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Table 4 Day 4 (end of infusion) values in PROWESS:individual surrogate performance score (PTEE)

From: Protein C: a potential biomarker in severe sepsis and a possible tool for monitoring treatment with drotrecogin alfa (activated)

Day 4 measure

DrotAA patients (mean [SD]/median)

Placebo patients (mean [SD]/median)

P a

Individual surrogate performance score (PTEE)b

Protein C (%)

70.6 (36.2)/67.0

62.7 (36.9)/59.0

<0.0001

57.2%

Protein S (%)

53.3 (29.0)/52.0

53.5 (30.2)/53.0

0.95

-0.8%c

Antithrombin III (%)

70.3 (27.0)/69.5

69.0 (28.0)/70.0

0.38

13.4%

Interleukin-6 (pg/ml)

3,649 (30,280)/75.5

4948 (33379)/79.5

0.78

0.3%d

Prothrombin time (seconds)

18.6 (7.4)/16.7

18.5 (8.4)/16.2

0.0003

-30.4%c, d

D-dimer (μg/ml)

4.63 (5.41)/3.12

7.13 (7.87)/4.61

<0.0001

40.5%d

Cardiovascular SOFA

1.48 (1.60)/1.00

1.67 (1.64)/1.00

0.01

40.8%

Respiratory SOFA

2.25 (1.03)/2.00

2.30 (1.01)/2.00

0.25

12.7%

Renal SOFA

0.74 (1.12)/0.00

0.80 (1.17)/0.00

0.39

10.6%

Hematologic SOFA

0.89 (1.12)/0.00

0.92 (1.15)/0.00

0.79

5.1%

Hepatic SOFA

0.61 (0.92)/0.00

0.53 (0.89)/0.00

0.04

-13.6%

  1. aP value for Wilcoxon rank-sum test. bThe performance score shows the proportion of drotrecogin alfa (activated; DrotAA) treatment effect explained (PTEE) based on logistic regression analyses that quantify the amount of the observed treatment effect on 28-day mortality that is attributable to the treatment effect of the individual biomarker. Because changes in these biomarkers are often interdependent (for example, protein C and cardiovascular SOFA improvements), the performance scores are not expected to add up to 100%. cA negative performance score means that the treatment adversely affected the variable. dFor biomarkers that varied greatly between mean and median values, analysis was based on median value. PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; SD, standard deviation; SOFA, Sequential Organ Failure Assessment.