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Table 3 Adverse events (safety population)

From: Results of a proof of concept, double-blind, randomized trial of a second generation antisense oligonucleotide targeting high-sensitivity C-reactive protein (hs-CRP) in rheumatoid arthritis

  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)