Table 5.
Treatment-Emergent Adverse Events (Pooled Schizophrenia Safety Population)
| Placebo (N=683) n (%) | Cariprazinea | |||||
|---|---|---|---|---|---|---|
| 1.5 mg (N=180) n (%) | 3 mg (N=619) n (%) | 4.5 mg (N=549) n (%) | 6 mg (N=794) n (%) | Total 1.5–6 mg/d (N=2048) n (%) | ||
| Death | 0 | 0 | 0 | 1 (0.0) | 2 (0.0) | 0 |
| SAE | 21 (3.1) | 4 (2.2) | 10 (1.6) | 17 (3.1) | 24 (3.0) | 55 (2.7) |
| AE related to study drop out | 54 (7.9) | 18 (10.0) | 49 (7.9) | 42 (7.7) | 64 (8.1) | 173 (8.4) |
| TEAE | 431 (63.1) | 118 (65.6) | 445 (71.9) | 370 (67.4) | 632 (79.6) | 1520 (74.2) |
| TEAEs >10% in the Total Cariprazine Group | ||||||
| Akathisiab | 23 (3.4) | 14 (7.8) | 97 (15.7) | 50 (9.1) | 143 (18.0) | 299 (14.6) |
| Insomniab | 69 (10.1) | 19 (10.6) | 79 (12.8) | 68 (12.4) | 122 (15.4) | 287 (14.0) |
| Headache | 81 (11.9) | 20 (11.1) | 63 (10.2) | 47 (8.6) | 118 (14.9) | 247 (12.1) |
| Other AEs of Interest Associated with Antipsychotic Treatment | ||||||
| Extrapyramidal disorder | 22 (3.2) | 15 (8.3) | 41 (6.6) | 33 (6.0) | 56 (7.1) | 143 (7.0) |
| Sedation | 21 (3.1) | 7 (3.9) | 21 (3.4) | 26 (4.7) | 22 (2.8) | 75 (3.7) |
| Somnolence | 13 (1.9) | 3 (1.7) | 20 (3.2) | 18 (3.3) | 23 (2.9) | 63 (3.1) |
| Prolactin elevationc | 1 (0.1) | 0 | 0 | 0 | 0 | 0 |
| Cognition impairmentc | 2 (0.3) | 2 (1.1) | 1 (0.2) | 3 (0.5) | 5 (0.6) | 11 (0.5) |
| Sexual dysfunctionc | 2 (0.3) | 1 (0.6) | 3 (0.5) | 6 (1.1) | 10 (1.3) | 20 (1.0) |
| Suicidalityc | 1 (0.1) | 0 | 6 (1.0) | 3 (0.5) | 9 (1.1) | 18 (0.9) |
| QT prolongationc | 1 (0.1) | 1 (0.6) | 7 (1.1) | 1 (0.2) | 6 (0.8) | 15 (0.7) |
| Weight increased | 10 (1.5) | 6 (3.3) | 40 (6.5) | 9 (1.6) | 50 (6.3) | 104 (5.1) |
| Treatment-Emergent Metabolic AEs | ||||||
| Hyperlipidemia-relatedc | 5 (0.7) | 2 (1.1) | 13 (2.1) | 9 (1.6) | 19 (2.4) | 43 (2.1) |
| Hyperglycemia/diabetes mellitus-relatedc | 7 (1.0) | 1 (0.6) | 12 (1.9) | 4 (0.7) | 8 (1.0) | 25 (1.2) |
Notes: aFor the fixed-dose studies, patients were counted to the dose level that they were randomized to; for the flexible-dose studies, modal daily doses were considered, meaning patients were counted to the dose level that they took for most of the time; bDose-dependency observed; cIncludes grouped terms organized under broader AE (Supplemental Table 2).
Abbreviations: AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.