A cross-sectional survey of patients and caregivers receiving Blincyto in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimisation measures

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32768
• EU PAS number:
  EUPAS17829
• Study ID:
  32768
• Official title and acronym:
  A cross-sectional survey of patients and caregivers receiving Blincyto in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimisation measures
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Educational materials targeting patients /caregivers and HCPs (physicians, nurses and pharmacists) have been implemented to help minimize the risks of neurological events and the potential for medication errors (MEs). A survey of patients and caregivers will help assess whether the processes put in place for the Blincyto educational efforts are effective in achieving a sufficient level of receipt and knowledge.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/09/2016

Actual: 05/09/2016

Study start date

Planned: 29/09/2017

Actual: 10/08/2017

Data analysis start date

Planned: 29/03/2019

Actual: 28/03/2019

Date of final study report

Planned: 29/11/2019

Actual: 13/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20150228 Protocol Ver 1 0 2016-10-18 redaction_Marked

Updated protocol

01.02.06 Public Redacted Protocol Ver 1.0 2016-11-06 English

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)