Table 3.
Major Hemorrhagic Events.*
| End Point | Overall (N = 19,114) | Aspirin (N = 9525) | Placebo (N = 9589) | Hazard Ratio (95% CI) | P Value | ||
|---|---|---|---|---|---|---|---|
| no. of participants with event | no. of participants with event | rate per 1000 person-yr | no. of participants with event | rate per 1000 person-yr | |||
| Major hemorrhage† | 626 | 361 | 8.6 | 265 | 6.2 | 1.38 (1.18–1.62) | <0.001 |
| Intracranial bleeding | |||||||
| Any | 179 | 107 | 2.5 | 72 | 1.7 | 1.50 (1.11–2.02) | — |
| Hemorrhagic stroke | 77 | 43 | 1.0 | 34 | 0.8 | 1.27 (0.81–2.00) | — |
| Subdural or extradural hemorrhage | 61 | 39 | 0.9 | 22 | 0.5 | 1.79 (1.06–3.02) | — |
| Subarachnoid hemorrhage‡ | 32 | 18 | 0.4 | 14 | 0.3 | 1.30 (0.64–2.60) | — |
| Extracranial bleeding | |||||||
| Upper gastrointestinal bleeding | 137 | 89 | 2.1 | 48 | 1.1 | 1.87 (1.32–2.66) | — |
| Lower gastrointestinal bleeding | 127 | 73 | 1.7 | 54 | 1.3 | 1.36 (0.96–1.94) | — |
| Bleeding at another site§ | 189 | 101 | 2.4 | 88 | 2.1 | 1.16 (0.87–1.54) | — |
| Fatal bleeding | |||||||
| Fatal major hemorrhage¶ | 52 | 28 | 0.7 | 24 | 0.6 | 1.18 (0.68–2.03) | — |
| Fatal hemorrhagic stroke | 26 | 13 | 0.3 | 13 | 0.3 | 1.01 (0.47–2.17) | — |
Because some end points were composites, a participant who had events for more than one component of the composite (e.g., stroke and then acute myocardial infarction) would contribute only the first event that occurred to the composite end point but would contribute an event to the separate analyses of each component. Hence, summation of the number of events for separate components of a composite end point does not equate to the number of events for the composite end point. The confidence intervals shown in this table have not been adjusted for multiple comparisons, and inferences drawn from them may not be reproducible.
Major hemorrhage, a prespecified secondary end point, was a composite of hemorrhagic stroke, symptomatic intracranial bleeding, or extracranial bleeding that led to transfusion, hospitalization, prolonged hospitalization, surgery, or death.
Data for subarachnoid hemorrhage included 18 persons who had subarachnoid hemorrhage and 14 who had a subarachnoid hemorrhagic stroke.
Bleeding at another site included hematuria, bleeding at a surgical site, bleeding after trauma, and epistaxis.
Data for fatal major hemorrhage included deaths that were adjudicated to be from major hemorrhage.