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. 2010 Sep;35(9):504-29.

An update on activated protein C (xigris) in the management of sepsis

Cesar Alaniz  1
Affiliations

An update on activated protein C (xigris) in the management of sepsis

Cesar Alaniz. P T. 2010 Sep.
No abstract available

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Figures

Figure 1
Figure 1
Cumulative 28-day mortality over time. The amended version of the protocol was introduced at Line A, the first interim analysis occurred at Line B, and the second interim analysis at Line C. (From FDA briefing document, BLA #125029/0.29)
See this image and copyright information in PMC

References

    1. Matthay MA. Severe sepsis: A new treatment with both anticoagulant and antiinflammatory properties. N Engl J Med. 2001:759–762. - PubMed
    1. Bernard G, Vincent JL, Laterre PF, et al. Efficacy and safety of activated protein C for severe sepsis. N Engl J Med. 2001;344:699–709. - PubMed
    1. FDA, Center for Drug Evaluation Research 2001 Meeting Documents, March 27, 2007. Available at: www.fda.gov/ohrms/dockets/ac/cder01.htm#Anti-Infective. Accessed June 7, 2010.
    1. FDA Clinical Review, BLA#125029/0. Drotrecogin alfa (activated) [Recombinant Human Activated Protein C (rhAPC)], Xigris. Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelo.... Indianapolis: Eli Lilly; November 21, 2001. Accessed June 7, 2010.
    1. Abraham E, Laterre P-F, Garg R, et al. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med. 2005;353:1332–1341. - PubMed

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