Giunta, Diego Hernan http://orcid.org/0000-0002-8427-6033
Karlsson, Pär http://orcid.org/0000-0002-7177-1713
Younus, Muhammad
Berglind, Ina Anveden
Kieler, Helle http://orcid.org/0000-0001-9338-7133
Reutfors, Johan http://orcid.org/0000-0003-1372-4262
Funding for this research was provided by:
Karolinska Institute
Article History
Received: 2 June 2023
Accepted: 28 December 2023
First Online: 5 January 2024
Declarations
:
: This study was conducted in compliance with the Declaration of Helsinki. The study protocol was approved by the Regional Ethical Board in Stockholm (2016/397–31). This research was part of the Post-Authorization Safety Study (PASS) titled “An Active Safety Surveillance Program to Monitor Selected Events in Patients with Long-Term Voriconazole Use” (protocol number A1501103), and was registered under EUPAS12624. Written informed consent, granting access to each specific medical record, was obtained from the responsible heads of each clinic accountable for the treatment of the patients and their medical records. Considering the retrospective nature of the study, the ethics committee waived the requirement for written informed consent from the patients. The medical records and the data were maintained confidentially and accessed only by the research team for the purpose of this study.
: Not applicable.
: DHG, PK, HK and JR are employees at the Centre for Pharmacoepidemiology, which receives grants from several entities (pharmaceutical companies, regulatory authorities and contract research organizations) for the performance of drug safety and drug utilization studies, unrelated to this work.MY is an employee and own stocks in Pfizer Inc.IAB has no competing interest to declare.