|
Serious adverse events including bleeding events through clinical trials |
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| Placebo-controlled studies |
Open-labela |
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|
|
|
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| PROWESS |
ADDRESS |
ENHANCE |
XPRESS |
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|
|
|
|
|
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| Adverse events |
DrotAA (n = 850) |
Placebo (n = 840) |
DrotAA (n = 1,317) |
Placebo (n = 1,293) |
DrotAA (n = 2,378) |
DrotAA (n = 1,935) |
|
|
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| Study drug infusion period* |
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| Serious events |
58 (6.8) |
55 (6.5) |
75 (5.7) |
78 (6.0) |
166 (7.0) |
128 (6.6) |
| Serious bleeds |
20 (2.4) |
8 (1.0) |
31 (2.4) |
15 (1.2) |
85 (3.6) |
46 (2.4) |
| CNS bleeds |
2 (0.2) |
0 |
4 (0.3) |
3 (0.2) |
15 (0.6) |
6 (0.3) |
| Days 0 through 28 |
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| Serious events |
106 (12.5) |
102 (12.1) |
182 (13.8) |
183 (14.2) |
319 (13.4) |
256 (13.2) |
| Serious bleeds |
30 (3.5) |
17 (2.0) |
51 (3.9) |
28 (2.2) |
155 (6.5) |
88 (4.5) |
| CNS bleeds |
2 (0.2) |
1 (0.1) |
6 (0.5) |
5 (0.4) |
35 (1.5) |
17 (0.9) |
|
*In PROWESS and ENHANCE, the study drug infusion period was defined as the actual infusion plus 1 day. In ADDRESS, RESOLVE and XPRESS, the study drug infusion period was defined as study days 0 through 6. Values are expressed as n (%). aENHANCE was an open-label study. XPRESS was a placebo-controlled study of the co-administration of heparin with drotrecogin alfa (activated); the drug under study was heparin; open-label drotrecogin alfa (activated) was administered to all patients. ADDRESS, Efficacy and Safety of Drotrecogin alfa [activated] in Adult Severe Sepsis Patients at Low Risk of Death; CNS, central nervous system; DrotAA, drotrecogin alfa (activated); ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C, drotrecogin alfa (activated); PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; XPRESS, Xigris and Prophylactic Heparin Evaluation in Severe Sepsis. Modified with permission from Williams MD, Macias W, Rustige J: Safety of drotrecogin alfa (activated): a fair comparison requires consistent definitions. Intensive Care Med 2007, 33:1487–1488. © Springer-Verlag. | ||||||
Fumagalli and Mignini Critical Care 2007 11(Suppl 5):S6 doi:10.1186/cc6157 |
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