Evaluation of the Potential Association Between Voriconazole Use and Squamous Cell Carcinoma (SCC) of Skin Among Patients With Lung or Lung/Heart Transplants

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VFEND
• Medical condition to be studied:
  Lung transplant

  Heart and lung transplant

Population studied

• Short description of the study population:
  Patients undergoing Lung Transplant at the study transplant centers between 1 January, 2005 and 31 December, 2008
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  471

Study design details

• Main study objective:
  To assess the potential association between voriconazole use and the development of SCC of the skin in patients with lung or heart/lung transplant.
• Outcomes:
  To assess the potential association between voriconazole use and the development of SCC of the skin in patients with lung or heart/lung transplant. To assess the potential association between voriconazole use and the development of melanoma in patients with lung or heart/lung transplant
• Data analysis plan:
  Descriptive statistics will be presented to describe patient characteristics such as age at transplant, sex, race/ethnicity, reasons for transplant, co-morbid conditions and immunosuppressive agents used in the voriconazole exposed and unexposed cohorts. Univariate and multivariate Cox proportional hazard regression analyses will be conducted to assess the association between voriconazole and SCC of the skin.