N/A
N=467
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
Non-Melanoma Skin Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01480219 ↗Enrolled (actual)
467
Serious AEs
—
Results posted
Mar 2013
Primary outcome: Primary: Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) — 34; 23 participants — p=0.042
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- voriconazole (Vfend) (Drug); no voriconazole (Vfend) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) |
34; 23 | 0.042 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01480219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.