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: NCT04194008
Description: The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
Frequency Threshold: 0
Time Frame: Up to 12 weeks
Study: NCT04194008
Study Brief: Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nerivio Device Treatment Treatment with active Nerivio device Nerivio: A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. 0 None 0 99 9 99 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in the arm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
viral infectioniral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leg pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Poison ivy rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View