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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2006-09
NCT00081796Uploaded 05-15-2020
Available for Download
PDS UID: Breast_Multipl_2004_414
Enhancing the Analytic Capacity of Breast_SanofiU_2004_135 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Breast_SanofiU_2004_135, were matched with like breast cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. An optional fifth linkage criterion based on BMI category has also been provided, so researchers can filter the set of linkages to stronger matches as desired. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset217
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fk5j-hx40
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.
ConditionsBreast Cancer
Metastases
Intervention TypeDrug: larotaxel (RPR109881, XRP9881)
Drug: capecitabine
Drug(s)N/A
Total Enrolled438
RandomizationRandomized
Blinding MethodNone
Arms InterventionN/A
Secondary IDXRP9881B-3001
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Brazil
Canada
Chile
Colombia
Czech Republic
Finland
France
Germany
Hungary
Israel
Italy
Korea, Republic of
Mexico
New Zealand
Poland
Portugal
Romania
Slovenia
South Africa
Spain
Taiwan
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLLinked Breast_SanofiU_2004_135 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYCODEBOOK_linked_breast135.pdf
DATA SUMMARYProc Contents Data Dictionary Linked_Breast_SanofiU_2004_135.pdf
DATA SUMMARYDescriptive_Stats_Linked_Breast_SanofiU_2004_135.xlsx
DATA (COMPARATOR ARM)linked_breast135.sas7bdat
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