Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

Table 4 Summary of adverse events and adverse drug reactions (Safety population)

	Placebo	Tofogliflozin
		10 mg	20 mg	40 mg
n	56	58	58	58
Number of patients with AEs	25 (44.6%)	35 (60.3%)	31 (53.4%)	31 (53.4%)
Number of AEs	40	80	62	69
Number of patients with ADRs	4 (7.1%)	16 (27.6%)	15 (25.9%)	16 (27.6%)
Number of ADRs	6	24	26	24
Deaths	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Serious AEs	2 (3.6%)*	2 (3.4%)†	0 (0.0%)	3 (5.2%)‡
Serious ADRs	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.7%)§
AEs leading to discontinuation	1 (1.8%)	1 (1.7%)	0 (0.0%)	2 (3.4%)
ADRs leading to discontinuation	0 (0.0%)	1 (1.7%)	0 (0.0%)	1 (1.7%)
AEs occurring in more than ≥5% of patients in any treatment groups
Infections and infestations
Nasopharyngitis	12 (21.4%)	9 (15.5%)	6 (10.3%)	6 (10.3%)
Upper respiratory tract infection	1 (1.8%)	0 (0.0%)	3 (5.2%)	2 (3.4%)
Investigations
Hyperketonemia	1 (1.8%)	2 (3.4%)	7 (12.1%)	8 (13.8%)
Ketonuria	0 (0.0%)	1 (1.7%)	3 (5.2%)	0 (0.0%)
Increased urinary β-2 microglobulin	1 (1.8%)	3 (5.2%)	0 (0.0%)	0 (0.0%)
Renal and urinary disorders
Pollakiuria	1 (1.8%)	3 (5.2%)	4 (6.9%)	6 (10.3%)
Musculoskeletal and connective tissue disorders
Back pain	3 (5.4%)	3 (5.2%)	2 (3.4%)	1 (1.7%)
Nervous system disorders
Headache	0 (0.0%)	3 (5.2%)	0 (0.0%)	1 (1.7%)
Other events of special interest in <5% of patients
Genitourinary infections
Cystitis	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.7)
Vulvitis	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.7)
Hypoglycemia	0 (0.0%)	1 (1.7)	0 (0.0%)	1 (1.7)
Increased urine volume	0 (0.0%)	0 (0.0%)	1 (1.7)	1 (1.7)
Volume-related events
Orthostatic hypotension	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.7)
Dizziness	1 (1.8%)	2 (3.4%)	0 (0.0%)	0 (0.0%)
Postural dizziness	0 (0.0%)	1 (1.7)	1 (1.7)	0 (0.0%)

*Fibular fracture in one patient; colon and esophageal cancer in one patient.
^†Meniscus disorder in one patient; unconsciousness in one patient.
^‡Myocardial ischemia in one patient; gastrointestinal interstitial cancer in one patient; whiplash and contusion in one patient.
^§Myocardial ischemia in one patient.
Abbreviations: AE Adverse event, ADR Adverse drug reaction.

ISSN: 1475-2840