Table 7:
Adverse Events for PGx Compared With TAU
| Author, Year | Measure | N PGx/N TAU | PGx | TAU | Summary Estimate (95% CI) | P Value |
|---|---|---|---|---|---|---|
| GeneSight | ||||||
| Greden et al, 201957 | Number of side effectsb Proportion of side effects |
560/607c | Mean 0.243 (SE 0.029) 15.6% |
Mean 0.237 (SE 0.028) 15.3% |
MD 0.01 (−;0.07 to 0.09)a RR 1.03 (0.78 to 1.34)a |
.855 .881 |
| Neuropharmagen | ||||||
| Han et al, 201860 | Change in FIBSER FIBSER frequency domain (≤ 2) FIBSER intensity domain (≤ 2) FIBSER burden domain(≤ 2) |
52/48 | Mean Δ –4.1 (SD 5.3) 96.2% 94.2% 92.3% |
Mean Δ –1.6 (SD 5.9) 83.3% 52.1% 50.0% |
NRd NRd NRd NRd |
.001 .035 < .001 < .001 |
| Perez et al, 201762 | FIBSER burden domain (≤ 2) for tolerability subpopulatione | 97/80 | 6 wk: 66.7% 12 wk: 68.5% |
6 wk: 50% 12 wk: 51.4% |
OR 2.0 (1.07 to 3.75) OR 2.06 (1.09 to 3.89) |
.029 .026 |
| Change in FIBSER frequency domain Change in FIBSER intensity domain Change in FIBSER burden domain |
143/143 | Mean Δ –0.68 (SD 2.35) Mean Δ –0.60 (SD 2.01) Mean Δ –0.57 (SD 2.00) |
Mean Δ –0.25 (SD 2.38) Mean Δ –0.09 (SD 1.92) Mean Δ –0.01 (SD 1.72) |
NRf NRf NRf |
.1280 .0303 .0125 |
|
| Genecept | ||||||
| Perlis et al, 202061 | Change in FIBSER frequency domaing Change in FIBSER intensity domaing Change in FIBSER burden domaing |
150/153 | Mean Δ –0.1 (SD 2.18) Mean Δ 0.0 (SD 1.86) Mean Δ –0.2 (SD 1.55) |
Mean Δ –0.2 (SD 2.18) Mean Δ 0.0 (SD 1.90) Mean Δ –0.2 (SD 1.59) |
MD 0.10 (−;0.39 to 0.59)a MD 0.00 (−;0.42 to 0.42)a MD 0.00 (−;0.35 to 0.35)a |
.69a 1.00a 1.00 a |
| CNSDose | ||||||
| Singh et al, 201564 | Intolerability rateh | 74/74 | 4% | 15% | RR 1.13 (1.01 to 1.25) | .027 |
| Unspecified Test | ||||||
| Shan et al, 201963 | Proportion of adverse reactionsi | 31/43j | 55.56% | 57.89% | NRe | NS |
Abbreviations: CI, confidence interval; FIBSER, Frequency, Intensity, and Burden of Side Effects Ratings; MD, mean difference; Mean Δ, mean change from baseline; NR, not reported; NS, not significant; OR, odds ratio, PGx, pharmacogenomic-guided treatment; PP, per protocol; RR, relative risk; SD, standard deviation, SE, standard error; TAU, treatment as usual.
Calculated using Review Manager on basis of data provided in article.
Measured at week 8. Defined as a probability of a causal link to the medication; side effects unrelated to medications not included.
Data provided only for per-protocol cohort and not overall cohort as with other outcomes.
Insufficient data provided to confirm denominator.
Calculated on basis of tolerability subpopulation (FIBSER > 0 at baseline).
Study data and P values assessed using ANOVA and therefore unadjusted values not calculated.
Based on symptoms over past week. Calculated as mean change from baseline to follow-up.
Patient needed to reduce dose or stop the antidepressant.
Assessed using Treatment Emergent Symptom Scale.
Number was included in full analysis protocol; however, unclear denominator was used for analyses.