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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)