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Table 5 Summary of results in support of biomarker status

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

  Type 0 biomarker: placebo baseline value versus mortality (see Table 2); categorized by ORa Type 0 biomarker: placebo day 4 value versus mortality (see Table 3); categorized by P valueb Type 1 biomarker: relationship of baseline value to DrotAA effect (see Figure 1); categorized by P valueb Surrogate (type 2 biomarker): improvement at day 4 with DrotAA (see Table 4); categorized by P valueb Surrogate (type 2 biomarker): surrogate performance score (see Table 4); categorized by PTEEc
Protein C +++ +++ ++ +++ +++
Protein S ++ +++ + - -
Antithrombin III +++ +++ - - +
Interleukin-6 +++ +++ - - -
Prothrombin time ++ +++ - +++ -
D-dimer ++ +++ - +++ ++
Cardiovascular SOFA ++ +++ - ++ ++
Respiratory SOFA ++ +++ - - +
Renal SOFA +++ +++ - - +
Hematologic SOFA ++ +++ - - +
Hepatic SOFA + +++ - + -
  1. Shown is the categorization based on the results of each analysis. To summarize the statistical analyses, the results from each analysis were categorized as follows. aOdds ratios (ORs) from Table 2: - = OR < 0; + = 0 ≤ OR < 1.5; ++ = OR 1.5 to 2.0; +++ = OR > 2.0. bP values from Tables 3 and 4, and Figure 1: - = P > 0.1; + = 0.051 <P ≤ 0.1; ++ = P 0.01 to 0.05; +++ = P < 0.01. cProportion of treatment effect explained (PTEE) from Table 4: - = negative or < 5%; + = 5% to < 25%; ++ = 25% to 50%; +++ = > 50%. DrotAA, drotrecogin alfa (activated); SOFA, Sequential Organ Failure Assessment.
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