Status: Finalised First registered on: 06/10/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS7619
Official titleRisk 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.
Study title acronym
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: EMA, Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/02/2012
Start date of data collection01/01/200401/01/2004
Start date of data analysis
Date of interim report, if expected
Date of final study report15/11/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSTADA Arzneimittel AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)004942121856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Schink 
First name Tania 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)004942121856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de 
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