TABLE 1.

Comparison of investigator-reported fatal myocardial infarction (MI)^# with adjudicated terms

	Causes of death by MAC
	Concordance	Discordance
		Underlying cause of death			Lack of information or evidence¶
Causes by investigator	Acute MI/MI	Aortic aneurysm	Brain neoplasm	Chronic obstructive pulmonary disease	Death	Sudden cardiac death	Sudden death	Total
Acute MI/MI	21	1	1	1	4	8	6	42
Post-procedural MI		1						1
Acute coronary syndrome						1	2	3
Total	21	2	1	1	4	9	8	46

MAC: mortality adjudication committee. ^#: MI is SMQ (standardised MedDRA query) ischaemic heart disease, sub-SMQ MI. ^¶: there was insufficient information/evidence for the MAC to assign a specific underlying cause of death so the categorical assignment was made based on MAC protocol-defined criteria. Sudden cardiac deaths were those occurring within 1 h of an abrupt change of a person's clinical state without other obvious non-cardiac cause, and sudden death refers to those occurring more than 1 h but less than 24 h of the patient last being observed alive and without evidence of a deteriorating medical condition. “Death” refers to unexplained death.