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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

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ClinicalTrials.gov Identifier: NCT01480219
Recruitment Status : Completed
First Posted : November 28, 2011
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Non-Melanoma Skin Carcinoma Drug: voriconazole (Vfend) Other: no voriconazole (Vfend)

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.

Study Type : Observational
Actual Enrollment : 467 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : August 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Any Voriconazole Drug: voriconazole (Vfend)
Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
Other Name: Vfend
No Voriconazole Other: 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.
Other Name: Vfend



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480219


Sponsors and Collaborators
Pfizer
University of Southern California
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01480219     History of Changes
Other Study ID Numbers: A1501098
First Posted: November 28, 2011    Key Record Dates
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013
Last Verified: February 2013

Keywords provided by Pfizer:
voriconazole
non-melanoma skin cancer
confounding
statistical adjustment
risk adjustment
lung transplant
heart/lung transplant
immunosuppression

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors