| 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) |