Table 2 |
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|
Comparison of adverse events between placebo and active-drug arms of a trial of interferon-β-1a in patients with rheumatoid arthritisa |
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|
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. |
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|
Genovese et al. Arthritis Res Ther 2004 6:R73 doi:10.1186/ar1026 |
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