No (%) of AEs through week 24
| Placebo (n = 97) | Combined* (n = 150) | |
|---|---|---|
| *The combined group included all patients randomised to infliximab and all patients randomised to placebo who entered early escape at week 16 or incorrectly received infliximab; †common AEs are AEs with event rate ⩾5% in the placebo group or the infliximab group. AEs are sorted by decreasing incidence in the infliximab column; ‡an AE was the primary reason for withdrawal in these patients. | ||
| ALT, alanine aminotransferase; AST, aspartate aminotransferase. | ||
| Any AE | 65 (67) | 100 (67) |
| Common AEs by WHOART preferred term† | ||
| Upper respiratory tract infection | 14 (14) | 15 (10) |
| Headache | 5 (5) | 9 (6) |
| Increased ALT | 1 (1) | 9 (6) |
| Pharyngitis | 4 (4) | 8 (5) |
| Sinusitis | 4 (4) | 8 (5) |
| Dizziness | 5 (5) | 6 (4) |
| AEs leading to withdrawal‡ | 1 (1) | 6 (4) |
| Serious AEs | 6 (6) | 13 (9) |
| Infusion reactions | 6 (6) | 11 (7) |