Table 2.

Adverse events and safety outcomes

Serious adverse events

5-point major adverse cardiovascular event - Cardiovascular death - Acute myocardial infarction - Ischemic or hemorrhagic stroke - Acute coronary revascularization procedures - Heart failure hospitalization Other clinical events - Death from any cause - Transient ischemic attack Readmissions including safety events - Syncope associated with hospitalization - Fall associated with hospitalization - Readmission for any cause

Adverse events of special interest

Safety events - Falls with or without injury but w/o hospitalization or emergency visit - Syncope with or without injury but w/o hospitalization or emergency visit - Transient impaired renal function Acute care utilization - Urgent care visit, not associated with serious adverse event - Emergency department visit, not associated with serious adverse event