Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000440

EU PAS number

EUPAS1000000440

Study ID

1000000440

Official title and acronym

DARWIN EU® – Incidence rates of venous thromboembolic events in patients with selected cancers

DARWIN EU® study

Yes

Study countries

Belgium
Denmark
Estonia
Finland
Germany
Netherlands
Spain
United Kingdom

Study description

The association between cancer and thromboembolic events was assessed in various studies. In a large cohort of cancer patients, the incidence of thromboembolic events was found to be higher in cases of renal cell, ovarian, pancreatic, stomach, and lung cancers, as well as acute myelogenous leukemia and non-Hodgkin lymphoma during the four months immediately preceding the cancer diagnosis (White, 2005).

The prevalence of thromboembolic events at the time of diagnosis was highest for pancreatic cancer and lowest for breast cancer in another registry-based study (Ohashi, 2020). The risk of thromboembolic events was increased for all cancer types in another study conducted in the United States (Petterson, 2015).
The incidence of thromboembolic events increased during the first few months of chemotherapy in a cohort of cancer patients followed for up to 12 months, with higher odds observed in pancreatic, gastric, and lung cancers (Khorana, 2013).

Certain cancer medications have also been associated with higher risks of thromboembolic events (Nalluri, 2008; Khorana, 2013). Additionally, major surgery is known to be associated with thromboembolic events, with an increased risk that persists for 90 to 120 days post-surgery (Björklund, 2024).

A high rate of recurrent thromboembolic events is observed over time following the discontinuation of anticoagulant therapy in patients with cancer-associated thrombosis (van Hylckama Vlieg, 2023).
When a potential safety signal of this nature (i.e. VTE associated with the use of a therapy) emerges in cancer populations, it can be challenging to assess the potential association without recent and reliable information on the background risk. This study addresses this knowledge gap by generating background incidence rates of thromboembolic events among patients 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:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C3-005_Thromboembolic events in cancers_V5.pdf

English (993.8 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable