Table 3.
Summary of the most frequent adverse events that occurred during the study (frequency ≥ 10% of patients)
| Number of patients (%) | |||||
|---|---|---|---|---|---|
| Adverse event (preferred term) | Placebo (n = 16) | IFN beta-1a 44 mcg biw (n = 17) | IFN beta-1a 44 mcg tiw (n = 16) | IFN beta-1a 66 mcg tiw (n = 18) | Total (n = 67) |
| Influenza-like symptoms | 3 (18.8) | 8 (47.1) | 6 (37.5) | 7 (38.9) | 24 (35.8) |
| Headache | 3 (18.8) | 8 (47.1) | 7 (43.8) | 4 (22.2) | 22 (32.8) |
| Injection-site reaction | 2 (12.5) | 5 (29.4) | 6 (37.5) | 5 (27.8) | 18 (26.9) |
| Fever | 2 (12.5) | 3 (17.6) | 5 (31.3) | 6 (33.3) | 16 (23.9) |
| Abdominal pain | 4 (25.0) | 2 (11.8) | 5 (31.3) | 5 (27.8) | 16 (23.9) |
| Injection-site inflammation | 2 (12.5) | 3 (17.6) | 5 (31.3) | 5 (27.8) | 15 (22.4) |
| Fatigue | 3 (18.8) | 3 (17.6) | 4 (25.0) | 2 (11.1) | 12 (17.9) |
| Nausea | 3 (18.8) | 3 (17.6) | 2 (12.5) | 3 (16.7) | 11 (16.4) |
| ESR increased | 0 | 2 (11.8) | 5 (31.3) | 3 (16.7) | 10 (14.9) |
| Arthralgia | 2 (12.5) | 4 (23.5) | 3 (18.8) | 1 (5.6) | 10 (14.9) |
| Injection-site rash | 0 | 3 (17.6) | 3 (18.8) | 2 (11.1) | 8 (11.9) |
| Rhinitis | 2 (12.5) | 2 (11.8) | 3 (18.8) | 1 (5.6)_ | 8 (11.9) |
| Myalgia | 1 (6.3) | 4 (23.5) | 2 (12.5) | 1 (5.6) | 8 (11.9) |
| Injection-site pain | 0 | 2 (11.8) | 1 (6.3) | 4 (22.2) | 7 (10.4) |
| Anaemia | 0 | 4 (23.5) | 2 (12.5) | 1 (5.6) | 7 (10.4) |
biw: twice weekly; ESR: erythrocyte sedimentation rate; IFN: interferon; tiw: three times weekly