Table 1 Thresholds for defining response levels
Change from baseline at week 49 in | Meaningful improvement | No meaningful improvement or decline | Meaningful decline |
|---|---|---|---|
FVC, % predicted | Increase ≥ 4% | Increase or decrease < 4% | Decrease ≥ 4% |
6MWT | Increase ≥ 39 m | Increase or decrease < 39 m | Decrease ≥ 39 m |