The primary objective of this study is to evaluate the practice patterns of rivaroxaban
usage invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer
The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding
for cancer patients on rivaroxaban.
This retrospective descriptive study will review charts of approximately375 cancer patients
prescribed rivaroxaban from January 1, 2012 to November 7, 2016 at UT MDACC for NVAF or
patients that had prior VTE and diagnosis of cancer. The list of patients prescribed
rivaroxaban during the study period will be obtained from Pharmacy Informatics. We will
review the eligibility of all patients on the pharmacy list who were prescribed rivaroxaban
during the study time-frame. The eligible patients who meet inclusion/exclusion criteria
will be identified. All available data concerning demographic, clinical parameters and
rivaroxaban usage will be collected for eligible patients from Pharmacy Informatics, CS,
Laboratory Informatics, and Clinical Informatics Databases.
The variables of interest include demographic information, clinical parameters (tumor type,
extent of disease, clinical exam findings, and presence of comorbidities, diagnostic
assessments, and treatment interventions), reason for rivaroxaban discontinuation and
outcomes. The confidentiality of all patient-specific data will be maintained. By using
Pharmacy Informatics and CS, we can capture most of patients prescribed rivaroxaban at the
UT MDACC.This is a descriptive study and the final sample size will depend on available
records for chart review from 01/01/2012 to 11/07/2016.
1. Age range: patient must be ≥ 18 years.
2. Male and female patients will be eligible for enrollment.
3. Patients diagnosed with deep-vein thrombosis of the lower and upper extremities,
pulmonary embolism or both or with non-valvular atrial fibrillation.
4. Patients must have active malignancy defined as a diagnosis of cancer (excluding
basal cell squamous cell carcinoma of the skin) within six months before enrollment,
have received any treatment for cancer within the previous six months or have
documented recurrent or metastatic cancer .
1. Patients who are on hemodialysis
2. Patients with valvular heart disease (using a coexisting prosthetic heart valve or
have a hemodynamically significant valve disease)
Carmen Escalante, MD
M.D. Anderson Cancer Center
Carmen Escalante, MD