Table 4.
Placebo N = 111 n (%) | Etoricoxib 90 mg qd N = 108 n (%) | Celecoxib 400 mg qd N = 107 n (%) | Ibuprofen 2,400 mg qd N = 107 n (%) | |
---|---|---|---|---|
Clinical Adverse Experiences (AEs) | ||||
≥1 AE | 40 (36.0) | 50 (46.3) | 45 (42.1) | 45 (42.1) |
≥1 Drug-related AE† | 13 (11.7) | 20 (18.5) | 15 (14.0) | 20 (18.7) |
≥1 Serious AE | 0 (0.0) | 1 (0.9) | 4 (3.7) | 2 (1.9) |
Discontinued due to an AE | 8 (7.2) | 12 (11.1) | 11 (10.3) | 11 (10.3) |
Gastrointestinal (GI) Nuisance Symptoms‡ | ||||
GI Symptom AEs | 2 (1.8) | 7 (6.5) | 4 (3.7) | 6 (5.6) |
Discontinuations | 0 (0.0) | 2 (1.9) | 0 (0.0) | 2 (1.9) |
Renovascular AEs | ||||
Lower Extremity Edema | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Discontinuations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Congestive Heart Failure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypertension§ | 1 (0.9) | 4 (3.7) | 1 (0.9) | 4 (3.7) |
Discontinuations | 0 (0.0) | 2 (1.9) | 0 (0.0) | 0 (0.0) |
Determined by the investigator to be possibly, probably or definitely drug related.
Includes abdominal pain, abdominal discomfort, acid reflux, dyspepsia, epigastric discomfort, heartburn, nausea and vomiting.
Hypertension was diagnosed by individual investigators; a formal set of parameters was not provided.