RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title:

Characterization of Patients Following Acute Venous Thromboembolism (VTE) and Safety and Effectiveness of Dabigatran Etexilate (DE) in the Treatment and Secondary Prevention of Acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Comparison to Vitamin K Antagonist (VKA) in Routine Clinical Practice - RE-COVERY DVT/PE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596230
• Other study ID #: 1160.188
• Status: Completed
• Start date: November 5, 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7797
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations

2. Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)

3. Age >= 18 years

4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months

5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection

Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism (VTE)

2. Current participation in a clinical trial for VTE indication or current use of an unapproved drug

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Argentina	Hospital Universitario Austral	Buenos Aires
Argentina	Hospital Aleman	Caba
Argentina	Hospital Italiano	Caba
Argentina	ICBA	Caba
Argentina	Clinica Juncal	Temperley
Austria	LKH Feldkirch	Feldkirch
Austria	LKH-Univ. Hospital Graz	Graz
Austria	Medical University of Innsbruck	Innsbruck
Belgium	ULB Hopital Erasme	Bruxelles
Belgium	C.H.U. de Charleroi	Charleroi
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Belgium	H.-Hartziekenhuis	Lier
Brazil	Hospital Vera Cruz	Belo Horizonte
Brazil	Faculdade de Ciencias Medicas da UNICAMP	Campinas
Brazil	Hospital das Clinicas da Faculdade de Medicina - FMUSP	São Paulo
Bulgaria	UMHAT St. George	Plovdiv
Bulgaria	MHAT 'Tokuda Hospital Sofia', EAD	Sofia
Bulgaria	National Heart Hospital, Sofia	Sofia
Bulgaria	Hospital Trakia Park	Stara Zagora
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital - Hamilton Health Sciences	Hamilton	Ontario
Chile	SMOLAM	Santiago
Colombia	Fundacion Cardiomet CEQUIN	Armenia
Colombia	Centro de Investigaciones Clinicas S.A.S	Cali
Colombia	Unidad de Investigaciones Clínicas	Cali
Colombia	Centro de Diagnostico Cardilogico	Cartagena
Colombia	Asociacion IPS Medicos Internistas de Caldas	Manizales
Colombia	Promotora Medica Las Americas SA	Medellin
Czechia	Rehabilitacni nemocnice Beroun	Beroun
Czechia	Diagangio s.r.o.	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Nemocnice Milosrdnych bratri	Brno
Czechia	University Hospital Brno	Brno
Czechia	CTC Hodonin s.r.o.	Hodonin
Czechia	MUDr. Ladislav Busak	Louny
Czechia	MUDr. Stanislav Bulir	Mlada Boleslav
Czechia	Nemocnice Náchod	Nachod
Czechia	MUDr. Dalibor Musil	Olomouc
Czechia	Fakultni nemocnice Plzen	Plzen
Czechia	Vseobecna fakultni nemocnice V Praze	Praha 2
Czechia	Institute for Clinical and Experimental Medicine	Praha 4
Egypt	Dr. Ashraf ElGhandour Private Clinic	Alexandria
Egypt	Private Clinic - Dr. Shawky	Cairo
Egypt	Private Clinic Dr. Mervat Mattar	Cairo
Egypt	Private Clinic Mohamed Moussa	Cairo
Egypt	Private Clinic - Dr. Ahmed Hassouna	Kalyoub
Germany	Franziskus-Krankenhaus, Berlin	Berlin
Germany	Städtisches Klinikum Dresden	Dresden
Germany	Praxis für Gefäßmedizin	Goerlitz
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitätsklinikum Heidelberg	Heidelberg
Greece	University Hospital of Alexandroupolis	Alexandroupolis
Greece	"Laiko" Hospital, 1st Vascular Surgery Clinic of UOA	Athens
Greece	Athens Hospital of Chest Diseases "Sotiria"	Athens
Greece	Gen. Hosp. of Chest Diseases "Sotiria", 3rd Internal Med. Cl	Athens
Greece	University General Hospital Attikon	Athens
Greece	Univ. Gen. Hosp. of Ioannina	Ioannina
Greece	General University Hospital of Larissa	Larissa
Greece	General Hospital of Athens "G. Gennimatas"	Thessaloniki
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloniki
Hungary	Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat	Balassagyarmat
Hungary	Jahn Ferenc Del-Pest Hospital	Budapest
Hungary	St. Istvan Hospital, Budapest	Budapest
Hungary	University Debrecen Hospital	Debrecen
Hungary	Pest Megyei Flor Ferenc Hospital	Kistarcsa
Hungary	Dorottya Kanizsai Hospital	Nagykanizsa
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Csongrad Country Dr Bugyi Istvan Hosp.	Szentes
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet	Szolnok
Italy	Clinica Villa dei Fiori	Acerra
Italy	Ospedale san Lazzaro	Alba
Italy	Policlinico di Bari	Bari
Italy	P.O. di Castelfranco Veneto	Castelfranco Veneto
Italy	Ospedale Civile degli Infermi	Faenza (RA)
Italy	Azienda Ospedaliera Vito Fazzi	Lecce
Italy	Spedali Riuniti di Livorno	Livorno
Italy	Ospedali Riuniti di Ancona	Macerata
Italy	SUN Seconda Università Napoli	Napoli
