Table 2 Comparison of adverse events between placebo and active-drug arms of a trial of interferon-β-1a in patients with rheumatoid arthritisa
Adverse event | Drug (n = 16) No. (%) | Placebo (n = 6) No. (%) |
|---|---|---|
Flu-like symptoms | ||
Arthralgias/myalgias | 6 (38) | 2 (33) |
Headache | 8 (50) | 1(17) |
Fatigue/weakness | 2 (13) | 1(17) |
Subjective fevers | 3 (19) | 0 |
Chills | 6 (38) | 0 |
Hypertension | 3 (19) | 0 |
Oral ulcers | 3 (19) | 0 |
Pain at injection site | 1 (6) | 0 |
Insomnia | 0 | 1(17) |
Depression/anxiety | 1 (6) | 1(17) |
Menstrual irregularities | 1 (6) | 1(17) |
Rash | 3 (19) | 1(17) |
Wheeze | 2 (13) | 0 |
Gastrointestinal distress | ||
Nausea | 2 (13) | 0 |
Abdominal pain | 2 (13) | 0 |
Diarrhea | 0 | 1 (17) |
Infections | ||
Upper respiratory infection | 2 (13) | 3 (50) |
Sinus infection | 0 | 1(17) |
Infection on right arm | 1 (6) | 0 |
Perineal fungal rash | 1 (6) | 0 |
Varicella-zoster rash | 1 (6) | 0 |
Other (single reports only) | 9 (56) * | 5 (83) ** |