Table 4.
Adverse events of dapagliflozin compared with placebo according to atrial fibrillation (history or baseline electrocardiogram)
| Adverse event | No AF (n = 2829) | AF (n = 1907) | p‐value for interaction | ||
|---|---|---|---|---|---|
| Placebo (n = 1413) | Dapagliflozin (n = 1416) | Placebo (n = 955) | Dapagliflozin (n = 952) | ||
| Discontinuation of study drug for any reason | 144 (10.2) | 144 (10.2) | 114 (11.9) | 105 (11.0) | 0.65 |
| Discontinuation of study drug due to adverse event | 64 (4.5) | 60 (4.2) | 52 (5.4) | 51 (5.4) | 0.85 |
| Volume depletion | 83 (5.9) | 101 (7.1) | 79 (8.3) | 77 (8.1) | 0.31 |
| Renal adverse event | 100 (7.1) | 77 (5.4) | 70 (7.3) | 76 (8.0) | 0.11 |
| Fracture | 27 (1.9) | 26 (1.8) | 23 (2.4) | 23 (2.4) | 0.91 |
| Amputation | 6 (0.4) | 10 (0.7) | 6 (0.6) | 3 (0.3) | 0.17 |
| Major hypoglycaemia | 1 (0.1) | 2 (0.1) | 3 (0.3) | 2 (0.2) | 0.47 |
| Diabetic ketoacidosis | 0 (0.0) | 1 (0.1) | 0 (0.0) | 2 (0.2) | N/A |
Values are given as n (%). A total of eight randomized patients were excluded from the safety analysis, as these were performed in patients who had undergone randomization and received at least one dose of dapagliflozin or placebo.
AF, atrial fibrillation; N/A, not appropriate.