Table 5 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
Procedure-related events | |||||
|---|---|---|---|---|---|
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% |