| Number of patients with SAEs | Refused surgery n = 40 | Surgery n = 248 | Medical n = 266 | Not randomised n = 72 |
| n (%) | n (%) | n (%) | n (%) | |
| Injury, poisoning, procedural | 1 (2.5) | 15 (6.0) | 2 (0.8) | 1 (1.5) |
| Gastrointestinal disorders | 0 | 12 (4.8) | 5 (1.9) | 1 (1.5) |
| Musculoskeletal/connective tissue | 0 | 2 (0.8) | 8 (3.0) | 0 |
| Infections and infestations | 1 (2.5) | 3 (1.2) | 6 (2.3) | 0 |
| General disorders | 0 | 5 (2.0) | 4 (1.5) | 0 |
| Cardiac disorders | 1 (2.5) | 4 (1.6) | 3 (1.1) | 0 |
| Neoplasms, benign/malignant | 0 | 2 (0.8) | 6 (2.3) | 0 |
| Reproductive system including breast | 0 | 1 (0.4) | 4 (1.5) | 0 |
| Respiratory, thoracic, mediastinal | 0 | 5 (2.0) | 1 (0.4) | 0 |
| Vascular disorders | 0 | 3 (1.2) | 3 (1.1) | 0 |
| Hepatobiliary disorders | 1 (2.5) | 3 (1.2) | 0 | 0 |