Event | TSC (N = 750) | Placebo (N = 250) | P values |
---|---|---|---|
Adverse events, number of patients with event, no. (%) | 24 (3.20%) | 8 (3.20%) | 1.0000 |
Possibly drug-related adverse events, no. (%) | 9 (1.20%) | 2 (0.80%) | 0.7404 |
gastrectasia | 1 (0.13%) | 0 | |
stomach ache | 1 (0.13%) | 0 | |
abdominal tympany | 2 (0.27%) | 1 (0.40%) | |
dizziness | 2 (0.27%) | 0 | |
conjunctival congestion | 1 (0.13%) | 0 | |
epistaxis | 1 (0.13%) | 1 (0.40%) | |
menometrorrhagia | 1 (0.13%) | 0 | |
Adverse events resulting in experiment discontinuation, no. (%) | 1 (0.10%) | 1 (0.40%) | 0.4377 |
epigastric pain | 1 (0.10%) | 0 | |
allergy with stomach ache | 0 | 1 (0.40%) | |
Serious adverse events, no. (%) | 0 | 0 | −/− |