|
Bleeding events for the 28-day study (period) in clinical trials evaluating DrotAA in severe sepsis |
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| All bleeding events (%) |
Serious bleeding events (%) |
CNS bleeding (%) |
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|
|
|
|
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| Study |
DrotAA |
Placebo |
P |
DrotAA |
Placebo |
P |
DrotAA |
Placebo |
P |
|
|
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| Adults |
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| Phase II [1] |
ND |
ND |
4.0 |
5.0 |
0.99 |
0 |
0 |
NS |
|
| PROWESS [2] |
ND |
ND |
3.5 |
2.0 |
0.06 |
0.2 |
0 |
NS |
|
| ENHANCE [11] |
ND |
NA |
6.5 |
NA |
1.5 |
NA |
NA |
||
| ADDRESS [12] |
ND |
ND |
3.9 |
2.2 |
0.01 |
0.5 |
0.4 |
NS |
|
| XPRESS [13]a |
12.4 |
10.9 |
0.32 |
3.9 |
5.2 |
0.16 |
1.0 |
0.7 |
0.49 |
| Children |
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| Phase Ib [14] |
20.5 |
NA |
4.8 |
NA |
2.4 |
NA |
NA |
||
| RESOLVE [15] |
ND |
ND |
6.7 |
6.8 |
0.97 |
4.6 |
2.1 |
0.13 |
|
|
aFor the XPRESS trial all patients received drotecogin alfa (activated; DrotAA). Placebo refers to absence of concomitant heparin prophylaxis during DrotAA infusion. ADDRESS, Administration of Drotrecogin alfa (activated) in early stage Severe Sepsis; ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C; NA, not applicable; ND, not described; 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. | |||||||||
Laterre Critical Care 2007 11(Suppl 5):S5 doi:10.1186/cc6156 |
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