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 |