Table 3 Patients with treatment‐emergent adverse events (⩾3%).
| Etanercept 50 mg once weekly (n = 155) | Etanercept 25 mg twice weekly (n = 150) | Placebo (n = 51) | |
|---|---|---|---|
| Non‐infectious adverse events | |||
| Any adverse event* | 55 (35.5) | 66 (44.0) | 18 (35.3) |
| Injection site reactions | 32 (20.7) | 34 (22.7) | 6 (11.8) |
| Back pain | 1 (0.6) | 1 (0.7) | 3 (5.9) |
| Abdominal pain | 5 (3.2) | 6 (4.0) | 1 (2.0) |
| Nausea | 3 (1.9) | 5 (3.3) | 2 (3.9) |
| Overdose | 6 (3.9) | 4 (2.7) | 1 (2.0) |
| Headache | 6 (3.9) | 4 (2.7) | 0 (0.0) |
| Diarrhoea | 6 (3.9) | 4 (2.7) | 0 (0.0) |
| Infectious adverse events | |||
| Any infection† | 35 (22.6) | 33 (22.0) | 12 (23.5) |
| Upper respiratory infection | 12 (7.7) | 12 (8.0) | 7 (13.7) |
| Pharyngitis or laryngitis | 6 (3.9) | 3 (2.0) | 0 (0) |
Values are n (%).
*Excluding injection site reactions and infections.
†Serious infections, erysipelas, was reported in the right ankle of one patient receiving etanercept 50 mg QW, and Streptococcus pyogenes at the insulin catheter site in one patient with diabetes receiving etanercept 25 mg BIW.