Table 4.

Summary of overall safety and selected adverse events (main study)^*

	Subjects, n (%)
	PBO (n = 192)	CANA 100 mg (n = 195)	CANA 300 mg (n = 197)
Any AE	101 (52.6)	119 (61.0)	118 (59.9)
AEs leading to discontinuation	2 (1.0)	6 (3.1)	4 (2.0)
AEs related to study drug†	18 (9.4)	34 (17.4)	50 (25.4)
Serious AEs	4 (2.1)	8 (4.1)	2 (1.0)
Deaths‡	1 (0.5)	1 (0.5)	0
Selected AEs
UTI	8 (4.2)	14 (7.2)	10 (5.1)
Genital mycotic infection
Male§¶	0	2 (2.5)	5 (5.6)
Female‖,**	4 (3.8)	10 (8.8)	8 (7.4)
Osmotic diuresis-related AEs
Pollakiuria††	1 (0.5)	5 (2.6)	6 (3.0)
Polyuria‡‡	0	0	6 (3.0)
Volume-related AEs
Postural dizziness	0	1 (0.5)	2 (1.0)
Orthostatic hypotension	0	0	2 (1.0)

AE, adverse event; CANA, canagliflozin; PBO, placebo; UTI, urinary tract infection.

^*All AEs are reported for regardless of rescue medication except for osmotic diuresis- and volume-related AEs, which are reported for prior to initiation of rescue therapy.

^†Possibly, probably or very likely related to study drug, as assessed by investigators.

^‡Death in the PBO group due to intracranial haemorrhage and brain hernia reported as serious AEs, and death in the CANA 100 mg group due to pneumonia, septic shock, acute renal failure and ischaemic hepatitis reported as serious AEs; neither death was considered by the reporting investigator to be drug-related.

^§PBO, n = 88; CANA 100 mg, n = 81; CANA 300 mg, n = 89.

^¶Including balanitis, balanitis candida, balanoposthitis and genital infection fungal.

^‖PBO, n = 104; CANA 100 mg, n = 114; CANA 300 mg, n = 108.

^**Including vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection and vulvovaginitis.

^††Increased urine frequency.

^‡‡Increased urine volume.