Table 2.
EPS-related AE subgroups | MedDRA preferred terms |
---|---|
Tremor | Tremor, essential tremor, intention tremor |
Dystonia | Oculogyration, oculogyric crisis, trismus, tongue spasm, tongue paralysis, cervical spasm, emprosthotonus, myotonia, pleurothotonus, risus sardonicus, muscle spasms, blepharospasm, dystonia, opisthotonus, torticollis, facial spasm, muscle contracture |
Hyperkinesia | Akathisia, hyperkinesia, periodic limb movement disorder, restless legs syndrome, restlessness |
Parkinsonism | Hypertonia, bradykinesia, cogwheel rigidity, drooling, musculoskeletal stiffness, akinesia, hypokinesia, nuchal rigidity, Parkinsonian gait, Parkinsonian rest tremor, parkinsonism, muscle rigidity, muscle tightness, glabellar reflex abnormal, on and off phenomenon, Parkinson’s disease, Parkinsonian crisis, extrapyramidal disorder, masked facies |
Dyskinesia | Dyskinesia, muscle contractions involuntary, movement disorder, muscle twitching, athetosis, chorea, choreoathetosis, tardive dyskinesia, myoclonus |
Abbreviations: AE, adverse event; EPS, extrapyramidal symptoms; MedDRA, Medical Dictionary for Regulatory Activities.