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Table 4 Most common adverse events and events of interest in evaluating COX-inhibitors

From: A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273]

  Placebo Etoricoxib 90 mg Naproxen 1000 mg
  (N = 357) (N = 353) (N = 181)
  n (%) n (%) n (%)
Most Common Adverse Events†    
Headache 20 (5.6) 24 (6.8) 6 (3.3)
Hypertension 5 (1.4) 12 (3.4) 5 (2.8)
Upper Respiratory Infection 11 (3.1) 8 (2.3) 8 (4.4)
Urinary Tract Infection 16 (4.5) 15 (4.2) 8 (4.4)
Events of Interest in Evaluating COX Inhibitors
   Gastrointestinal (GI) Adverse Events
GI Nuisance Symptoms 36 (10.1) 38 (10.8) 21 (11.6)
Discontinuations 2 (0.6) 2 (0.6) 2 (1.1)
   Renovascular Adverse Events
Lower Extremity Edema (LEE) 3 (0.8) 3 (0.8) 2 (1.1)
Discontinuations due to LEE 0 (0.0) 0 (0.0) 0 (0.0)
Congestive Heart Failure 0 (0.0) 0 (0.0) 0 (0.0)
Hypertension 5 (1.4) 12 (3.4) 5 (2.8)
Discontinuations due to hypertension 0 (0.0) 0 (0.0) 1 (0.6)
  1. † Incidence ≥ 3% in any treatment group. 
  2. ‡ Includes abdominal pain, acid reflux, dyspepsia, epigastric discomfort, heartburn, nausea, and vomiting.