Table 4.
TEAEs related to suicide over induction and optimization/maintenance phases (all enrolled analysis set)
| TEAEs related to suicide | Korea (n = 26) | Malaysia (n = 19) | Taiwan (n = 33) | Asian (n = 78) | Non-Asian (n = 724) | Total (n = 802) |
|---|---|---|---|---|---|---|
| TEAEs related to suicide | 2 (7.7) | 1 (5.3) | 5 (15.2) | 8 (10.3) | 34 (4.7) | 42 (5.2) |
| Suicidal ideation | 2 (7.7) | 1 (5.3) | 3 (9.1) | 6 (7.7) | 20 (2.8) | 26 (3.2) |
| Intentional self-injury | 0 | 0 | 2 (6.1) | 2 (2.6) | 5 (0.7) | 7 (0.9) |
| Suicide attempt | 1 (3.8) | 0 | 0 | 1 (1.3) | 6 (0.8) | 7 (0.9) |
| Suicidal behavior | 0 | 0 | 0 | 0 | 3 (0.4) | 3 (0.4) |
| Completed suicide | 0 | 0 | 0 | 0 | 1 (0.1) | 1 (0.1) |
| Depression suicidal | 0 | 0 | 0 | 0 | 1 (0.1) | 1 (0.1) |
Values are presented as number (%).
TEAE, treatment-emergent adverse event.