Table 2 Clinical and laboratory adverse events

Headache

13

Upper respiratory disorders

9

Vertigo

7

Gastrointestinal disorders

5

Edema, itching, dermatitis

6

Herpes zoster

4

Restlessness

2

Urinary tract infections

3

Fatigue

4

Infections

2

Menstrual disorders

2

Ovarian cyst

1

Sacral cyst

1

Muscular pain

1

Weight loss

3

Depression

1

Hypertension

1

Tachycardia

1

Total

66

Laboratory abnormalities

Number of subjects

Increased white blood cells

9

Increased bilirubin

2

Increased ALT/AST

2

Proteinuria

1

Anemia

1

Total

15