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Summary of all fatal bleeding events related and unrelated to drotrecogin alfa (activated) in all clinical trials |
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| During infusion period |
Post-Infusion Period |
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|
|
|
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| Type of event |
Drug related (n [%]) |
Not related (n [%]) |
Drug related (n [%]) |
Not related (n [%]) |
|
|
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| All ICH bleeding |
12 (0.4) |
4 (0.1) |
6 (0.2) |
10 (0.4) |
| Fatal ICH bleeding |
7 (0.3) |
2 (0.07) |
1 (0.04) |
7 (0.3) |
| Fatal non-ICH bleeding |
3 (0.1) |
0 (0) |
0 (0) |
0 (0) |
|
A total of 2786 patients treated with drotrecogin alfa (activated) infusion were included in this analysis. ICH, intracranial hemorrhage. | ||||
Bernard et al. Critical Care 2003 7:155 doi:10.1186/cc2167 |
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