Table 3. . Summary of selected safety outcomes from the CANVAS Program Analysis comprising of CANVAS and CANVAS-R trials.

Outcome	Events per 1000 patient-years		p-value
	Canagliflozin	Placebo
All serious adverse events	104.3	120.0	0.04
Diabetic ketoacidosis	0.6	0.3	0.14
Amputation	6.3	3.4	<0.001
All fractures	15.4	11.9	0.02
Low-trauma fractures	11.6	9.2	0.06
Male genital infections	34.9	10.8	<0.001
Osmotic diuresis (CANVAS only)	34.5	13.3	<0.001
Volume depletion (CANVAS only)	26	18.5	0.009
Acute kidney injury (CANVAS only)	3.0	4.1	0.33
Urinary tract infection (CANVAS only)	40.0	37.0	0.38
Female mycotic genital infection (CANVAS only)	68.8	17.5	<0.001