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 |