Table 8.
Summary of AEs
| 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) |
AE adverse event, C-SSRS Columbia-Suicide Severity Rating Scale, ICH International Conference on Harmonization, QD once daily
aNumber of patients with a post-baseline C-SSRS