Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g

NCT ID: NCT01480219

Last Updated: 2013-03-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.

Detailed Description

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N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.

Conditions

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Non-Melanoma Skin Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Any Voriconazole

voriconazole (Vfend)

Intervention Type DRUG

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

No Voriconazole

no voriconazole (Vfend)

Intervention Type OTHER

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Interventions

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voriconazole (Vfend)

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Intervention Type DRUG

no voriconazole (Vfend)

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Intervention Type OTHER

Other Intervention Names

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Vfend Vfend

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study.

Exclusion Criteria

* Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

Other Identifiers

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A1501098

Identifier Type: -

Identifier Source: org_study_id

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