Table 3.

Safety outcomes in the safety population

		Dapagliflozin (n=613)	Placebo (n=616)
Any serious adverse event, including death		65 (10·6%)	82 (13·3%)
Adverse event with the outcome of death		32 (5·2%)	48 (7·8%)
Discontinuation due to adverse event		44 (7·2%)	55 (8·9%)
Adverse events of interest
	Acute kidney injury	21 (3·4%)	34 (5·5%)
	Diabetic ketoacidosis	2 (0·3%)	0

Data are n (%). Data show the number and proportion of patients with the listed outcome with an onset date on or after the date of the first dose and up to and including 2 days after the last dose of the study medication.