A Cross-sectional Survey to Evaluate Patient Knowledge of Safety Messages Included in the Patient Safety Brochure and Patient Alert Card for IMLYGIC®

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45945
• EU PAS number:
  EUPAS31213
• Study ID:
  45945
• Official title and acronym:
  A Cross-sectional Survey to Evaluate Patient Knowledge of Safety Messages Included in the Patient Safety Brochure and Patient Alert Card for IMLYGIC®
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Netherlands
• Study description:
  The overall objective of this study is to evaluate awareness of the IMLYGIC PEB and knowledge of the key messages included in the IMLYGIC PEB among physicians who completed the required IMLYGIC training.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 12 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 11/07/2018

Actual: 11/07/2018

Study start date

Planned: 30/04/2021

Actual: 01/04/2021

Data analysis start date

Planned: 08/11/2021

Actual: 27/09/2021

Date of final study report

Planned: 01/03/2022

Actual: 23/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20180062_01.02.06 Public Redacted Protocol Ver 1.0 2019-10-14 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)