Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

Table 2 Summary of adverse events (AEs) reported during the trial (safety population)

	CNIC-Polypill (N = 247)	Usual care (N = 245)
Any AE, n (%)	70 (28.3)	50 (20.4)
Severe	7 (2.8)	3 (1.2)
Leading to temporary treatment discontinuation	3 (1.2)	1 (0.4)
Leading to permanent treatment discontinuation	15 (6.1)	3 (1.2)
Leading to trial discontinuation	18 (3.7)	3 (1.2)
Serious AEs*, n (%)	6 (2.3)	3 (1.2)
Leading to death	0 (0.0)	0 (0.0)
Deaths, n (%)	0 (0.0)	0 (0.0)
Treatment-related AEs, n (%)	17 (6.9)	2 (0.8)
Leading to permanent treatment discontinuation	10 (4.1)	0 (0.0)
Serious	1 (0.4)	0 (0.0)

*A serious AE was defined as any untoward medical occurrence that: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; 5) leads to a congenital anomaly/birth defect in the offspring of a subject; 6) is an important medical event that may expose the subject to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization

ISSN: 1471-2261