| ETN | Placebo | |
| Subjects n | 68 | 63 |
| AEs | ||
| Serious noninfectious# | ||
| Any | 1 (1.5) | 0 (0.0) |
| Anaphylactoid reaction | 1 (1.5) | 0 (0.0) |
| Serious and medically important infectious¶ | ||
| Any | 2 (2.9) | 5 (7.9) |
| Acute diverticulitis | 1 (1.5) | 0 (0.0) |
| Meningitis | 1 (1.5) | 0 (0.0) |
| Influenza syndrome | 0 (0.0) | 2 (3.2) |
| Cystitis | 0 (0.0) | 1 (1.6) |
| Lower respiratory infection | 0 (0.0) | 1 (1.6) |
| Bronchitis | 0 (0.0) | 1 (1.6) |
| Otitis | 0 (0.0) | 1 (1.6) |
Data are presented as n (%), unless otherwise stated. ETN: etanercept. #: those that may result in death, are life-threatening, require subject hospitalisation or prolongation of an existing hospitalisation, or result in a persistent or significant disability or incapacity, cancer, or congenital anomaly or birth defect; ¶: those requiring hospitalisation or parenteral antibiotics.