Table 2.
Primary efficacy outcomes*
| VTE diagnosis at enrollment | New PE | New venous thrombosis | New venous thrombosis and PE | Total | Frequency | 95% CI |
|---|---|---|---|---|---|---|
| Any VTE | 7 | 4 | 3 | 14 | 14/1421 = 1.0% | 0.5 to 1.7% |
| PE | 4 | 1 | 2 | 7 | 7/518 = 1.4% | 0.5 to 2.8% |
| Venous thrombosis | 3 | 3 | 1 | 7 | 7/903 = 0.8% | 0.3 to 1.6% |
Abbreviations: VTE venous thromboembolism, PE pulmonary embolism, , CI confidence interval.
Defined as image-proven new or extended thrombosis requiring hospital admission. An additional 3 patients had new VTE but were not admitted: 2 patients with initial DVT had new PE diagnosed and 1 patient with initial PE had new DVT diagnosed