Table 2.
PP3M exposure and dosing (mITT population).
| Parameter | Total (n = 305) | LOCF endpoint SR |
|
|---|---|---|---|
| Yes (n = 172) | No (n = 133) | ||
| Follow-up duration, days, mean (SD) | 352.7 (52.3) | 362.4 (11.5) | 340.1 (76.5) |
| Exposure duration, days, mean (SD) | 263.0 (42.5) | 271.7 (7.4) | 251.6 (62.1) |
| Baseline dosea (Day 1) Mean (SD) | 363.6 (115.4) | 362.84 (116.4) | 364.6 (114.5) |
| Month 3 dose, mg | |||
| Mean (SD) | 366.7 (117.7) | 361.8 (117.3) | 373.3 (118.4) |
| Month 6 dose, mg | |||
| Mean (SD) | 362.6 (119.8) | 357.8 (117.7) | 369.3 (122.9) |
| Month 9 dose, mg | |||
| Mean (SD) | 363.6 (119.5) | 356.2 (117.2) | 374.2 (122.6) |
| Month 12 dose, mg | |||
| Mean (SD) | 362.5 (118.8) | 356.2 (117.2) | 370.5 (120.7) |
| Patients with ⩾1 dose increase, n (%) b | 11 (3.6) | 1 (0.6) | 10 (7.5) |
| Patients with ⩾1 dose decrease, n (%) b | 15 (4.9) | 10 (5.8) | 5 (3.8) |
a
One patient received an incorrect PP1M to PP3M dose conversion.
b
Some patients had two or more dose increases/decreases.
LOCF, last observation carried forward; mITT, modified intent-to-treat; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation; SD, standard deviation; SR, symptomatic remission.