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Table 3 Absolute risk difference of adverse events for vortioxetine compared to placebo

From: The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis

 

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%); I2 = 0% 2 trials

0.1% (−1.5% to 1.6%); I2 = 1.6% 6 trials

1.9% (0.1% to 3.7%)*; I2 = 0% 6 trials

4.4% (1.4% to 7.4%)*; I2 = 0% 3 trials

3.6% (0.1% to 7.2%)*; I2 = 58% 4 trials

Serious adverse events

−0.7% (−3.1% to 1.7%) 1 trial

−1.3% (−3% to 0.3%); I2 = 0% 2 trials

0% (−1% to 1%); I2 = 0% 6 trials

0% (−0.9% to 0.9%); I2 = 0% 6 trials

0.1% (−0.9% to 1.0%); I2 = 2% 3 trials

0.1% (−0.6% to 0.9%); I2 = 0% 4 trials

Nausea

3.6% (−2.0% to 9.2%) 1 trial

6.8% (1.4% to 12.1%)*; I2 = 0% 2 trials

12.4% (8.9% to 15.9%)*; I2 = 23% 6 trials

16.6% (11.1% to 22.2%)*; I2 = 68% 6 trials

21.0% (15.9% to 26.1%)*; I2 = 0% 3 trials

20.3% (16.5% to 24.2%)*; I2 = 0% 4 trials

Vomiting

not reported

0.1% (−1.6% to 1.8%); I2 = 0% 2 trials

1.6% (0.1% to 3.1%)*; I2 = 0% 4 trials

3.3% (0.8% to 5.9%)*; I2 = 20% 4 trials

6.4% (0.7% to 12.1%)*; I2 = 65% 2 trials

5.5% (1.2% to 9.8%)*; I2 = 49% 2 trials

Headache

−1.4% (−7.5% to 4.6%) 1 trial

−0.1% (−5.6% to 5.4%); I2 = 0% 2 trials

−0.5% (−4.2% to 3.2%); I2 = 30% 6 trials

−0.5% (−3.3% to 2.4%); I2 = 0% 6 trials

2.2% (−2.1% to 6.5%); I2 = 0% 3 trials

4.1% (−0.7% to 7.5%); I2 = 0% 4 trials

Diarrhea

0% (−2.8% to 2.8%) 1 trial

−3.0% (−6.8% to 0.8%); I2 = 0% 2 trials

0.3% (−2.5% to 3.1%); I2 = 48% 6 trials

1.1% (−1.1% to 3.3%); I2 = 0% 5 trials

3.7% (−1.5% to 8.8%); I2 = 60% 3 trials

1.4% (−1.8% to 4.7%); I2 = 0% 3 trials

Dizziness

−1.4% (−4.2% to 1.3%) 1 trial

−0.1% (−4.3% to 4.1%); I2 = 24% 2 trials

−0.1% (−2.1% to 1.8%); I2 = 0% 6 trials

−0.3% (−4.0% to 3.4%); I2 = 56% 5 trials

1.3% (−4.4% to 7.0%); I2 = 68% 3 trials

2.9% (−3.6% to 9.4%); I2 = 76% 3 trials

Dry mouth

−0.7% (−3.8% to 2.4%) 1 trial

−0.3% (−7.3% to 6.7%); I2 = 65% 2 trials

0.8% (−1.2% to 2.8%); I2 = 0% 6 trials

−0.1% (−4.1% to 4.0%); I2 = 64% 5 trials

−0.5% (−3.3% to 2.4%); I2 = 0% 3 trials

0.6% (−4.9% to 6.1%); I2 = 63% 3 trials

Hyperhydrosis

−0.7% (−2.7% to 1.3%) 1 trial

−0.0% (−1.6% to 1.6%); I2 = 0% 2 trials

0.5% (−0.7% to 1.8%); I2 = 0% 6 trials

2.4% (−1.2% to 6.0%); I2 = 71% 3 trials

−1.0% (−3.2% to 1.1%); I2 = 0% 2 trials

−1.8% (−5.6% to 2.0%); I2 = 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%); I2 = 0% 4 trials

−0.7% (−2.5% to 1.2%); I2 = 15% 6 trials

−2.7% (−5.8% to 0.4%); I2 = 0% 2 trials

1.2% (−2.2% to 4.6%); I2 = 48% 3 trials

Insomnia

not reported

0.5% (−2.7% to 3.8%); I2 = 0% 2 trials

−0.0% (−1.9% to 1.9%); I2 = 0% 4 trials

−0.4% (−2.5% to 1.7%); I2 = 0% 4 trials

0.1% (−2.9% to 3.2%); I2 = 5% 2 trials

0.4% (−5.1% to 5.9%); I2 = 64% 2 trials

Fatigue

2.1% (−0.6% to 4.9%) 1 trial

−1.4% (−3.5% to 0.8%); I2 = 0% 2 trials

0.4% (−1.4% to 2.2%); I2 = 34% 6 trials

0.2% (−1.2% to 1.7%); I2 = 0% 5 trials

0.5% (−2.2% to 3.2%); I2 = 24% 3 trials

−0.8% (−5.8% to 4.2%); I2 = 79% 3 trials

  1. *P < 0.05.