Table 3.
Adverse Events
| Number of Patients, (%) | Creatinine-based eGFR | Cystatin C-based eGFR | ||||||
|---|---|---|---|---|---|---|---|---|
| eGFR 30 to <60 mL/min/1.73 m2 | eGFR ≥60 mL/min/1.73 m2 | eGFR 30 to <60 mL/min/1.73 m2 | eGFR ≥60 mL/min/1.73 m2 | |||||
| PBO | DAPA | PBO | DAPA | PBO | DAPA | PBO | DAPA | |
| n | 256 | 333 | 1767 | 2389 | 151 | 169 | 1829 | 2484 |
| ≥1 AE | 174 (68.0) | 236 (70.9) | 956 (54.1) | 1396 (58.4) | 101 (66.9) | 116 (68.6) | 1004 (54.9) | 1472 (59.3) |
| ≥1 SAE | 23 (9.0) | 24 (7.2) | 97 (5.5) | 120 (5.0) | 15 (9.9) | 12 (7.1) | 101 (5.5) | 126 (5.1) |
| ≥1 AE leading to discontinuation | 24 (9.4) | 39 (11.7) | 51 (2.9) | 81 (3.4) | 14 (9.3) | 26 (15.4) | 58 (3.2) | 91 (3.7) |
| AEs of special interest | ||||||||
| Genital infections | 1 (0.4) | 19 (5.7) | 11 (0.6) | 144 (6.0) | 0 | 8 (4.7) | 12 (0.7) | 150 (6.0) |
| Urinary tract infections | 16 (6.3) | 22 (6.6) | 53 (3.0) | 118 (4.9) | 10 (6.6) | 11 (6.5) | 58 (3.2) | 126 (5.1) |
| Renal AEsa | 25 (9.8) | 54 (16.2) | 16 (0.9) | 29 (1.2) | 16 (10.6) | 32 (18.9) | 25 (1.4) | 48 (1.9) |
| Hypovolemia AEsb | 4 (1.6) | 6 (1.8) | 12 (0.7) | 23 (1.0) | 3 (2.0) | 3 (1.8) | 11 (0.6) | 25 (1.0) |
| Hypoglycemiac | 54 (21.1) | 71 (21.3) | 181 (10.2) | 337 (14.1) | 29 (19.2) | 26 (15.4) | 201 (11.0) | 373 (15.0) |
| Major | 0 | 0 | 1 (0.1) | 3 (0.1) | 0 | 0 | 1 (0.1) | 3 (0.1) |
| Minor | 51 (19.9) | 68 (20.4) | 158 (8.9) | 305 (12.8) | 28 (18.5) | 24 (14.2) | 176 (9.6) | 340 (13.7) |
| Other | 9 (3.5) | 9 (2.7) | 26 (1.5) | 43 (1.8) | 2 (1.3) | 1 (0.6) | 33 (1.8) | 50 (2.0) |
AE adverse event, DAPA dapagliflozin, eGFR estimated glomerular filtration rate, PBO placebo, SAE serious adverse event
aIncludes renal impairment, renal failure, GFR decrease, or blood creatinine or cystatin C increase
bIncludes hypotension, dehydration, or hypovolemia
cMajor = symptomatic episode requiring third-party assistance owing to severe impairment of consciousness or behavior, with plasma glucose <3 mmol/L and prompt recovery with glucose or glucagon administration. Minor = symptomatic or asymptomatic episode with plasma glucose <3.5 mmol/L. Other = suggestive episode reported but not meeting the criteria for major or minor episodes