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 |