A Cross-Sectional Post-Authorization Safety Study to Assess Healthcare Provider Awareness of Risks Associated with Zydelig® in the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28467
• EU PAS number:
  EUPAS16606
• Study ID:
  28467
• Official title and acronym:
  A Cross-Sectional Post-Authorization Safety Study to Assess Healthcare Provider Awareness of Risks Associated with Zydelig® in the European Union
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  GS-EU-313-4226: Non interventional, cross sectional survey of medical oncologists and hematologists in the European Union.The primary objective of this study was to determine the HCPs’ level of knowledge about the newly identified infection risks associated with Zydelig treatment and the corresponding recommendations to minimize these risks.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 142 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 09/01/2017

Actual: 09/01/2017

Study start date

Planned: 27/11/2017

Actual: 29/11/2017

Data analysis start date

Planned: 17/07/2018

Actual: 22/10/2018

Date of final study report

Planned: 20/12/2018

Actual: 12/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe, Ltd.

Study protocol

Initial protocol

protocol+GS-EU-313-4226-19apr2017

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)