Table 3.

Primary safety outcomes

VTE diagnosis at enrollment	Bleeding requiring hospitalization*	Frequency	95% CI	ISTH severe bleed	Frequency	95% CI
Any VTE	12	12/1421 = 0.8%	0.4 to 1.5%	2	2/1421 = 0.1%	0–0.5%
PE	4	4/518 =0.8%	0.2 to 1.9%	1	1/518 =0.2%	0–1.0%
Venous thrombosis	8	8/903 = 0.9%	0.3 to 1.7%	1	1/903 = 0.1%	0–0.6%

Abbreviations: VTE venous thromboembolism, PE pulmonary embolism, CI confidence interval, ISTH-International Society for Thrombosis and Haemostasis;

^*Causes of bleeding: Lower gastrointestinal (5), Hematemesis (4), hematuria (1), menorrhagia (1), epistaxis (1)