Table 2.
Exposure-adjusted incidence rates for AEs by study and cohort
| First-HD | Open-label extension | |||
|---|---|---|---|---|
| Deutetrabenazine (n = 45) | Placebo (n = 45) | Rollover cohort (n = 82) | Switch cohort (n = 37) | |
| AEs | EAIR (number of AEs/person-year) | |||
| Any AE | 4.32 (27/6.2) | 4.65 (27/5.8) | 2.57 (76/29.6) | 4.02 (35/8.7) |
| SAEs | 0.10 (1/10.4) | 0.10 (1/10.0) | 0.11 (17/158.6) | 0.14 (11/77.0) |
| Severe AEs | 0.19 (2/10.4) | 0.10 (1/10.1) | 0.10 (16/161.0) | 0.09 (7/79.9) |
| Treatment-related AEs | 2.54 (19/7.5) | 1.44 (12/8.4) | 0.69 (55/79.5) | 0.83 (26/31.2) |
| AEs leading to dose reduction | 0.30 (3/10.1) | 0.31 (3/9.8) | 0.13 (20/151.4) | 0.14 (10/72.4) |
| AEs leading to dose suspension | 0.10 (1/10.4) | 0.10 (1/10.1) | 0.05 (8/166.8) | 0.04 (3/83.3) |
| AEs leading to withdrawal | 0.10 (1/10.4) | 0.10 (1/10.1) | 0.06 (11/181.0) | 0.03 (3/87.3) |
| AEs of interest | ||||
| Fall | 0.20 (2/10.1) | 0.42 (4/9.6) | 0.24 (31/129.1) | 0.26 (16/60.6) |
| Somnolence | 0.53 (5/9.5) | 0.21 (2/9.7) | 0.11 (16/148.9) | 0.19 (11/59.0) |
| Depressiona | 0.19 (2/10.3) | 0.31 (3/9.8) | 0.19 (27/140.4) | 0.11 (8/74.8) |
| Anxiety | 0.10 (1/10.3) | 0.10 (1/9.9) | 0.14 (22/156.2) | 0.19 (13/68.5) |
| Insomnia | 0.30 (3/10.1) | 0.21 (2/9.7) | 0.13 (19/142.3) | 0.08 (6/78.9) |
| Akathisia and restlessness with agitationb | 0.19 (2/10.4) | 0.10 (1/10.1) | 0.05 (9/173.8) | 0.09 (7/80.8) |
| Suicidalityc | 0.10 (1/10.4) | 0 (0/10.1) | 0.04 (7/173.8) | 0.02 (2/84.6) |
| Dysphagiad | 0 (0/10.4) | 0.10 (1/9.9) | 0.03 (6/173.8) | 0.06 (5/78.6) |
| Parkinsonisme | 0 (0/10.4) | 0 (0/10.1) | 0.03 (5/173.7) | 0.05 (4/82.0) |
AE adverse event, EAIR exposure-adjusted incidence rate, PT preferred term, SAE serious adverse event
aAE of interest of depression included the following selected PTs: all PTs containing “depression”
bAE of interest of akathisia and restlessness with agitation included the following selected PTs: akathisia, hyperkinesia, psychomotor hyperactivity, restlessness, agitation
cAE of interest of suicidality included the following PTs: completed suicide, suicidal depression, intentional overdose, intentional self-injury, deliberate poisoning, self-injurious ideation, suicidal behavior, suicidal ideation, suicide attempt
dAE of interest of dysphagia included the following selected PTs: aphagia, dysphagia
eAE of interest of parkinsonism included the following selected PTs: akinesia, bradykinesia, cogwheel rigidity, freezing phenomenon, hypertonia, masked facies, muscle rigidity, on and off phenomenon, parkinsonian crisis, parkinsonian gait, parkinsonian rest tremor, parkinsonism, Parkinson’s disease, resting tremor