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 @ 1:50 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT00277095
Description: None
Frequency Threshold: 5
Time Frame: 18 Months
Study: NCT00277095
Study Brief: ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ProACT Implantable device None None 4 124 112 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CVA SYSTEMATIC_ASSESSMENT Vascular disorders ICH GCP April 1996 View
Low Heart Rate SYSTEMATIC_ASSESSMENT Cardiac disorders ICH GCP April 1996 View
Ulcerative Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICH GCP April 1996 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations ICH GCP April 1996 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICH GCP April 1996 View
Other Non Genitourinary SYSTEMATIC_ASSESSMENT General disorders ICH GCP April 1996 View
Worsening Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICH GCP April 1996 View
Balloon Migration SYSTEMATIC_ASSESSMENT Investigations ICH GCP April 1996 View
Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICH GCP April 1996 View
Perforation During Implant SYSTEMATIC_ASSESSMENT Investigations ICH GCP April 1996 View
Gastrointestinal Condition SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICH GCP April 1996 View
Oncological/hematologic Condition SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ICH GCP April 1996 View
Infection, Genitourinary SYSTEMATIC_ASSESSMENT Infections and infestations ICH GCP April 1996 View
Balloon Erosion SYSTEMATIC_ASSESSMENT Investigations ICH GCP April 1996 View
Cardiac Condition SYSTEMATIC_ASSESSMENT Cardiac disorders ICH GCP April 1996 View
Device Failure, other SYSTEMATIC_ASSESSMENT Investigations ICH GCP April 1996 View
Pain Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICH GCP April 1996 View
Infection, Urinary Tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders ICH GCP April 1996 View
Dermotologic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ICH GCP April 1996 View
Device Failure, Leakage SYSTEMATIC_ASSESSMENT Investigations ICH GCP April 1996 View
Pain, nongenitourinary SYSTEMATIC_ASSESSMENT General disorders ICH GCP April 1996 View