Table 3. Exploratory Outcomes Representing Health-Related Quality of Life.
Exploratory outcomes | Patients with measurement | Between-group difference | ||||
---|---|---|---|---|---|---|
Pamrevlumab (n = 181) | Placebo (n = 175) | Absolute difference (95% CI) | P value | |||
No. (%) | Change in outcome, least-squares mean (SD) |
No (%) | Change in outcome, least-squares mean (SD) |
|||
Quantitative lung fibrosis volume, mLa | 157 (86.7) | 251.4 (478.14) | 143 (81.7) | 268.0 (465.87) | −16.58 (−103.21 to 70.05) | .71 |
St George’s Respiratory Questionnaire scoreb | 153 (84.5) | 11.3 (25.47) | 133 (76.0) | 12.1 (24.86) | −0.72 (−5.44 to 3.99) | .76 |
University of California San Diego–Shortness of Breath Questionnaire scorec | 147 (81.2) | 19.6 (34.51) | 129 (73.7) | 20.5 (34.00) | −0.91 (−7.40 to 5.59) | .78 |
Leicester Cough Questionnaire scored | 154 (85.1) | −2.4 (6.00) | 137 (78.3) | −2.7 (5.78) | 0.36 (−0.73 to 1.46) | .52 |
This computer-assisted quantitative scoring system measures the degree and progression of lung fibrosis viewed by high-resolution computed tomography. Volumes range from 0 mL to maximum lung volume; greater volumes represent increased fibrosis.
The score range is from 0 to 100; lower scores indicate better health and fewer symptoms. A score between 25 and 50 indicates moderate impairment. A score greater than 50 indicates severe impairment in health-related quality of life and the ability to complete activities of daily living.
The score range is from 0 to 120; lower scores indicate lower severity of shortness of breath. A score between 20 and 60 indicates moderate shortness of breath. A score of 60 or greater indicates severe shortness of breath that would have an effect on daily living and health-related quality of life.
The score range is from 3 to 21; lower scores indicate greater health impairment due to cough. A score between 14 and 17 indicates moderate impairment due to cough. A score greater than 17 indicates severe impairment that would have an effect on daily living and health-related quality of life.