Table 1 AE reported by the patients within the trial period
Number of patients | Percentage of AE | Percentage of patients | |
|---|---|---|---|
Do not like the feeling and do not want to continue using the device | 29 | 29.29% | 1.25% |
Sleepiness during the Cefaly® session | 12 | 12.12% | 0.52% |
Headache after a Cefaly® session | 12 | 12.12% | 0.52% |
Reversible forehead skin irritation | 5 | 5.05% | 0.22% |
Insomnia | 4 | 4.04% | 0.17% |
Feeling of fatigue | 3 | 3.03% | 0.13% |
Persistent forehead paresthesia for several minutes after the session | 3 | 3.03% | 0.13% |
Feeling of stress during the session | 3 | 3.03% | 0.09% |
Allergic skin reaction | 2 | 2.02% | 0.09% |
Dental pain during the session or at the beginning | 2 | 2.02% | 0.09% |
Inability to keep eyes open during sessions | 2 | 2.02% | 0.09% |
Feeling of contusion on the forehead during a few days | 2 | 2.02% | 0.09% |
Pre-existing tinnitus increased during the session | 1 | 1.01% | 0.04% |
Tinnitus appearing during some sessions | 1 | 1.01% | 0.04% |
Red eye after a session | 1 | 1.01% | 0.04% |
Eyes weeping during a session | 1 | 1.01% | 0.04% |
Wake up during night with a feeling of anxiety and tremor | 1 | 1.01% | 0.04% |
Vertigo during the first session | 1 | 1.01% | 0.04% |
Vomiting after a session | 1 | 1.01% | 0.04% |
Forehead skin burning sensation during a session | 1 | 1.01% | 0.04% |
Cervical pain during sessions | 1 | 1.01% | 0.04% |
Cervical pain with nausea after the two first sessions | 1 | 1.01% | 0.04% |
Short feeling of electrical shock | 1 | 1.01% | 0.04% |
Slight pain at one eyebrow during the first session | 1 | 1.01% | 0.04% |
Nausea and vertigo during sessions | 1 | 1.01% | 0.04% |
Nausea during sessions | 1 | 1.01% | 0.04% |
More head pain when using the device during a headache | 1 | 1.01% | 0.04% |
Forehead and cranial anaesthesia feeling during a few hours after a session | 1 | 1.01% | 0.04% |
Pressure feeling between the eyebrows during sessions | 1 | 1.01% | 0.04% |
Numbness at the back of the head after a session | 1 | 1.01% | 0.04% |
Stronger paresthesia feeling on the left side | 1 | 1.01% | 0.04% |
Stronger paresthesia feeling on the right side | 1 | 1.01% | 0.04% |
Subjective tachycardia during a session | 1 | 1.01% | 0.04% |
Migraine feeling during sessions | 1 | 1.01% | 0.04% |