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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.