Table 5 Summary of AEs during Part II
Etoricoxib 60 mg/60 mg n = 350 | Etoricoxib 60 mg/90 mg n = 363 | |
|---|---|---|
N (%) with AEs | 67 (19.1) | 89 (24.5) |
N (%) with AEs determined by the investigator to be drug related | 15 (4.3) | 16 (4.4) |
N (%) with serious AEs | 4 (1.1) | 5 (1.4) |
N (%) who discontinued due to AEs | 5 (1.4) | 7 (1.9) |
Most Common AEs (incidence >2 % in one or more treatment groups) | ||
Nasopharyngitis | 8 (2.3) | 9 (2.5) |
Prespecified AEs of Interest | ||
Hypertension-related AEs | 8 (2.3) | 7 (1.9) |
Discontinuation due to hypertension-related AEs | 0 (0.0) | 0 (0.0) |
Edema-related AEs | 1 (0.3) | 2 (0.6) |
Discontinuation due to edema-related AEs | 0 (0.0) | 0 (0.0) |
Congestive heart failure, pulmonary edema, or cardiac failure | 0 (0.0) | 0 (0.0) |