Table 2. Summary of Treatment-Emergent Adverse Events (TEAEs).
Patients | No. (%) | ||
---|---|---|---|
Deutetrabenazine | Placebo (n = 51) | ||
High dose (n = 52) | Low dose (n = 54) | ||
Any TEAE | 34 (65) | 24 (44) | 25 (49) |
Treatment-related TEAE | 25 (48) | 14 (26) | 7 (14) |
Serious TEAE | 1 (2) | 0 | 0 |
Serious treatment-related TEAE | 0 | 0 | 0 |
TEAE leading to | |||
Death | 0 | 0 | 0 |
Study drug discontinuation | 3 (6) | 0 | 1 (2) |
Dose interruption | 2 (4) | 1 (2) | 1 (2) |
Dose reduction | 3 (6) | 0 | 0 |
Most common (>4%) TEAEs in any treatment group | |||
Somnolence | 8 (15) | 2 (4) | 1 (2) |
Headache | 6 (12) | 8 (15) | 4 (8) |
Nasopharyngitis | 6 (12) | 2 (4) | 3 (6) |
Fatigue | 5 (10) | 1 (2) | 0 |
Increased appetite | 4 (8) | 1 (2) | 0 |
Vomiting | 3 (6) | 1 (2) | 4 (8) |
Tic | 3 (6) | 0 | 1 (2) |
Nausea | 2 (4) | 3 (6) | 0 |
Pain in extremity | 2 (4) | 0 | 3 (6) |