Incidence of adverse events
| SSZ (n = 112) | Placebo (n = 118) | |
|---|---|---|
| SSZ, sulfasalazine. | ||
| Values are n (%). | ||
| *Significantly higher than in the placebo arm (p<0.05). | ||
| Any adverse event | 93 (83.0) | 98 (83.1) |
| Serious adverse event | 6 (5.4) | 10 (8.5) |
| Fatal serious adverse event | 0 (0.0) | 0 (0.0) |
| Adverse events possibly related to drug under study | 64 (57.1) | 52 (44.1) |
| Adverse events occurring in ⩾5% of patients in either treatment group | ||
| Headache | 19 (17.0) | 17 (14.4) |
| Nausea | 17 (15.2) | 11 (9.3) |
| Abdominal pain | 16 (14.3) | 16 (13.6) |
| Rhinitis | 15 (13.4) | 18 (15.3) |
| Aesthenia | 15 (13.4)* | 5 (4.2) |
| Diarrhoea | 10 (8.9) | 15 (12.7) |
| Vertigo | 10 (8.9) | 3 (2.5) |
| Back pain | 9 (8.0) | 5 (4.2) |
| Vomiting | 9 (8.0) | 4 (3.4) |
| Arthralgia | 8 (7.1) | 8 (6.8) |
| Pain | 8 (7.1) | 7 (5.9) |
| Rash | 8 (7.1) | 6 (5.1) |
| Bronchitis | 7 (6.3) | 9 (7.6) |
| Pruritis | 6 (5.4) | 12 (10.2) |
| Pharyngitis | 6 (5.4) | 10 (8.5) |