Table 3.
Primary and Secondary Outcomes in the Final Analysis Population
| Treatment Group (n = 94) |
Control Group (n = 99) |
Difference or RR (95% CrI) |
|
|---|---|---|---|
| Primary endpoint: change in PaO2/FiO2 ratio at 48 h, mm Hg | |||
| Overall population | 28.3 (89.3) | −1.4 (68.9) | 39.1 (18.1 to 60.3) |
| Stratified by baseline PaO2/FiO2 ratio | |||
| <100 mm Hg | 85.9 (72.1) | 31.0 (44.6) | 50.6 (5.1 to 95.6) |
| 100–200 mm Hg | 34.6 (74.1) | 10.2 (53.2) | 32.5 (1.9 to 63.1) |
| ⩾200 mm Hg | −0.6 (101.9) | −28.5 (80.9) | 27.6 (−16.5 to 72.3) |
| Secondary endpoints | |||
| Mortality within 28 d, n (%) | 27 (28.7) | 27 (27.3) | RR, 0.85 (0.50 to 1.46) |
| Mortality within 90 d, n (%) | 32 (34.0) | 32 (32.3) | RR, 0.87 (0.52 to 1.43) |
| Time to PaO2/FiO2 ratio > 300 mm Hg, d* | 8.7 (5.0) | 8.4 (6.5) | 0.44 (−3.63 to 4.53) |
| Patients reaching PaO2/FiO2 ratio > 300 mm Hg, n (%)* | 33 (35.1) | 21 (21.2) | RR, 2.03 (1.11 to 3.86) |
Definition of abbreviations: CrI = credible interval; RR = risk ratio.
Data are presented as mean (SD) unless otherwise noted.
*
Measured over 28 days after randomization in survivors with baseline PaO2/FiO2 < 300 mm Hg, as prespecified (67 patients in the treatment group and 72 in the control group).