Table 5 Summary of AEs Part II
Etoricoxib 60 mg/60 mg n = 313 n (%) | Etoricoxib 60 mg/90 mg n = 319 n (%) | Etoricoxib 90 mg/90 mg n = 145 n (%) | Naproxen 1000 mg/1000 mg n = 142 n (%) | |
|---|---|---|---|---|
N (%) with AEs | 97 (31.0) | 103 (32.3) | 38 (26.2) | 44 (31.0) |
N (%) with AEs determined by the investigator to be drug related | 20 (6.4) | 20 (6.3) | 7 (4.8) | 12 (8.5) |
N (%) with serious AEs | 1 (0.3) | 7 (2.2) | 5 (3.4) | 2 (1.4) |
N (%) who discontinued due to AEs | 3 (1.0) | 9 (2.8) | 4 (2.8) | 2 (1.4) |
Serious AEs | ||||
Angina Pectoris | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Left ventricular hypertrophy | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Glaucoma | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gastric Ulcer | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Gastric Ulcer Hemorrhage | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Death | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Non-cardiac Chest Pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Abscess | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Diverticulitis | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Sialoadenitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Contusion | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Rib Fracture | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Skin Abrasion | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Ankylosing Spondylitis | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Rotator Cuff Syndrome | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Ear Neoplasm | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Renal Cell Carcinoma | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Ischemic Stroke | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Depression | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Pulmonary Embolism | 0 (0.0) | 0 (0.0) | 2 (1.4) | 0 (0.0) |
Deep Vein Thrombosis | 0 (0.0) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Hypertension | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Most Common AEs (incidence >2 % in one or more treatment groups) | ||||
Upper Abdominal Pain | 7 (2.2) | 2 (0.6) | 0 (0.0) | 4 (2.8) |
Influenza | 1 (0.3) | 2 (0.6) | 2 (1.4) | 3 (2.1) |
Nasopharyngitis | 9 (2.9) | 11 (3.4) | 4 (2.8) | 3 (2.1) |
Urinary tract infection | 2 (0.6) | 7 (2.2) | 0 (0.0) | 1 (0.7) |
Contusion | 2 (0.6) | 0 (0.0) | 3 (2.1) | 3 (2.1) |
Arthralgia | 8 (2.6) | 2 (0.6) | 2 (1.4) | 0 (0.0) |
Headache | 6 (1.9) | 7 (2.2) | 5 (3.4) | 4 (2.8) |
Hypertension | 9 (2.9) | 9 (2.8) | 3 (2.1) | 4 (2.8) |
Prespecified AEs of Interest | ||||
Hypertension-related AEs | 14 (4.5) | 10 (3.1) | 3 (2.1) | 4 (2.8) |
Discontinuation due to hypertension-related AEs | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Edema-related AEs | 4 (1.3) | 4 (1.3) | 0 (0.0) | 3 (2.1) |
Discontinuation due to edema-related AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Congestive heart failure, pulmonary edema, or cardiac failure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |