Table 2.

Summary of adverse events (AE)

	Empagliflozin 10 mg (n = 32) n (%)	Empagliflozin 25 mg (n = 33) n (%)
≥ 1 AE	19 (59.4)	22 (66.7)
≥ 1 Severe AE	1 (3.1)	0
≥ 1 Drug-related AE	3 (9.4)	7 (21.2)
Vulvovaginal candidiasis	0	2 (6.1)
Cystitis	1 (3.1)	0
Urinary tract infection	0	1 (3.0)
Hypoglycaemia	0	1 (3.0)
Loss of consciousness	1 (3.1)	0
Pollakiuria	1 (3.1)	1 (3.0)
Pruritis genital	0	1 (3.0)
Blood ketone body increased	1 (3.1)	1 (3.0)
≥1 AE leading to discontinuation	1 (3.1)	1 (3.0)
≥ 1 Serious AE	2 (6.3)	1 (3.0)
Death	0	0
AEs of special interest
Hypoglycaemia	0 (0.0)	1 (3.0)
Events consistent with urinary tract infection	1 (3.1)	2 (6.1)
Events consistent with genital infection	0	2 (6.1)
Bone fracture	1 (3.1)	0
Events consistent with volume depletion	0	0
Diabetic ketoacidosis	0	0
Decreased renal function	0	0
Lower limb amputation	0	0