Adverse Events (MedDRA preferred term)

Number of patients, n (%)

Patients with any adverse event

580 (2.9)

Gastrointestinal disorders

206 (1.0)

Nausea

144 (0.72)

Vomiting

75 (0.38)

Nervous system disorders

152 (0.76)

Dysgeusia

126 (0.63)

Dizziness

26 (0.13)

General disorders and administration site conditions

136 (0.68)

Feeling hot

119 (0.60)

Skin and subcutaneous tissue disorders

107 (0.54)

Rash

69 (0.35)

Pruritus

23 (0.12)

Respiratory, thoracic and mediastinal disorders

32 (0.16)