An Observational Study to Assess the Effectiveness of the Neulasta® Patient Alert Card and to Measure Medication Errors Related to the Use of the Neulasta® On-Body Injector (20170701)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50359
• EU PAS number:
  EUPAS28762
• Study ID:
  50359
• Official title and acronym:
  An Observational Study to Assess the Effectiveness of the Neulasta® Patient Alert Card and to Measure Medication Errors Related to the Use of the Neulasta® On-Body Injector (20170701)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Netherlands

  Slovakia

  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/03/2019

Actual: 15/03/2019

Study start date

Planned: 31/03/2020

Actual: 31/03/2020

Data analysis start date

Planned: 31/03/2022

Actual: 13/01/2022

Date of final study report

Planned: 30/04/2022

Actual: 09/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

csr-20170701-protocol_public-redacted-approved-version

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)