Study identification

PURI

https://redirect.ema.europa.eu/resource/49944

EU PAS number

EUPAS17848

Study ID

49944

Official title and acronym

An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices (20150136)

DARWIN EU® study

No

Study countries

Austria
Czechia
Finland
France
Germany
Greece
Italy
Netherlands
Poland
Portugal
Sweden
Switzerland
United Kingdom

Study status

Finalised
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 interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Updated protocol
English (1.91 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)