Table 5 |
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Summary of results in support of biomarker status |
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|
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 |
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|
|
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|
Protein C |
+++ |
+++ |
++ |
+++ |
+++ |
|
Protein S |
++ |
+++ |
+ |
- |
- |
|
Antithrombin III |
+++ |
+++ |
- |
- |
+ |
|
Interleukin-6 |
+++ |
+++ |
- |
- |
- |
|
Prothrombin time |
++ |
+++ |
- |
+++ |
- |
|
D-dimer |
++ |
+++ |
- |
+++ |
++ |
|
Cardiovascular SOFA |
++ |
+++ |
- |
++ |
++ |
|
Respiratory SOFA |
++ |
+++ |
- |
- |
+ |
|
Renal SOFA |
+++ |
+++ |
- |
- |
+ |
|
Hematologic SOFA |
++ |
+++ |
- |
- |
+ |
|
Hepatic SOFA |
+ |
+++ |
- |
+ |
- |
|
|
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|
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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|
Shorr et al. Critical Care 2008 12:R45 doi:10.1186/cc6854 |
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