Table 4 Summary of AEs Part I
Etoricoxib 60 mg n = 702 n (%) | Etoricoxib 90 mg n = 155 n (%) | Naproxen 1000 mg n = 156 n (%) | |
|---|---|---|---|
N (%) with AEs | 222 (31.6) | 36 (23.2) | 47 (30.1) |
N (%) with AEs determined by the investigator to be drug related | 85 (12.1) | 11 (7.1) | 21 (13.5) |
N (%) with serious AEs | 5 (0.7) | 1 (0.6) | 0 (0.0) |
N (%) who discontinued due to AEs | 22 (3.1) | 2 (1.3) | 6 (3.8) |
Most Common AEs (incidence >2 % in one or more treatment groups) | |||
Upper abdominal pain | 19 (2.7) | 2 (1.3) | 6 (3.8) |
Diarrhea | 16 (2.3) | 2 (1.3) | 3 (1.9) |
Nasopharyngitis | 20 (2.8) | 3 (1.9) | 1 (0.6) |
Dysgeusia | 0 (0.0) | 4 (2.6) | 1 (0.6) |
Headache | 18 (2.6) | 6 (3.9) | 2 (1.3) |
Hypertension | 21 (3.0) | 5 (3.2) | 6 (3.8) |
Serious AEs | |||
Appendicitis | 0 (0.0) | 1 (0.6) | 0 (0.0) |
Hip Fracture | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Ankylosing Spondylitis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Cerebral Infarction | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Cerebrovascular Accident | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Headache | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Prostatitis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Hypertensive crisis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Prespecified AEs of Interest | |||
Hypertension-related AEs | 35 (5.0) | 6 (3.9) | 6 (3.8) |
Discontinuation due to hypertension-related AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Edema-related AEs | 4 (0.6) | 0 (0.0) | 0 (0.0) |
Discontinuation due to edema-related AEs | 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) |