Table 2.
Time-to-Relapse during the Double-Blind Phase and Number (%) of Patients That Remained Relapse Free (PP Analysis Set)
| PP3M | PP1M | Total | ||
|---|---|---|---|---|
| Number of assessed | 458 | 490 | 948 | |
| Number of censored (%)* | 421(92) | 445(91) | 866(91) | |
| Number of relapsed (%) | 37(8) | 45(9) | 82(9) | |
| Time-to-relapse (days)a | ||||
| 25% Quantile (95% CI) | ( ; ) | ( ; ) | ( ; ) | |
| Median (95% CI) | ( ; ) | ( ; ) | ( ; ) | |
| 75% Quantile (95% CI) | ( ; ) | ( ; ) | ( ; ) | |
| Relapse-freea | ||||
| Week 48 (DB) | ||||
| Percentage relapse-free | 91.2 | 90.0 | ||
| Difference (PP3M-PP1M) | 1.2 | |||
| 95% CI | (-2.7; 5.1) | |||
Abbreviations: DB, double-blind; PP, per protocol; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation.
a Based on Kaplan-Meier product limit estimates. Note: 25%, 50%, and 75% quantiles of time-to-relapse are not estimable.
* Censored include patients who completed the DB phase without relapses and patients who withdrew early during the DB phase.