Table 1 Efficacy and safety outcomes of the phase III EINSTEIN DVT study

Efficacy outcomes (ITT population)

(n = 1731)

(n = 1718)

Recurrent VTE* (%)

2.1

3.0

0.68 (0.44–1.04)

<0.001

Safety outcomes (safety population)

(n = 1718)

(n = 1711)

First major or non-major clinically relevant bleeding^† (%)

8.1

8.1

0.97 (0.76–1.22)

0.77

Major bleeding (%)

0.8

1.2

0.65 (0.33–1.30)

0.21

Non-major clinically relevant bleeding (%)

7.3

7.0

Total mortality (%)

2.2

2.9

0.67 (0.44–1.02)

0.06

Any treatment-emergent adverse event (%)

62.7

63.1

Net clinical benefit

2.9

4.2

0.67 (0.47–0.95)

0.03

(composite of symptomatic, recurrent VTE plus major bleeding, %)