Xarelto Regulatory Post-Marketing Surveillance

Bayer3,388 enrolled

Overview

This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA). 1. Known and unknown adverse reactions, especially serious adverse reactions 2. Incidence of adverse reactions under the routine drug use 3. Factors that may affect the safety of the drug 4. Factors that may affect the effectiveness of the drug 5. Other safety information related to overuse, drug interaction and laboratory abnormalities 6. Other adverse reactions

Study Type

OBSERVATIONAL

Enrollment

3,388

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female and male patients \>/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study Exclusion Criteria: * Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment * Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding) * Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * Pregnant or lactating women * Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)

Outcomes

Primary Outcomes

Adverse event collection

Time frame: From the start of signed consent to 4 weeks after discharge

Secondary Outcomes

Duration of treatment

Time frame: Whole treatment period