Long Term Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20180238) (Blinatumomab Long Term PMS Japan)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33033
• EU PAS number:
  EUPAS29685
• Study ID:
  33033
• Official title and acronym:
  Long Term Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20180238) (Blinatumomab Long Term PMS Japan)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  To investigate the incidence of CTCAE grade ≥ 3 events of each safety specification of the Japan Risk Management Plan (neurologic events, infections, cytokine release syndrome, tumor lysis syndrome, myelosuppression and Pancreatitis) in patients receiving long term administration of blinatumomab
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 27/11/2018

Actual: 18/12/2018

Study start date

Planned: 20/12/2019

Actual: 08/01/2020

Data analysis start date

Planned: 30/09/2024

Actual: 30/09/2024

Date of final study report

Planned: 31/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Protocol-Published Original blinatumomab 20180238 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only