention None Renal and urinary disorders None View
Dysuria None Renal and urinary disorders None View
False Passage None Renal and urinary disorders None View
Perforation - Bladder None Renal and urinary disorders None View
Nausea None Gastrointestinal disorders None View
Pain/Discomfort - Back None Musculoskeletal and connective tissue disorders None View
Nocturia None Renal and urinary disorders None View
Dizziness None General disorders None View
Abdominal Bloating/Gas None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Fluid Overload (Hypervolemia) None Vascular disorders None View
Loss of appetite None Gastrointestinal disorders None View
Actelectasis None Respiratory, thoracic and mediastinal disorders None View
Bladder Spasm None Renal and urinary disorders None View
Clot in catheter None Renal and urinary disorders None View
Disease progession None Renal and urinary disorders None View
Hemorrhoid None General disorders None View
Increased Creatinine None Renal and urinary disorders None View
Inguinal Hernia None Musculoskeletal and connective tissue disorders None View
Kidney Stone None Renal and urinary disorders None View
Light Headed None General disorders None View
Tunnel Vision None Eye disorders None View
Vasovagal Reaction None Cardiac disorders None View
Bladder Neck Contracture/Outlet Obstruct None Renal and urinary disorders None View