Table 3 Safety analyses
Dapagliflozin (n = 162) | Placebo (n = 162) | |
|---|---|---|
All reported adverse events | 44 (27.2%) | 38 (23.5%) |
Serious adverse events | 31 (19.1%) | 22 (13.6%) |
Adverse events resulting in discontinuation of study medication | 18 (11.1%) | 15 (9.3%) |
Drug adverse events | 7 (4.3%) | 8 (4.9%) |
All-cause death | 1 (0.6%) | 2 (1.2%) |
Nonfatal MI | 0 (0%) | 1 (0.6%) |
Stroke | 0 (0%) | 1 (0.6%) |
Acute kidney injury | 5 (3.1%) | 5 (3.1%) |
DKA | 0 (0%) | 0 (0%) |
Volume depletion events | 11 (6.8%) | 7 (4.3%) |
Severe hypoglycemic events | 0 (0%) | 0 (0%) |
Lower limb amputations | 0 (0%) | 0 (0%) |
