Table 3.
Adverse events and serious adverse events according to baseline eGFR
| Adverse events | eGFR≥45 to <60 ml/min per 1.73 m2 | eGFR≥60 to <90 ml/min per 1.73 m2 | eGFR≥90 ml/min per 1.73 m2 | |||
|---|---|---|---|---|---|---|
| Placebo, n=274 | DAPA 10 mg, n=252 | Placebo, n=1233 | DAPA 10 mg, n=1251 | Placebo, n=671 | DAPA 10 mg, n=723 | |
| ≥1 AE | 192 (70.1) | 172 (68.3) | 671 (54.4) | 730 (58.3) | 365 (54.4) | 430 (59.4) |
| ≥1 SAE | 26 (9.5) | 19 (7.5) | 72 (5.8) | 66 (5.3) | 27 (4.0) | 35 (4.8) |
| AEs leading to study drug discontinuation | 27 (9.9) | 25 (9.9) | 40 (3.2) | 42 (3.4) | 15 (2.2) | 22 (3.0) |
| AEs of special interest | ||||||
| Hypoglycemiaa | 62 (22.6) | 52 (20.6) | 145 (11.8) | 172 (13.7) | 39 (5.8) | 78 (10.8) |
| UTI | 15 (5.5) | 15 (6.0) | 40 (3.2) | 55 (4.4) | 21 (3.1) | 31 (4.3) |
| Genital infection | 2 (0.7) | 16 (6.3) | 4 (0.3) | 70 (5.6) | 8 (1.2) | 42 (5.8) |
| Renal function | 21 (7.7) | 36 (14.3) | 14 (1.1) | 21 (1.7) | 3 (0.4) | 5 (0.7) |
| Volume reduction | 4 (1.5) | 8 (3.2) | 9 (0.7) | 19 (1.5) | 3 (0.4) | 2 (0.3) |
| SAEs of special interest | ||||||
| UTI | 1 (0.4) | 0 | 0 | 1 (<0.1) | 0 | 0 |
| Genital infection | 0 | 0 | 0 | 0 | 0 | 0 |
| Renal function | 0 | 0 | 0 | 1 (<0.1) | 0 | 1 (0.1) |
| Volume reduction | 1 (0.4) | 1 (0.4) | 1 (<0.1) | 1 (<0.1) | 0 | 0 |
AE, adverse event; SAE, serious adverse event; UTI, urinary tract infection.
a
Major episodes (defined as symptomatic episodes requiring external assistance with a capillary or plasma glucose value <54 mg/dl [3 mmol/L] and prompt recovery after glucose or glucagon administration) n (%): 0 (0.0) and 1 (0.4), 1 (0.1) and 1 (0.1), and 1 (0.1) and 2 (0.3) in the placebo and dapagliflozin 10 mg/d groups, respectively, for eGFR≥45 and <60 ml/min per 1.73 m2, ≥60 and <90 ml/min per 1.73 m2, and ≥90 ml/min per 1.73 m2.