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