Table 3.
Absolute decline in FVC percentage of predicted value (compared with baseline) over 12 months
| Placebo group | Cyclophosphamide group | |||||
|---|---|---|---|---|---|---|
| Number of subjects | Absolute decline in FVC % predicted, mean (SD) | p Value | Number of subjects | Absolute decline in FVC % predicted, mean (SD) | p Value | |
| Visual maximum fibrosis score | ||||||
| 0–25 % | 19 | 0.1 (9.0) | 0.019 | 13 | −3.4 (6.3) | 0.04 |
| 26–100 % | 29 | −6.2 (8.3) | 30 | 1.2 (6.6) | ||
| Goh and Wells criteria, unadjusted stratification | ||||||
| <20 % | 22 | −1.6 (10.2) | 0.15 | 15 | −1.0 (6.7) | 0.49 |
| >20 % | 25 | −5.5 (8.0) | 30 | 0.6 (7.7) | ||
| Goh and Wells criteria with indeterminate results on HRCT (10–30 %), adjusted stratification | ||||||
| Minimal disease | 8 | 2.2 (9.8) | 0.08 | 12 | −1.1 (4.3) | 0.47 |
| Extensive disease | 39 | −4.9 (8.7) | 32 | 0.3 (8.2) | ||
| QILD WL | ||||||
| <20 % | 10 | 0.3 (6.8) | 0.07 | 5 | −7.9 (9.7) | 0.12 |
| >20 % | 37 | −4.9 (9.5) | 38 | 0.8 (5.7) | ||
| QILD ZM | ||||||
| <25 % | 2 | 5.0 (7.5) | 0.32 | 2 | −12.3 (1.5) | 0.001 |
| >25 % | 45 | −4.1 (9.1) | 41 | 0.4 (6.4) | ||
| QLF WL | ||||||
| <20 % | 42 | −3.0 (9.1) | 0.16 | 39 | −0.4 (6.7) | 0.70 |
| >20 % | 5 | −9.8 (8.7) | 4 | 1.4 (8.2) | ||
| QLF ZM | ||||||
| <25 % | 27 | −1.4 (10.1) | 0.03 | 24 | −1.2 (7.2) | 0.26 |
| >25 % | 20 | −6.9 (6.8) | 19 | 1.1 (6.2) | ||
FVC % predicted percentage of predicted forced vital capacity, HRCT high-resolution computed tomography, QILD WL quantitative assessment of total extent of interstitial lung disease in whole lung, QILD ZM quantitative assessment of total extent of interstitial lung disease in zone of maximal involvement, QLF WL quantitative percentage with fibrosis in whole lung, QLF ZM quantitative percentage with fibrosis in zone of maximal involvement, SD standard deviation Negative score denotes worsening in FVC