Table 3.
Absolute risk difference of adverse events for vortioxetine compared to placebo
| 1 mg | 2.5 mg | 5 mg | 10 mg | 15 mg | 20 mg | |
|---|---|---|---|---|---|---|
| Withdrawals due to adverse events | 0.7% (−2.4% to 3.8%) 1 trial | −0.6% (−4.3% to 3.1%); I 2 = 0% 2 trials | 0.1% (−1.5% to 1.6%); I 2 = 1.6% 6 trials | 1.9% (0.1% to 3.7%)*; I 2 = 0% 6 trials | 4.4% (1.4% to 7.4%)*; I 2 = 0% 3 trials | 3.6% (0.1% to 7.2%)*; I 2 = 58% 4 trials |
| Serious adverse events | −0.7% (−3.1% to 1.7%) 1 trial | −1.3% (−3% to 0.3%); I 2 = 0% 2 trials | 0% (−1% to 1%); I 2 = 0% 6 trials | 0% (−0.9% to 0.9%); I 2 = 0% 6 trials | 0.1% (−0.9% to 1.0%); I 2 = 2% 3 trials | 0.1% (−0.6% to 0.9%); I 2 = 0% 4 trials |
| Nausea | 3.6% (−2.0% to 9.2%) 1 trial | 6.8% (1.4% to 12.1%)*; I 2 = 0% 2 trials | 12.4% (8.9% to 15.9%)*; I 2 = 23% 6 trials | 16.6% (11.1% to 22.2%)*; I 2 = 68% 6 trials | 21.0% (15.9% to 26.1%)*; I 2 = 0% 3 trials | 20.3% (16.5% to 24.2%)*; I 2 = 0% 4 trials |
| Vomiting | not reported | 0.1% (−1.6% to 1.8%); I 2 = 0% 2 trials | 1.6% (0.1% to 3.1%)*; I 2 = 0% 4 trials | 3.3% (0.8% to 5.9%)*; I 2 = 20% 4 trials | 6.4% (0.7% to 12.1%)*; I 2 = 65% 2 trials | 5.5% (1.2% to 9.8%)*; I 2 = 49% 2 trials |
| Headache | −1.4% (−7.5% to 4.6%) 1 trial | −0.1% (−5.6% to 5.4%); I 2 = 0% 2 trials | −0.5% (−4.2% to 3.2%); I 2 = 30% 6 trials | −0.5% (−3.3% to 2.4%); I 2 = 0% 6 trials | 2.2% (−2.1% to 6.5%); I 2 = 0% 3 trials | 4.1% (−0.7% to 7.5%); I 2 = 0% 4 trials |
| Diarrhea | 0% (−2.8% to 2.8%) 1 trial | −3.0% (−6.8% to 0.8%); I 2 = 0% 2 trials | 0.3% (−2.5% to 3.1%); I 2 = 48% 6 trials | 1.1% (−1.1% to 3.3%); I 2 = 0% 5 trials | 3.7% (−1.5% to 8.8%); I 2 = 60% 3 trials | 1.4% (−1.8% to 4.7%); I 2 = 0% 3 trials |
| Dizziness | −1.4% (−4.2% to 1.3%) 1 trial | −0.1% (−4.3% to 4.1%); I 2 = 24% 2 trials | −0.1% (−2.1% to 1.8%); I 2 = 0% 6 trials | −0.3% (−4.0% to 3.4%); I 2 = 56% 5 trials | 1.3% (−4.4% to 7.0%); I 2 = 68% 3 trials | 2.9% (−3.6% to 9.4%); I 2 = 76% 3 trials |
| Dry mouth | −0.7% (−3.8% to 2.4%) 1 trial | −0.3% (−7.3% to 6.7%); I 2 = 65% 2 trials | 0.8% (−1.2% to 2.8%); I 2 = 0% 6 trials | −0.1% (−4.1% to 4.0%); I 2 = 64% 5 trials | −0.5% (−3.3% to 2.4%); I 2 = 0% 3 trials | 0.6% (−4.9% to 6.1%); I 2 = 63% 3 trials |
| Hyperhydrosis | −0.7% (−2.7% to 1.3%) 1 trial | −0.0% (−1.6% to 1.6%); I 2 = 0% 2 trials | 0.5% (−0.7% to 1.8%); I 2 = 0% 6 trials | 2.4% (−1.2% to 6.0%); I 2 = 71% 3 trials | −1.0% (−3.2% to 1.1%); I 2 = 0% 2 trials | −1.8% (−5.6% to 2.0%); I 2 = 66% 2 trials |
| Nasopharyngitis | −2.1% (−7.1% to 2.8%) 1 trial | 3.7% (−1.6% to 9.0%) 1 trial | 0.7% (−1.2% to 2.5%); I 2 = 0% 4 trials | −0.7% (−2.5% to 1.2%); I 2 = 15% 6 trials | −2.7% (−5.8% to 0.4%); I 2 = 0% 2 trials | 1.2% (−2.2% to 4.6%); I 2 = 48% 3 trials |
| Insomnia | not reported | 0.5% (−2.7% to 3.8%); I 2 = 0% 2 trials | −0.0% (−1.9% to 1.9%); I 2 = 0% 4 trials | −0.4% (−2.5% to 1.7%); I 2 = 0% 4 trials | 0.1% (−2.9% to 3.2%); I 2 = 5% 2 trials | 0.4% (−5.1% to 5.9%); I 2 = 64% 2 trials |
| Fatigue | 2.1% (−0.6% to 4.9%) 1 trial | −1.4% (−3.5% to 0.8%); I 2 = 0% 2 trials | 0.4% (−1.4% to 2.2%); I 2 = 34% 6 trials | 0.2% (−1.2% to 1.7%); I 2 = 0% 5 trials | 0.5% (−2.2% to 3.2%); I 2 = 24% 3 trials | −0.8% (−5.8% to 4.2%); I 2 = 79% 3 trials |
*P < 0.05.