Table 3 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) |