Table 2.
Adverse events occurring in patients in either treatment group through week 24
| Number (%) of patients | ||
|---|---|---|
| Etanercept + placebo (n = 239) | Etanercept + methotrexate (n = 239) | |
| Any adverse event | 143 (59·8) | 179 (74·9) |
| Incidence ≥ 5% | ||
| Nasopharyngitis | 26 (10·9) | 23 (9·6) |
| Headache | 22 (9·2) | 22 (9·2) |
| Upper respiratory tract infection | 12 (5·0) | 20 (8·4) |
| Nausea | 7 (2·9) | 13 (5·4) |
| Patients with any increased hepatic transaminases considered to be an adverse eventa | 4 (1·7) | 7 (2·9) |
| SGPT/ALT increased | 3 (1·3) | 6 (2·5) |
| Leading to study withdrawal | 1 (0·4) | 4 (1·7)b |
| SGOT/AST increased/abnormal | 3 (1·3) | 5 (2·1) |
| Leading to study withdrawal | 1 (0·4) | 4 (1·7)b |
SGPT/ALT, serum glutamic pyruvic transaminase/alanine aminotransferase; SGOT/AST, serum glutamic oxaloacetic transaminase/aspartate aminotransferase.
a
Includes increased SGPT/ALT, increased SGOT/AST, increased hepatic enzymes, abnormal liver function test, and/or abnormal SGOT/AST considered to be adverse events. bRepresents the same four patients.