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

Study identification

• EU PAS number:
  EUPAS5269
• Study ID:
  28286
• Official title and acronym:
  Evaluation of the Potential Association Between Voriconazole Use and Squamous Cell Carcinoma (SCC) of Skin Among Patients With Lung or Lung/Heart Transplants
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Belgium

  Canada

  France

  Germany

  Italy

  Netherlands

  Spain

  Switzerland

  United States
• Study description:
  This retrospective cohort study will assess the potential association between voriconazole use and the development of SCC of skin in patients with lung or heart/lung transplant. Patients will be identified from a multicenter, multinational database of lung transplant patients being developed at the University of Toronto, Canada. This database will contain retrospective patient-level data from several lung transplant centers in the EU and North America.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Health Network/University of Toronto

Multiple centres: 14 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 25/11/2013

Actual: 25/11/2013

Study start date

Planned: 09/12/2013

Actual: 09/12/2013

Data analysis start date

Planned: 19/05/2015

Date of final study report

Planned: 31/12/2015

Actual: 04/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)