Table 3

Major adverse events in patients with diabetes mellitus

Adverse eventEvacetrapib
n/N (%)
Placebo
n/N (%)
TotalP value
Serious adverse event1657/4127 (40.2)1682/4109 (40.9)3339/8236 (40.5)0.47
Hypoglycemia149/3699 (4.0)138/3678 (3.8)287/7377 (3.9)0.54
Acute pancreatitis13/3699 (0.4)3/3678 (0.1)16/7377 (0.2)0.013
Chronic pancreatitis3/3699 (0.1)0/3678 (0.0)3/7377 (0.0)0.25
Cancer301/3699 (8.1)283/3678 (7.7)584/7377 (7.9)0.48
Pancreatic cancer6/3699 (0.2)11/3678 (0.3)17/7377 (0.2)0.22
Angioedema7/3699 (0.2)3/3678 (0.1)10/7377 (0.1)0.34
Maximum ALT≥3× ULN20/4095 (0.5)21/4075 (0.5)41/8170 (0.5)0.86
Maximum AST≥3× ULN11/4095 (0.3)16/4073 (0.4)27/8168 (0.3)0.33
Median % change in modified GFR (IQR)−1.6 (−8.6 to 5.8)−2.4 (−9.5 to 4.5)−2.1 (−9.0 to 5.1)<0.001
Dialysis1/3699 (0.0)1/3678 (0.0)2/7377 (0.0)1.000
  • ALT, alanine aminotransferase; AST, aspartate transaminase; GFR, glomerular filtration rate; ULN, upper limits of normal.