An Active Safety Surveillance Program To Monitor Selected Events In Patients With Long-Term Voriconazole Use

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48463
• EU PAS number:
  EUPAS12624
• Study ID:
  48463
• Official title and acronym:
  An Active Safety Surveillance Program To Monitor Selected Events In Patients With Long-Term Voriconazole Use
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Contact details

Helle Kieler

Study contact

[e-mail]

Helle Kieler

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 21/01/2016

Data collection

Planned: 01/09/2016

Actual: 12/04/2016

Start date of data analysis

Actual: 14/11/2016

Date of final study report

Planned: 30/06/2022

Actual: 29/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

Voriconazole__NIS_Protocol_A1501103_ ENCEPP SDPP 12624

Updated protocol

Voriconazole__NIS_Protocol_A1501103_ Amend I_18June2015_EU PAS Register_Final

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)