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) ** |
aAll the differences in occurrences were tested by Fisher's exact test (one-tailed) and were statistically not significant. *Hypoglycemia, paresthesia on left side of face, contact dermatitis, photosensitivity, flare of arthritis, cramping in toes, dysphagia, nasal lesion, blurred vision. **Hematuria, burn on arm, tachycardia, paresthesia on left leg, lymphadenopathy.