3. Adverse events.
| Adverse event | Study | Brexpiprazole | Placebo | Odds ratio | 95% CI | ||
| Event | Total | Event | Total | ||||
| Abdominal pain | Thase 2015a | 1 | 188 | 0 | 191 | 2.04 | 0.12 to 6.27 |
| Agitation | Bauer 2019 | 3 | 444 | 0 | 441 | 6.00 | 0.36 to 9.97 |
| Alteration in taste | NCT03149991 | 4 | 25 | 2 | 26 | 2.29 | 0.38 to 4.08 |
| Asthenia | Hobart 2018a | 4 | 197 | 0 | 206 | 8.54 | 0.51 to 12.53 |
| Atrial fibrillation | Thase 2015a | 0 | 188 | 1 | 191 | 0.51 | 0.01 to 3.54 |
| Bilateral hand pain | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Blurred vision | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Circulatory collapse | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.12 to 6.19 |
| Comminuted fracture | Thase 2015a | 1 | 188 | 0 | 191 | 2.04 | 0.12 to 6.27 |
| Chronic obstructive pulmonary disease | NCT00797966 | 1 | 121 | 0 | 126 | 2.10 | 0.13 to 6.36 |
| Depression | NCT01052077 | 0 | 185 | 1 | 187 | 0.50 | 0.01 to 3.54 |
| Diplopia | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Dissociation/detachment | NCT03149991 | 2 | 25 | 3 | 26 | 0.67 | 0.10 to 2.55 |
| Dry mouth | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Dyspnoea | NCT01837797 | 1 | 9 | 0 | 6 | 1.50 | 0.08 to 5.62 |
| Elevated alanine transaminase | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Euphoria | NCT03149991 | 1 | 25 | 1 | 26 | 1.04 | 0.06 to 3.87 |
| False‐positive investigation result | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Family stress | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.12 to 6.19 |
| Forearm fracture | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Gait disturbance | NCT01837797 | 1 | 9 | 0 | 6 | 1.50 | 0.08 to 5.62 |
| Gastric distress | NCT03149991 | 2 | 25 | 0 | 26 | 4.52 | 0.26 to 8.74 |
| Hot flushes | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Hypotension | NCT01052077 | 0 | 185 | 1 | 187 | 0.50 | 0.01 to 3.54 |
| Increased salivation postdose | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Influenza | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Insomnia/sleep disturbance | NCT03149991 | 2 | 25 | 3 | 26 | 0.67 | 0.10 to 2.55 |
| Intentional overdose | Bauer 2019 | 0 | 444 | 2 | 441 | 0.25 | 0.01 to 3.24 |
| Irregular/early menses | NCT03149991 | 1 | 25 | 1 | 25 | 1.00 | 0.06 to 3.83 |
| Lethargy | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Light headedness | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Loss of consciousness | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.19 to 6.19 |
| Lower extremity oedema, bilateral | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Major depression | Bauer 2019 | 1 | 444 | 1 | 441 | 0.99 | 0.06 to 3.77 |
| Muscle aches | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Obesity | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.12 to 6.19 |
| Ovarian cyst | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Pancreatitis | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.12 to 6.19 |
| Panic episode | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Parkinson's disease | NCT01837797 | 1 | 9 | 0 | 6 | 1.50 | 0.08 to 5.62 |
| Pneumonia | Thase 2015a | 0 | 188 | 1 | 191 | 0.51 | 0.01 to 3.54 |
| Prolactin 3 above limit of normal: male | Thase 2015b | 1 | 456 | 1 | 221 | 0.48 | 0.03 to 3.26 |
| Prolactin 3 times above limit of normal: female | Thase 2015b | 2 | 456 | 0 | 221 | 2.43 | 0.12 to 5.47 |
| Renal mass | NCT00797966 | 0 | 121 | 1 | 126 | 0.52 | 0.01 to 3.55 |
| Restless legs | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Ruptured cerebral aneurism | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Sciatica | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Seizure | Bauer 2019 | 1 | 444 | 0 | 441 | 1.99 | 0.12 to 6.19 |
| Serious injurious behaviour | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Shakiness | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Sinus bradycardia | NCT01052077 | 0 | 185 | 3 | 187 | 0.17 | 0.01 to 3.11 |
| Suicide attempt | Bauer 2019 | 0 | 444 | 1 | 441 | 0.50 | 0.01 to 3.53 |
| Syncope | Thase 2015a | 1 | 188 | 0 | 191 | 2.04 | 0.12 to 6.27 |
| Tinnitus | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.58 |
| Twitching of left‐side lower lip | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Ulna fracture | NCT00797966 | 1 | 121 | 0 | 126 | 2.10 | 0.13 to 6.36 |
| Unsteadiness of gait | NCT03149991 | 1 | 25 | 0 | 26 | 2.17 | 0.13 to 6.50 |
| Urinary hesitancy | NCT03149991 | 1 | 25 | 1 | 26 | 1.04 | 0.06 to 3.87 |
| Vertigo | Hobart 2018b | 1 | 192 | 0 | 202 | 2.12 | 0.13 to 6.38 |
| Vivid dreams | NCT03149991 | 0 | 25 | 1 | 26 | 0.50 | 0.01 to 3.54 |
| Shift: serum glucose normal to high (< 100 mg/dL to ≥ 126 mg/dL) | Bauer 2019 | 9 | 444 | 2 | 441 | 4.54 | 0.98 to 6.08 |
| Shift: serum glucose impaired to high (≥ 100 mg/dL and < 126 mg/dL to ≥ 126 mg/dL) | Bauer 2019 | 15 | 444 | 7 | 441 | 2.17 | 0.88 to 3.07 |
| Shift: high‐density lipoprotein‐cholesterol normal to low (≥ 40 mg/dL to < 40 mg/dL) | Bauer 2019 | 27 | 444 | 21 | 441 | 1.29 | 0.72 to 1.88 |
| Shift: triglycerides normal to high (< 150 mg/dL to ≥ 200 mg/dL and < 500 mg/dL) | Bauer 2019 | 36 | 444 | 27 | 441 | 1.35 | 0.81 to 1.87 |
| Shift: triglycerides normal/borderline to high (< 200 mg/dL to ≥ 200 mg/dL and < 500 mg/dL) | Bauer 2019 | 70 | 444 | 46 | 441 | 1.61 | 1.08 to 2.01 |
| High‐density lipoprotein‐cholesterol normal to low (40 mg/dL to < 40 mg/dL) | Hobart 2018a | 11 | 197 | 5 | 206 | 2.38 | 0.81 to 3.45 |
| Triglycerides normal to high (< 150 mg/dL to 200 mg/dL and < 500 mg/dL) | Hobart 2018a | 11 | 197 | 8 | 206 | 1.46 | 0.58 to 2.40 |
| Triglycerides normal/borderline to high (< 200 mg/dL to 200 mg/dL and < 500 mg/dL) | Hobart 2018a | 24 | 197 | 13 | 206 | 2.06 | 1.02 to 2.77 |
| Prolactin > 2 times upper limit: female | Hobart 2018a | 1 | 197 | 0 | 206 | 3.15 | 0.13 to 6.36 |
| Prolactin > 2 times upper limit: male | Hobart 2018a | 4 | 197 | 3 | 206 | 1.40 | 0.31 to 2.91 |
| Prolactin > 3 times upper limit: female | Hobart 2018a | 2 | 197 | 2 | 206 | 1.05 | 0.15 to 3.02 |
| Prolactin > 3 times upper limit: male | Hobart 2018a | 1 | 197 | 0 | 206 | 3.15 | 0.13 to 6.36 |
CI: confidence interval.