Table 1.
CFQ-R adjusted change scores from baseline through week 48 by treatment group
| CFQ-R Scale | Placebo | Ivacaftor | ||||
|---|---|---|---|---|---|---|
| (N = 70b) | (N = 80b) | |||||
| Baseline | Change | Baseline | Change | Treatment effect | p-valuea | |
| Body Image | 80.3 | −1.2 | 81.0 | 1.5 | 2.7 | 0.086 |
| Digestive Symptoms | 85.4 | 0.4 | 85.2 | 0.8 | 0.5 | 0.732 |
| Eating Problems | 91.9 | −1.1 | 91.8 | 2.2 | 3.3 | 0.002 |
| Emotional Functioning | 83.6 | −1.4 | 86.0 | 0.7 | 2.1 | 0.096 |
| Health Perceptions | 71.7 | −3.6 | 72.1 | 4.0 | 7.6 | <0.001 |
| Physical Functioning | 80.2 | −1.7 | 76.1 | 2.7 | 4.4 | 0.006 |
| Respiratory Symptoms | 68.5c | −2.7 | 70.2 | 5.9 | 8.6 | <0.001 |
| Role Functioning | 85.9 | 0.1 | 86.3 | −0.5 | −0.6 | 0.651 |
| Social Functioning | 71.9 | −1.0 | 72.1 | 3.3 | 4.3 | 0.003 |
| Treatment Burden | 65.7 | 1.0 | 64.5 | 4.3 | 3.3 | 0.042 |
| Vitality | 64.7 | −2.8 | 64.3 | 2.7 | 5.5 | 0.002 |
| Weight | 78.1 | 1.7 | 79.0 | 6.9 | 5.3 | 0.053 |
Health Perceptions, Role Functioning, Vitality and Weight are not included in the Child self-report version of the CFQ-R; results for these scales are based on the Teen/Adult version only (N = 64 for placebo and N = 76 for Ivacaftor)
a P-value for overall post-baseline treatment effect, estimated using a mixed-effect model for repeated measures with fixed effects for study visit, treatment group, and adjustment for continuous baseline values of age, percent predicted FEV1 and domain score
bAnalysis sample includes patients with a baseline assessment and at least one post-baseline assessment
c n = 71