Arterial Thromboembolic Event, Cardiovascular Event, Vomiting
Conditions
Keywords
highly emetogenic chemotherapy, HEC, moderately emetogenic chemotherapy, MEC
Brief summary
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
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.
Interventions
DRUGHEC or MEC
Any HEC or MEC, including aprepitant
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| 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. | First day of first HEC/MEC cycle to 30 days past first day of last cycle |
Outcome results
None listed