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Table 2 Comparison of incidence of adverse events

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

Safety Outcome Before Matching After Matching
  First-HD TETRA-HD p-valuea Active p-valuea Placebo First-HD TETRA-HD p-valuea Active p-valuea Placebo
  DTB (n = 45) PBO (n = 45) TBZ (n = 54) PBO (n = 30)    DTB (n = 45) PBO (n = 45) TBZ (n = 54) PBO (n = 30)   
Any AE, % 60.0 60.0 90.7 70.0 <0.001 0.377 41.2 55.8 90.7 70.0 <0.001 0.253
 Moderate to severe 22.2 26.7 68.5 33.3 <0.001 0.534 15.7 26.9 68.5 33.3 <0.001 0.584
 Mild 37.8 33.3 22.2 36.7 0.090 0.766 25.5 28.8 22.2 36.7 0.759 0.503
At least one SAE, % 2.2 2.2 7.4 0.0 0.241 0.411 0.6 1.4 7.4 0.0 0.059 0.613
Discontinuation for any reason, % 2.2 4.4 9.3 3.3 0.144 0.810 0.6 4.8 9.3 3.3 0.030 0.760
Discontinuation due to AE, % 2.2 2.2 9.3 0.0 0.144 0.411 0.6 1.7 9.3 0.0 0.030 0.555
Dose reduction due to AE, % 6.7 6.7 44.4 3.3 <0.001 0.529 6.3 5.6 44.4 3.3 <0.001 0.624
Dose reduction/suspension due to AE, % 8.9 8.9 44.4 3.3 <0.001 0.345 6.8 7.3 44.4 3.3 <0.001 0.420
Individual AEsb
 Agitation, % 2.2 0.0 14.8 0.0 0.030 0.6 0.0 14.8 0.0 0.004
 Akathisia (PI), % 2.2 2.2 18.5 0.0 0.010 0.411 1.4 1.8 18.5 0.0 0.002 0.545
 Anxiety, % 2.2 2.2 14.8 3.3 0.030 0.770 0.8 1.4 14.8 3.3 0.004 0.577
 Coughing, % 0.0 0.0 7.4 10.0 0.062 0.030 0.0 0.0 7.4 10.0 0.040 0.071
 Depression, % 2.2 6.7 14.8 0.0 0.030 0.149 0.2 6.2 14.8 0.0 0.003 0.202
 Depression/agitated depression, % 4.4 6.7 14.8 0.0 0.088 0.149 0.8 6.2 14.8 0.0 0.004 0.202
 Diarrhea, % 8.9 0.0 7.4 10.0 0.788 0.030 7.1 0 7.4 10.0 0.951 0.071
 Drowsiness/somnolence, % 11.1 4.4 31.5 3.3 0.015 0.810 8.9 3.6 31.5 3.3 0.006 0.947
 Fall, % 4.4 8.9 16.7 13.3 0.054 0.541 3.3 10.5 16.7 13.3 0.021 0.748
 Fatigue, % 6.7 4.4 22.2 13.3 0.032 0.164 3.3 2.7 22.2 13.3 0.002 0.108
 Insomnia, % 6.7 4.4 25.9 0.0 0.011 0.242 3.9 2.2 25.9 0.0 <0.001 0.456
 Nausea, % 2.2 4.4 13.0 6.7 0.051 0.675 0.6 4.0 13.0 6.7 0.007 0.641
 Parkinsonism (PI), % 0.0 0.0 14.8 0.0 0.007 0.0 0.0 14.8 0.0 0.002
 Vomiting, % 0.0 6.7 5.6 3.3 0.108 0.529 0.0 6.4 5.6 3.3 0.080 0.548
  1. AE adverse event, DTB deutetrabenazine, PBO placebo, SAE serious adverse event, TBZ tetrabenazine
  2. a p-values are for the comparison between respective arms (i.e. active vs active and placebo vs placebo) for the First-HD and TETRA-HD trials. Bolded values indicate significant differences between the active arms (p < 0.05). bThose safety outcomes sourced from the tetrabenazine FDA-approved prescribing information have been identified by “(PI)”