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%)

Values are shown as absolute numbers (percentages) for patients with events.