Table 3

Cardiovascular reports on evolocumab registered at the FDA Adverse Event Reporting System (FAERS) (as of 30 June 2022)

	No reports	Fatal	Serious (incl. death)
Cardiac disorders	2241	137	1875
Myocardial infarction	651	55	620
Heart failure*	189	12	183
Vascular disorders	1886	35	991
Nervous system disorders—stroke and TIA	641	33	622
Stroke†	541	31	526
Transient ischaemic accident (TIA)	100	2	96
Stroke+TIA	641	33	622
Cardiovascular disorders‡	4768	205	3488
Total adverse event reports (all reaction groups)	89 366	1132	14 986
CV events out of total adverse events	5.3%	18.1%	23.3%

*Cardiac failure congestive, cardiac failure, cardiac failure acute, cardiac dysfunction, cardiac failure chronic.
†Cerebrovascular accident, cerebral infarction, cerebral haemorrhage, haemorrhagic stroke, subaracnoid haemorrhage, ischaemic stroke, haemorrhage intracraneal, cerebral thrombosis, embolic stroke, haemorrhagic cerebral infarction, cerebral venous thrombosis, cerebral artery thrombosis, brain stem stroke, brain stem infarction, brain stem haemorrhage, lacunar stroke, lacunar infarction, thrombotic stroke, basilar artery thrombosis, stroke in evolution and embolic cerebral infarction.
‡Cardiac disorders, vascular disorders, stroke and transient ischaemic accident.