ETNA-VTE Europe
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Prospective, single-arm, observational PASS; 18-M FU
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310 sites across 8 European countries
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2700 edoxaban-treated acute DVT and/or PE in/outpatients across multiple healthcare settings
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Edoxaban
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To quantify the real-world, long-term rate of VTE recurrence in patients prescribed edoxaban as part of acute VTE treatment
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Q4 2016a – Q4 2018
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Mortality, recurrent VTE, bleeding events, hepatic events, ADRs, hospitalisation for CV causes, edoxaban adherence/discontinuation
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O
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RIETE [21]
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Prospective, observational study; 3-M FU
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192 sites across 19 countries worldwide (78% of data from weSpain)
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6855 acute DVT and/or PE in/outpatients across a range of healthcare settings
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Standard therapy (pre-DOACs)
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To improve physician knowledge of the natural history of thromboembolic disease and develop scores to identify patients at high risk of complications
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March 2001 – Feb 2004
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Mortality, recurrent VTE, bleeding events
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C
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XALIA [22, 24]
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Prospective, observational PASS; 12-M FU
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Multiple sitesbin 21 countries worldwide
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5142 acute DVT (±PE) patients at hospitals or community care centres
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Rivaroxaban and standard therapy
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To assess the safety and effectiveness of rivaroxaban for the treatment of symptomatic DVT
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June 2012 – March 2014
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Mortality, recurrent VTE, bleeding events, CV events, treatment satisfaction/adherence/discontinuation, healthcare resource utilisation, TEAEs
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C
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PREFER in VTE [13, 14]
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Prospective, observational study; 12-M FU
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381 sites across 7 European countries
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3455 acute DVT and/or PE in/outpatients across a range of healthcare settings
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DOACs (pre-edoxaban)
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To explore patient characteristics, VTE management strategies, healthcare resource usage and associated costs
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Jan 2013 – Jan 2014
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Mortality, recurrent VTE, bleeding events, MI, stroke, SE, post- thrombotic syndrome, CV events
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C
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GARFIELD-VTE [20, 25]
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Prospective, observational study; two sequential cohorts; 3-Y FU
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415 sites across 28 countries worldwide
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10,878 acute DVT and/or PE in/outpatients across a range of healthcare settings
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Standard therapy and DOACs
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To identify regional/temporal treatment variations and assess their impact on clinical/economic outcomes
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July 2014 – Sept 2016
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Mortality, recurrent VTE, bleeding events, post-thrombotic syndrome, chronic thromboembolic pulmonary hypertension, healthcare resource utilisation
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O
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RE-COVERY [23, 26]
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Prospective, observational PASS; 12-M FU
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~17b sites in 5 countries worldwide
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~ 8000 acute DVT and/or PE patients
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Dabigatran and VKA
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To characterise the VTE patient population and compare the safety and effectiveness of dabigatran to VKA
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Nov 2015 – Dec 2018
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Mortality, recurrent VTE, bleeding events
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O
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