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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT03138369
Description: Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03138369
Study Brief: Vestibular Stimulation to Trigger Adipose Loss Clinical Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sham Vestibular Nerve Stimulation Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve. 0 None 0 11 5 11 View
Vestibular Nerve Stimulation Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used. 0 None 1 11 6 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multi-resistant bacterial infection - Non-device related SAE NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View