Table 3.
Adverse events (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 | 23 | 79 | 24 | 71 | 22 | 112 | 69 | 262 |
| Musculoskeletal and connective tissue disorders | 18 | 41 | 24 | 44 | 22 | 48 | 64 | 133 |
| Joint effusion | 17 | 20 | 22 | 27 | 20 | 27 | 59 | 74 |
| Arthralgia | 6 | 10 | 4 | 4 | 6 | 8 | 16 | 22 |
| Joint swelling | 3 | 4 | 2 | 3 | 1 | 2 | 6 | 9 |
| Joint crepitation | – | – | 4 | 4 | 2 | 2 | 6 | 6 |
| Chondropathy | 1 | 1 | 1 | 1 | 1 | 2 | 3 | 4 |
| Back pain | 1 | 1 | – | – | 2 | 2 | 3 | 3 |
| Tendonitis | – | – | 1 | 1 | 2 | 2 | 3 | 3 |
| Joint lock | – | – | 2 | 2 | – | – | 2 | 2 |
| Muscular weakness | 1 | 2 | – | – | – | – | 1 | 2 |
| Nervous system disorders | 5 | 16 | 2 | 2 | 1 | 30 | 8 | 48 |
| Infections and infestations | 5 | 7 | 8 | 10 | 4 | 7 | 17 | 24 |
| Injury, poisoning and procedural complications | 6 | 6 | 5 | 7 | 7 | 10 | 18 | 23 |
| Gastrointestinal disorders | 1 | 1 | 1 | 1 | 3 | 5 | 5 | 7 |
| Metabolism and nutrition disorders | 1 | 1 | – | – | 2 | 4 | 3 | 5 |
| General disorders and admin. site conditions | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 4 |
| Vascular disorders | 1 | 1 | 1 | 1 | 2 | 2 | 4 | 4 |
| Cardiac disorders | 1 | 1 | 1 | 1 | – | – | 2 | 2 |
| Ear and labyrinth disorders | 1 | 1 | – | – | 1 | 1 | 2 | 2 |
| Immune system disorders | 1 | 1 | 1 | 1 | – | – | 2 | 2 |
| Surgical and medical procedures | – | – | – | – | 1 | 2 | 1 | 2 |
MedDRA SOC and preferred terms are used. Numbers of patients (n P) and events (n E) are given. Inclusion for all n P (all) >1