Table 3.
Disposition and Reasons for Discontinuation
| Disposition Events | 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 (%) | Totalb 1.5–6 mg/d (N=2048) n (%) | ||
| Pooled Schizophrenia Studiesc | ||||||
| Completed study | 350 (51.2) | 97 (53.9) | 284 (45.9) | 367 (66.8) | 334 (42.1) | 1082 (52.8) |
| Prematurely discontinued | 333 (48.8) | 84 (46.7) | 351 (56.7) | 198 (36.1) | 520 (65.5) | 1153 (56.3) |
| Reason for Discontinuation | ||||||
| Did not meet inclusion/exclusion criteria | 2 (0.3) | 1 (0.6) | — | — | 1 (0.1) | 2 (0.1) |
| Relapse eventd | 47 (6.9) | — | 9 (1.5) | — | 26 (3.3) | 35 (1.7) |
| Adverse event | 76 (11.1) | 28 (15.6) | 73 (11.8) | 53 (9.7) | 97 (12.2) | 251 (12.3) |
| Insufficient therapeutic response | 100 (14.6) | 18 (10.0) | 47 (7.6) | 45 (8.2) | 52 (6.5) | 162 (7.9) |
| Protocol violation | 9 (1.3) | 3 (1.7) | 24 (3.9) | 16 (2.9) | 36 (4.5) | 79 (3.9) |
| Withdrawal of consent | 74 (10.8) | 30 (16.7) | 148 (23.9) | 62 (11.3) | 193 (24.3) | 433 (21.1) |
| Lost to follow-up | 12 (1.8) | 1 (0.6) | 20 (3.2) | 13 (2.4) | 39 (4.9) | 73 (3.6) |
| Other reasons | 13 (1.9) | 3 (1.7) | 30 (4.8) | 9 (1.6) | 76 (9.6) | 118 (5.8) |
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; bTotal=the number of patients from the short-term studies (n=1114) plus the overall number of patients from the long-term studies (n=1122) minus the number of patients continuing from a lead-in study to an open-label extension (n=188); cCompletion and discontinuation values may not sum to 100% because patients who completed a lead-in study and discontinued in an extension study were counted twice (once for completed and once for discontinuation); dRestricted to relapse prevention study only.