Study identification

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

Finalised
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Hala Sayed

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Saudi Limited 100% Funding
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only