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Table 5 Summary of AEs during Part II

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

  Etoricoxib 60 mg/60 mg n = 350 Etoricoxib 60 mg/90 mg n = 363
N (%) with AEs 67 (19.1) 89 (24.5)
N (%) with AEs determined by the investigator to be drug related 15 (4.3) 16 (4.4)
N (%) with serious AEs 4 (1.1) 5 (1.4)
N (%) who discontinued due to AEs 5 (1.4) 7 (1.9)
Most Common AEs (incidence >2 % in one or more treatment groups)
 Nasopharyngitis 8 (2.3) 9 (2.5)
Prespecified AEs of Interest
 Hypertension-related AEs 8 (2.3) 7 (1.9)
 Discontinuation due to hypertension-related AEs 0 (0.0) 0 (0.0)
 Edema-related AEs 1 (0.3) 2 (0.6)
 Discontinuation due to edema-related AEs 0 (0.0) 0 (0.0)
 Congestive heart failure, pulmonary edema, or cardiac failure 0 (0.0) 0 (0.0)