FOR US HEALTHCARE PROFESSIONALS ONLY
EPS-related reactions by MeDRA-preferred term1
| Open-Label Phase (relative to open-label baseline) | Double-Blind Phase (relative to double-blind baseline) | ||
|---|---|---|---|
| Paliperidone Palmitate1* (n=506) | Placebo (n=145) | INVEGA TRINZA® (n=160) | |
| Overall percentage of subjects with EPS-related adverse reactions | 10% | 3% | 8% |
| Parkinsonism† | 4% | 0% | 4% |
| Hyperkinesia‡ | 5% | 2% | 5% |
| Tremor | 2% | 0% | 1% |
| Dyskinesia | <1% | 1% | 1% |
| Dystonia§ | 1% | 0% | 1% |
MedDRA=Medical Dictionary for Regulatory Activities.
*During the open-label phase, patients received several doses of INVEGA SUSTENNA® (paliperidone palmitate) followed by a single dose of INVEGA TRINZA®.
†Parkinsonism group included: cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, musculoskeletal stiffness, parkinsonism.
‡Hyperkinesia group included: akathisia, restlessness.
§Dystonia group included: blepharospasm, dystonia, muscle spasms.
Reference: 1. INVEGA TRINZA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.
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