Table 3.
Baseline demographics and clinical characteristics: pooled LAI studies versus pooled oral studies (safety analysis set)
| Paliperidone LAI (n = 1293) | Oral paliperidone (n = 963) | LAI-PBO (n = 510) | Oral-PBO (n = 355) | |
|---|---|---|---|---|
| Age (years), mean (SD) | 40 (10.7) | 38 (10.8) | 40 (11.1) | 39 (11.1) |
| Men, n (%) | 881 (68) | 591 (61) | 338 (66) | 235 (66) |
| Race, n (%) | ||||
| White | 737 (57) | 592 (61) | 284 (56) | 219 (62) |
| Black | 395 (31) | 207 (21) | 155 (30) | 80 (23) |
| Asian | 138 (11) | 88 (9) | 64 (13) | 29 (8) |
| Other | 23 (2) | 76 (8) | 7 (1) | 27 (8) |
| Baseline PANSS total score, mean (SD) | 89 (11.7) | 93 (11.8) | 90 (12.0) | 94 (11.7) |
| Weight (kg), mean (SD) | 80 (21.0) | 76 (19.8) | 80 (20.9) | 78 (20.0) |
| Schizophrenia type, n (%) | ||||
| Paranoid | 1133 (88) | 779 (81) | 439 (86) | 285 (80) |
| Disorganized | 25 (2) | 39 (4) | 12 (2) | 14 (4) |
| Catatonic | 3 (0.2) | 5 (1) | 4 (1) | 0 |
| Residual | 9 (1) | 20 (2) | 7 (1) | 7 (2) |
| Undifferentiated | 123 (10) | 120 (12) | 48 (9) | 49 (14) |
| Age at diagnosis (years), mean (SD) | 25 (8.4) | 26 (8.5) | 26 (8.7) | 26 (9.6) |
| Mean (SD) days of exposure | 45.4 (32.55) | 33.3 (13.47) | 35.3 (31.42) | 28.4 (13.66) |
| Previous hospitalizations, n (%) | ||||
| 0 | 75 (6) | 116 (12) | 41 (8) | 41 (12) |
| 1–3 | 676 (52) | 533 (55) | 252 (49) | 194 (54) |
| ≥4 | 542 (42) | 313 (33) | 217 (43) | 120 (34) |
Abbreviations: EPS, extrapyramidal symptoms; ER, extended-release; LAI, long-acting injectable; LAI-PBO, placebo group in LAI studies; Oral-PBO, placebo group in oral paliperidone studies; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.