Table 3. Adverse Events of Dapagliflozin Compared With Placebo According to Sex.
| Adverse event | Women (n = 1107) | Men (n = 3629) | P value for interaction | ||
|---|---|---|---|---|---|
| Placebo (n = 545) | Dapagliflozin (n = 562) | Placebo (n = 1823) | Dapagliflozin (n = 1806) | ||
| Discontinuation of study drug for any reason | 69 (12.7) | 74 (13.2) | 189 (10.4) | 175 (9.7) | .57 |
| Discontinuation of study drug owing to adverse event | 28 (5.1) | 23 (4.1) | 88 (4.8) | 88 (4.9) | .45 |
| Discontinuation of study drug owing to genital infection | 0 | 1 (0.2) | 0 | 6 (0.3) | NA |
| Discontinuation of study drug owing to patient decision | 39 (7.2) | 44 (7.8) | 84 (4.6) | 71 (3.9) | .35 |
| Discontinuation of study drug owing to study-specific discontinuation criteriaa | 0 | 1 (0.2) | 0 | 1 (0.1) | NA |
| Discontinuation of study drug owing to severe noncompliance to protocol | 0 | 1 (0.2) | 3 (0.2) | 5 (0.3) | NA |
| Discontinuation of study drug for other reasons | 2 (0.4) | 6 (1.1) | 18 (1.0) | 11 (0.6) | .07 |
| Volume depletion | 32 (5.9) | 49 (8.7) | 130 (7.1) | 129 (7.1) | .11 |
| Renal adverse event | 37 (6.8) | 42 (7.5) | 133 (7.3) | 111 (6.1) | .29 |
| Fracture | 12 (2.2) | 19 (3.4) | 38 (2.1) | 30 (1.7) | .13 |
| Amputation | 4 (0.7) | 2 (0.4) | 8 (0.4) | 11 (0.6) | .28 |
| Major hypoglycemia | 3 (0.6) | 2 (0.4) | 1 (0.1) | 2 (0.1) | .46 |
| Diabetic ketoacidosis | 0 (0.0) | 2 (0.4) | 0 (0.0) | 1 (0.1) | NA |
| Fournier’s gangrene | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | NA |
Abbreviation: NA, not applicable.
a
A total of 8 randomized patients were excluded from the safety analysis because these were performed in patients who had undergone randomization and received at least 1 dose of dapagliflozin or placebo.