Summary of adverse events occurring in more than 5% of the patients
| Events | Placebo, 0.05 ml (n = 34) | Placebo, 0.5 ml (n = 39) | IFNβ, 2.2 μg (n = 67) | IFNβ, 44 μg (n = 68) |
|---|---|---|---|---|
| Values are n (%). | ||||
| CRP, C reactive protein; ESR, erythrocyte sedimentation rate; IFNβ, interferon beta; SGOT, aspartate aminotransferase, SGPT, alanine aminotransferase. | ||||
| Injection site reaction | 1 (3) | 2 (5) | 9 (13) | 16 (24) |
| Flu-like symptoms | 4 (12) | 4 (10) | 12 (18) | 27 (40) |
| Headache | 4 (12) | 1 (3) | 9 (13) | 9 (13) |
| Fever | 0 | 1 (3) | 4 (6) | 10 (15) |
| Fatigue | 3 (9) | 1 (3) | 4 (6) | 5 (7) |
| Rhinitis | 5 (15) | 4 (10) | 11 (16) | 4 (6) |
| Coughing | 2 (6) | 2 (5) | 5 (7) | 7 (10) |
| Upper respiratory tract infection | 0 | 5 (13) | 6 (9) | 1 (1) |
| Nausea | 4 (12) | 0 | 5 (7) | 6 (9) |
| Diarrhoea | 2 (6) | 2 (5) | 3 (5) | 4 (6) |
| SGPT increased | 0 | 1 (3) | 3 (5 | 8 (12) |
| SGOT increased | 0 | 1 (3) | 2 (3) | 8 (12) |
| Arthralgia | 3 (9) | 1 (3) | 2 (3) | 5 (7) |
| Rheumatoid arthritis aggravated | 5 (15) | 5 (13) | 17 (25) | 19 (28) |
| Increased ESR | 2 (6) | 3 (8) | 6 (9) | 11 (16) |
| Increased CRP | 11 (32) | 6 (15) | 10 (15) | 11 (16) |