Status: Ongoing First registered on: 01/03/2016
Last updated on: 26/02/2018
1. Study identification
EU PAS Register NumberEUPAS12624
Official titleAn Active Safety Surveillance Program To Monitor Selected Events In Patients With Long-Term Voriconazole Use
Study title acronym
Study typeObservational study
Brief description of the studyThis is an observational cohort study examining the safety profile of Voriconazole in adults and pediatric patients, particularly those with long-term Voriconazole use (≥180 days of treatment). The study will utilize data from Swedish National Registers including the Swedish Prescribed Drug Register (SPDR), the Swedish Cancer Register (SCR), the National Patient Register (NPR), the Causes of Death Register (CDR), and the Registers of Statistics Sweden.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine/Clinical epidemiology unit
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/en/meds/centre-for-pharmacoepidemiology
Details of (Primary) lead investigator
Title Professor
Last name Kieler
First name Helle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/01/2016
Start date of data collection01/09/201612/04/2016
Start date of data analysis14/11/2016
Date of interim report, if expected
Date of final study report30/06/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Kieler
First name Helle
Address line 1Department of Medicine Solna
Address line 2T2 Karolinska University Hospital 
Address line 3 
CityStockholm 
Postcode171 76 
CountrySweden
Phone number (incl. country code)46736334492 
Alternative phone number 
Fax number (incl. country code) 
Email address Helle.Kieler@ki.se
Public Enquiries
Title Dr 
Last name Younus 
First name Muhammad 
Address line 1500 Arcola Road 
Address line 2 
Address line 3 
CityCollegeville 
Postcode19426 
CountryUnited States 
Phone number (incl. country code)14848656663 
Alternative phone number 
Fax number (incl. country code) 
Email address muhammad.younus2@pfizer.com 
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