Table 5

Summary of safety data (SAS, n=244)

Patients with at least oneNumber of patients (%)
 AE4 (1.6)
 AE leading to study withdrawal3 (1.2)
 Drug-related AE2 (0.8)
 Non-serious AE4 (1.6)
Type of AENumber of events (%)
Nervous system disorders
 Headache2 (0.8)
 Syncope1 (0.4)
Musculoskeletal and connective tissue disorders
 Myalgia2 (0.8)
 Arthralgia1 (0.4)
 Neck pain1 (0.4)
Cardiac disorders
 Tachycardia1 (0.4)
General disorders and administration site conditions
 Fatigue1 (0.4)
Psychiatric disorders
 Depressive symptom1 (0.4)
Skin and subcutaneous tissue disorders
 Rash pruritic1 (0.4)
  • Multiple entries possible.

  • AE, adverse event; SAS, safety analysis set.