Table 3.
Mean changes from baseline in the open-label period of the randomized withdrawal study
| Nonrandomized | Randomized | |||
|---|---|---|---|---|
| n = 96 | n = 20 | |||
| Measures, mean (SD) | Baseline | Changea | Baseline | Changea |
| Pain, range 0-10 | 6.5 (1.4) | −1.1 (1.6) | 6.1 (1.3) | −3.3 (1.0) |
| PGIS, range 1-7 | 4.0 (0.8) | −0.4 (1.0) | 4.0 (0.8) | −1.0 (1.0) |
| PedsQL-Generic Core Scales, range 0-100 | 55.6 (14.8) | 4.5 (13.0) | 54.2 (11.4) | 10.9 (10.9) |
| PedsQL-Multidimensional Fatigue Scale, range 0-100 | 46.1 (17.6) | 5.8 (15.3) | 41.3 (13.3) | 13.3 (12.1) |
| MASC, range 0-117 | 45.1 (16.5) | −2.4 (12.2) | 46.1 (13.4) | −5.4 (13.2) |
| CDI, range 0-54b | 11.9 (7.1) | −1.2 (5.0) | 11.1 (5.5) | −2.4 (4.9) |
aChanges are based on end-of-treatment values. Negative changes represent mean improvements in pain, PGIS, MASC, and CDI scores; positive values represent mean improvements in PedsQL scores. For pain, data were based on electronic entries from Week 7 (i.e., the last week prior to randomization). For other measures, data were based on last available open-label assessments, including those from patients who prematurely discontinued the study
bPrimarily used in this study as a safety assessment to monitor changes in depressive symptoms
CDI = Children’s Depression Inventory, MASC = Multidimensional Anxiety Scale, PGIS = Patient Global Impression of Severity, PedsQL = Pediatric Quality of Life Inventory-Teen Report, SD = standard deviation