|
Parameters
|
Tofogliflozin treatment group (n = 169)
|
Conventional treatment group (n = 171)
|
|---|
|
Any adverse events
|
76 (45.0)
|
92 (53.8)
|
|
Severe adverse events
|
26 (15.4)
|
31 (18.1)
|
|
Death
|
0 (0)
|
0 (0)
|
|
Worsening of glycemic control
|
7 (4.1)
|
17 (9.9)
|
|
Hypoglycemia
|
17 (10.1)
|
17 (9.9)
|
|
Myocardial infarction
|
1 (0.6)
|
0 (0)
|
|
Other coronary artery diseases
|
3 (1.8)
|
1 (0.6)
|
|
Stroke
|
0 (0)
|
3 (1.8)
|
|
Subarachnoid hemorrhage
|
0 (0)
|
1 (0.6)
|
|
Peripheral artery disease
|
1 (0.6)
|
0 (0)
|
|
Heart failure
|
0 (0)
|
1 (0.6)
|
|
Arrhythmia
|
3 (1.8)
|
0 (0)
|
|
Blood pressure reductions
|
2 (1.2)
|
1 (0.6)
|
|
Venous thrombosis
|
0 (0)
|
1 (0.6)
|
|
Volume depletion
|
1 (0.6)
|
0 (0)
|
|
Gastric cancer
|
1 (0.6)
|
0 (0)
|
|
Hepatic cancer
|
2 (1.2)
|
0 (0)
|
|
Prostate cancer
|
1 (0.6)
|
1 (0.6)
|
|
Brest cancer
|
1 (0.6)
|
2 (1.2)
|
|
Colon cancer
|
1(1)
|
0 (0)
|
|
Malignant lymphoma
|
1 (0.6)
|
1 (0.6)
|
|
Anemia
|
1 (0.6)
|
3 (1.8)
|
|
Sleep apnea syndrome
|
0 (0)
|
1 (0.6)
|
|
Vertigo
|
2 (1.2)
|
2 (1.2)
|
|
ophthalmic diseases
|
3 (1.8)
|
7 (4.1)
|
|
Otolaryngology disease
|
7 (4.1)
|
4 (2.3)
|
|
Dental diseases
|
4 (2.4)
|
0 (0)
|
|
Influenza, common cold
|
22 (13.0)
|
23 (13.5)
|
|
Pneumonia
|
0 (0)
|
2 (1.2)
|
|
Other respiratory disease
|
2 (1.2)
|
2 (1.2)
|
|
Epigastric discomfort
|
3 (1.8)
|
1 (0.6)
|
|
Digestive tract disease
|
18 (10.7)
|
14 (8.2)
|
|
Liver dysfunction
|
1 (0.6)
|
1 (0.6)
|
|
Renal dysfunction
|
0 (0)
|
3 (1.8)
|
|
Urinary lithiasis
|
1 (0.6)
|
1 (0.6)
|
|
Dyslipidemia
|
0 (0)
|
3 (1.8)
|
|
Thyroid disease
|
3 (1.8)
|
1 (0.6)
|
|
Urinary tract infection
|
3 (1.8)
|
7 (4.1)
|
|
Genital infection
|
2 (1.2)
|
0 (0)
|
|
Genital pruritus
|
2 (1.2)
|
0 (0)
|
|
Dermatitis
|
2 (1.2)
|
1 (0.6)
|
|
Eruption
|
5 (3.0)
|
4 (2.3)
|
|
Muscle spasm
|
2 (1.2)
|
1 (0.6)
|
|
Bone fracture
|
3 (1.8)
|
3 (1.8)
|
|
Other orthopedic disease
|
4 (2.4)
|
12 (7.0)
|
|
Edema
|
0 (0)
|
2 (1.2)
|
|
General fatigue
|
1 (0.6)
|
1 (0.6)
|
|
Traumatic injury
|
0 (0)
|
3 (1.8)
|
|
Others
|
16 (9.5)
|
22 (12.9)
|
- Data are presented as number (%) of patients
