n (%) | BI 2 mg QD (n = 123) | BI 5 mg QD (n = 122) | BI 10 mg QD (n = 122) | BI 25 mg QD (n = 123) | Placebo QD (n = 120) | Total (n = 610) |
---|---|---|---|---|---|---|
Patients with any AE | 57 (46.3) | 64 (52.5) | 55 (45.1) | 62 (50.4) | 54 (45.0) | 292 (47.9) |
Patients with severe AEs | 3 (2.4) | 3 (2.5) | 3 (2.5) | 2 (1.6) | 4 (3.3) | 15 (2.5) |
Patients with investigator-defined drug-related AEs | 19 (15.4) | 20 (16.4) | 22 (18.0) | 24 (19.5) | 19 (15.8) | 104 (17.0) |
Patients with AEs leading to discontinuation of the trial drug | 5 (4.1) | 7 (5.7) | 4 (3.3) | 2 (1.6) | 2 (1.7) | 20 (3.3) |
Patients with AEs of special interest | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.8) | 1 (0.2) |
Patients with serious AEs | 5 (4.1) | 4 (3.3) | 4 (3.3) | 4 (3.3) | 5 (4.2) | 22 (3.6) |
Fatal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Immediately life-threatening | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.2) |
Disability/incapacity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Required or prolonged hospitalization | 5 (4.1) | 3 (2.5) | 3 (2.5) | 4 (3.3) | 1 (0.8) | 16 (2.6) |
Congenital anomaly or birth defect | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Other medically important serious events | 0 (0.0) | 1 (0.8) | 1 (0.8) | 0 (0.0) | 4 (3.3) | 6 (1.0) |
Patients with other significant AEs (according to ICH E3) | 3 (2.4) | 6 (4.9) | 3 (2.5) | 2 (1.6) | 1 (0.8) | 15 (2.5) |
Suicidal intent based on C-SSRS | n = 123a | n = 122a | n = 122a | n = 122a | n = 118a | n = 607a |
Suicidal ideation (1–3) | 3 (2.4) | 1 (0.8) | 2 (1.6) | 2 (1.6) | 3 (2.5) | 11 (1.8) |
Active suicidal ideation with intent (4–5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Suicidal behavior (6–10) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Self-injurious behavior without suicidal intent | 0 (0.0) | 1 (0.8) | 2 (1.6) | 0 (0.0) | 1 (0.8) | 4 (0.7) |
Eye disorders | 3 (2.4) | 0 (0.0) | 5 (4.1) | 4 (3.3) | 3 (2.5) | 15 (2.5) |
Hemoglobin decreased | 0 (0.0) | 1 (0.8) | 1 (0.8) | 6 (4.9) | 0 (0.0) | 8 (1.3) |