Table.

Cardiac and vascular serious adverse events occurring in AstraZeneca-sponsored phase 3 trials of tixagevimab–cilgavimab

		PROVENT*		STORM CHASER†		TACKLE‡
		Tixagevimab–cilgavimab (n=3461)	Placebo (n=1736)	Tixagevimab–cilgavimab (n=749)	Placebo (n=372)	Tixagevimab–cilgavimab (n=452)	Placebo (n=451)
Participants with cardiac serious adverse events		38 (1·1%)	8 (0·5%)	2 (0·3%)	2 (0·5%)	3 (0·7%)	3 (0·7%)
	Acute myocardial infarction	6 (0·2%)	3 (0·2%)	0	1 (0·3%)	2 (0·4%)	0
	Myocardial infarction	8 (0·2%)	1 (0·1%)	1 (0·1%)	0	0	0
	Cardiac failure congestive	6 (0·2%)	0	0	0	0	0
	Atrial fibrillation	3 (0·1%)	2 (0·1%)	0	0	0	0
	Coronary artery disease	2 (0·1%)	1 (0·1%)	0	1 (0·3%)	0	0
	Acute left ventricular failure	1 (<0·1%)	1 (0·1%)	0	0	1 (0·2%)	0
	Angina unstable	2 (0·1%)	0	0	0	0	0
	Arteriosclerosis coronary artery	1 (<0·1%)	1 (0·1%)	0	0	0	0
	Angina pectoris	1 (<0·1%)	0	0	0	0	0
	Arrhythmia	1 (<0·1%)	0	0	0	0	2 (0·4%)
	Atrioventricular block complete	1 (<0·1%)	0	0	0	0	0
	Bradycardia	1 (<0·1%)	0	0	0	0	0
	Cardiac arrest	0	0	1 (0·1%)	0	0	0
	Cardiac failure	1 (<0·1%)	0	1 (0·1%)	0	0	1 (0·2%)
	Cardiac failure acute	1 (<0·1%)	0	0	0	0	0
	Cardio-respiratory arrest	1 (<0·1%)	0	0	0	0	0
	Cardiogenic shock	1 (<0·1%)	0	0	0	0	0
	Cardiomegaly	1 (<0·1%)	0	0	0	0	0
	Cardiomyopathy	1 (<0·1%)	0	0	0	0	0
	Left ventricular failure	1 (<0·1%)	0	0	0	0	0
	Mitral valve disease	1 (<0·1%)	0	0	0	0	0
	Paroxysmal atrioventricular block	1 (<0·1%)	0	0	0	0	0
	Stress cardiomyopathy	0	1 (0·1%)	0	0	0	0
	Ventricular arrhythmia	1 (<0·1%)	0	0	0	0	0
	Sudden cardiac death§	0	0	0	0	1 (0·2%)	0
Participants with vascular serious adverse events		8 (0·2%)	5 (0·3%)	0	0	2 (0·4%)	0
	Hypertension	6 (0·2%)	0	0	0	0	0
	Hypotension	1 (<0·1%)	2 (0·1%)	0	0	0	0
	Aortic aneurysm	0	1 (0·1%)	0	0	0	0
	Deep vein thrombosis	1 (<0·1%)	0	0	0	0	0
	Hypertensive crisis	0	0	0	0	1 (0·2%)	0
	Hypertensive urgency	0	1 (0·1%)	0	0	0	0
	Peripheral artery thrombosis	0	0	0	0	1 (0·2%)	0
	Shock haemorrhagic	0	1 (0·1%)	0	0	0	0

Data are n (%). MedDRA=Medical Dictionary for Regulatory Activities.

^*Median follow up of 414 days for tixagevimab–cilgavimab and 413 days for placebo; data cutoff April 13, 2022.

^†Median follow up of 405 days for tixagevimab–cilgavimab and 402 days for placebo; data cutoff April 4, 2022.

^‡Median follow up of 170 days for both tixagevimab–cilgavimab and placebo; data cutoff Jan 14, 2022.

^§Sudden cardiac death was reported under system organ class “general disorders and administration site conditions”. Available data presented for PROVENT and TACKLE studies beyond published follow-up periods.1, 2 Some participants had more than one cardiac or vascular serious adverse event; participants with multiple events of the same system organ class are counted only once in that system organ class. In PROVENT, one participant in the tixagevimab–cilgavimab arm experienced both cardiac and vascular serious adverse event. Cardiac and vascular serious adverse events categorised by MedDRA system organ class as “cardiac disorders” and “vascular disorders” and preferred terms using MedDRA version 24.0. Serious adverse events were defined in study protocols as an adverse event occurring during any study phase (ie, run-in, treatment, washout, or follow-up) that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-participant hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; or is an important medical event that could jeopardise the participant or might require medical treatment to prevent one of the listed outcomes.