Table 2.
Comparison of safety parameters between placebo- and rFVIIa-treated patients
| 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 | |||
| Patients | 12 (92; 68–98) | 14 (82; 60–92) | 0.61 |
| Events | 26 | 33 | |
| Thromboembolic serious adverse eventsa | |||
| 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 |
Data are presented as number of patients (percentage; 90% confidence interval) or median [minimum-maximum]. aBoth thromboembolic serious adverse events were part of the entire cohort of 12 serious adverse events reported for the placebo group. bP values apply to the two-sided Wilcoxon rank test. All other P values apply to the two-sided Fisher exact tests. rFVIIa, recombinant activated factor VII.