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Table 4 Summary of AEs during Part I

From: Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial

  Placebo n = 118 Etoricoxib 60 mg n = 819 Etoricoxib 90 mg n = 467
N (%) with AEs 30 (25.4) 248 (30.3) 168 (36.0)
N (%) with AEs determined by the investigator to be drug related 8 (6.8) 64 (7.8) 59 (12.4)
N (%) with serious AEs 0 (0.0) 7 (0.9) 2 (0.4)
N (%) who discontinued due to AEs 4 (3.4) 27 (3.3) 24 (5.1)
Most Common AEs (incidence >2 % in one or more treatment groups)
 Upper abdominal pain 2 (1.7) 12 (1.5) 11 (2.4)
 Nausea 0 (0.0) 19 (2.3) 5 (1.1)
 Peripheral edema 0 (0.0) 8 (1.0) 10 (2.1)
 Nasopharyngitis 1 (0.8) 14 (1.7) 14 (3.0)
 Blood pressure increased 2 (1.7) 10 (1.2) 13 (2.8)
 Headache 6 (5.1) 25 (3.1) 17 (3.6)
 Hypertension 0 (0.0) 20 (2.4) 15 (3.2)
Prespecified AEs of Interest
 Hypertension-related AEsa 2 (1.7) 34 (4.2) 26 (5.6)
 Discontinuation due to hypertension-related AEs 2 (1.7) 3 (0.4) 11(2.4)
 Edema-related AEsb 0 (0.0) 8 (1.0) 10 (2.1)
 Discontinuation due to edema-related AEs 0 (0.0) 0 (0.0) 2 (0.4)
 Congestive heart failure, pulmonary edema, or cardiac failure 0 (0.0) 0 (0.0) 0 (0.0)
  1. aHypertension-related AEs included development of hypertension or worsening of preexisting hypertension
  2. bEdema-related AEs included edema, lower extremity edema, and peripheral edema