Table 2 Safety data (safety analysis set)
Overall | With T2DM | Without T2DM | |
|---|---|---|---|
(N = 180) | (n = 127) | (n = 53) | |
Any TEAE | 52 (28.9) | 36 (28.4) | 16 (30.2) |
Serious TEAEs | 4 (2.2) | 3 (2.4) | 1 (1.9) |
Cellulitis | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Ileus | 1 (0.6) | 0 (0.0) | 1 (1.9) |
Upper limb fracture | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Glaucoma surgery | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Cataract operation | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Any ADR | 16 (8.9) | 9 (7.1) | 7 (13.2) |
Hyperkalemia | 5 (2.8) | 1 (0.8) | 4 (7.6) |
Dizziness | 2 (1.1) | 2 (1.6) | 0 (0.0) |
Dizziness postural | 1 (0.6) | 0 (0.0) | 1 (1.9) |
Feeling abnormal | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Blood potassium increased | 5 (2.8) | 3 (2.4) | 2 (3.8) |
Glomerular filtration rate decreased | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Liver function test increased | 1 (0.6) | 1 (0.8) | 0 (0.0) |
Serious ADRs | 0 (0.0) | 0 (0.0) | 0 (0.0) |
