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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT00904969
Description: Only adverse events related to the study device or procedure are displayed.
Frequency Threshold: 0
Time Frame: Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits.
Study: NCT00904969
Study Brief: A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treated Participants Participants in which a device placement was attempted. None None 2 50 25 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Incontinence - Persistant SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Intra-operative Bleeding of Aberrant Vessel SYSTEMATIC_ASSESSMENT Vascular disorders Other: Internal View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-Void Dribbling SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Pain/ Discomfort With Erections SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Other: Internal View
Urinary Incontinence - De Novo Stress SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Scrotal Pain/ Swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other: Internal View
Groin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Other: Internal View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Other: Internal View
Decreased Penile Sensitivity SYSTEMATIC_ASSESSMENT Nervous system disorders Other: Internal View
Penile Pain with Orgasm SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Other: Internal View
Worsening Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Pain/ Discomfort SYSTEMATIC_ASSESSMENT General disorders Other: Internal View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Urinary Incontinence - Persistent SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other: Internal View
Ecchymosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other: Internal View
Edema of Penis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other: Internal View
Light Post-Op Bleed SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other: Internal View