Table 4.
Absolute risk difference of adverse events for vortioxetine compared to a serotonin norepinephrine reuptake inhibitor
| 1 mg | 2.5 mg | 5 mg | 10 mg | 15 mg | 20 mg | |
|---|---|---|---|---|---|---|
| Withdrawals due to adverse events | No trials | −6.2% (95% CI −10.7 to −1.8%)*; I 2 = 0% 2 trials | −4.7% (95% CI −9.0 to −0.4%)*; I 2 = 38% 4 trials | −4.4% (95% CI −9.7 to 0.9%); I 2 = 0% 2 trials | 2.3% (95% CI −1.7 to 6.3%); I 2 = 0% 2 trials | 4.4% (95% CI 0.1 to 8.7%)*; I 2 = 0% 2 trials |
| Serious adverse events | −1.0% (95% CI −2.5 to 0.6%); I 2 = 0% 2 trials | 0.1%(95% CI −1.1 to 1.3%); I 2 = 0% 4 trials | 0.4% (95% CI −1.6 to 2.4%); I 2 = 0% 2 trials | −0.3% (95% CI −3.6 to 3.1%); I 2 = 74% 2 trials | −0.1% (95% CI −1.3 to 1.1%); I 2 = 0% 2 trials | |
| Nausea | −21.2% (95% CI −30.2 to −12.3%); I 2 = 42% 2 trials | −12.2% (95% CI −17.4 to −7.0%); I 2 = 0% 4 trials | −4.2% (95% CI −20.0 to 11.5%); I 2 = 73% 2 trials | −2.8% (95% CI −10.3 to 4.7%); I 2 = 73% 2 trials | −1.1% (95% CI −8.6 to 6.4%); I 2 = 0% 2 trials | |
| Vomiting | −2.8% (95% CI −5.5 to −0.1%)*; I 2 = 0% 2 trials | −1.1% (95% CI −3.7 to 1.5%); I 2 = 0% 3 trials | 1.2% (95% CI −6.5 to 9.0%); I 2 = 71% 2 trials | −3.2% (95% CI −8.8 to 2.3%) 1 trial | 0.4% (95% CI −5.7 to 6.6%) 1 trials | |
| Headache | −0.3% (95% CI −5.8 to 5.2%); I 2 = 0% 2 trials | −1.8% (95% CI −5.8 to 2.2%); I 2 = 0% 4 trials | −2.1% (95% CI −8.5 to 4.3%); I 2 = 0% 2 trials | −0.6% (95% CI −6.0 to 4.9%); I 2 = 0% 2 trials | −1.8% (95% CI −9.0 to 5.5%); I 2 = 43% 2 trials | |
| Diarrhea | −3.7% (95% CI −11.8 to 4.4%); I 2 = 77% 2 trials | −1.8% (95% CI −5.0 to 1.4%); I 2 = 26% 4 trials | 1.5% (95% CI −2.4 to 5.3%); I 2 = 0% 2 trials | −0.8% (95% CI −5.2 to 3.6%); I 2 = 7% 2 trials | −1.6% (95% CI −7.6 to 4.4%); I 2 = 46% 2 trials | |
| Dizziness | −9.9% (95% CI −14.7 to −5.1%)*; I 2 = 0% 2 trials | −7.0% (95% CI −12.5 to −1.5%)*; I 2 = 62% 4 trials | −9.1% (95% CI −15.7 to −2.5%)*; I 2 = 40% 2 trials | −5.7% (95% CI −10.3 to −1.0)*; I 2 = 0% 2 trials | −4.2% (95% CI −9.0 to 0.6%); I 2 = 0% 2 trials | |
| Dry mouth | −9.5% (95% CI −22.7 to 3.8%); I 2 = 86% 2 trials | −10.4% (95% CI −18.1 to 2.8%)*; I 2 = 77% 4 trials | −5.2% (95% CI −9.8 to −0.5%)*; I 2 = 5% 2 trials | −6.8% (95% CI −11.3 to −2.3%)*; I 2 = 0% 2 trials | −3.4% (95% CI −8.3 to 1.5%); I 2 = 0% 2 trials | |
| Hyperhydrosis | −5.3% (95% CI −8.5 to −2.2%)*; I 2 = 0% 2 trials | −6.0% (95% CI −9.5 to −2.6%)*; I 2 = 35% 4 trials | −4.6% (95% CI −8.6 to −0.6%)*; I 2 = 0% 2 trials | −4.5% (95% CI −7.5 to −1.4%)*; I 2 = 0% 2 trials | −5.4% (95% CI −9.4 to −1.4%)*; I 2 = 43% 2 trials | |
| Nasopharyngitis | 5.8% (95% CI 1.1 to 10.5%)* 1 trial | 4.6% (95% CI 1.0 to 8.3%)*; I 2 = 0% 2 trials | 1.4% (95% CI −1.6 to 4.3%); I 2 = 0% 2 trials | 0.7% (95% CI −3.6 to 5.0%) 1 trial | 2.5% (95% CI −2.2 to 7.2%) 1 trial | |
| Insomnia | −3.3% (95% CI −7.1 to 0.5%); I 2 = 0% 2 trials | −3.2% (95% CI −6.7 to 0.2%); I 2 = 0% 3 trials | −6.4% (95% CI −10.5 to −2.3%)*; I 2 = 0% 2 trials | −5.9% (95% CI −11.4 to −0.4%)* 1 trial | −0.9% (95% CI −7.3 to 5.5%) 1 trial | |
| Fatigue | −5.3% (95% CI −8.3 to −2.3%)*; I 2 = 0% 2 trials | −4.7% (95% CI −7.3 to −2.1%)*; I 2 = 0% 4 trials | −3.3% (95% CI −6.9 to 0.3%); I 2 = 0% 2 trials | −3.7% (95% CI −8.8 to 1.4%); I 2 = 43% 2 trials | −3.6% (95% CI −7.6 to 0.3%); I 2 = 11% 2 trials |
*P < 0.05.