Placebo n = 118 | Etoricoxib 60 mg n = 819 | Etoricoxib 90 mg n = 467 | |
---|---|---|---|
N (%) with AEs | 30 (25.4) | 248 (30.3) | 168 (36.0) |
N (%) with AEs determined by the investigator to be drug related | 8 (6.8) | 64 (7.8) | 59 (12.4) |
N (%) with serious AEs | 0 (0.0) | 7 (0.9) | 2 (0.4) |
N (%) who discontinued due to AEs | 4 (3.4) | 27 (3.3) | 24 (5.1) |
Most Common AEs (incidence >2 % in one or more treatment groups) | |||
Upper abdominal pain | 2 (1.7) | 12 (1.5) | 11 (2.4) |
Nausea | 0 (0.0) | 19 (2.3) | 5 (1.1) |
Peripheral edema | 0 (0.0) | 8 (1.0) | 10 (2.1) |
Nasopharyngitis | 1 (0.8) | 14 (1.7) | 14 (3.0) |
Blood pressure increased | 2 (1.7) | 10 (1.2) | 13 (2.8) |
Headache | 6 (5.1) | 25 (3.1) | 17 (3.6) |
Hypertension | 0 (0.0) | 20 (2.4) | 15 (3.2) |
Prespecified AEs of Interest | |||
Hypertension-related AEsa | 2 (1.7) | 34 (4.2) | 26 (5.6) |
Discontinuation due to hypertension-related AEs | 2 (1.7) | 3 (0.4) | 11(2.4) |
Edema-related AEsb | 0 (0.0) | 8 (1.0) | 10 (2.1) |
Discontinuation due to edema-related AEs | 0 (0.0) | 0 (0.0) | 2 (0.4) |
Congestive heart failure, pulmonary edema, or cardiac failure | 0 (0.0) | 0 (0.0) | 0 (0.0) |