|
Number of procedure-related 28-day serious bleeding events by site of hemorrhage sorted from largest to smallest percentage of serious bleeding events that were procedure-related in all clinical trials |
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| Procedure-related events |
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|
|
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| Site of hemorrhage |
During infusion period |
Postinfusion period |
Total procedure-related |
All SBEs1 |
% Procedure-related |
|
|
|||||
| Vascular |
5 |
2 |
7 |
7 |
100.0 |
| Retroperitoneal |
2 |
1 |
3 |
3 |
100.0 |
| Intraabdominal |
5 |
4 |
9 |
10 |
90.0 |
| Skin/soft tissue |
9 |
3 |
12 |
15 |
80.0 |
| Intrathoracic |
8 |
3 |
11 |
20 |
55.0 |
| Other/undetermined |
2 |
5 |
7 |
14 |
50.0 |
| Spleen |
0 |
1 |
1 |
3 |
33.3 |
| Gastrointestinal |
3 |
5 |
8 |
44 |
18.2 |
| ICH |
0 |
0 |
0 |
32 |
0.0 |
| Total |
34 |
24 |
58 |
148 |
39.2% |
|
A total of 2786 patients treated with drotrecogin alfa (activated) infusion were included in this analysis. 1All serious bleeding events (SBEs) combines both procedure-related and non-procedure-related events during the 28-day period. ICH, intracerebral hemorrhage. | |||||
Bernard et al. Critical Care 2003 7:155 doi:10.1186/cc2167 |
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