Italy	Ospedale Gaetano Bernabeo	Ortona (CH)
Italy	Osp. Civico e Benfratelli "M. Ascoli e G. Di Cristina"	Palermo
Italy	Azienda Universitaria-Universita' La Sapienza	Roma
Italy	Univ. Cattolica del Sacro Cuore	Roma
Italy	Ospedale Civile	Sassari
Italy	A. O. Ospedale Circolo Fond. Macchi	Varese
Italy	A. O. Ospedale di Vimercate	Vimercate (Mi)
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital Seoul	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Liepaja Regional Hospital, Therapy Department	Liepaja
Latvia	Riga East University Hospital	Riga
Latvia	VSV Centrs, Stalte Private Practice, Talsi	Talsi
Latvia	Gita Rancane Doctor Practice in Cardiology	Ventspils
Lebanon	American University of Beirut Medical Center	Beirut
Lebanon	Bellevue Medical Center	Beirut
Lebanon	Clemenceau Medical Center	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	Ain Wazein Hospital	El-Chouf
Lebanon	Centre Hospitalier Universitaire Notre Dame de Secours	Jbeil
Lebanon	Hammoud Hospital University Medical Center	Saida
Malaysia	Hospital Raja Perempuan Zainab II, Kota Bharu	Kota Bahru
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Mexico	Clinica Vascular de Guadalajara	Guadalajara
Mexico	Instituto Jalisciense de Metabolismo, SC	Guadalajara
Mexico	Hospital_Angeles Centro Médicodel Potosí	San Luis Potosí
Mexico	Arke Estudios Clinicos SA de CV	Veracruz
Netherlands	OLVG, locatie Oosterpark	Amsterdam
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	St. Antonius ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Tweesteden Ziekenhuis, locatie Tilburg	Tilburg
New Zealand	Palmerston North Hospital	Palmerston North
Peru	Centro Medico Piura	Piura
Philippines	Makati Medical Center	Makati
Philippines	Philippine General Hospital	Manila, Philippines
Philippines	St. Luke's Medical Center, QC	Quezon City
Poland	Szpital Uniwersytecki nr 2 im.dr J. Biziela	Bydgoszcz
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny nr 4	Bytom
Poland	Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego	Ostroleka
Poland	4. Military Clinical Hospital with Polyclinic SP ZOZ	Wroclaw
Portugal	Hospital Ponta Delgada	Ponta Delgada
Portugal	Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António	Porto
Portugal	Hospital CUF Porto	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Romania	Private Practice Cardiology Dr. Pop Calin Florin	Baia Mare
Romania	Emergency University Hospital, Bucharest	Bucharest
Romania	Spitalul Clinic Municipal Cluj Napoca	Cluj-Napoca
Russian Federation	Regional Clinical Hospital#3	Chelyabinsk
Russian Federation	LLC Medical Union New Hospital	Ekaterinburg
Russian Federation	Medical Center "Angioline"	Ekaterinburg
Russian Federation	State Autonomous Institution of Health	Kemerovo
Russian Federation	City Clinical Hospital 1 (1-Gradskaya)	Moscow
Russian Federation	City Clinical Hospital n.a. V.V. Veresaev	Moscow
Russian Federation	Federal Research and Clinical Center of Special Medical Help	Moscow
Russian Federation	Hospital #15 named after O.M.Filatov	Moscow
Russian Federation	Novosibirsk Research Institute	Novosibirsk
Russian Federation	Rostov Medical University	Rostov on Don
Russian Federation	City Clinical Hospital No. 2, St. Petersburg	St. Petersburg
Russian Federation	City Hospital Saint Elizaveta, Dept. Endocrinology	St. Petersburg
Russian Federation	Dorozghnaya hospital	St.Petersburg
Russian Federation	St.Petersburg State Medical University n. a. II Mechnikov	St.Petersburg
Russian Federation	Clinical hospital of BGMU	Ufa
Russian Federation	Clinical emergency hospital #15	Volgograd
Russian Federation	Voronezh Regional Hospital N1	Voronezh
Russian Federation	Yaroslavl Regional Clin. Hospital	Yaroslavl
Saudi Arabia	King Fahad Medical City	Riyadh
Serbia	Clinical Center Bezanijska kosa, Belgrade	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Medical Center Zvezdara, Belgrade	Belgrade
Serbia	General Hospital MediGroup	Belgrade
Serbia	Institute for Cardiovascular diseases Dedinje	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Centre Nis	Nis
Serbia	Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol	Sremska Kamenica
Serbia	General Hospital Valjevo	Valjevo
Slovakia	ALIAN s.r.o., Bardejov, Dzupinova, Maria	Bardejov
Slovakia	KARDIO-ANGIO, s.r.o.	Levice
Slovakia	HeMart, s.r.o.	Martin
Slovakia	ABE-AS, s.r.o.	Nitra
Slovakia	MEDIVASA s.r.o., Outpatient Clinic, Zilina	Zilina
Slovenia	GH Celje	Celje
Slovenia	Univ. Clinic of Respiratory and Allergic Diseases, Golnik	Golnik
Slovenia	UCC Maribor	Maribor
Slovenia	Hospital Topolsica	Topolsica
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Thammasat University Hospital	Pathum Tani
