Table 7 Summary of all fatal bleeding events related and unrelated to drotrecogin alfa (activated) in all clinical trials
During infusion period | Post-Infusion Period | |||
|---|---|---|---|---|
Type of event | Drug related (n [%]) | Not related (n [%]) | Drug related (n [%]) | Not related (n [%]) |
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) |