Table 4.
Adverse events considered probably or possibly treatment-related (safety population)
| Dose group | Low | Medium | High | All | ||||
|---|---|---|---|---|---|---|---|---|
| N = 25 | N = 25 | N = 25 | N = 75 | |||||
| n P | n E | n P | n E | n P | n E | n P | n E | |
| Any SOC | 17 | 34 | 24 | 41 | 22 | 38 | 63 | 113 |
| Musculoskeletal and connective tissue disorders | 17 | 30 | 24 | 37 | 22 | 34 | 63 | 101 |
| Joint effusion | 17 | 20 | 22 | 27 | 19 | 25 | 58 | 72 |
| Arthralgia | 3 | 4 | 2 | 2 | 3 | 4 | 8 | 10 |
| Joint swelling | 2 | 3 | 2 | 2 | – | – | 4 | 5 |
| Joint crepitation | – | – | 3 | 3 | 2 | 2 | 5 | 5 |
| Chondropathy | – | – | – | – | 1 | 2 | 1 | 2 |
| Muscular weakness | 1 | 2 | – | – | – | – | 1 | 2 |
| Joint lock | – | – | 2 | 2 | – | – | 2 | 2 |
| Muscle atrophy | – | – | 1 | 1 | – | – | 1 | 1 |
| Patellofemoral pain syndrome | 1 | 1 | – | – | – | – | 1 | 1 |
| Tendonitis | – | – | – | – | 1 | 1 | 1 | 1 |
| Injury, poisoning and procedural complications | – | – | 3 | 3 | 3 | 3 | 6 | 6 |
| Ligament sprain | – | – | – | – | 3 | 3 | 3 | 3 |
| Fall | – | – | 2 | 2 | – | – | 2 | 2 |
| Wound dehiscence | – | – | 1 | 1 | – | – | 1 | 1 |
| General disorders and admin. site conditions | 1 | 1 | 1 | 1 | – | – | 2 | 2 |
| Pain | 1 | 1 | 1 | 1 | – | – | 2 | 2 |
| Vascular disorders | 1 | 1 | – | – | 1 | 1 | 2 | 2 |
| Deep vein thrombosis | – | – | – | – | 1 | 1 | 1 | 1 |
| Lymphoedema | 1 | 1 | – | – | – | – | 1 | 1 |
| Cardiac disorders | 1 | 1 | – | – | – | – | 1 | 1 |
| Tachycardia | 1 | 1 | – | – | – | – | 1 | 1 |
| Ear and labyrinth disorders | 1 | 1 | – | – | – | – | 1 | 1 |
| Sudden hearing loss | 1 | 1 | – | – | – | – | 1 | 1 |
Numbers of patients (n P) and events (n E) are given