Unadjusted clinical outcomes during initial therapy with LMWH
| . | Capped dose . | Uncapped dose . | Rate ratio (95% CI) . | ||
|---|---|---|---|---|---|
| n . | Events per 100 patient-years . | n . | Events per 100 patient-years . | ||
| Patients, n | 454 | 2392 | |||
| Duration of therapy, d | |||||
| Mean ± SD | 15 ± 21 | 14 ± 32 | 0.650 | ||
| Median (IQR) | 11 (8-14) | 10 (8-13) | 0.001 | ||
| Event | |||||
| Recurrent PE | 2 | 10.9 (1.82-35.9) | 3 | 3.21 (0.82-8.73) | 3.39 (0.40-22.8) |
| Recurrent DVT | 0 | — | 3 | 3.21 (0.82-8.74) | — |
| Recurrent VTE | 2 | 10.9 (1.82-35.9) | 6 | 6.43 (2.61-13.4) | 1.69 (0.24-8.00) |
| Major bleeding | 0 | — | 24 | 25.7 (16.8-37.7) | — |
| Gastrointestinal | 0 | — | 5 | 5.35 (1.96-11.8) | — |
| Hematoma | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Intracranial | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Recurrent VTE or major bleeding | 2 | 11.0 (1.82-35.9) | 30 | 32.2 (22.1-45.4) | 0.34 (0.05-1.20) |
| Death | 1 | 5.43 (0.27-26.8) | 21 | 22.5 (14.3-33.8) | 0.24 (0.01-1.30) |
| Cause of death | |||||
| Pulmonary embolism | 1 | 5.43 (0.27-26.8) | 9 | 9.63 (4.70-17.7) | 0.56 (0.03-3.43) |
| Sudden, unexpected | 0 | — | 2 | 2.14 (0.36-7.06) | — |
| Respiratory failure | 0 | — | 0 | — | — |
| Bleeding | 0 | — | 2 | 2.14 (0.36-7.06) | — |
| Disseminated cancer | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Composite outcome | 2 | 10.9 (1.82-35.9) | 47 | 50.5 (37.6-66.6) | 0.22 (0.04-0.75) |
| . | Capped dose . | Uncapped dose . | Rate ratio (95% CI) . | ||
|---|---|---|---|---|---|
| n . | Events per 100 patient-years . | n . | Events per 100 patient-years . | ||
| Patients, n | 454 | 2392 | |||
| Duration of therapy, d | |||||
| Mean ± SD | 15 ± 21 | 14 ± 32 | 0.650 | ||
| Median (IQR) | 11 (8-14) | 10 (8-13) | 0.001 | ||
| Event | |||||
| Recurrent PE | 2 | 10.9 (1.82-35.9) | 3 | 3.21 (0.82-8.73) | 3.39 (0.40-22.8) |
| Recurrent DVT | 0 | — | 3 | 3.21 (0.82-8.74) | — |
| Recurrent VTE | 2 | 10.9 (1.82-35.9) | 6 | 6.43 (2.61-13.4) | 1.69 (0.24-8.00) |
| Major bleeding | 0 | — | 24 | 25.7 (16.8-37.7) | — |
| Gastrointestinal | 0 | — | 5 | 5.35 (1.96-11.8) | — |
| Hematoma | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Intracranial | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Recurrent VTE or major bleeding | 2 | 11.0 (1.82-35.9) | 30 | 32.2 (22.1-45.4) | 0.34 (0.05-1.20) |
| Death | 1 | 5.43 (0.27-26.8) | 21 | 22.5 (14.3-33.8) | 0.24 (0.01-1.30) |
| Cause of death | |||||
| Pulmonary embolism | 1 | 5.43 (0.27-26.8) | 9 | 9.63 (4.70-17.7) | 0.56 (0.03-3.43) |
| Sudden, unexpected | 0 | — | 2 | 2.14 (0.36-7.06) | — |
| Respiratory failure | 0 | — | 0 | — | — |
| Bleeding | 0 | — | 2 | 2.14 (0.36-7.06) | — |
| Disseminated cancer | 0 | — | 4 | 4.28 (1.36-10.3) | — |
| Composite outcome | 2 | 10.9 (1.82-35.9) | 47 | 50.5 (37.6-66.6) | 0.22 (0.04-0.75) |