Table 4.
Adverse Events by Treatment Group
| N (%) | Dimdazenil (n = 367) | Placebo (n = 178) | P-value |
|---|---|---|---|
| TEAE | 174 (47.41) | 71 (39.89) | 0.100 |
| Serious TEAE | 2 (0.54) | 2 (1.12) | 0.600 |
| Reduction of platelet count | 1 (0.27) | 0 (0.00) | |
| Rib fracture | 0 (0.00) | 1 (0.56) | |
| Diabetic foot | 1 (0.27) | 0 (0.00) | |
| Spontaneous abortion | 0 (0.00) | 1 (0.56) | |
| TEAE rate more than 2% in any group | |||
| Hyperuricemia | 3 (0.82) | 4 (2.25) | 0.472 |
| Vertigo | 11 (3.00) | 5 (2.81) | 1.000 |
| Headache | 16 (4.36) | 4 (2.25) | 0.331 |
| Dizzy | 46 (12.53) | 9 (5.06) | 0.006 |
| Ocular hypertension | 10 (2.72) | 7 (3.93) | 0.441 |
| TRAE | 110 (29.97) | 39 (21.91) | 0.052 |
| TRAE rate of more than 2% in any group | |||
| Vertigo | 10 (2.72) | 5 (2.81) | 1.000 |
| Dizzy | 36 (9.81) | 8 (4.49) | 0.043 |
| Ocular hypertension | 9 (2.45) | 7 (3.93) | 0.417 |
TEAE, treatment emerged adverse event; TRAE, treatment-related adverse event.