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Table 3 Summary of safety (safety analysis set)

From: Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy

 

Placebo-etanercept (N = 104)

Etanercept-etanercept (N = 106)

All patients (N = 210)

Patients reporting an AE, n (%)

   

 Weeks 1–12 (double-blind portion)

63 (60.6)

71 (67.0)

134 (63.8)

 Weeks 1–24

80 (76.9)

83 (78.3)

163 (77.6)

Patients reporting an SAE, n (%)

   

 Weeks 1–12 (double-blind portion)

2 (1.9)

3 (2.8)

5 (2.4)

 Weeks 1–24

3 (2.9)

4 (3.8)

7 (3.3)

Patients reporting an SIE, n (%)

   

 Weeks 1–12 (double-blind portion)

0 (0)

0 (0)

0 (0)

 Weeks 1–24

0 (0)

1 (0.9)

1 (0.5)

Patients reporting an infection, n (%)

   

 Weeks 1–12 (double-blind portion)

23 (22.1)

30 (28.3)

53 (25.2)

 Weeks 1–24

46 (44.2)

39 (36.8)

85 (40.5)

  1. AE: adverse event; SAE: serious adverse event; SIE: serious infectious event.