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

Study identification

• 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 institutions and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Actual:28/02/2012

Study start date

Planned:01/01/2004

Actual:01/01/2004

Date of final study report

Actual:15/11/2013

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)