Table 2 Safety data (safety analysis set)
Overall N = 283 | SGLT2i n = 148 | Non-SGLT2i n = 135 | |
|---|---|---|---|
Any TEAE | 102 (36.0) | 52 (35.1) | 50 (37.0) |
Serious TEAEs | 5 (1.8) | 2 (1.4) | 3 (2.2) |
Cellulitis | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Large intestine polyp | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Diabetes mellitus | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Atrial fibrillation | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Upper limb fracture | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Glaucoma surgery | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Cataract operation | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Any ADR | 31 (11.0) | 15 (10.1) | 16 (11.9) |
Hyperkalemia | 7 (2.5) | 3 (2.0) | 4 (3.0) |
Blood potassium increased | 6 (2.1) | 1 (0.7) | 5 (3.7) |
Dizziness | 5 (1.8) | 4 (2.7) | 1 (0.7) |
Dizziness postural | 2 (0.7) | 2 (1.4) | 0 (0.0) |
Headache | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Dermal cyst | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Rash | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Blood pressure decreased | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Glomerular filtration rate decreased | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Hepatic enzyme increased | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Salivary gland neoplasm | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Eyelid edema | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Tinnitus | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Palpitations | 1 (0.4) | 0 (0.0) | 1 (0.7) |
Liver disorder | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Feeling abnormal | 1 (0.4) | 1 (0.7) | 0 (0.0) |
Serious ADRs | 0 (0.0) | 0 (0.0) | 0 (0.0) |
