Table 3 Summary of reported AEs from the pooled analysis
n (%) | BI 409306 10 mg QD (n = 77) | BI 409306 25 mg QD (n = 74) | BI 409306 50 mg QD (n = 76) | BI 409306 25 mg BID (n = 76) | Placebo (n = 149) |
|---|---|---|---|---|---|
Patients with any AE | 34 (44.2) | 30 (40.5) | 45 (59.2) | 37 (48.7) | 67 (45.0) |
Patients with severe AEs* | 2 (2.6) | 1 (1.4) | 1 (1.3) | 1 (1.3) | 1 (0.7) |
Patients with investigator-defined, drug-related AEs | 5 (6.5) | 5 (6.8) | 15 (19.7) | 8 (10.5) | 12 (8.1) |
Patients with AEs leading to discontinuation of trial drug | 1 (1.3) | 1 (1.4) | 2 (2.6) | 1 (1.3) | 5 (3.4) |
Patients with AEs of special interest | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Patients with SAEs | 1 (1.3) | 3 (4.1) | 1 (1.3) | 4 (5.3) | 9 (6.0) |
Resulted in death | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Was life-threatening | 0 (0) | 0 (0) | 1 (1.3) | 0 (0) | 0 (0) |
Persisted or caused significant disability/incapacity | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Required, or prolonged, hospitalisation | 1 (1.3) | 2 (2.7) | 0 (0) | 4 (5.3) | 7 (4.7) |
Congenital anomaly or birth defect | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Other medically important serious event | 0 (0) | 1 (1.4) | 0 (0) | 1 (1.3) | 2 (1.3) |
Patients with other significant AEs (according to ICH E3) | 0 (0) | 0 (0) | 1 (1.3) | 0 (0) | 4 (2.7) |