Table 3.
TEAEs and key safety data from 52-week brexpiprazole studies for the treatment of schizophrenia
| Relapse-prevention study8 | Safety study 110 | Safety study 29 | |||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Stabilization phase (n=464), n (%) | Maintenance phase
|
Total (n=1,031), n (%) | Total (n=281), n (%) | ||||
|
| |||||||
| At least one TEAE | 267 (57.5) | 42 (43.3) | 58 (55.8) | At least one TEAE | 623 (60.4) | At least one TEAE | 235 (83.6) |
| Serious TEAE | 34 (7.3) | 3 (3.1) | 11 (10.6) | Serious TEAE | 82 (8.0) | Serious TEAE | 37 (13.2) |
| TEAE leading to discontinuation | 41 (8.8) | 5 (5.2) | 12 (11.5) | TEAE leading to discontinuation | 151 (14.6) | TEAE leading to discontinuation | 43 (15.3) |
| Headache | 23 (5.0) | 6 (6.2) | 10 (9.6) | Worsening of schizophrenia | 120 (11.6) | Nasopharyngitis | 65 (23.1) |
| Insomnia | 56 (12.1) | 5 (5.2) | 8 (7.7) | Insomnia | 89 (8.6) | Worsening of schizophrenia | 63 (22.4) |
| Nasopharyngitis | 16 (4.3) | 3 (3.1) | 7 (6.7) | Weight gain | 80 (7.8) | Akathisia | 24 (8.5) |
| Worsening of schizophrenia | 28 (6.0) | 3 (3.1) | 7 (6.7) | Headache | 66 (6.4) | Headache | 22 (7.8) |
| Psychotic disorder | 5 (1.1) | 1 (1.0) | 6 (5.8) | Agitation | 56 (5.4) | Weight gain | 19 (6.8) |
| Agitation | 30 (6.5) | 1 (1.0) | 3 (2.9) | Akathisia | 49 (4.8) | Insomnia | 17 (6.0) |
| Akathisia | 42 (9.1) | 1 (1.0) | 1 (1.0) | Back pain | 17 (6.0) | ||
| Weight gain | 24 (5.2) | 1 (1.0) | 0 | Somnolence | 16 (5.7) | ||
|
| |||||||
| Additional key events (%) | |||||||
|
| |||||||
| Weight gain ≥7% | 11.3 | 5.2 | 1.0 | Weight gain ≥7% | 18.6 | Weight gain ≥7% | 24.2 |
| Suicidal ideation | NR | NR | NR | Suicidal ideation | 3.6 | Suicidal ideation | 7.8 |
| Suicidal behavior | 0.2 | NR | NR | Suicidal behavior | 0.2 | Suicidal behavior | 0.4 |
Notes: TEAEs occurring in ≥5% of participants in any group after the conversion phase for the three phase III brexpiprazole studies focusing on the efficacy or safety of brexpiprazole in the treatment of adults with schizophrenia were included in this table. Akathisia occurred at a rate <5% in safety study 1, but was included in this table because akathisia had occurred at rates of >5% in previous placebo-controlled brexpiprazole studies. Also included are safety data pertaining to weight gain ≥7% total body weight from enrollment to last observation and suicidal ideation/behavior.
Abbreviations: TEAEs, treatment-emergent adverse events; NR, not reported.