Non-serious adverse events reported during double-blind and/or open label phase of study in at least 5% of patients.
| Adverse Event, n (% of patients) | Placebo to IFX* | IFX to IFX |
|---|---|---|
| Total | 157 (89.2) | 181 (92.3) |
| Mild | 87 (70.3) | 106 (71.6) |
| Moderate | 59 (59.5) | 67 (71.8) |
| Severe | 11 (21.6) | 8 (15.4) |
| Nasopharyngitis | 5 (13.5) | 3 (7.7) |
| Upper respiratory tract infection | 1 (2.7) | 3 (7.7) |
| Pruritus | 1 (2.7) | 3 (7.7) |
| Nausea | 2 (5.4) | 1 (2.6) |
| Dizziness | 2 (5.4) | 1 (2.6) |
| Headache | 2 (5.4) | 1 (2.6) |
| Infusion site reaction | 2 (5.4) | 0 (0) |
| Pyrexia | 2 (5.4) | 0 (0) |
| Urticaria | 2 (5.4) | 2 (5.1) |
| Infusion site urticaria | 0 (0) | 2 (5.1) |
↵* Cross-over group (placebo to infliximab); IFX-IFX: infliximab-only group.