Table 3.
Incidence of adverse events
| Placebo (n = 4904) | EMPA 10 mg (n = 4858) | EMPA 25 mg (n = 5057) | EMPA 10/25 mg (n = 10,177) | |
|---|---|---|---|---|
| ≥ 1 AE | 197.62 | 170.01 | 168.59 | 168.89 |
| ≥ 1 drug-related AEa | 15.45 | 19.57 | 19.38 | 19.54 |
| ≥ 1 AE leading to discontinuation | 7.40 | 6.57 | 6.38 | 6.43 |
| ≥ 1 severe AEb | 10.43 | 8.80 | 9.51 | 9.04 |
| ≥ 1 serious AEc | 18.61 | 15.29 | 16.07 | 15.52 |
| Fatal | 1.57 | 1.24 | 1.01 | 1.12 |
Data are the rate/100 patient-years. A patient may be counted in more than one seriousness criterion. MedDRA version used for reporting: 20.1
AE adverse event, EMPA empagliflozin, MedDRA Medical Dictionary for Regulatory Activities
aInvestigator-defined
bAn AE that is incapacitating or causing inability to work or perform usual activities
cAn AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is deemed serious for any other reason