Pts, n (%) | BI 695501 (n=324) | Adalimumab originator (n=321) |
---|---|---|
≥1 TEAE | 138 (42.6) | 148 (46.1) |
≥1 TEAE related to trial drug | 36 (11.1) | 44 (13.7) |
≥1 Non-serious TEAE | 135 (41.7) | 141 (43.9) |
≥1 serious TEAE | 12 (3.7) | 18 (5.6) |
≥1 serious TEAE related to trial drug | 1 (0.3) | 5 (1.6) |
A TEAE leading to trial drug discontinuation | 8 (2.5) | 11 (3.4) |
A TEAE leading to death | 0 (0.0) | 0 (0.0) |