Number and percentage of patients with adverse events (AEs) during the 12-week double-blind period
| Placebo (N=97) n (%) | Adalimumab (N=95) n (%) | |
|---|---|---|
| Any AE | 57 (58.8) | 55 (57.9) |
| Serious AE | 1 (1.0) | 3 (3.2) |
| AE leading to discontinuation of study drug | 1 (1.0) | 2 (2.1) |
| Infectious AE | 28 (28.9) | 28 (29.5) |
| Serious infection | 0 | 0 |
| Malignancy | 0 | 0 |
| Hepatic-related AE | 4 (4.1) | 4 (4.2) |