Table 4 Extrapyramidal Symptoms (Safety Population)
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) |