Study: NCT02791893

Adverse event: Chest pains occurred shortly after randomization
Serious: yes
Organ System: General disorders
Notes: After randomization but before the first use of the VNS device, the patient started experiencing chest pains. Patient was admitted into the hospital overnight for testing. Results were negative. The event does not appear to be device related.
Frequency: 1 affected / 13 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Burning/stinging sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Facial droops
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Lip droop/quiver
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Metallic taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain/radiating pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Redness/irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Small bumps
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Burning/stinging sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Facial droops
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Frequent stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Lip droop/quiver
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Metallic taste
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pain/radiating pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Redness/irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk