Table 6.
Time to events for elevations in hepatic transaminases and APTC events (Safety Population)
| Lumiracoxib 100 mg o.d. (n = 755) | Lumiracoxib 100 mg b.i.d. (n = 1,519) | Celecoxib 200 mg o.d. (n = 758) | ||||
| Time interval (days) | No. of subjects with events within the interval | Incidence rate within the interval (%) | No. of subjects with events within the interval | Incidence rate within the interval (%) | No. of subjects with events within the interval | Incidence rate within the interval (%) |
| AST/ALT >3 × ULN | ||||||
| 1 – 49 | 0 | 0.00 | 4 | 0.26 | 1 | 0.13 |
| 50 – 105 | 1 | 0.15 | 7 | 0.53 | 1 | 0.15 |
| 106 – 196 | 6 | 1.15 | 18 | 1.64 | 1 | 0.19 |
| 197 – 287 | 3 | 0.76 | 5 | 0.63 | 0 | 0.00 |
| >287 | 1 | 0.28 | 1 | 0.14 | 0 | 0.00 |
| Definite/probable APTC events | ||||||
| 1 – 49 | 0 | 0.00 | 1 | 0.07 | 0 | 0.00 |
| 50 – 105 | 0 | 0.00 | 1 | 0.07 | 1 | 0.13 |
| 106 – 196 | 1 | 0.13 | 1 | 0.07 | 0 | 0.00 |
| 197 – 287 | 1 | 0.13 | 3 | 0.20 | 1 | 0.13 |
| >287 | 1 | 0.13 | 0 | 0.00 | 0 | 0.00 |
o.d. = once daily; b.i.d. = twice daily.