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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT03465904
Description: None
Frequency Threshold: 0
Time Frame: The data was collected during the 24 hours following the beginning of the treatment
Study: NCT03465904
Study Brief: A Phase III Trial of e-TNS for the Acute 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
Verum 2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation. 0 None 0 298 22 259 View
Sham 2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation. 0 None 1 303 8 279 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis leading to appendectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Forehead paresthesias, discomfort, or burning NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea / Vomiting NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neck Stiffness / Muscle tension NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsened Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Orodynia - tooth or jaw pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Discomfort or Cramping NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Excessive Sweating NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleepiness / Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View