Table 1.
Summary of adverse events (Phase A + B)
| Event | Placebo/metformin n = 153 | Ertugliflozin 5 mg n = 156 | Ertugliflozin 15 mg n = 152 |
|---|---|---|---|
| ≥1 AE(s) | 102 (66.7) | 100 (64.1) | 95 (62.5) |
| Drug‐related AEsa | 45 (29.4) | 42 (26.9) | 37 (24.3) |
| ≥1 SAE(s) | 7 (4.6) | 10 (6.4) | 6 (3.9) |
| Deaths | 0 | 1b | 0 |
| AEs resulting in discontinuation of study medication | 10 (6.5) | 7 (4.5) | 6 (3.9) |
| AEs associated with osmotic diuresis | |||
| Pollakiuria | 3 (2.0) | 5 (3.2) | 3 (2.0) |
| Polyuria | 0 | 3 (1.9) | 2 (1.3) |
| Nocturia | 3 (2.0) | 1 (0.6) | 0 |
Abbreviations: AE, adverse event; SAE, serious adverse event.
Data are presented as n (%), including rescue therapy.
a
Determined by the investigator to be related to the drug.
b
One participant in the ERTU 5‐mg group died during the post‐randomization follow‐up period (ruptured cerebral aneurysm, which the investigator assessed as not related to study medication). For all other AEs, this table contains events that occurred between the first dose and 14 d after the final dose of study medication.