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Clinical Trials/NCT01480219
NCT01480219
Completed
Not Applicable

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, 2002-2009

Pfizer0 sites467 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
voriconazole (Vfend)
Conditions
Non-Melanoma Skin Carcinoma
Sponsor
Pfizer
Enrollment
467
Primary Endpoint
Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
March 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Any Voriconazole

Intervention: voriconazole (Vfend)

No Voriconazole

Intervention: no voriconazole (Vfend)

Outcomes

Primary Outcomes

Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)

Time Frame: Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8

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