Table 5.
Change from Baseline to Endpoint of OL and DB Phases in Body Weight, EPS Scales, ECG, Injection Site Evaluations and Laboratory Parameters (ITT [OL] Analysis Set and Safety Analysis Set)a
| Parameter | N | OL | N | PP3M | N | PP1M |
|---|---|---|---|---|---|---|
| Body weight, kg | ||||||
| Change from baseline | 495 | 2.19 (6.97) | 495 | 3.07 (6.71) | ||
| Abnormal weight percent change | ||||||
| Decrease ≥7% | 494 | 37 (7) | 493 | 21 (4) | ||
| Increase ≥7% | 494 | 75 (15) | 493 | 81 (16) | ||
| Fasting glucose (mmol/L) | ||||||
| Change from baseline | 473 | -0.004 (1.02) | 476 | 0.086 (0.95) | ||
| Fasting cholesterol (mmol/L) | ||||||
| Change from baseline | 471 | 0.034 (0.74) | 475 | 0.043 (0.72) | ||
| Fasting LDL cholesterol (mmol/L) | ||||||
| Change from baseline | 471 | 0.0533 (0.65) | 475 | 0.0579 (0.63) | ||
| Fasting HDL cholesterol (mmol/L) | ||||||
| Change from baseline | 471 | -0.0396 (0.30) | 475 | -0.0234 (0.24) | ||
| Fasting triglycerides (mmol/L) | ||||||
| Change from baseline | 471 | 0.086 (0.77) | 475 | 0.010 (0.78) | ||
| Insulin (pmol/L) | ||||||
| Change from baseline | 489 | 1.1 (116.40) | 485 | 6.9 (124.10) | ||
| Prolactin (µg/L) | ||||||
| Change from baseline | 495 | -2.29 (24.31) | 493 | 0.56 (20.03) | ||
| Prolactin (µg/L), high relative to OL baseline, n (%) | ||||||
| Men | 256 | 99 (38.7) | 267 | 119 (44.6) | ||
| Women | 239 | 76 (31.8) | 226 | 74 (32.7) | ||
| AIMS total score, Median (range) | ||||||
| Change from baseline | 494 | 0.0 (-5;6) | 495 | 0.0 (-12;4) | ||
| BARS Global Clinical Rating of Akathisia (baseline [DB]), n (%) | ||||||
| Absent | 495 | 460 (92.9) | 495 | 460 (92.9) | ||
| Questionable | 495 | 27 (5.5) | 495 | 26 (5.3) | ||
| Mild akathisia | 495 | 6 (1.2) | 495 | 9 (1.8) | ||
| Moderate akathisia | 495 | 2 (0.4) | 495 | 0 (0.0) | ||
| Marked akathisia | 495 | 0 (0.0) | 495 | 0 (0.0) | ||
| Severe akathisia | 495 | 0 (0.0) | 495 | 0 (0.0) | ||
| BARS Global Clinical Rating of Akathisia (End point [DB]), n (%) | ||||||
| Absent | 495 | 460 (92.9) | 495 | 456 (92.1) | ||
| Questionable | 495 | 25 (5.1) | 495 | 29 (5.9) | ||
| Mild Akathisia | 495 | 8 (1.6) | 495 | 10 (2.0) | ||
| Moderate Akathisia | 495 | 2 (0.4) | 495 | 0 (0.0) | ||
| Marked Akathisia | 495 | 0 (0.0) | 495 | 0 (0.0) | ||
| Severe Akathisia | 495 | 0 (0.0) | 495 | 0 (0.0) | ||
| SAS Global Score, Median (Range) | ||||||
| Change from Baseline | 495 | 0.00 (-0.9;0.5) | 495 | 0.00 (-1.4;1.5) | ||
| QTcF, n (%) | ||||||
| ≤30 (msec) | 1366 | 1308 (96) | 494 | 435 (88) | 494 | 464 (94) |
| >30–60 (msec) | 1366 | 58 (4) | 494 | 58 (12) | 494 | 29 (6) |
| >60 (msec) | 494 | 1 (<1) | 494 | 1 (<1) | ||
| Induration, DB baseline, Absent | 504 | 479 (95) | 512 | 491 (96) | ||
| Mild | 504 | 24 (5) | 512 | 21 (4) | ||
| Moderate | 504 | 1 (<1) | 512 | 0 | ||
| DB endpoint, Absent | 501 | 484 (97) | 503 | 488 (97) | ||
| Mild | 501 | 17 (3) | 503 | 15 (3) | ||
| Redness, DB baseline, Absent | 504 | 487 (97) | 512 | 494 (96) | ||
| Mild | 504 | 17 (3) | 512 | 18 (4) | ||
| DB endpoint, Absent | 501 | 498 (99) | 503 | 498 (99) | ||
| Mild | 501 | 3 (1) | 503 | 5 (1) | ||
| Swelling, DB baseline Absent | 504 | 482 (96) | 512 | 496 (97) | ||
| Mild | 504 | 22 (4) | 512 | 16 (3) | ||
| DB endpoint, Absent | 501 | 500 (>99) | 503 | 502 (>99) | ||
| Mild | 501 | 1 (<1) | 503 | 1 (<1) | ||
Abbreviations: AIMS, abnormal involuntary movement scale; BARS, Barnes Akathisia Rating Scale; DB, double-blind; OL, open-label; QTcF, QTc interval calculated using the Fridericia formula; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation; SAS, Simpson-Angus Scale.
a The data presented is change from OL baseline to OL endpoint for OL analysis, and for DB, the data presented is change from DB baseline to DB endpoint.