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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