A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus

Table 4 Adverse event (AE) summary measures in the APaT population; Treatment Period + 21 days

Patients, n (%)	Omarigliptin N = 2092	Placebo N = 2100	Difference^a
With one or more
AEs	1605 (77.2)	1583 (75.4)	1.8 (−0.8, 4.4)
Drug-related^b AEs	268 (12.8)	215 (10.2)	2.6 (0.6, 4.5)
Serious AEs	476 (22.8)	467 (22.2)	0.5 (−2.0, 3.0)
Serious drug-related^b AEs	8 (0.4)	6 (0.3)	0.1 (−0.3, 0.5)
Who died	39 (1.9)	30 (1.4)	0.4 (−0.3, 1.2)
Who discontinued due to
An AE	77 (3.7)	68 (3.2)	0.4 (−0.7, 1.6)
A drug-related^b AE	21 (1.0)	18 (0.9)	0.1 (−0.5, 0.8)
A serious AE	37 (1.8)	28 (1.3)	0.4 (−0.3, 1.2)
A serious drug-related^b AE	3 (0.1)	1 (0.0)	0.1

^aDifference in % vs. placebo; estimate (95% CI) was computed only for AE summary endpoints with at least four patients having events in one or more treatment groups
^bAssessed by the investigator as related to study drug

ISSN: 1475-2840