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Table 4 Extrapyramidal Symptoms (Safety Population)

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

  Cariprazine 1.5–3 mg/d n = 170 Cariprazine 4.5–6 mg/d n = 361 Cariprazine 9 mg/d n = 148 Cariprazine Overall N = 679
Discontinuation due to EPS-related TEAEs, n (%)
 Any EPS including akathisia and restlessness 7 (4.1) 4 (1.1) 1 (0.7) 12 (1.8)
 Any EPS excluding akathisia and restlessness 3 (1.8) 3 (0.8) 1 (0.7) 7 (1.0)
Incidence of common EPS-related TEAEs (≥5 of patients in any group), n (%)a
 Akathisia 40 (23.5) 45 (12.5) 20 (13.5) 105 (15.5)
 Tremor 17 (10.0) 19 (5.3) 11 (7.4) 47 (6.9)
 Restlessness 13 (7.6) 17 (4.7) 8 (5.4) 38 (5.6)
 Extrapyramidal disorder 11 (6.5) 22 (6.1) 12 (8.1) 45 (6.6)
EPS rating scales, mean change (SD)b
 AIMS total score 0.1 (1.5) 0.0 (1.5) 0.1 (1.6) 0.0 (1.5)
 BARS total score 0.3 (1.7) −0.1 (0.9) 0.1 (1.1) 0.1 (1.2)
 SAS total score 0.4 (3.0) −0.3 (1.7) 0.1 (1.6) 0.0 (2.1)
Patients with treatment-emergent akathisia or parkinsonism, n/N1 (%)a,c
 Akathisia (BARS baseline ≤2 and postbaseline >2) 40/162 (24.7) 55/360 (15.3) 24/148 (16.2) 119/670 (17.8)
 Parkinsonism (SAS baseline ≤3 and postbaseline >3) 25/162 (15.4) 30/360 (8.3) 17/148 (11.5) 72/670 (10.7)
  1. The preferred terms for EPS-related AEs are akathisia, bradykinesia, cogwheel rigidity, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, musculoskeletal stiffness, oculogyric crisis, oromandibular dystonia, parkinsonism, restlessness, salivary hypersecretion, tardive dyskinesia, tongue spasm, tremor, trismus, and torticollis
  2. AIMS Abnormal Involuntary Movement Scale, BARS Barnes Akathisia Rating Scale, EPS Extrapyramidal symptoms, TEAE Treatment-emergent adverse event, SAS Simpson-Angus Scale
  3. aAny time during open-label treatment
  4. bMean change from baseline to end of open-label treatment
  5. cN1 is the subset of patients with nonmissing baseline and end-of-study values in the specific baseline category during open-label treatment; n is the number of patients who met the criteria during open-label treatment