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Table 1 CFQ-R adjusted change scores from baseline through week 48 by treatment group

From: Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial

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

  1. 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)
  2. 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
  3. bAnalysis sample includes patients with a baseline assessment and at least one post-baseline assessment
  4. c n = 71