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

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

Patients, n (%) Omarigliptin N = 2092 Placebo N = 2100 Differencea
With one or more
 AEs 1605 (77.2) 1583 (75.4) 1.8 (−0.8, 4.4)
 Drug-relatedb 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-relatedb 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-relatedb 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-relatedb AE 3 (0.1) 1 (0.0) 0.1
  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
  2. bAssessed by the investigator as related to study drug