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 @ 5:21 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT03631550
Description: Adverse events related or unrelated to the study device and/or procedure were collected per study participant from Enrollment (randomization) through study exit. The ITT data analysis set served as the principal data analysis set for the safety analyses.
Frequency Threshold: 0
Time Frame: Adverse events data were collected per study participant from Enrollment (randomization) through study exit. ie 70 days
Study: NCT03631550
Study Brief: The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of 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
Active Relivion Active device Relivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation 0 None 0 67 8 67 View
Sham Relivion Sham device Relivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation 0 None 0 64 2 64 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unpleasant sensation during treatment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Scalp numbness sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Twitching NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
inner ear scratch NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
lip numbness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pressure/discomfort of head NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View