Table 5.

Incidence of treatment-emergent adverse events of special interest for ipragliflozin (50 mg) in the pooled comparative studies

N (%)	TEAE	Drug-related TEAE	TEAE leading to discontinuation	Drug-related TEAE leading to discontinuation	TEAE severitya
					Mild	Moderate	Severe
Urinary tract infection
Ipragliflozin	37 (3.1)	27 (2.2)	3 (0.2)	3 (0.2)	4 (0.3)	33 (2.7)	0
Placebo	27 (3.4)	15 (1.9)	0	0	24 (3.0)	3 (0.4)	0
Genital infection
Ipragliflozin	29 (2.4)	22 (1.8)	1 (0.1)	1 (0.1)	24 (2.0)	4 (0.3)	1 (0.1)
Placebo	5 (0.6)	3 (0.4)	1 (0.1)	1 (0.1)	5 (0.6)	0	0
Pollakiuria or polyuria
Ipragliflozin	72 (6.0)	65 (5.4)	1 (0.1)	1 (0.1)	70 (5.8)	2 (0.2)	0
Placebo	16 (2.0)	12 (1.5)	0	0	16 (2.0)	0	0
Volume depletion
Ipragliflozin	59 (4.9)	36 (3.0)	2 (0.2)	2 (0.2)	57 (4.7)	2 (0.2)	0
Placebo	14 (1.8)	5 (0.6)	1 (0.1)	0	12 (1.5)	2 (0.3)	0
Cardiovascular events
Ipragliflozin	1 (0.1)	0	1 (0.1)	0	0	1 (0.1)	0
Placebo	4 (0.5)	3 (0.4)	3 (0.4)	3 (0.4)	1 (0.1)	0	3 (0.4)
Fracture
Ipragliflozin	7 (0.6)	0	1 (0.1)	0	4 (0.3)	2 (0.2)	1 (0.1)
Placebo	5 (0.6)	0	0	0	2 (0.3)	3 (0.4)	0
Renal disorder
Ipragliflozin	11 (0.9)	3 (0.2)	1 (0.1)	0	9 (0.7)	1 (0.1)	1 (0.1)
Placebo	13 (1.6)	5 (0.6)	1 (0.1)	0	13 (1.6)	0	0
Malignant tumours
Ipragliflozin	3 (0.2)	0	2 (0.2)	0	2 (0.2)	1 (0.1)	0
Placebo	3 (0.4)	1 (0.1)	2 (0.3)	1 (0.1)	1 (0.1)	1 (0.1)	1 (0.1)
Skin and subcutaneous tissue disorders
Ipragliflozin	93 (7.7)	31 (2.6)	12 (1.0)	11 (0.9)	85 (7.0)	6 (0.5)	2 (0.2)
Placebo	35 (4.4)	7 (0.9)	1 (0.1)	0	33 (4.1)	2 (0.3)	0

For definitions for adverse events of special interest, see Supplementary Table S1

TEAE treatment-emergent adverse event

^aPatient counted once under maximum severity