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Table 6 Summary of serious adverse events and adverse events

From: Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study

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)
  1. Data are presented as number (%) of patients