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 @ 1:17 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT02791893
Description: Adverse events were logged by description, date of occurrence, severity, and whether or not they were serious. Subjects were counted as having experienced a specific adverse event if they reported it at any of the three time points.
Frequency Threshold: 5
Time Frame: Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020).
Study: NCT02791893
Study Brief: Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VNS Device Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day VNS device: Hand held device to use for self administration of vagus nerve stimulation. 0 None 1 13 9 13 View
Inactive Device Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks. VNS device: Hand held device to use for self administration of vagus nerve stimulation. Inactive device: Hand held device to use for self administration of simulated vagus nerve stimulation. 0 None 0 14 9 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pains occurred shortly after randomization SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Burning/stinging sensation SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Facial droops SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Frequent stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Lip droop/quiver SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metallic taste SYSTEMATIC_ASSESSMENT General disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle tightness SYSTEMATIC_ASSESSMENT General disorders None View
Numbness SYSTEMATIC_ASSESSMENT General disorders None View
Pain/radiating pain SYSTEMATIC_ASSESSMENT General disorders None View
Redness/irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Small bumps SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Tenderness SYSTEMATIC_ASSESSMENT General disorders None View
Tingling sensation SYSTEMATIC_ASSESSMENT General disorders None View