| Adverse event (AE) | Patients, n (%) | Events, E (E/100-PYs) |
| Any AE | 1104 (94.4) | 9979 (768.1) |
| Any serious AE | 288 (24.6) | 456 (35.1) |
| AE leading | ||
| to discontinuation | 224 (19.2) | 284 (21.9) |
| Infectious AE | 705 (60.3) | 1793 (138.0) |
| Serious infectious AE | 70 (6.0) | 82 (6.3) |
| Injection-site reactions | 238 (20.4) | 388 (29.9) |
| Opportunistic infectious AE | 24 (2.1) | 28 (2.2) |
| Tuberculosis | 3 (0.2) | 3 (0.2) |
| Malignant neoplasms AE | 20 (1.7) | 21 (1.6) |
| Fatal AE | 2 (0.2) | 2 (0.2) |
| Death* | 1 (<0.1) | 1 (<0.1) |
*Death count = 1; the second fatal AE occurred outside of the reporting period.