SAEs within 3 months by system organ class
| Present trial (n=120) | |
| No of patients with SAEs | 23 (19.2) |
| SAEs by system organ class | |
| Cardiac disorders | 1 (0.8) |
| Eye disorders | 1 (0.8) |
| Gastrointestinal disorders | 1 (0.8) |
| Hepatobiliary disorders | 2 (1.7) |
| Infections and infestations | 4 (3.3) |
| Injury, poisoning and procedural complications | 2 (1.7) |
| Musculoskeletal and connective tissue disorders | 1 (0.8) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.8) |
| Nervous system disorders | 11 (9.2) |
| Respiratory, thoracic and mediastinal disorders | 3 (2.5) |
SAE, serious adverse event.