Study identification

PURI

https://redirect.ema.europa.eu/resource/29004

EU PAS number

EUPAS7619

Study ID

29004

Official title and acronym

Risk of Venous Thromboembolism and All-Cause Mortality in Cancer Patients Treated with Epoetins either with or without Transfusions versus Cancer Patients Treated with Transfusions alone

DARWIN EU® study

No

Study countries

Germany

Study description

The objective of this study was to assess the risk of venous thromboembolism (VTE) and all-cause mortality in incident cancer patients receiving epoetin treatment either with or without additional transfusions compared to cancer patients receiving blood transfusions alone in Germany in a real world setting for the time period between January 01, 2004 and December 31, 2009.A nested case-control analysis using conditional logistic regression was conducted to estimate adjusted ORs with corresponding 95% CIs for VTE and treatment with epoetin and/or transfusions in two different time windows. Further, multivariable Cox proportional hazard regression models were applied to assess the risk of all-cause mortality comparing patients receiving epoetin treatment to those treated with transfusions. Therefore a respective time-dependent exposure variable was included.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Tania Schink

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

STADA Arzneimittel AG
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)