Table 3.
Incidence of treatment-emergent tardive dyskinesia in paliperidone extended release and paliperidone palmitate studies
| Schizophrenia studies* | Paliperidone palmitate studies | Paliperidone ER studies | ||
|---|---|---|---|---|
| N = 1689 n (%) | Event/Patient years | N = 2054 n (%) | Event/Patient years | |
| Tardive dyskinesia (spontaneously reported adverse event) | 3 (0.18) | 3/1292.85 = 0.23% | 2 (0.10) | 2/1367.78 = 0.15% |
| Probable tardive dyskinesia (Schooler–Kane criteria) | 2 (0.12) | 2/1292.85 = 0.15% | 4 (0.19) | 4/1367.78 = 0.29% |
| Persistent tardive dyskinesia (Schooler–Kane criteria) | 2 (0.12) | 2/1292.85 = 0.15% | 1 (0.05) | 1/1367.78 = 0.07% |
*
There was no incidence of TD in the 1 bipolar study that met inclusion criteria and hence not represented in this table; The total patient years for PP studies were 1292.85; the total patient years for Pali ER studies were 1367.78.