CV Events in Emetogenic Chemotherapy

NCT ID: NCT01366599

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12058 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vomiting Cardiovascular Event Arterial Thromboembolic Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients enrolled in IHCIS in 2006

Patients enrolled in IHCIS in 2006

HEC or MEC

Intervention Type DRUG

Any HEC or MEC, including aprepitant

Interventions

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HEC or MEC

Any HEC or MEC, including aprepitant

Intervention Type DRUG

Eligibility Criteria

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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.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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WEUKSTV4114

Identifier Type: OTHER

Identifier Source: secondary_id

115777

Identifier Type: -

Identifier Source: org_study_id

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