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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 467
- Primary Endpoint
- Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) (Drug)
No Voriconazole
Intervention: no voriconazole (Vfend) (Other)
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
Secondary Outcomes
No secondary outcomes reported