Table 2.
Time to Relapse During DB Phase and Number of Patients Who Remained Relapse Free at End of DB Phase (ITT-DB Analysis Set)
| PP6M (n = 478) | PP3M (n = 224) | Total (n = 702) | |
|---|---|---|---|
| No. assessed | 478 | 224 | 702 |
| No. censored (%)a | 442 (92.5) | 213 (95.1) | 655 (93.3) |
| No. of relapse (%) | 36 (7.5) | 11 (4.9) | 47 (6.7) |
| Time to relapse (days)b | |||
| 25% Quantile (95% CI) | NE | NE | NE |
| Median (95% CI) | NE | NE | NE |
| 75% Quantile (95% CI) | NE | NE | NE |
| Relapse freeb | |||
| End of 12 mo (d 365 [DB]) | |||
| Percentage relapse free | 91.9 | 94.8 | |
| Difference (PP6M − PP3M) | −2.9 | ||
| 95% CI | (−6.8; 1.1) |
Abbreviations: CI, confidence interval; DB, double-blind; ITT, intent-to-treat; NE, not estimable; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation.
a Censored include patients who completed the DB phase without relapses and patients who withdrew early during the DB phase.
b Based on Kaplan-Meier product limit estimates.