TABLE 4.
Primary analysis of key secondary end-points
| End-point | Estimated difference (95% CI) (rGM-CSF versus control) # | p-value # |
| Pulmonary gas transfer | ||
| PaO2 (mmHg) | 9.5 (5.7–13.3) | <0.0001 |
| PA–aO2 (mmHg) | −10.1 (−14.8– −5.4) | <0.0001 |
| DLCO (% predicted) | 11.6 (1.9–21.3) | 0.022 |
| Pulmonary function | ||
| VC (% predicted) | 2.3 (−5.3–9.9) | 0.532 |
| Radiological assessment | ||
| GGO score | −0.822 (−1.7–0.01) | 0.053 |
| SF-36 general health score | 4.72 (−1.88–11.33) | 0.149 |
| Serum biomarkers | ||
| CyFra21.1 (ng·mL−1) | −0.24 (−0.44– −0.04) | 0.022 |
| CEA (ng·mL−1) | −0.47 (−0.71– −0.22) | 0.001 |
| KL-6 (U·mL−1) | −3689 (−6972– −406) | 0.030 |
rGM-CSF: recombinant granulocyte–macrophage colony-stimulating factor; PaO2: arterial oxygen tension; PA–aO2: alveolar–arterial oxygen tension difference; DLCO: diffusing capacity of the lung for carbon monoxide; VC: (slow) vital capacity; GGO: ground glass opacification; SF-36: Short Form 36-question Health Survey; Cyfra21.1: cytokeratin-19 fragment antigen; CEA: carcinoembryonic antigen; KL-6: Krebs von den Lungen. #: after adjustment for baseline value, gender, age and the numbers of patients at risk at each point, the between-group difference (95% CI) and p-value were calculated using repeated measures ANOVA.