Evaluation of the Effectiveness of a Xospata Routine Risk Minimisation Measure (RMM) and an Additional Risk Minimisation Measure (aRMM): A Cross-sectional Survey Study among Healthcare Professionals to Assess Awareness and Knowledge

Study identification

• EU PAS number:
  EUPAS37354
• Study ID:
  50133
• Official title and acronym:
  Evaluation of the Effectiveness of a Xospata Routine Risk Minimisation Measure (RMM) and an Additional Risk Minimisation Measure (aRMM): A Cross-sectional Survey Study among Healthcare Professionals to Assess Awareness and Knowledge
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France

  Germany

  Italy

  Netherlands

  Sweden
• Study description:
  This study will assess the awareness and knowledge of three selected safety concerns (Posterior Reversible Encephalopathy Syndrome PRES, QT prolongation, and Differentiation Syndrome DS) among HCPs. The primary objective is to describe HCPs' awareness and knowledge of the three selected safety responses (PRES, QT prolongation, and DS) associated with Xospata use. The secondary objective is to assess the percentage of HCPs that recall receiving and/or reviewing the Xospata routine RMM (SmPC) and the Xospata aRMM (HCP educational materials).
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Study timelines

Date when funding contract was signed

Actual:20/03/2020

Study start date

Planned:08/07/2021

Actual:30/09/2021

Data analysis start date

Planned:09/07/2022

Actual:17/08/2022

Date of final study report

Planned:11/11/2022

Actual:21/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

2215-PV-0001