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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.
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