Lumiracoxib 200mg od (n = 487) | Lumiracoxib 400mg od (n = 491) | Celecoxib 200mg od (n = 481) | Placebo (n = 243) | |
---|---|---|---|---|
Results are shown as No . | ||||
AE, adverse event GI, gastrointestinal NOS, not otherwise specified od, once daily. | ||||
Most frequently reported AEs | ||||
Nasopharyngitis | 34 7.0 | 28 5.7 | 23 4.8 | 12 4.9 |
Headache | 19 3.9 | 29 5.9 | 27 5.6 | 9 3.7 |
Abdominal pain upper | 23 4.7 | 25 5.1 | 25 5.2 | 6 2.5 |
Arthralgia | 15 3.1 | 11 2.2 | 14 2.9 | 11 4.5 |
Dyspepsia | 19 3.9 | 21 4.3 | 17 3.5 | 9 3.7 |
Diarrhoea | 13 2.7 | 18 3.7 | 11 2.3 | 2 0.8 |
Back pain | 8 1.6 | 14 2.9 | 17 3.5 | 8 3.3 |
Hypertension NOS | 8 1.6 | 17 3.5 | 12 2.5 | 2 0.8 |
Influenza | 11 2.3 | 16 3.3 | 11 2.3 | 7 2.9 |
Prespecified AEs | 94 19.3 | 101 20.6 | 77 16.0 | 30 12.3 |
GI events | 85 17.5 | 96 19.6 | 72 15.0 | 25 10.3 |
Peripheral oedema | 6 1.2 | 4 0.8 | 6 1.2 | 4 1.6 |
Chest pain | 3 0.6 | 4 0.8 | 2 0.4 | 1 0.4 |