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Table 5 Summary of treatment-emergent adverse events (AEs)

From: Effect of mirtazapine versus selective serotonin reuptake inhibitors on benzodiazepine use in patients with major depressive disorder: a pragmatic, multicenter, open-label, randomized, active-controlled, 24-week trial

 

Mirtazapine, n = 27

Sertraline, n = 32

Paroxetine, n = 18

n (%)

n (%)

n (%)

Total number of patients with AEs

16 (59.3)

7 (21.9)

12 (66.7)

Serious AEs (SAEs)

0 (0.0)

2 (6.3)

0 (0.0)

Brain hemorrhagea

0 (0.0)

1 (3.1)

0 (0.0)

Hospitalization due to depression deterioration

0 (0.0)

1 (3.1)

0 (0.0)

AEs leading to discontinuation except for SAEs

7 (25.9)

1 (3.1)

5 (27.8)

Sedation including somnolence

3 (11.1)

0 (0.0)

0 (0.0)

Insomnia

1 (3.7)

0 (0.0)

0 (0.0)

Abnormal liver function test

1 (3.7)

0 (0.0)

0 (0.0)

Eruption

1 (3.7)

0 (0.0)

0 (0.0)

Dysgeusia

1 (3.7)

0 (0.0)

0 (0.0)

Nausea

0 (0.0)

1 (3.1)

1 (5.6)

Sexual dysfunction (erection failure)

0 (0.0)

0 (0.0)

1 (5.6)

Mania

0 (0.0)

0 (0.0)

2 (11.1)

Panic attack

0 (0.0)

0 (0.0)

1 (5.6)

Specific symptoms of AEs except for SAEs

 Sedation including somnolence

9 (33.3)

0 (0.0)

3 (16.7)

 Insomnia

2 (3.7)

1 (3.1)

0 (0.0)

 Akathisia

1 (3.7)

0 (0.0)

2 (11.1)

 Irritability

1 (3.7)

1 (3.1)

1 (5.6)

 Mania

0 (0.0)

0 (0.0)

2 (11.1)

 Weight increased

3 (11.1)

0 (0.0)

0 (0.0)

 Increased appetite

1 (3.7)

0 (0.0)

0 (0.0)

 Headache

0 (0.0)

0 (0.0)

2 (11.1)

 Dizziness

0 (0.0)

0 (0.0)

1 (5.6)

 Nausea

1 (3.7)

5 (15.6)

4 (22.2)

 Fatigue

3 (11.1)

0 (0.0)

2 (11.1)

 Eruption

1 (3.7)

0 (0.0)

0 (0.0)

 Abnormal liver function test

1 (3.7)

0 (0.0)

0 (0.0)

 Dysgeusia

1 (3.7)

0 (0.0)

0 (0.0)

 Sexual dysfunction (erection failure)

0 (0.0)

0 (0.0)

1 (5.6)

 Hyperhidrosis

0 (0.0)

0 (0.0)

2 (11.1)

 Constipation

0 (0.0)

0 (0.0)

1 (5.6)

  1. AE adverse event, SAE serious adverse event
  2. aBrain hemorrhage was unrelated to sertraline administration according to the diagnosis by the neurosurgeon. All AEs were treatment emergent