Table 2 Reported AEs in haloperidol studies
Study* | Described safety outcomes in the manuscript | Definitions | Events per total patients analyzed | Events per total patients analyzed in intervention arm |
|---|---|---|---|---|
1 | Extrapyramidal symptoms | According to the modified Simpson Angus Scale | 0.01 | 0.01 |
Akathisia | According to 10 cm visual analog scale | Not reported | Not reported | |
QTc prolongation | QTc > 500 ms on study day #1 & 2 ECGs or telemetry | 0. 15 | 0.16 | |
Agitated delirium and oversedation | According to the Richmond Agitation-Sedation Scale | 1.28 | 1.27 | |
Torsades de Pointes | None provided | 0 | 0 | |
Drug reaction with eosinophilia | None provided | 0 | 0 | |
23 | Extrapyramidal symptoms | Dystonia, tremor, myoclonus, tics, rigidity, akathisia | 0.04 | 0.05 |
QTc prolongation | QTc > 500 ms and 10% increase from baseline | 0.06 | 0.06 | |
Drowsiness | None provided | Not reported | Not reported | |
36 | Extrapyramidal symptoms | Signs of extrapyramidal symptoms measured twice daily | 0.02 | 0.03 |
QTc prolongation | QTc ≥ 500 ms or ≥ 60 ms above baseline | 0.07 | 0. 12 | |
Excessive sedation | As determined by the clinical team | 0.02 | 0.03 | |
Hypotension | Systolic blood pressure ≤ 90 mmHg) | 0.33 | 0.03 |