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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT04126408
Description: Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
Frequency Threshold: 0
Time Frame: through study completion, up to 14 days
Study: NCT04126408
Study Brief: Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
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 Arm gammaCore sham device which will not provide stimulation of the vagus nerve gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache. 1 None 0 21 5 21 View
Treatment Group Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache. 0 None 0 19 9 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders other View
tingling sensation SYSTEMATIC_ASSESSMENT General disorders other View
pain at stimulation NON_SYSTEMATIC_ASSESSMENT General disorders other View
muscle twitching NON_SYSTEMATIC_ASSESSMENT General disorders other View
transient facial droop SYSTEMATIC_ASSESSMENT General disorders other View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders other View
hoarseness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders other View
dysgusia SYSTEMATIC_ASSESSMENT General disorders other View
dyspnea SYSTEMATIC_ASSESSMENT General disorders other View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders other View
coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders other View
hoarseness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders other View