A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), placebo (an inactive
substance that is compared with a drug to test whether the drug has a real
effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a
specific acute medical illness and have other risk factors for venous thromboembolism (VTE).
The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and
VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of
a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study
drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total
of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in
a 1:1 ratio. The total duration for a patient who completes the study after randomization is
expected to be 75 days.

Key Inclusion Criteria:

- The duration of the index hospitalization must have been at least 3 and no more than
10 consecutive days

- Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE
Risk Score of: greater than or equal 4, or 3 with D-dimer > 2* upper limit of normal
(ULN), or 2 with D-dimer > 2*ULN

Key Exclusion Criteria:

- Any serious bleeding within 3 months prior to randomization or occurring during index
hospitalization

- Serious trauma (including head trauma) within 4 weeks before randomization

- History of hemorrhagic stroke at any time in the past

- Any medical condition that requires chronic use of any parenteral or oral
anticoagulation