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Figure 2 | Annals of Intensive Care

Figure 2

From: Design, conduct, and analysis of a multicenter, pharmacogenomic, biomarker study in matched patients with severe sepsis treated with or without drotrecogin Alfa (activated)

Figure 2

In data transfer #1, data from each patient in each of the ten cohorts are submitted and patients are considered for eligibility criteria. Then, patients are segregated into the non-INDICATED (do not meet criteria for high risk of death as per FDA and EU approvals for DAA) and INDICATED (fulfill FDA or EU approvals for DAA) populations (see text for details). Then, DAA-treated patients are matched with DAA-free patients (controls). Subsequently, the matched sets are locked together. Then, the genotype and outcomes data are transferred (data transfer #2 described below) for each patient thereby creating a final dataset of non-INDICATED and INDICATED populations. Finally, the non-INDICATED and INDICATED datasets are merged to create the final dataset of the severe sepsis (SEVSEP) population. In parallel with the matching process, each center sends DNA for genotyping to the laboratory and genotyping is done while blinded to treatment group and outcome. The genotype data and outcome data are then sent via each center to the central dataset as data transfer #2.

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