A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

This is a randomized (study medication is assigned by chance), open-label (all people know
the identity of the intervention), parallel-group, multicenter (study conducted at multiple
sites) study to evaluate that low risk PE participants who are discharged from the ED and
treated with rivaroxaban compared to participants who are treated with initial
hospitalization and standard-of-care. The study consists of a Screening and Randomization
Period, followed by a 90-day open-label treatment period, and an end of study/early
withdrawal (EOS) visit. The duration of study participation for each participant is
approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two
treatments. Safety will be monitored during the study.

Inclusion Criteria:

- Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic
deep vein thrombosis (DVT)

- A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low
risk of clinical deterioration as determined by the Hestia criteria

- Have no contraindications to and be able to complete randomized treatment and all
study assessments

- Have a life expectancy of at least 6 months

- Must be willing and able to adhere to the prohibitions and restrictions specified in
this protocol

Exclusion Criteria:

- Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450)
inhibitors (such as but not limited to ketoconazole, telithromycin or protease
inhibitors) use within 4 days before randomization, or planned use during the study.
Itraconazole use within 7 days before randomization or planned use during the study

- Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited
to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital,
carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned
use during the study

- Who Has contraindications to the use of any anticoagulant therapy (example, bleeding
diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy
documented at Screening)

- Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its
excipients

- Woman who is pregnant, or breast-feeding, or planning to become pregnant