Overview of AEs (SAF)
| Patients with, n (%) | AEs occurring day 1 to week 58 | AEs occurring week 24 to week 58 | ||||
| BI 695501 to BI 695501 (n=324) | Humira to BI 695501 (n=146) | Humira to Humira (n=175) | BI 695501 to BI 695501 (n=298) | Humira to BI 695501 (n=146) | Humira to Humira (n=148) | |
| At least one AE | 193 (59.6) | 93 (63.7) | 105 (60.0) | 126 (42.3) | 62 (42.5) | 51 (34.5) |
| At least one drug-related AE | 62 (19.1) | 28 (19.2) | 40 (22.9) | 39 (13.1) | 17 (11.6) | 17 (11.5) |
| At least one serious AE | 18 (5.6) | 10 (6.8) | 17 (9.7) | 6 (2.0) | 6 (4.1) | 5 (3.4) |
| At least one serious drug-related AE | 2 (0.6) | 1 (0.7) | 6 (3.4) | 1 (0.3) | 0 (0.0) | 2 (1.4) |
| AE leading to study drug discontinuation | 13 (4.0) | 6 (4.1) | 12 (6.9) | 5 (1.7) | 6 (4.1) | 1 (0.7) |
AE, treatment-emergent adverse event; n, number of patients per group; SAF, safety analysis set.