|
Rates of serious bleeding events classified as during the infusion period and postinfusion period in all clinical trials |
||||
| SBE during infusion period |
SBE postinfusion period |
|||
|
|
|
|||
| Population |
Patients (n) |
% (95% CI) |
Patients (n) |
% (95% CI) |
|
|
||||
| Placebo (n = 881) |
6 |
0.7 (0.3–1.5) |
14 |
1.6 (0.8–2.7) |
| Drotrecogin alfa (activated) |
||||
| All controlled trials (n = 940) |
20 |
2.0 (1.3–3.3) |
15 |
1.6 (0.9–2.6) |
| All open-label studies (n = 1578) |
49 |
3.1 (2.3–4.1) |
45 |
2.9 (2.1–3.8) |
| All compassionate-use studies (n = 268) |
10 |
3.7 (1.8–6.8) |
9 |
3.4 (1.6–6.3) |
| All treated patients (n = 2786) |
79 |
2.8 (2.3–3.5) |
69 |
2.5 (1.9–3.1) |
|
CI, confidence interval; SBE, serious bleeding event. | ||||
Bernard et al. Critical Care 2003 7:155 doi:10.1186/cc2167 |
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