Phase I study in healthy male subjects: summary of adverse events (AEs)
SRD | MRD | |||||||
Placebo | BI 1015550 | Placebo | BI 1015550 | |||||
36 mg | 48 mg | Total | 6 mg twice daily | 12 mg twice daily | Total | |||
Number of subjects | 6 (100.0) | 6 (100.0) | 6 (100.0) | 12 (100.0) | 8 (100.0) | 8 (100.0) | 8 (100.0) | 16 (100.0) |
Subjects with any AE | 1 (16.7) | 4 (66.7) | 4 (66.7) | 8 (66.7) | 3 (37.5) | 2 (25.0) | 5 (62.5) | 7 (43.8) |
Subjects with investigator-defined drug-related AEs | 1 (16.7) | 2 (33.3) | 4 (66.7) | 6 (50.0) | 1 (12.5) | 2 (25.0) | 4 (50.0) | 6 (37.5) |
Data are presented as n (%). SRD: single rising dose; MRD: multiple rising dose.