Table 6 Summary of serious adverse events and adverse events
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) |