Table 3.
Patients with treatment-emergent adverse events (AEs)
| Treatment-emergent AE category, n (%) | IFX+NPX N=105 |
PBO+NPX N=52 |
|---|---|---|
| Any AE | 61 (58.1) | 26 (50.0) |
| Any serious AE | 5 (4.8) | 3 (5.8) |
| AE related to study medication | 36 (34.3) | 12 (23.1) |
| AE leading to early withdrawal | 4 (3.8) | 1 (1.9) |
| Dyspepsia | 1 (1.0) | 0 |
| Tuberculosis | 1 (1.0) | 0 |
| Hepatic enzyme increased | 1 (1.0) | 0 |
| Worsening of ankylosing spondylitis | 0 | 1 (1.9) |
| Breast cancer | 1 (1.0) | 0 |
| Infections and infestations occurring in >1 patient in either group | ||
| Nasopharyngitis | 11 (10.5) | 4 (7.7) |
| Localised infection | 2 (1.9) | 2 (3.8) |
| Cystitis | 1 (1.0) | 2 (3.8) |
| Bronchitis | 2 (1.9) | 1 (1.9) |
| Gastroenteritis | 3 (2.9) | 0 |
| Oral herpes | 2 (1.9) | 0 |
| Tonsillitis | 2 (1.9) | 0 |
IFX, infliximab; NPX, naproxen; PBO, placebo.