| Placebo | rFVIIa | P value |
---|---|---|---|
Number of patients | 13 | 17 | - |
Adverse events | 12 (92; 68–98) | 15 (88; 67–96) | 1 |
   Patients | 31 | 44 |  |
   Events |  |  |  |
Serious adverse events | Â | Â | Â |
   Patients | 12 (92; 68–98) | 14 (82; 60–92) | 0.61 |
   Events | 26 | 33 |  |
Thromboembolic serious adverse eventsa | Â | Â | Â |
   Patients | 2 (15; 3–51) | 0 (0; 0–53) | 0.18 |
   Events | 2 | 0 |  |
Mortality (total) | 6 (46; 22–71) | 5 (29; 12–56) | 0.19 |
Early mortality (≤48 hours) | 3 (23; 7–56) | 2 (12; 2–43) | 0.63 |
Late mortality (>48 hours to 30 days) | 3 (23; 7–56) | 3 (18; 5–47) | 1 |
Multiorgan failure | 2 (15; 3–51) | 3 (18; 5–47) | 1 |
Acute respiratory distress syndrome | 2 (15; 3–51) | 2 (12; 2–43) | 1 |
Intensive care unit-free daysb | 0 [0–21] | 3 [0–23] | 0.26 |
Ventilator-free daysb | 0 [0–25] | 10 [0–24] | 0.19 |