Table 2.
Therapeutic response from baseline to week 13 (full analysis set)
| Paliperidone palmitate week 13 N=610 |
|
|---|---|
| PANSS score decreased ≥20% | |
| n | 488 |
| Response rate (%) | 80.0 |
| 95% CI (%) | 76.6–83.1 |
| Full analysis set, n/N (%) | |
| Achieved response at week 1 | 188/596 (31.5) |
| Achieved response at week 5 | 403/610 (66.1) |
| Achieved response at week 9 | 462/610 (75.7) |
| PANSS score decreased ≥30% | |
| n | 443 |
| Response rate (%) | 72.6 |
| 95% CI (%) | 68.9–76.1 |
| Full analysis set, n/N (%) | |
| Achieved response at week 1 | 102/596 (17.1) |
| Achieved response at week 5 | 314/610 (51.5) |
| Achieved response at week 9 | 389/610 (63.8) |
| PANSS score decreased ≥50% | |
| n | 322 |
| Response rate (%) | 52.8 |
| 95% CI (%) | 48.7–56.8 |
| Full analysis set, n/N (%) | |
| Achieved response at week 1 | 26/596 (4.4) |
| Achieved response at week 5 | 153/610 (25.1) |
| Achieved response at week 9 | 255/610 (41.8) |
Notes: The percent change of PANSS total score is defined as (100× change)/(baseline −30), as 30 is the lowest value of PANSS; 95% CI is the confidence interval of the rate calculated based on exact interval method of binomial distribution model.
Abbreviations: CI, confidence interval; n, number of patients who achieved response; N, total number of patients observed; PANSS, Positive and Negative Syndrome scale.