Table 2.
Demographics and baseline characteristics of patients identified with tardive dyskinesia-safety analysis set
| Treatment | Age (years) | Gender | BMI (kg/m2) | Age at diagnosis of schizophrenia (years) | Duration of paliperidone exposure (days) | Mean dose (SD) (mg/mg eq.) | Actual Day of AE Onset | Time to Probable TD | Time to Persistent TD | Actual day of disposition | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind | Open- label | ||||||||||
| TD as spontaneously reported adverse events | |||||||||||
| Pali ER | 29 | Woman | 36.0 | 24 | 402 | 11.2 (1.94) | 157 | – | – | 45 | 402 |
| Pali ER | 54 | Woman | 31.2 | 31 | 4 | 9.0 (0) | 4 | – | – | 5 | - |
| PP | 43 | Man | 32.6 | 26 | 197 | 150.0 (0) | 92 | – | – | – | 197 |
| PP | 60 | Man | 18.4 | 31 | 197 | 87.5 (23.15) | 64 | – | – | – | 197 |
| PP | 58 | Woman | 24.6 | 57 | 569 | 47.6 (7.52) | 652* | – | – | – | 652 |
| TD using Schooler–Kane criteria | |||||||||||
| Probable TD (Persistent TD marked with*) | |||||||||||
| Pali ER* | 53 | Woman | 34.5 | 46 | 417 | 9.2 (1.53) | – | 316 | 417 | 43 | 417 |
| PP* | 43 | Man | 17.9 | 28 | 621 | 50.0 (0) | – | 427 | 511 | – | 621 |
| PP* | 57 | Man | 32.5 | 26 | 372 | 51.8 (6.68) | – | 176 | 372 | 372 | – |
| Pali ER | 79 | Woman | 24.7 | NA | 211 | 6.7 (1.95) | – | 155 | – | 43 | 211 |
| Pali ER | 56 | Man | 21.6 | 54 | 200 | 9.0 (0) | – | 155 | – | 43 | 204 |
| Pali ER | 57 | Woman | 19.8 | 25 | 336 | 7.7 (1.49) | – | 309 | – | 41 | 378 |
TD, tardive dyskinesia; BMI, body mass index; Pali ER, paliperidone extended release; PP, paliperidone palmitate.
*
Persistent TD cases.