Table 4 Incidence of deaths and SAEs (Safety population)
| Â | Lumiracoxib 400 mg od (n= 154) | Rofecoxib 25 mg od (n= 155) |
|---|---|---|
Patients with serious AEs | Â | Â |
   Death n (%) | 0 (0.0) | 0 (0.0) |
   Non-fatal SAEs n (%) | 0 (0.0) | 1 (0.6) |
Patients with other significant AEs | Â | Â |
   Pre-specified AEs (GI events or oedema) n (%) | 73 (47.4) | 64 (41.3) |
   AEs leading to dose adjustment/interruption n (%) | 0 (0.0) | 3 (1.9) |
Discontinuation due to | Â | Â |
   Any AEs including SAEs n (%) | 8 (5.2) | 7 (4.5) |
   SAEs n (%) | 0 (0.0) | 0 (0.0) |
   AEs (non-serious) n (%) | 8 (5.2) | 7 (4.5) |