Study identification

EU PAS number

EUPAS1000000814

Study ID

1000000814

Official title and acronym

DARWIN EU® - Time to onset of thromboembolic events in adults with selected types of cancer

DARWIN EU® study

Yes

Study countries

Belgium
Denmark
Estonia
Finland
Germany
Netherlands
Spain
United Kingdom

Study description

Thromboembolic events are a common complication for individuals with cancer, with risk varying according to the cancer type, suggesting that mechanisms that play a role in the occurrence of these events may be specific to the cancer type itself or its treatment mechanisms. Haematological malignancies and lung, pancreas, stomach, bowel, and brain cancers are generally associated with a high risk of thrombosis, whilst prostate and breast cancers are associated with low risk of thrombosis.
When a safety signal of a thromboembolic event appears in cancer populations, it can be challenging to assess a potential association with the oncologic treatment without reliable information on the background risk. This study is intended to address this knowledge gap by generating evidence on the time to onset of different venous thromboembolic events among adults with selected cancer types.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Anton Barchuk

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable