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Table 1 Drotrecogin alfa (activated) clinical trials

From: The safety profile of drotrecogin alfa (activated)

Study

Study type/patients or treatments included

Number of patients included

Study period

Reference

EVAA

Dose-finding phase II

131

1997 to 1998

[10]

PROWESS

Phase III

1,690

1998 to 2000

[11]

ENHANCE

Open-label

2,378

2001 to 2003

[12]

ADDRESS

Low risk for death

2,640

2002 to 2004

[13]

RESOLVE

Sepsis in children

477

2002 to 2005

[24]

XPRESS

Heparin + DrotAA

1,927

2003 to 2005

[14]

  1. ADDRESS, Efficacy and Safety of Drotrecogin alfa [activated] in Adult Severe Sepsis Patients at Low Risk of Death; DrotAA, drotrecogin alfa (activated); ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C, drotrecogin alfa (activated); EVAA, [dose finding study]; PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; RESOLVE, REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective; XPRESS, Xigris and Prophylactic Heparin Evaluation in Severe Sepsis.
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Critical Care

ISSN: 1364-8535