Table 3. Summary of Treatment-Emergent Adverse Events (Safety Sample).
| Event | Placebo (n = 116), No. (%) | Brexpiprazole, No. (%) | ||
|---|---|---|---|---|
| 2 or 3 mg (n = 226) | 2-mg Subgroup (n = 73) | 3-mg Subgroup (n = 153) | ||
| At least 1 TEAE | 36 (31.0) | 92 (40.7) | 28 (38.4) | 64 (41.8) |
| At least 1 serious TEAE | 3 (2.6)a | 6 (2.7)b | 0 | 6 (3.9) |
| Discontinuation due to adverse event | 5 (4.3)c | 12 (5.3)d | 1 (1.4) | 11 (7.2) |
| Death | 0 | 1 (0.4)e | 0 | 1 (0.7) |
| TEAEs with an incidence ≥2% in the brexpiprazole, 2 or 3 mg, group and an incidence greater than placebo | ||||
| Somnolence | 1 (0.9) | 8 (3.5) | 3 (4.1) | 5 (3.3) |
| Nasopharyngitis | 2 (1.7) | 7 (3.1) | 3 (4.1) | 4 (2.6) |
| Dizziness | 2 (1.7) | 6 (2.7) | 1 (1.4) | 5 (3.3) |
| Asthenia | 0 | 5 (2.2) | 0 | 5 (3.3) |
| Diarrhea | 1 (0.9) | 5 (2.2) | 3 (4.1) | 2 (1.3) |
| Urinary tract infection | 1 (0.9) | 5 (2.2) | 0 | 5 (3.3) |
| Other TEAEs of interest | ||||
| Fall | 2 (1.7) | 4 (1.8) | 2 (2.7) | 2 (1.3) |
| Akathisia | 0 | 2 (0.9) | 0 | 2 (1.3) |
| Extrapyramidal disorder | 0 | 2 (0.9) | 1 (1.4) | 1 (0.7) |
| Hip fracture | 1 (0.9) | 1 (0.4) | 0 | 1 (0.7) |
| Sedation | 0 | 1 (0.4) | 0 | 1 (0.7) |
Abbreviation: TEAE, treatment-emergent adverse event.
Hip fracture, positive SARS-CoV-2 test result, and psychotic disorder.
Urinary tract infection (n = 2), cardiac failure, COVID-19, pneumonia, fall, hip fracture, cachexia, dehydration, metabolic acidosis, mental status changes, acute kidney injury, and hypertension (some patients reported >1).
Positive SARS-CoV-2 test result (n = 2), agitation, psychotic disorder, and hypertensive crisis.
Asthenia (n = 2), anemia, COVID-19, pneumonia, urinary tract infection, viral infection, fall, hip fracture, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood pressure increased, dehydration, metabolic acidosis, akathisia, dizziness, somnolence, hallucination, insomnia, mental status changes, acute kidney injury, and respiratory disorder (some patients reported >1).
Cardiac failure.