Placebo | ISIS-CRP Rx | ISIS-CRP Rx | ISIS-CRP Rx | |
---|---|---|---|---|
100 mg | 200 mg | 400 mg | ||
Number = 12 | Number = 12 | Number = 13 | Number = 14 | |
Overall adverse events, n (%) | 8 (66.7) | 7 (58.3) | 11 (84.6) | 12 (85.7) |
Adverse events with incidence 10% or greater in all ISIS-CRPRx dosed patients by treatment excluding adverse events at the injection site, | ||||
Rheumatoid arthritis, number (%) | 1 (8.3) | 1 (8.3) | 2 (15.4) | 2 (14.3) |
Blood creatinine increased, number (%) | 1 (8.3) | 2 (16.7) | 1 (7.7) | 1 (7.1) |
Adverse events-infections, number (%) | 4 (33.3) | 1 (8.3) | 2 (15.4) | 4 (28.6) |
Nasopharyngitis, number (severity) | 1 (moderate) | 1 (mild) | 1 (mild) | 1 (moderate) |
Upper respiratory infection, number (severity) | 0 | 0 | 0 | 1 (mild) |
Rhinitis, number (severity) | 1 (mild) | 0 | 0 | 0 |
Bronchitis, number (severity) | 2 (moderate) | 0 | 1 (moderate) | 0 |
Urinary tract infection/cystitis, number (severity) | 0 | 1 (mild) | 1 (moderate) | 2 (mild) |
Foot infection, number (severity) | 0 | 0 | 0 | 1 (mild) |
Pyelonephritis chronic, number (severity) | 1 (mild) | 0 | 0 | 0 |
Adverse events-injection site reactions | ||||
Overall, number (%) | 0 | 3 (25) | 3 (23) | 3 (21) |
Erythema, number (%) | 0 | 3 (25) | 3 (23) | 3 (21) |
Pruritus, number (%) | 0 | 1 (8) | 0 | 0 |
Pain, number (%) | 0 | 0 | 0 | 1 (7) |
Swelling, number (%) | 0 | 0 | 0 | 1 (7) |