Adverse events and serious adverse events during baseline and treatment phases
| Events during baseline phase (320 patient months) | Events during treatment phase (706 patient months) | |
| Any adverse event | 73 | 220 |
| Mild | 47 (64.4%) | 127 (57.7%) |
| Moderate | 25 (34.3%) | 85 (38.6%) |
| Severe | 1 (1.4%) | 8 (3.6%) |
| Infections Common cold Urinary tract infection | 35 (47.9%) 24 (68.6%) 5 (14.3%) | 72 (32.7%) 43 (59.7%) 9 (1.5%) |
| Gastrointestinal | 0 (0%) | 38 (17.3%) |
| Neurological | 13 (17.8%) | 21 (9.5%) |
| Musculoskeletal/soft tissue | 4 (5.5%) | 17 (7.7%) |
| Pain | 3 (4.1%) | 17 (7.7%) |
| Dermatology/skin | 2 (2.7%) | 14 (6.4%) |
| Ophthalmological and ENT (ear, nose, throat) | 1 (1.4%) | 7 (3.2%) |
| Rheumatologic | 1 (1.4%) | 6 (2.7%) |
| Psychiatric/sleep | 3 (4.1%) | 4 (1.8%) |
| Sexual/reproductive function | 1 (1.4%) | 4 (1.8%) |
| Pulmonary/upper respiratory tract | 0 (0%) | 2 (0.9%) |