Table 8.

Summary of overall safety and selected AEs during the 26-week double-blind extension period (weeks 26–52)^*

Patients,n(%)	PBO (n = 156)	CANA 100 mg (n = 157)	CANA 300 mg (n = 156)
Any AE	53 (44.5)	64 (50.4)	72 (56.3)
AEs leading to discontinuation	2 (1.7)	2 (1.6)	3 (2.3)
AEs related to study drug†	4 (3.4)	11 (8.7)	21 (16.4)
Serious AEs	6 (5.0)	3 (2.4)	2 (1.6)
Deaths	0	0	0
Selected AEs
UTI	4 (3.4)	4 (3.1)	5 (3.9)
Genital mycotic infection
Men‡§	0	1 (1.6)	3 (4.2)
Women¶, **	0	4 (6.2)	2 (3.5)
Osmotic diuresis-related AEs††	0	1 (0.8)	1 (0.8)
Volume-related AEs‡‡	1 (0.8)	1 (0.8)	3 (2.3)
Documented hypoglycaemia episodes§§	10 (9.7)	28 (22.4)	34 (27.2)
Severe episodes	0	0	1 (0.8)

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

^*All AEs are reported for regardless of rescue medication; hypoglycaemia episodes are reported for prior to rescue medication.

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

^‡PBO, n = 61; CANA 100 mg, n = 62; CANA 300 mg, n = 71.

^§Including balanitis.

^¶PBO, n = 58; CANA 100 mg, n = 65; CANA 300 mg, n = 57.

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

^††Including dry mouth and urine output increased.

^‡‡Including dizziness postural, hypotension, and syncope.

^§§Including biochemically documented episodes (≤ 3.9 mmol/l) with or without symptoms and severe episodes (i.e. requiring the assistance of another individual or resulting in seizure or loss of consciousness).