CV Events in Emetogenic Chemotherapy

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01366599

Collaborator

(none)

12,058

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Condition or Disease	Intervention/Treatment	Phase
Vomiting Cardiovascular Event Arterial Thromboembolic Event	Drug: HEC or 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 Design

Study Type:

Observational

Actual Enrollment :

12058 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Patients enrolled in IHCIS in 2006 Patients enrolled in IHCIS in 2006	Drug: HEC or MEC Any HEC or MEC, including aprepitant

Arm

Intervention/Treatment

Patients enrolled in IHCIS in 2006

Drug: HEC or MEC

Any HEC or MEC, including aprepitant

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)