Table 3.
Adverse events
| Total | Empagliflozin | Placebo | |
|---|---|---|---|
| Serious adverse events | |||
| Death | 3 | 3 | 0 |
| Non-cardiovascular death | 1 | 1 | 0 |
| Death from cardiovascular cause | 2 | 2 | 0 |
| Any hospitalization | 63 (69) | 31 (35) | 32 (34) |
| Hospitalization due to heart failure | 7 (10) | 3 (6) | 4 (4) |
| Hospitalization due to cardiovascular event | 7 (7) | 2 (2) | 5 (5) |
| Adverse events of special interest | |||
| Hepatic injury | 2 | 1 | 1 |
| Renal injury | 0 | 0 | 0 |
| Metabolic acidosis and diabetic ketoacidosis | 0 | 0 | 0 |
| Event involving lower limb amputation | 0 | 0 | 0 |
| Other adverse events | |||
| Urinary tract infection | 18 (26) | 11 (18) | 7 (8) |
| Genital fungal infection | 9 (9) | 7 (7) | 2 (2) |
Given numbers are participants with adverse events (number of events). Renal injury: >two-fold increase creatinine. Hepatic injury: AST/ALT ≥three-fold ULN with elevation of total bilirubin ≥two-fold ULN or AST/ALT elevation ≥five-fold ULN.