Table 2.
Primary and secondary outcomes in patients enrolled in BRUISE CONTROL-1 and -2 trials
| Trial outcomes | Total subjects = 1308 (BC-1: 661 and BC-2: 647) |
|---|---|
| Clinically significant haematoma (CSH) | 80/1308 (6.1%) |
| CSH prolonged hospitalization | 23/1308 (1.8%) |
| CSH requiring interruption of anti-coagulation | 73/1308 (5.6%) |
| CSH requiring re-operation | 14/1308 (1.1%) |
| Non-clinically significant haematomaa | 21/647 (3.3%) |
| Any haematomaa | 34/647 (5.3%) |
| All-cause mortality | 7/1308 (0.5%) |
Data are expressed as n/N (%).
a
These variables were available only for patients enrolled in the BRUISE CONTROL-2 trial.