Table 3. TEAEs Within the Depression and Suicide/Self-injury SMQs.
| Patients | No. (%) | ||
|---|---|---|---|
| Deutetrabenazine | Placebo (n = 51) | ||
| High-dose (n = 52) | Low-dose (n = 54) | ||
| Patients with ≥1 depressiona SMQ TEAE | 4 (8) | 1 (2) | 0 |
| Psychiatric disorders | 2 (4) | 1 (2) | 0 |
| Depression | 1 (2) | 0 | 0 |
| Mood swings | 1 (2) | 0 | 0 |
| Depressed mood | 0 | 1 (2) | 0 |
| Nervous system disorders | 2 (4) | 0 | 0 |
| Disturbance in attention | 1 (2) | 0 | 0 |
| Psychomotor hyperactivity | 1 (2) | 0 | 0 |
| Patients with ≥1 suicide or self-injury SMQ TEAE | 1 (2)b | 0 | 1 (2)c |
| Psychiatric disorders | 1 (2) | 0 | 1 (2) |
| Suicidal ideation | 1 (2) | 0 | 1 (2) |
| Intentional self-injury | 0 | 0 | 1 (2) |
Abbreviations: SMQ, standard MedDRA query; TEAE, treatment-emergent adverse event.
a
Excludes suicide and self-injury.
b
This participant experienced mild suicidal ideation lasting 1 day, considered unrelated to study drug.
c
This participant experienced moderate suicidal ideation, mild self-injury, and moderate behavior disorder. The self-injury and suicidal ideation were considered possibly related to study drug.