Table 2. Summary of TEAEs in Safety Group.
| TEAE | Patients, No. (%) | |
|---|---|---|
| Deutetrabenazine (n = 58) | Placebo (n = 59) | |
| Any TEAE | 38 (66) | 33 (56) |
| Treatment-related TEAE | 29 (50) | 12 (20) |
| Serious TEAE | 0 | 0 |
| Serious treatment-related TEAE | 0 | 0 |
| TEAE | ||
| Leading to death | 0 | 0 |
| Leading to study drug discontinuation | 1 (2) | 1 (2) |
| Leading to dose interruption | 4 (7) | 5 (8) |
| Leading to dose reduction | 7 (12) | 1 (2) |
| Most common (ie, >4%) TEAEs in either treatment group | ||
| Fatigue | 7 (12) | 3 (5) |
| Weight increase | 7 (12) | 1 (2) |
| Headache | 6 (10) | 6 (10) |
| Somnolence | 5 (9) | 1 (2) |
| Nausea | 4 (7) | 5 (8) |
| Diarrhea | 4 (7) | 1 (2) |
| Enuresis | 4 (7) | 0 |
| Vomiting | 3 (5) | 3 (5) |
| Pyrexia | 3 (5) | 2 (3) |
| Increased appetite | 3 (5) | 1 (2) |
| Anxiety | 2 (3) | 3 (5) |
| Depressed mood | 2 (3) | 3 (5) |
| Suicidal ideation | 1 (2) | 3 (5) |
| Abdominal pain | 1 (2) | 3 (5) |
| Upper respiratory tract infection | 0 | 7 (12) |
Abbreviation: TEAE, treatment-emergent adverse event.