Table 3.
Major adverse events in patients with diabetes mellitus
| Adverse event | Evacetrapib n/N (%) |
Placebo n/N (%) |
Total | P value |
| Serious adverse event | 1657/4127 (40.2) | 1682/4109 (40.9) | 3339/8236 (40.5) | 0.47 |
| Hypoglycemia | 149/3699 (4.0) | 138/3678 (3.8) | 287/7377 (3.9) | 0.54 |
| Acute pancreatitis | 13/3699 (0.4) | 3/3678 (0.1) | 16/7377 (0.2) | 0.013 |
| Chronic pancreatitis | 3/3699 (0.1) | 0/3678 (0.0) | 3/7377 (0.0) | 0.25 |
| Cancer | 301/3699 (8.1) | 283/3678 (7.7) | 584/7377 (7.9) | 0.48 |
| Pancreatic cancer | 6/3699 (0.2) | 11/3678 (0.3) | 17/7377 (0.2) | 0.22 |
| Angioedema | 7/3699 (0.2) | 3/3678 (0.1) | 10/7377 (0.1) | 0.34 |
| Maximum ALT≥3× ULN | 20/4095 (0.5) | 21/4075 (0.5) | 41/8170 (0.5) | 0.86 |
| Maximum AST≥3× ULN | 11/4095 (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 |
| Dialysis | 1/3699 (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.