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