Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in Saudi Arabia

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000266
• EU PAS number:
  EUPAS1000000266
• Study ID:
  1000000266
• Official title and acronym:
  Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in Saudi Arabia
• DARWIN EU® study:
  No
• Study countries:
  Saudi Arabia
• Study description:
  Pfizer Saudi Limited will conduct a non-interventional, cross-sectional survey of healthcare professionals (HCPs) to evaluate the effectiveness of the aRMMs being implemented across Saudi Arabia to mitigate the risks of phototoxicity, SCC of the skin and hepatic toxicity in patients prescribed voriconazole (Vfend®).; ; To ensure that the risks are adequately managed, aRMMs in Saudi Arabia have been implemented since Feb 2023. The aRMM material distribution has been started on 05-Feb-2023 and continued until 05-Feb-2024 to the relevant HCPs who may initiate or manage patients on Vfend®. The RM tools are the HCP Checklist, HCP Question & Answer (Q&A) Brochure and Patient Alert Card. HCPs who the materials are targeting will be invited to participate in the survey.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 29/04/2024

Study start date

Planned: 15/11/2024

Actual: 11/11/2024

Date of final study report

Planned: 30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Saudi Limited 100% Funding

Study protocol

Initial protocol

A1501110_Non Interventional Study Protocol (Combined)_V1_16AUG2024_Redacted.pdf

Regulatory

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