- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366599
CV Events in Emetogenic Chemotherapy
May 23, 2017 updated by: GlaxoSmithKline
Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients were not recruited for nor enrolled in this study.
This study is a retrospective observational study.
Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort.
All diagnoses and treatment are recorded in the course of routine medical practice.
Study Type
Observational
Enrollment (Actual)
12058
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
IHCIS, 2005-2007.
The Impact National Managed Care Benchmark Database™ (formally known as Integrated Healthcare Information Services - IHCIS - prior to its purchase by Ingenix, Inc and referred to as IHCIS within GSK) is a comprehensive, de-identified U.S. healthcare claims database that is representative of the non-elderly, insurance-carrying population in the U.S. The database contains inpatient/outpatient and pharmacy claims, lab results and enrollment information on over 82 million lives from 1997 to 2007.
Over 75 percent of all patients in the database have both medical and pharmacy benefits and, on average, 23.4 months of enrollment/claims information; the annual attrition rate is roughly 15-25 percent.
The data are collected from over 45 different healthcare plans serving members across nine census regions.
The database is HIPAA compliant and features encrypted member and provider IDs.
Description
Inclusion Criteria:
- Enrollment in IHCIS in 2006
- At least one HEC or MEC claim in 2006
Exclusion Criteria:
- HEC or MEC claim three months before first HEC/MEC claim - "wash-in" period (i.e. must be enrolled for three months prior to first HEC/MEC claim. For patients whose first HEC/MEC event is between January 1,2006 and March 31, 2006, enrollment criteria for inclusion in the study may extend as far back as October 1, 2005)
- HEC or MEC claims prior to 45 days after last HEC or MEC claim - "wash-out" period. (For patients whose last claim in 2006 was seen after December 1, 2006 enrollment into 2007 to look for further treatment and the 45 day "wash-out" period will be required.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients enrolled in IHCIS in 2006
|
Any HEC or MEC, including aprepitant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Calculate the frequency and percent of patients with selected cardiovascular and arterial thromboembolic events in the analysis period, stratifying by any use of aprepitant (Emend) during the analysis period.
Time Frame: First day of first HEC/MEC cycle to 30 days past first day of last cycle
|
First day of first HEC/MEC cycle to 30 days past first day of last cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
June 2, 2011
First Submitted That Met QC Criteria
June 2, 2011
First Posted (Estimate)
June 6, 2011
Study Record Updates
Last Update Posted (Actual)
May 24, 2017
Last Update Submitted That Met QC Criteria
May 23, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115777
- WEUKSTV4114 (Other Identifier: GSK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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