| Placebo | Etanercept | |
| N = 139 | N = 257 | |
| 58.3 patient-years | 587.0 patient-years | |
| Adverse events* | ||
| No. of patients reporting, n (%) | 107 (77.0) | 234 (91.1) |
| Leading to study withdrawal, n (%) | 1 (0.7) | 14 (5.4) |
| No. of events | 352 | 1779 |
| Exposure adjusted event rate (per patient-year) | 6.0 | 3.0 |
| Serious adverse events | ||
| No. of patients reporting n (%) | 4 (2.9) | 33 (12.8) |
| Leading to study withdrawal n (%) | 0 (0.0) | 7 (2.7) |
| No. of events | 4 | 46 |
| Exposure adjusted event rate (per patient-year) | 0.07 | 0.08 |
| Infections | ||
| No. of patients reporting n (%) | 43 (30.9) | 187 (72.8) |
| Leading to study withdrawal n (%) | 0 (0.0) | 4 (1.6) |
| No. of events | 56 | 642 |
| Exposure adjusted event rate (per patient-year) | 1.0 | 1.1 |
| Serious infections | ||
| No. of patients reporting n (%) | 1 (0.7) | 6 (2.3) |
| Leading to study withdrawal n (%) | 0 (0.0) | 1 (0.4) |
| No. of events | 1 | 9 |
| Exposure adjusted event rate (per patient-year) | 0.02 | 0.02 |
| Injection site reactions | ||
| No. of patients reporting n (%) | 13 (9.4) | 57 (22.2) |
| Leading to study withdrawal n (%) | 0 (0.0) | 1 (0.4) |
| Death | 0 (0.0) | 0 (0.0) |
*Excluding infectious episodes and injection site reactions.
Placebo; N = the total number of patients that received placebo in the 24-week RCT.
Etanercept; N = the total number of patients who received at least one dose of etanercept in the open-label extension.
Exposure-adjusted event rates are the total number of events reported per patient-year.
% = (n/N*100).