Table II.
Mean Changes in KIT Scores by Treatment Group
| Placebo | Romiplostim | |||
|---|---|---|---|---|
| Weekly KIT Score | Change from Baseline | Weekly KIT score | Change from baseline | |
| Child self‐report | ||||
| Baseline | 68.9 (16.8) | – | 66.8 (16.0) | – |
| n = 12 | n = 28 | |||
| Week 8 | 77.2 (17.4) | 9.1 (12.8)a | 76.3 (14.8) | 9.4 (13.9)a |
| n = 13 | N = 11 | n = 30 | n = 28 | |
| Week 16 | 76.9 (17.3) | 8.4 (15.6) | 78.1 (14.4) | 10.7 (14.3)a |
| n = 12 | n = 10 | n = 29 | n = 27 | |
| Week 25 (end of study) | 78.0 (18.9) | 9.8 (15.7) | 80.2 (14.8) | 13.7 (16.7)a |
| n = 13 | n = 11 | n = 30 | n = 28 | |
| Between group difference in mean change from baselineb (P‐value) | N.S. | |||
| Parent impact | ||||
| Baseline | 35.5 (17.0) | – | 34.4 (19.0) | – |
| n = 18 | n = 40 | |||
| Week 8 | 39.2 (20.7) | 3.6 (17.3) | 48.3 (22.5) | 13.3 (11.7)a |
| n = 17 | n = 16 | n = 42 | n = 40 | |
| Week 16 | 48.3 (18.9) | 12.3 (15.4)a | 50.1 (22.9) | 15.4 (16.4)a |
| n = 18 | n = 17 | n = 41 | n = 39 | |
| Week 25 (end of study) | 49.4 (18.2) | 12.8 (16.3)a | 53.7 (25.4) | 17.5 (16.7)a |
| n = 17 | n = 16 | n = 39 | n = 37 | |
| Between group difference in mean change from baselineb (P‐value) | P = 0.015 | |||
All cell values are mean (SD) and sample size. Change from baseline only includes patients who provided responses at both time points. Note that change from baseline was calculated only using data for those with complete assessments at baseline and the follow‐up assessment period of interest.
Indicates that confidence interval for mean change from baseline does not include zero, indicating statistical significance
A mixed‐effects repeated measures analysis was conducted to estimate the difference between treatment groups in mean changes in KIT scores pooled using follow‐up data from weeks 8, 16, and 25, controlling for baseline score, the child's age, race, and gender.
N.S., not statistically significant.