Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 2:39 PM
Ignite Modification Date: 2025-12-26 @ 2:39 PM
NCT ID: NCT01876706
Description: AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
Frequency Threshold: 5
Time Frame: 5 Years;
Study: NCT01876706
Study Brief: UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UroLift Arm Subjects that undergo the UroLift System procedure 3 None 12 51 47 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gallbladder necrosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Lung mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Urge Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.a View