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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.