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. 2023 Oct 24;47(2):zsad272. doi: 10.1093/sleep/zsad272

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.