Table 2.
Exploratory endpoints (change from baseline after treatment) in FAS and PPS population
| Exploratory endpoints | Mean change from baseline (95% CI) in FAS population | Mean change from baseline (95% CI) in PPS population | ||||
|---|---|---|---|---|---|---|
| Oxygen group | Hydrogen/oxygen group | P value | Oxygen group | Hydrogen/oxygen group | P value | |
| Pulmonary function | ||||||
| FVC | 0.18 (0.07, 0.29) | 0.10 (− 0.01,0.21) | 0.309 | 0.19 (0.08, 0.31) | 0.10 (− 0.01, 0.21) | 0.250 |
| FEV1 | 0.12 (0.06, 0.19) | 0.11 (0.04, 0.18) | 0.769 | 0.13 (0.06, 0.19) | 0.11 (0.03, 0.18) | 0.698 |
| FEV1/FVC (%) | 1.52 (− 0.40, 3.44) | 2.45 (− 0.10, 4.99) | 0.563 | 1.22 (− 0.83, 3.29) | 2.29 (− 0.39, 4.97) | 0.529 |
| Arterial blood gas | ||||||
| pH | 0.001 (− 0.013, 0.014) | 0.004 (− 0.009, 0.018) | 0.700 | 0.001 (− 0.013, 0.016) | 0.003 (− 0.010, 0.017) | 0.875 |
| PaO2 (mmHg) | − 0.45 (− 5.65, 4.75) | 3.46 (− 5.77, 12.70) | 0.461 | 1.39 (− 3.87, 6.65) | 4.46 (− 5.74, 14.66) | 0.592 |
| PaCO2 (mmHg) | 0.71 (− 1.09, 2.51) | − 1.09 (− 2.88, 0.71) | 0.160 | 0.53 (− 1.42, 2.48) | -0.55 (− 2.44, 1.34) | 0.424 |
| HCO3− (mmol/L) | 0.61 (− 0.39, 1.62) | − 0.36 (− 1.20, 0.48) | 0.136 | 0.56 (− 0.49, 1.61) | − 0.14 (− 1.03, 0.76) | 0.315 |
FVC forced vital capacity, FEV1 forced expiratory volume in 1 s, PaO2 arterial oxygen pressure, PaCO2 arterial carbon dioxide pressure, HCO3− bicarbonate, 95% CI 95% confidence interval, FAS full analysis set, PPS per-protocol set