Skip to main content

Table 3 Summary risk difference comparison of adverse events

From: Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease

Safety Outcome Unadjusted Risk Difference Adjusted Risk Difference
DTB vs TBZ 95% CI p-value DTB vs TBZ 95% CI p-value
Any AE, % −20.7 −47.9, 6.4 0.135 −35.3 −72.4, 1.8 0.063
 Moderate to severe −39.6 −67.1, −12.2 0.005 −46.4 −79.4, −13.3 0.006
 Mild 18.9 −9.6, 47.4 0.194 11.1 −24.4, 46.6 0.540
At least one SAE, % −7.4 −16.7, 1.9 0.117 −8.2 −17.4, 1.0 0.080
Discontinuation for any reason, % −8.1 −20.6, 4.3 0.201 −10.1 −23.4, 3.2 0.136
Discontinuation due to AE, % −9.3 −19.1, 0.6 0.065 −10.4 −20.3, −0.4 0.041
Dose reduction due to AE −41.1 −59.1, −23.1 <0.001 −40.5 −62.0, −19.0 <0.001
Dose reduction/suspension due to AE −41.1 −60.0, −22.3 <0.001 −41.6 −63.9, −19.3 <0.001
Individual AEsa
 Agitation, % −12.6 −23.0, −2.2 0.018 −14.2 −24.6, −3.8 0.007
 Akathisia (PI), % −18.5 −30.5, −6.5 0.003 −18.9 −32.0, −5.8 0.005
 Anxiety, % −11.5 −24.4, 1.5 0.083 −12.0 −25.2, 1.2 0.074
 Coughing, % 2.6 −10.2, 15.4 0.692 2.6 −10.2, 15.4 0.692
 Depression, % −19.3 −32.0, −6.6 0.003 −20.8 −33.8, −7.8 0.002
 Depression/agitated depression, % −17.0 −30.4, −3.7 0.013 −20.2 −33.9, −6.5 0.004
 Diarrhea, % 11.5 −3.8, 26.8 0.141 9.7 −9.4, 28.7 0.320
 Drowsiness/somnolence, % −21.5 −39.2, −3.7 0.018 −22.9 −44.9, −0.8 0.042
 Fall, % −7.8 −26.5, 11.0 0.417 −10.6 −32.1, 10.9 0.336
 Fatigue, % −6.7 −25.6, 12.3 0.491 −8.3 −28.3, 11.7 0.416
 Insomnia, % −23.7 −38.7, −8.7 0.002 −24.3 −40.9, −7.6 0.004
 Nausea, % −8.5 −23.2, 6.1 0.255 −9.7 −24.7, 5.4 0.207
 Parkinsonism (PI), % −14.8 −24.3, −5.3 0.002 −14.8 −24.3, −5.3 0.002
 Vomiting, % −8.9 −20.4, 2.6 0.129 −8.7 −21.1, 3.8 0.173
  1. AE adverse event, CI confidence interval, DTB deutetrabenazine, SAE serious adverse event, TBZ tetrabenazine
  2. aThose safety outcomes sourced from the tetrabenazine FDA-approved prescribing information have been identified by “(PI)”. Bolded values indicate significant risk differences between deutetrabenazine and tetrabenazine (p < 0.05)