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Table 2 Comparison of safety parameters between placebo- and rFVIIa-treated patients

From: Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hocanalysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial

  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
  1. 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.