TABLE 3.

Treatment-related adverse events and serious adverse events

Total population	368
Patients with adverse events	53 (14)
Adverse events occurring most frequently (≥2% of patients)
Nervous system disorders	26 (7)
General disorders and administration site conditions	12 (3)
Musculoskeletal and connective tissue disorders	9 (2)
Skin and subcutaneous tissue disorders	9 (2)
Gastrointestinal disorders	6 (2)
Patients with adverse events leading to treatment discontinuation#	9 (2)
Patients with adverse events leading to study withdrawal	7 (2)
Serious adverse events	2 (<1)
Hypersensitivity	1 (<1)
Pharyngeal swelling	1 (<1)
Fatal serious adverse events	0 (0)

Data are presented as n or n (%). ^#: the adverse events leading to treatment discontinuation included headache (n=2 (<1%)), dizziness (n=1 (<1%)), paraesthesia (n=1 (<1%)), dyspepsia (n=1 (<1%)), nausea (n=1 (<1%)), palpitations (n=1 (<1%)), tachycardia (n=1 (<1%)), vertigo (n=1 (<1%)), noncardiac chest pain (n=1 (<1%)), hypersensitivity (n=1 (<1%)), arthralgia (n=1 (<1%)), pharyngeal swelling (n=1 (<1%)) and pruritus (n=1 (<1%)); two adverse events were not coded.