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Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy


N/A
N/A
N/A
Not Enrolling
Both
Vomiting, Cardiovascular Event, Arterial Thromboembolic Event

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Trial Information

Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy


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.


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.)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

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.

Outcome Time Frame:

First day of first HEC/MEC cycle to 30 days past first day of last cycle

Safety Issue:

Yes

Authority:

United States: No Health Authority

Study ID:

115777

NCT ID:

NCT01366599

Start Date:

May 2009

Completion Date:

July 2009

Related Keywords:

  • Vomiting
  • Cardiovascular Event
  • Arterial Thromboembolic Event
  • highly emetogenic chemotherapy
  • HEC
  • moderately emetogenic chemotherapy
  • MEC
  • Thromboembolism
  • Embolism
  • Vomiting

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