Incidence of newly-occurring adverse events (AEs) over time. Denominators are the number of patients on treatment during the indicated years (NB: incidences of certain AEs appear higher in later years compared with previous years due to a lower number of patients on treatment). Newly-occurring AEs were those not experienced by the same patient previously among patients on treatment during a given year (1 year = 365.25 days). *Includes the high-level group terms (HLGTs) cardiac arrhythmias, pericardial disorders, and heart failures under the cardiac disorders system organ class (SOC); relevant preferred terms (PTs) (cardiac death, sudden cardiac death, sudden death) under the general disorders and administration site SOC conditions; relevant PTs (decreased ejection fraction, abnormal electrocardiogram QT interval, prolonged electrocardiogram QT, long QT syndrome, congenital long QT syndrome, Torsade de pointes, ventricular tachycardia) under the SOC investigations. †HLGTs included: coronary artery disorders, atherosclerosis, stenosis, vascular insufficiency and necrosis, embolism and thrombosis; high-level terms (HLTs) included arterial therapeutic procedures (excluding aortic), central nervous system hemorrhages and cerebrovascular accidents, central nervous system vascular disorders not elsewhere classified (NEC), non-site specific vascular disorders NEC, peripheral vascular disorders NEC (excluding the PTs flushing and hot flash), transient cerebrovascular events, vascular imaging procedures NEC, and vascular therapeutic procedures NEC and all subordinate terms. ‡HLGTs included: vascular hypertensive disorders and cardiac and vascular investigations (excluding enzyme tests), the HLT vascular tests NEC (including blood pressure); PTs included: abnormal blood pressure, abnormal ambulatory blood pressure, increased ambulatory blood pressure, abnormal diastolic blood pressure, increased diastolic blood pressure, increased blood pressure, abnormal systolic blood pressure, and increased systolic blood pressure. §HLT included: renal failure and impairment; PTs included: blood creatinine abnormal, blood creatinine increased, creatinine renal clearance abnormal, creatinine renal clearance decreased, glomerular filtration rate abnormal, glomerular filtration rate decreased. ALT: alanine aminotransferase; AST: aspartate aminotransferase; URTI: upper respiratory tract infection; UTI: urinary tract infection; n: number.