Table 3.
Adverse events by body mass index category and randomized treatment
| Adverse event | Under/normal‐ weight | Overweight | Obesity class I | Obesity class II/III | P‐value for interaction | ||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo | Dapagliflozin | Placebo | Dapagliflozin | Placebo | Dapagliflozin | Placebo | Dapagliflozin | ||
| No | 676 | 668 | 855 | 865 | 500 | 511 | 337 | 322 | |
| Discontinuation due to adverse event, n (%) | 36 (5.3) | 36 (5.4) | 33 (3.9) | 46 (5.3) | 25 (5.0) | 15 (2.9) | 22 (6.5) | 14 (4.3) | 0.09 |
| Volume depletion, n (%) | 53 (7.8) | 56 (8.4) | 53 (6.2) | 62 (7.2) | 40 (8.0) | 39 (7.6) | 16 (4.7) | 21 (6.5) | 0.80 |
| Renal adverse event, n (%) | 55 (8.1) | 36 (5.4) | 53 (6.2) | 56 (6.5) | 35 (7.0) | 32 (6.3) | 27 (8.0) | 29 (9.0) | 0.29 |
| Bone fracture, n (%) | 14 (2.1) | 19 (2.8) | 16 (1.9) | 18 (2.1) | 11 (2.2) | 5 (1.0) | 9 (2.7) | 7 (2.2) | 0.31 |
| Amputation, n (%) | 0 (0.0) | 0 (0.0) | 6 (0.7) | 4 (0.5) | 5 (1.0) | 5 (1.0) | 1 (0.3) | 4 (1.2) | 0.23 |
| Major hypoglycaemia, n (%) | 2 (0.3) | 1 (0.1) | 2 (0.2) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.6) | n/a |