Table 5.
Summary of Changes From Baseline in Serum Prolactin Levels, ECG, EPS Scales, and Injection Site Evaluations During the DB Phase (DB Safety Analysis Set)
| PP6M (n = 478) | PP3M (n = 224) | |
|---|---|---|
| Prolactin, µg/L | n = 477 | n = 221 |
| Mean (SD) change from baseline | −3.03 (22.37) | 3.89 (27.93) |
| QTcF, n (%), msec | n = 474 | n = 220 |
| ≤30 | 422 (89.0) | 194 (88.2) |
| >30-60 | 50 (10.5) | 26 (11.8) |
| >60 | 2 (0.4) | 0 |
| AIMS total score, median (range) | n = 477 | n = 221 |
| Changes from baseline | 0.0 (−7, 14) | 0.0 (−3, 2) |
| BARS global clinical rating of akathisia, DB baseline, n (%) | n = 478 | n = 224 |
| Absent | 453 (94.8) | 218 (97.3) |
| Questionable | 16 (3.3) | 6 (2.7) |
| Mild akathisia | 9 (1.9) | 0 (0.0) |
| Moderate akathisia | 0 (0.0) | 0 (0.0) |
| Marked akathisia | 0 (0.0) | 0 (0.0) |
| Severe akathisia | 0 (0.0) | 0 (0.0) |
| BARS global clinical rating of akathisia, DB end point, n (%) | n = 477 | n = 221 |
| Absent | 451 (94.5) | 212 (95.9) |
| Questionable | 19 (4.0) | 7 (3.2) |
| Mild akathisia | 6 (1.3) | 2 (0.9) |
| Moderate akathisia | 1 (0.2) | 0 (0.0) |
| Marked akathisia | 0 (0.0) | 0 (0.0) |
| Severe akathisia | 0 (0.0) | 0 (0.0) |
| SAS global score, median (range) | n = 477 | n = 220 |
| Change from baseline | 0.0 (−1;2) | 0.0 (−1;2) |
| Injection site evaluationa | ||
| Redness, DB baseline | n = 478 | n = 224 |
| Absent | 473 (99.0) | 222 (99.1) |
| Mild | 5 (1.0) | 2 (0.9) |
| DB endpoint | n = 477 | n = 223 |
| Absent | 476 (99.8) | 222 (99.6) |
| Mild | 1 (0.2) | 1 (0.4) |
| Induration/swelling, DB baseline | n = 478 | n = 224 |
| Absent | 469 (98.1) | 220 (98.2) |
| Mild | 9 (1.9) | 4 (1.8) |
| DB endpoint | n = 477 | n = 223 |
| Absent | 475 (99.6) | 222 (99.6) |
| Mild | 2 (0.4) | 1 (0.4) |
| Tenderness, DB baseline | n = 478 | n = 224 |
| Absent | 425 (88.9) | 207 (92.4) |
| Mild | 48 (10.0) | 16 (7.1) |
| Moderate | 5 (1.0) | 1 (0.4) |
| DB endpoint | n = 477 | n = 223 |
| Absent | 474 (99.4) | 221 (99.1) |
| Mild | 3 (0.6) | 2 (0.9) |
| Injection site pain (mm)b | ||
| DB baseline, n | 478 | 224 |
| Mean (SD) | 17.2 (20.86) | 15.0 (18.98) |
| DB endpoint, n | 477 | 223 |
| Mean (SD) | 5.4 (10.78) | 4.54 (8.93) |
Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BARS, Barnes Akathisia Rating Scale; DB, double-blind; ECG, electrocardiogram; EPS, extrapyramidal symptoms; ITT, intent-to-treat; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation; QTcF, QT interval, corrected according to Fridericia’s formula; SAS, Simpson-Angus Scale.
a Investigator assessment.
b Assessment of local tolerability by the patient using a visual analog scale (VAS) (within 30 mins of injection) presented as a 100-mm horizontal line on which the patient’s pain intensity is represented by a point between the “no pain at all” (0) and “unbearably painful” (100).