Study identification

PURI

https://redirect.ema.europa.eu/resource/50133

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 institution and networks

Institutions

Contact details

Kimball Samantha

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Astellas
Study protocol
Initial protocol

Xospata_NI-PASS Protocol_v2.0_09Dec2020 Redacted

English (1.95 MB - PDF)View document
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)