Table 4.
Occurrence of Prespecified Adverse Events in Patients Enrolled in Asia and Outside Asia
| Patients Enrolled in Asia (n = 1,092) |
Patients Not Enrolled in Asia (n = 3,644) |
Interaction P Value | |||
|---|---|---|---|---|---|
| Dapagliflozin (n = 540) | Placebo (n = 552) | Dapagliflozin (n = 1,828) | Placebo (n = 1,816) | ||
| Discontinuation of trial treatment for any reason | 52 (9.6) | 61 (11.1) | 197 (10.8) | 197 (10.8) | 0.52 |
| Discontinuation of trial treatment due to adverse event | 20 (3.7) | 26 (4.7) | 91 (5.0) | 90 (5.0) | 0.45 |
| Volume depletion | 37 (6.9) | 30 (5.4) | 141 (7.7) | 132 (7.3) | 0.52 |
| Renal adverse event | 24 (4.4) | 40 (7.2) | 129 (7.1) | 130 (7.2) | 0.09 |
| Fracture | 9 (1.7) | 12 (2.2) | 40 (2.2) | 38 (2.1) | 0.53 |
| Amputation | 0 (0.0) | 1 (0.2) | 13 (0.7) | 11 (0.6) | — |
| Major hypoglycemia | 0 (0.0) | 1 (0.2) | 4 (0.2) | 3 (0.2) | — |
| Diabetic ketoacidosis | 0 (0.0) | 0 (0.0) | 3 (0.2) | 0 (0.0) | — |
Values are n (%). The safety population included all the patients who had undergone randomization and received at least 1 dose of dapagliflozin or placebo (n = 2,368 in both treatment groups).