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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT02573402
Description: None
Frequency Threshold: 0
Time Frame: About 4 weeks
Study: NCT02573402
Study Brief: The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transcutaneous Tibial Nerve Stimulation Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis. 0 None 0 12 4 12 View
Control Control (Sham stimulation). Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. 0 None 0 7 3 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pressure Injury SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis/Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View