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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT01383018
Description: All device and/or procedure related events were collected for this study.
Frequency Threshold: 0
Time Frame: Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.
Study: NCT01383018
Study Brief: PROPPER Prospective Registry of Outcomes With Penile Prosthesis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AMS Penile Prosthesis Receipients Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices. 44 None 36 1380 72 1380 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Other - Substernal Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Device Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erosion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Reservoir Herniation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac Event - Non-specific NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cylinder Crossover NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Device Cylinder Aneruysm/Bulge NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Edema - Scrotal NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Extrusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain/Discomfort - Penile NON_SYSTEMATIC_ASSESSMENT General disorders None View
Perforation - Other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Peyronie's Disease NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Proximal Corporal Perforation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary Embolus NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urethral Obstruction NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Would Dehiscence NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other - Decreased Oxygen Saturation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Device Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erosion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View
Reservoir Herniation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Superficial Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device Cylinder Aneurysm/Bulge NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Migration (pump) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urethral Trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Extrusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Malposition NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Pain/Discomfort - Groin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Priapism NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Adhesion of the Pump/Scrotum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Allergic reaction/Hypersensitivity Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Auto Inflation NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Bladder Neck Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device Placement Failure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Edema - Penile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Investigations None View
Fibrosis NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Fibrous Capsule Formation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematospermia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Incorrect Size - Cylinders too Large NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Increased Blood Loss NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Inguinal Hernia Formation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain/Discomfort - Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain/Discomfort - Penile NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain/Discomfort With Erections NON_SYSTEMATIC_ASSESSMENT General disorders None View
Patient Dissatisfaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Perforation - Other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Peyronie's Disease NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Proximal Corporal Perforation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary Tract Infection - UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Dehiscence NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Migration (Pump) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Migration (Pump) NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Pain/Discomfort - Groin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain/Discomfort - Testicular NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain/Discomfort - Testicular NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other - Buckling of left cylinder led to left downward curvature NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other - Painful mass in right hemiscrotum NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other - Left distal tip migration with pain at tip of penis with intercourse NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other - Right cylinder protruding NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other - Pinching sensation around the resevoirs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other - Change in curvature of penis (increase in curvature) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other - Proximal cross over during IPP surgery NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other - Incisional drainage NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other - Bilateral corporal aneurysm NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other - Proximal crossover NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other - Slight separation of penoscrotal wound NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View