Adverse event or safety variable | Y-75 (n= 36) | Placebo (n= 36) |
---|---|---|
Volunteer with at least one adverse event, n (%) | 9 (25.00) | 5 (13.89) |
Total number of adverse events | 14 | 5 |
Clinical adverse event leading to discontinuation of study drug | 0 | 0 |
Serious adverse event | 0 | 0 |
Probably drug-related adverse event | 0 | 1 |
Most common adverse events (with incidence >5% of volunteers), n (%) | ||
Gastrointestinal disease | 3 (8.33) | 2 (6.25) |
Infection | 3 (8.33) | 1 (2.78) |
Musculoskeletal and connective disease | 2 (6.25) | 1 (2.78) |