Table 5 Adverse events

AE related to surgery

2

 Superficial infection (hardware removal) (SAE)

1

 Neck pain along the lead

1

Transient AE related to test stimulation

(Resolving after voltage reduction or contact change)

5

 Complex oculomotor disturbances^a

4

 Loss of consciousness with hemiparesia (SAE)

1

AE and changes during “On” period

6

 Mild hunger increase

3

 Mild hunger decrease

1

 Mild libido decrease

2

AE and changes during “Off” period

8

 Mild hunger increase

2

 Mild hunger decrease

1

 Mild thirst increase

1

 Mild thirst decrease

1

 Mild libido decrease

1

 Increased testosterone level

1

 Shorten menstrual cycle

1

AE and changes related to chronic stimulation

8

 Facial flush attacks

1

 Changes in blood pressure response to posture

1

 Severe micturition syncopes (SAE)

1

 Basal blood pressure changes

0

 Basal heart rate changes

0

 Body temperature changes

0

 Moderate weight increase (5 kg)

1

 Mild hunger increase

1

 Mild hunger decrease

1

 Mild libido decrease

1

 Significant electrolyte changes

0

 Increased testosterone level

1

 Other significant hormonal changes

0