Table 1.
Patient demographic and baseline characteristics
| Characteristic | Asenapine (n = 244) | Olanzapine (n = 224) | All patients (N = 468) |
|---|---|---|---|
| Study A75010138 | |||
| Sex, male, n (%) | 176 (72.1) | 170 (75.9) | 346 (73.9) |
| Race, n (%) | |||
| White | 110 (45.1) | 95 (42.4) | 205 (43.8) |
| Black | 98 (40.2) | 95 (42.4) | 193 (41.2) |
| Asian | 5 (2) | 2 (0.9) | 7 (1.5) |
| Other | 31 (12.7) | 32 (14.3) | 63 (13.5) |
| Age (years) | |||
| 18–64, n (%) | 239 (98) | 217 (96.9) | 456 (97.4) |
| ≥65, n (%) | 5 (2) | 7 (3.1) | 12 (2.6) |
| Mean (SD) | 43.1 (11.43) | 42.8 (11.27) | 42.9 (11.34) |
| Median | 45 | 45 | 45 |
| Weight (kg) | |||
| Mean (SD) | 84 (19.01) | 85.7 (18.71) | 84.8 (18.86) |
| Median (min, max) | 82.1 (46, 188) | 83.9 (42, 150) | 82.5 (42, 188) |
| BMI kg/m2 | |||
| Mean, n (SD) | 28.3 (5.72) | 28.8 (5.81) | 28.5 (5.76) |
| Median (min, max) | 27 (18, 55) | 28.3 (17, 51) | 28 (17, 55) |
| Total PANSS score (LOCF) | |||
| n | 228 | 217 | |
| Mean (SD) | 75.9 (11.45) | 75.4 (11.94) | |
| Median (min, max) | 75.0 (48, 118) | 74.0 (51, 124) | |
| PANSS positive subscale score (LOCF) | |||
| n | 234 | 218 | |
| Mean (SD) | 18.2 (4.08) | 18.2 (4.21) | |
| Median (min, max) | 18.0 (9, 29) | 18.0 (9, 28) | |
| PANSS Marder negative score (LOCF) | |||
| n | 234 | 218 | |
| Mean (SD) | 26.9 (4.76) | 27.0 (4.50) | |
| Median (min, max) | 26.0 (9, 48) | 26.0 (20, 47) | |
| NSA total score (LOCF) | |||
| n | 234 | 218 | |
| Mean (SD) | 60.1 (10.17) | 61.1 (10.79) | |
| Median (min, max) | 60.0 (29, 88) | 62.0 (23, 87) | |
| Asenapine (n = 241) | Olanzapine (n = 240) | All patients (N = 481) | |
|
| |||
| Study P255439 | |||
| Sex, male n (%) | 164 (68.0) | 164 (68.3) | 328 (68.2) |
| Race, n (%) | |||
| White | 216 (89.6) | 214 (89.2) | 430 (89.4) |
| Black | 16 (6.6) | 17 (7.1) | 33 (6.9) |
| Asian | 9 (0.0) | 1 (0.4) | 1 (0.2) |
| Other | 9 (3.7) | 8 (3.3) | 17 (3.5) |
| Age (years) | |||
| 18–64, n (%) | 231 (95.9) | 235 (97.9) | 466 (96.9) |
| ≥65, n (%) | 10 (4.1) | 5 (2.1) | 15 (3.1) |
| Mean (SD) | 40.7 (12.73) | 40.3 (11.65) | 40.5 (12.19) |
| Median | 40 | 40 | 40 |
| Weight (kg) | |||
| Mean (SD) | 79.3 (15.89) | 80.3 (16.07) | 79.8 (15.97) |
| Median (min, max) | 79 (44.0, 122.2) | 79 (43.0, 140.0) | 79 (43.0, 140.0) |
| BMI kg/m2 | |||
| Mean, n (SD) | 26.6 (4.53) | 26.9 (4.83) | 26.7 (4.68) |
| Median (min, max) | 26 (16.4, 41.0) | 26 (17.5, 44.4) | 26 (16.4, 44.4) |
| Total PANSS score (LOCF) | |||
| n | 216 | 217 | |
| Mean (SD) | 74.6 (11.3) | 73.7 (12.0) | |
| Median (min, max) | 74.0 (51, 108) | 72.0 (48, 124) | |
| PANSS positive subscale score (LOCF) | |||
| n | 216 | 217 | |
| Mean (SD) | 11.4 (2. 99) | 11.2 (3.05) | |
| Median (min, max) | 11.0 (7, 20) | 11.0 (7, 20) | |
| PANSS Marder negative score (LOCF) | |||
| n | 216 | 217 | |
| Mean (SD) | 27.0 (3.87) | 26.7 (4.07) | |
| Median (min, max) | 27.0 (20, 38) | 26.0 (20, 44) | |
| NSA total score (LOCF) | |||
| n | 216 | 217 | |
| Mean (SD) | 60.3 (9.03) | 60.3 (8.62) | |
| Median (min, max) | 60.0 (38, 81) | 60.0 (28, 81) | |
Abbreviations: BMI, body mass index; PANSS, Positive and Negative Syndrome Scale; LOCF, last observation carried forward; NSA, Negative Symptom Assessment; SD, standard deviation.