CV Events in Emetogenic Chemotherapy

GlaxoSmithKline12,058 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,058

Conditions

Vomiting Cardiovascular Event Arterial Thromboembolic Event

Interventions

HEC or MECDRUG

Any HEC or MEC, including aprepitant

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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