VNS Common Adverse Events

• Stimulation Related Side Effects
  • Localized stimulation related effects:
    • occur during stimulation
    • diminish over time
    • are controllable (can adjust stimulation parameters to diminish incidence)
  • Localized stimulation related side effects include:
    • hoarseness/voice alteration
    • throat pain
    • coughing
    • dyspnea (feeling short of breath)
    • paresthesia
    • muscle pain
    • headache
    • nasal congestion
  • NO significant cardiac or gastrointestinal effects
  • adverse effects rated as mild or moderate ~99% of the time
  • NO evidence of increased mortality of SUDEP

Potential Side Effects	Anticonvulsant Medication	VNS
depression	yes	no
fatigue	yes	no
nausea & dizziness	yes	no
insomnia	yes	no
confusion	yes	no
cognitive impairment	yes	no
weight gain	yes	no
sexual dysfunction	yes	no

• Surgical & Device Related Problems
  • infection - fever
  •  
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• VNS Study E03: Common Adverse Events related to stimulation

• VNS Study E04: Common Adverse Events
  • Baseline = 1 Month and Treatment Period = 3 months

• VNS Study E05: Significant Adverse Effects (costart) During Treatment
  • Adverse Effects in the HIGH and LOW Stimulation groups were rated as mild or moderate ~99% of the time.
• VNS Long Term Side Effects

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