CV Events in Emetogenic Chemotherapy

Completed

• Conditions: Arterial Thromboembolic Event; Cardiovascular Event; Vomiting
• Interventions: Drug: HEC or MEC

• Registration Number: NCT01366599
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12058

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients enrolled in IHCIS in 2006	HEC or MEC	Patients enrolled in IHCIS in 2006

Primary Outcome Measures

Name	Time	Method
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