Rivaroxaban for the treatment of deep vein thrombosis and ...

o EINSTEIN-DVT dose-ranging study 36 did not use 15mg bid for the first 21 days as
indicated by the license, but rather used 20mg throughout the study.
Outcomes reported are not defined in a way comparable to the outcomes reported in the
pivotal EINSTEIN-DVT trial. 21
Both of these studies are described and discussed in detail in Appendix 1.
Two studies, both reported in the same journal article, 21 were included in the analysis and
interpretation of the MS. Of these, the ERG consider the most important and relevant information to
come from the EINSTEIN-DVT 21 study. The EINSTEIN-Ext 21 has some limitations, outlined in
section 3.1, mainly to do with study population and comparator, but does provided some data of
relevance. Data relating to the population of interest (DVT patients) within EINSTEIN-Ext have been
made available to the ERG after a request to the manufacturer and are presented in section 4.2.2.3.
However, the analyses provided were limited. 17 As both trials have some relevance, data from both is
presented here, including the data for the whole EINSTEIN-Ext trial, as well as the DVT subgroup of
interest.
It should be noted that the ERG have not had access to the European public assessment report (EPAR)
(these are expected to be made available in early February 2012). Nor have the ERG had access to
correspondence between the European Medicines Agency (EMA) and the manufacturer in relation to
the licensing of the product. The manufacturer state that discussions with the EMA centred on the
design and conduct of the phase III trials. It is unclear if/when these documents will be made
available.
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