Table 2

Listing of adverse events (AEs) by systems organ class (SOC) and preferred term (PT)

SOC/PTTotal population (N=876)
All AEs
Patients with at least one AE 43 (4.9%)
Total number of AEs 67
Cardiac disorders
 Angina pectoris2 (0.2%)
 Atrial fibrillation1 (0.1%)
 Mitral valve incompetence1 (0.1%)
 Tricuspid valve incompetence1 (0.1%)
Gastrointestinal disorders
 Abdominal distension1 (0.1%)
 Abdominal pain2 (0.2%)
 Gastritis1 (0.1%)
 Gastrointestinal motility disorder1 (0.1%)
 Nausea15 (1.6%)
 Toothache1 (0.1%)
 Vomiting3 (0.3%)
 Intestinal transit time increased1 (0.1%)
General disorders and administration site conditions
 Asthenia1 (0.1%)
 Chest discomfort1 (0.1%)
 Injection site hypersensitivity1 (0.1%)
 Injection site urticaria1 (0.1%)
Infections and infestations
 Cellulitis1 (0.1%)
 Diabetic gangrene1 (0.1%)
 Gangrene1 (0.1%)
 Nasopharyngitis1 (0.1%)
 Pharyngotonsillitis1 (0.1%)
 Tooth infection1 (0.1%)
 Upper respiratory tract infection2 (0.2%)
Metabolism and nutrition disorders
 Decreased appetite1 (0.1%)
 Hypoglycaemia13 (1.5%)
 Hypomagnesaemia1 (0.1%)
Musculoskeletal and connective tissue disorders
 Exostosis1 (0.1%)
Nervous system disorders
 Diabetic neuropathy1 (0.1%)
 Dizziness2 (0.2%)
 Headache4 (0.5%)
Respiratory, thoracic and mediastinal disorders
 Pneumothorax1 (0.1%)
Vascular disorders
 Peripheral arterial occlusive disease1 (0.1%)