Table 2.
Summary of adverse events
| Patients | Placebo | Ertugliflozin 5 mg | Ertugliflozin 15 mg |
|---|---|---|---|
| n (%) | 448 (32.5) | 466 (33.8) | 463 (33.6) |
| With ≥ 1 AE | 235 (52.5) | 208 (44.6) | 232 (50.1) |
| With ≥ 1 SAE | 13 (2.9) | 13 (2.8) | 9 (1.9) |
| Discontinued treatment because of an AE | 7 (1.6) | 9 (1.9) | 7 (1.5) |
| Who died | 0 | 0 | 0 |
| With AEs of special interest | |||
| GMI (female) a | 7 (3.4) | 22 (9.9) | 28 (12.6) |
| GMI (male) b | 1 (0.4) | 9 (3.7) | 9 (3.7) |
| UTI | 19 (4.2) | 20 (4.3) | 20 (4.3) |
| Symptomatic hypoglycemia | 9 (2.0) | 13 (2.8) | 15 (3.2) |
| Hypovolemia | 8 (1.8) | 3 (0.6) | 4 (0.9) |
a
n = 207 for placebo, 223 for ertugliflozin 5 mg, and 222 for ertugliflozin 15 mg.
b
n = 241 for placebo, 243 for ertugliflozin 5 mg, and 241 for ertugliflozin 15 mg.
AE, adverse event; GMI, genital mycotic infection; SAE, serious adverse event; UTI, urinary tract infection.