Turkey	Ankara Atatürk Training and Research Hospital	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Uludag University Medical Faculty	Bursa
Turkey	Dicle University Medical Faculty	Diyarbakir
Turkey	Dr. Ersin Arslan Public Hospital	Gaziantep
Turkey	Suleyman Demirel University Medical Faculty	Isparta
Turkey	Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Zuhura	Istanbul
Turkey	Medipol University Medical Faculty	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Izmir Tepecik Training and Research Hospital	Izmir
Turkey	Karaman Government Hospital	Karaman
Turkey	Kayseri Training And Research Hospital	Kayseri
Turkey	RTE University Medical Faculty	Rize
Turkey	Ozel Uzmanlar Yalova Hospital	Yalova
United Arab Emirates	Thumbay Hospital	Dubai
United Kingdom	Barnsley Hospital	Barnsley
United Kingdom	North Hampshire Hospital	Basingstoke
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Queen's Hospital	Burton on Trent
United Kingdom	University Hospital of North Durham	Durham
United Kingdom	St Thomas' Hospital	London
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	North Tyneside General Hospital	North Shields
United Kingdom	Craigavon Area Hospital	Portadown
United Kingdom	Salisbury District Hospital	Salisbury
United States	Ellipsis Group	Atlanta	Georgia
United States	Fox Valley Clinical Research Center, LLC	Aurora	Illinois
United States	Johns Hopkins University	Baltimore	Maryland
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	The University Of Texas at Houston	Houston	Texas
United States	Research Associates of Jackson	Jackson	Tennessee
United States	University Of Mississippi Medical Center	Jackson	Mississippi
United States	Lycoming Internal Medicine, Inc	Jersey Shore	Pennsylvania
United States	Cardiology Center of Houston, PA	Katy	Texas
United States	Vidant Multispecialty Clnc Kinston	Kinston	North Carolina
United States	Cardiovascular Innovation and Research Center	Long Beach	California
United States	Wellstar Cardiovascular Medicine	Marietta	Georgia
United States	Cardio Voyage	McKinney	Texas
United States	Health and Life Research Institute, LLC	Miami	Florida
United States	Med-Care Research	Miami	Florida
United States	Pines Care Research Center	Pembroke Pines	Florida
United States	Sanford Cardiology	Sanford	North Carolina
United States	Tampa General Hospital	Tampa	Florida
United States	Waukesha Heart Institute	Waukesha	Wisconsin
Vietnam	Bach Mai hospital	Hanoi
Vietnam	115 People Hospital	Ho Chi Minh
Vietnam	Cho Ray Hospital	Ho Chi Minh
Vietnam	Gia Dinh People Hospital	Ho Chi Minh
Vietnam	University Medical Center of Ho Chi Minh City	Ho Chi Minh city

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  Egypt,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lebanon,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Slovenia,  Thailand,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective 1: Age	Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.; The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary	Objective 1: Sex	Sex of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.; The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary	Objective 1: Index Event	Type of index event (e.g., DVT or PE or DVT and PE) diagnosed at the time of acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.; The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary	Objective 1: Anticoagulant Treatment	Type of treatment received following acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.; The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary	Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs)	Incidence rate of ISTH (International Society on Thrombosis and Haemostasis) major bleeding and CRNMB (clinically relevant non major bleeding) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.; For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary	Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality	Incidence rate of Symptomatic Recurrent VTE (Venous Thromboembolism) including VTE related mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.; For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary	Objective 2: Incidence Rate of Recurrent DVT and/or PE	Incidence rate of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.; For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary	Objective 2: Incidence Rate of VTE-related Mortality	Incidence rate of VTE-related Mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.; For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary	Objective 2: Incidence Rate of All-cause Mortality	Incidence rate of all-cause mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.; For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).