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

Table 5 Summary of results in support of biomarker status

	Type 0 biomarker: placebo baseline value versus mortality (see Table 2); categorized by OR^a	Type 0 biomarker: placebo day 4 value versus mortality (see Table 3); categorized by P value^b	Type 1 biomarker: relationship of baseline value to DrotAA effect (see Figure 1); categorized by P value^b	Surrogate (type 2 biomarker): improvement at day 4 with DrotAA (see Table 4); categorized by P value^b	Surrogate (type 2 biomarker): surrogate performance score (see Table 4); categorized by PTEE^c
Protein C	+++	+++	++	+++	+++
Protein S	++	+++	+	-	-
Antithrombin III	+++	+++	-	-	+
Interleukin-6	+++	+++	-	-	-
Prothrombin time	++	+++	-	+++	-
D-dimer	++	+++	-	+++	++
Cardiovascular SOFA	++	+++	-	++	++
Respiratory SOFA	++	+++	-	-	+
Renal SOFA	+++	+++	-	-	+
Hematologic SOFA	++	+++	-	-	+
Hepatic SOFA	+	+++	-	+	-

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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