Study: NCT02546362

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 11 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 2 affected / 50 at risk

Adverse event: Neck pain
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 3 affected / 50 at risk

Adverse event: Forehead pain during the session
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 7 affected / 50 at risk

Adverse event: Persistence of sensation
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 1 affected / 50 at risk

Adverse event: Sedative effect
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 9 affected / 50 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 7 affected / 50 at risk

Adverse event: Toothache
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 2 affected / 50 at risk

Adverse event: Eye watering, tears
Serious: no
Organ System: Nervous system disorders
Notes: Expected side effect of the Cefaly® device
Frequency: 2 affected / 50 at risk

Adverse event: Shingles outbreak
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unexpected side effect of the Cefaly® device
Frequency: 1 affected / 50 at risk

Adverse event: Worsening fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unexpected side effect of the Cefaly® device
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Unexpected side effect of the Cefaly® device
Frequency: 4 affected / 50 at risk

Adverse event: Increase in sinus pain
Serious: no
Organ System: Nervous system disorders
Notes: Unexpected side effect of the Cefaly® device
Frequency: 1 affected / 50 at risk

Adverse event: Spacey feeling
Serious: no
Organ System: Nervous system disorders
Notes: Unexpected side effect of the Cefaly® device
Frequency: 1 affected / 50 at risk

Adverse event: Normal sensation of the Cefaly® device
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Including itching/tingling/stinging/twitching/vibration/numbness on forehead, scalp, eyes, eyelids, face, lips. But that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events.
Frequency: 12 affected / 50 at risk

Adverse event: Burning sensation on forehead or scalp, in eyelids or eyebrows
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events
Frequency: 2 affected / 50 at risk

Adverse event: Heaviness in eyelids
Serious: no
Organ System: Nervous system disorders
Notes: Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events
Frequency: 2 affected / 50 at risk

Adverse event: Forehead pressure
Serious: no
Organ System: Nervous system disorders
Notes: Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events
Frequency: 12 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 4 affected / 50 at risk

Adverse event: Paranasal sinus discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Worsening IBS (Irritable Bowel Syndrome)
Serious: no
Organ System: Renal and urinary disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Low back spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Flu infection, Cold virus infection, Sinus infection
Serious: no
Organ System: Infections and infestations
Notes: Relation to the device not suspected
Frequency: 4 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Back pain and stiffness
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Worsening fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Gastrointestinal virus
Serious: no
Organ System: Infections and infestations
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Right knee injury
Serious: no
Organ System: Surgical and medical procedures
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Multiple joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Female sterilisation
Serious: no
Organ System: Surgical and medical procedures
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Increase in depression
Serious: no
Organ System: Psychiatric disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Rash on ankles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Viral respiratory illness
Serious: no
Organ System: Infections and infestations
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Worsening right knee or foot pain
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 2 affected / 50 at risk

Adverse event: Swollen right thigh and knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Ringing in the ears/Ears ache
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Relation to the device not suspected
Frequency: 3 affected / 50 at risk

Adverse event: Burning sensation in both legs and right shoulder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Body tingling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk

Adverse event: Cold sensation in left cheek
Serious: no
Organ System: Nervous system disorders
Notes: Relation to the device not suspected
Frequency: 1 affected / 50 at risk