Systemic adverse events (Safety set*)
| Preferred term, n (%) | Total (N=936) | Unilaterally treated (n=879) | Bilaterally treated (n=113) |
| Patients with systemic AEs, n (%) | 157 (16.8) | 132 (15.0) | 25 (22.1) |
| Anaemia | 4 (0.4) | 3 (0.3) | 1 (0.9) |
| Lymphadenopathy | 1 (0.1) | 0 | 1 (0.9) |
| Arrhythmia | 1 (0.1) | 0 | 1 (0.9) |
| Goitre | 1 (0.1) | 0 | 1 (0.9) |
| Abdominal pain upper | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Gastro-oesophageal reflux | 1 (0.1) | 0 | 1 (0.9) |
| Inguinal hernia | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Nausea | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Fatigue | 1 (0.1) | 0 | 1 (0.9) |
| Fever | 10 (1.1) | 8 (0.9) | 2 (1.8) |
| Hepatic lesion | 1 (0.1) | 0 | 1 (0.9) |
| Bronchitis | 9 (1.0) | 7 (0.8) | 2 (1.8) |
| Influenza | 16 (1.7) | 11 (1.3) | 5 (4.4) |
| Pneumonia | 5 (0.5) | 3 (0.3) | 2 (1.8) |
| Femur fracture | 7 (0.8) | 6 (0.7) | 1 (0.9) |
| Fall | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Pancreatic injury | 1 (0.1) | 0 | 1 (0.9) |
| Rib fracture | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Wrist fracture | 1 (0.1) | 0 | 1 (0.9) |
| Hypoglycaemia | 1 (0.1) | 0 | 1 (0.9) |
| Arthralgia | 4 (0.4) | 4 (0.5) | 0 |
| Osteoarthritis | 4 (0.4) | 4 (0.5) | 0 |
| Breast cancer | 1 (0.1) | 0 | 1 (0.9) |
| Prostate cancer treatment | 1 (0.1) | 0 | 1 (0.9) |
| Depression | 3 (0.3) | 2 (0.2) | 1 (0.9) |
| Acute kidney injury | 1 (0.1) | 0 | 1 (0.9) |
| Renal cyst | 1 (0.1) | 0 | 1 (0.9) |
| Chronic obstructive pulmonary disease | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Cough | 4 (0.4) | 4 (0.5) | 0 |
| Pneumothorax | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Respiratory disorder | 1 (0.1) | 0 | 1 (0.9) |
| Respiratory distress | 1 (0.1) | 0 | 1 (0.9) |
| Respiratory failure | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Mastectomy | 1 (0.1) | 0 | 1 (0.9) |
| Blood pressure fluctuation | 1 (0.1) | 0 | 1 (0.9) |
| Peripheral vascular disorder | 1 (0.1) | 0 | 1 (0.9) |
| Varicose vein ruptured | 1 (0.1) | 0 | 1 (0.9) |
| Patients with serious systemic AEs | 60 (6.4) | 51 (5.8) | 9 (8.0) |
| Anaemia | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Goitre | 1 (0.1) | 0 | 1 (0.9) |
| Hepatic lesion | 1 (0.1) | 0 | 1 (0.9) |
| Pneumonia | 5 (0.5) | 3 (0.3) | 2 (1.8) |
| Femur fracture | 7 (0.8) | 6 (0.7) | 1 (0.9) |
| Pancreatic injury | 1 (0.1) | 0 | 1 (0.9) |
| Breast cancer | 1 (0.1) | 0 | 1 (0.9) |
| Prostate cancer recurrent | 1 (0.1) | 0 | 1 (0.9) |
| Chronic obstructive pulmonary disease | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Respiratory disorder | 1 (0.1) | 0 | 1 (0.9) |
| Mastectomy | 1 (0.1) | 0 | 1 (0.9) |
| Patients with non-serious systemic AEs | 111 (11.9) | 90 (10.2) | 21 (18.6) |
| Lymphadenopathy | 1 (0.1) | 0 | 1 (0.9) |
| Arrhythmia | 1 (0.1) | 0 | 1 (0.9) |
| Bradycardia | 1 (0.1) | 0 | 1 (0.9) |
| Ventricular extrasystoles | 1 (0.1) | 0 | 1 (0.9) |
| Abdominal pain upper | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Inguinal hernia | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Nausea | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Fatigue | 1 (0.1) | 0 | 1 (0.9) |
| Fever | 10 (1.1) | 8 (0.9) | 2 (1.8) |
| Bronchitis | 9 (1.0) | 7 (0.8) | 2 (1.8) |
| Influenza | 15 (1.6) | 10 (1.1) | 5 (4.4) |
| Fall | 1 (0.1) | 0 | 1 (0.9) |
| Rib fracture | 2 (0.2) | 1 (0.1) | 1 (0.9) |
| Wrist fracture | 1 (0.1) | 0 | 1 (0.9) |
| Hypoglycaemia | 1 (0.1) | 0 | 1 (0.9) |
| Arthralgia | 4 (0.4) | 4 (0.5) | 0 |
| Depression | 3 (0.3) | 2 (0.2) | 1 (0.9) |
| Cough | 4 (0.4) | 4 (0.5) | 0 |
| Pneumothorax | 1 (0.1) | 0 | 1 (0.9) |
| Respiratory distress | 1 (0.1) | 0 | 1 (0.9) |
| Respiratory failure | 1 (0.1) | 0 | 1 (0.9) |
| Blood pressure fluctuation | 1 (0.1) | 0 | 1 (0.9) |
| Peripheral vascular disorder | 1 (0.1) | 0 | 1 (0.9) |
| Varicose vein ruptured | 1 (0.1) | 0 | 1 (0.9) |
Preferred Term≥0.5% in any group are included in this table.
All systemic AEs during the study and reported, independently from the definition of the risk period. Each patient could have more than one AE. Except for the number of AEs, patients were counted only once in each row. Terms were coded using MedDRA dictionary, version 18.1.
*Consisted of all enrolled patients who signed the informed consent, received at least one dose of study drug and had at least one postbaseline safety assessment.
AE, adverse event; MedDRA, Medical Dictionary for Drug Regulatory Activities.