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CV Events in Emetogenic Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01366599
First received: June 2, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

June 2, 2011
June 2, 2011
May 2009
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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CV Events in Emetogenic Chemotherapy
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Vomiting
  • Cardiovascular Event
  • Arterial Thromboembolic Event
Drug: HEC or MEC
Any HEC or MEC, including aprepitant
Patients enrolled in IHCIS in 2006
Patients enrolled in IHCIS in 2006
Intervention: Drug: HEC or MEC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12058
July 2009
July 2009   (final data collection date for primary outcome measure)

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.)
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01366599
115777, WEUKSTV4114
No
Cheri Hudson; Clinical Disclosure Advisor, GlaxoSmithKline
GlaxoSmithKline
Not Provided
Not Provided
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP