Table 2.
Observed event rates of efficacy and safety outcomes.
| Patients with event/total patients (%) |
||||
|---|---|---|---|---|
| Stratum | Placebo | 2.5 mg BID | 5 mg BID | |
| Efficacy outcomes | ||||
| MI, ischemic stroke, nonhemorrhagic CV death | Aspirin | 35/350 (10.0) | 24/343 (7.0) | 23/341 (6.7) |
| Aspirin plus thieno | 317/4712 (6.7) | 256/4712 (5.4) | 246/4709 (5.2) | |
| Combined | 352/5062 (7.0) | 280/5055 (5.5) | 269/5050 (5.3) | |
| MI, ischemic stroke, death from all causes | Aspirin | 35/350 (10.0) | 24/343 (7.0) | 23/341 (6.7) |
| Aspirin plus thieno | 326/4712 (6.9) | 263/4712 (5.6) | 256/4709 (5.4) | |
| Combined | 361/5062 (7.1) | 287/5055 (5.7) | 279/5050 (5.5) | |
| Safety outcomes | ||||
| TIMI major bleeding | Aspirin | 2/352 (0.6) | 2/343 (0.6) | 4/342 (1.2) |
| Aspirin plus thieno | 25/4773 (0.5) | 66/4772 (1.4) | 81/4768 (1.7) | |
| Combined | 27/5125 (0.5) | 68/5115 (1.3) | 85/5110 (1.7) | |
| Clinically significant bleeding | Aspirin | 11/352 (3.1) | 19/343 (5.5) | 23/342 (6.7) |
| Aspirin plus thieno | 316/4773 (6.6) | 567/4772 (11.9) | 725/4768 (15.2) | |
| Combined | 327/5125 (6.4) | 586/5115 (11.5) | 748/5110 (14.6) | |
BID, twice daily; CV, cardiovascular; MI, myocardial infarction; thieno, thienopyridine; TIMI, Thrombolysis in Myocardial Infarction.