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. |
|||
|
Kluger et al. Critical Care 2007 11:R85 doi:10.1186/cc6092 |
|||
