TABLE 3

Treatment-related adverse events and serious adverse events

Total population368
Patients with adverse events53 (14)
Adverse events occurring most frequently (≥2% of patients)
 Nervous system disorders26 (7)
 General disorders and administration site conditions12 (3)
 Musculoskeletal and connective tissue disorders9 (2)
 Skin and subcutaneous tissue disorders9 (2)
 Gastrointestinal disorders6 (2)
Patients with adverse events leading to treatment discontinuation#9 (2)
Patients with adverse events leading to study withdrawal7 (2)
Serious adverse events2 (<1)
 Hypersensitivity1 (<1)
 Pharyngeal swelling1 (<1)
Fatal serious adverse events0 (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.