|
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. | ||||||
Fleischmann et al. BMC Musculoskeletal Disorders 2008 9:32 doi:10.1186/1471-2474-9-32 |
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