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Table 3 Treatment-Emergent Adverse Events During Open-Label Treatment (Safety Population)

From: The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis

Summary of Adverse Events Cariprazine 1.5–3 mg/d n = 170 n (%) Cariprazine 4.5–6 mg/d n = 361 n (%) Cariprazine 9 mg/d n = 148 n (%) Cariprazine Overall N = 679 n (%)
Patients with ≥1 TEAE 141 (82.9) 287 (79.5) 127 (85.8) 555 (81.7)
Patients with ≥1 SAE 17 (10.0) 37 (10.2) 28 (18.9) 82 (12.1)
Deaths 0 1 (0.3) 0 1 (0.1)
AEs leading to discontinuations 28 (16.5) 29 (8.0) 27 (18.2)a 84 (12.4)
AEs leading to study discontinuation in >2% in any group
 Akathisia 4 (2.4) 1 (0.3) 0 5 (0.7)
 Schizophrenia 5 (2.9) 7 (1.9) 9 (6.1) 21 (3.1)
 Psychotic disorder 2 (1.2) 3 (0.8) 8 (5.4) 13 (1.9)
Incidence of common TEAEs (≥5% in any group)
 Akathisia 40 (23.5) 45 (12.5) 20 (13.5) 105 (15.5)
 Insomnia 22 (12.9) 43 (11.9) 25 (16.9) 90 (13.3)
 Headache 25 (14.7) 47 (13.0) 15 (10.1) 87 (12.8)
 Weight increased 23 (13.5) 38 (10.5) 10 (6.8) 71 (10.5)
 Anxiety 10 (5.9) 36 (10.0) 12 (8.1) 58 (8.5)
 Tremor 17 (10.0) 19 (5.3) 11 (7.4) 47 (6.9)
 Extrapyramidal disorder 11 (6.5) 22 (6.1) 12 (8.1) 45 (6.6)
 Schizophrenia 11 (6.5) 12 (3.3) 16 (10.8) 39 (5.7)
 Nausea 12 (7.1) 20 (5.5) 6 (4.1) 38 (5.6)
 Restlessness 13 (7.6) 17 (4.7) 8 (5.4) 38 (5.6)
 Dyspepsia 9 (5.3) 18 (5.0) 10 (6.8) 37 (5.4)
 Nasopharyngitis 10 (5.9) 19 (5.3) 5 (3.4) 34 (5.0)
 Blood creatine phosphokinase increased 7 (4.1) 17 (4.7) 9 (6.1) 33 (4.9)
 Dizziness 8 (4.7) 18 (5.0) 7 (4.7) 33 (4.9)
 Psychotic disorder 4 (2.4) 13 (3.6) 13 (8.8) 30 (4.4)
 Constipation 8 (4.7) 18 (5.0) 2 (1.4) 28 (4.1)
 Somnolence 6 (3.5) 11 (3.0) 9 (6.1) 26 (3.8)
 Dry mouth 5 (2.9) 5 (1.4) 11 (7.4) 21 (3.1)
 Back pain 2 (1.2) 18 (5.0) 1 (0.7) 21 (3.1)
  1. aOne cariprazine 9 mg/d patient had an AE resulting in discontinuation that was previously categorized as withdrawal of consent