Advertisement
Table 5 Summary of adverse events
| Cohort 1 | Cohort 2 | |||||
|---|---|---|---|---|---|---|
| System organ class | 25 M (n = 10) | 50 M (n = 10) | P1 (n = 10) | 75 M (n = 10) | 150 M (n = 10) | P2 (n = 10) |
| Any adverse event | 24 (7) | 13 (7) | 21 (7) | 17 (7) | 11 (6) | 11 (6) |
| Blood and lymphatic system disorders | 0 | 1 (1) | 1 (1) | 0 | 0 | 0 |
| Endocrine disorders | 0 | 0 | 0 | 1 (1) | 0 | 0 |
| Eye disorders | 0 | 1 (1) | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | 1 (1) | 0 | 2 (2) | 1 (1) | 0 | 3 (3) |
| General disorders and administration site conditions | 2 (1) | 4 (2) | 0 | 9 (6) | 4 (3) | 0 |
| Infections and infestations | 3 (3) | 1 (1) | 4 (3) | 0 | 1 (1) | 1 (1) |
| Injury, poisoning, and procedural complications | 0 | 0 | 1 (1) | 2 (1) | 3 (3) | 0 |
| Investigations | 2 (2) | 1 (1) | 1 (1) | 0 | 1 (1) | 2 (2) |
| Metabolism and nutrition disorders | 4 (3) | 0 | 3 (3) | 0 | 0 | 1 (1) |
| Musculoskeletal and connective tissue disorders | 6 (3) | 3 (3) | 5 (4) | 4 (2) | 2 (2) | 3 (2) |
| Nervous system disorders | 1 (1) | 0 | 1 (1) | 0 | 0 | 0 |
| Renal and urinary disorders | 0 | 1 (1) | 0 | 0 | 0 | 0 |
| Reproductive system and breast disorders | 1 (1) | 0 | 0 | 0 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 0 | 0 | 0 | 1 (1) |
| Skin and subcutaneous tissue disorders | 1 (1) | 0 | 1 (1) | 0 | 0 | 0 |
| Surgical and medical procedures | 2 (1) | 0 | 0 | 0 | 0 | 0 |
| Vascular disorders | 1 (1) | 1 (1) | 2 (1) | 0 | 0 | 0 |
