Table 3.

Trial outcome events.

Primary efficacy outcome:

• Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism

Secondary efficacy outcomes:a

• Cardiovascular death (including death due to all types of hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction

• All-cause mortality

• Individual components of the primary and secondary efficacy outcomes (stroke, cardiovascular death, and myocardial infarction) as well as

• Recurrent ischemic stroke (including TIA with positive neuroimaging)

• Disabling/fatal stroke (modified Rankin score ≥4) at 90 days after recurrence

Primary safety outcome:

• Major bleeding meeting ISTH criteria12

Secondary safety outcomes:

• Life-threatening bleeding

• Clinically relevant nonmajor bleeding

• Intracranial hemorrhage

^aListed in the order of sequential testing.

ISTH: International Society on Thrombosis and Haemostasis; TIA: transient ischemic attack.