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 @ 2:58 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT00803959
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00803959
Study Brief: Value of Urodynamic Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Office Evaluation Only (no UDS) UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. None None 30 315 39 315 View
Urodynamic Testing (UDS Arm) UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. None None 21 315 49 315 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bladder Perforation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intraoperative Bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other: Fascial Wound Dehiscence SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other: Vaginal Perforation with sling SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other: episode of postoperative bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Voiding dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mesh complication: erosion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mesh complication: exposure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Granulation Tissue SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Recurrent UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical site infection: deep incisional SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Anesthetic Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intraoperative Bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mesh complication: erosion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mesh complication: exposure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical site infection: superficial incisional SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical site infection: organ/space SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Culture proven UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Empiric UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Recurrent UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Granulation tissue SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Voiding dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View