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