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
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.
Study protocol
Initial protocol
English (1.03 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only