Clinical trial NCT00694382: Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Official title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Cancer
Keywords: chemotherapy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 3212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Detailed description: Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).

The study period per participant was variable depending on the duration of chemotherapy. It included:

* a screening period up to 3 weeks,
* a double-blind treatment period,
* a follow-up period of 1 month.

Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).

Eligibility criteria: Inclusion Criteria:

Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy

Exclusion Criteria:

* Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
* High risk of bleeding;
* Severe renal impairment (estimated creatinine clearance \<30 mL/min);
* ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4;
* Major surgery within 4 weeks before randomization;
* Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\].

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
timeFrame: From randomization up to 3 days after last study drug injection
measure: Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
timeFrame: From randomization up to 3 days after last study drug injection
Secondary outcomes:
measure: Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
timeFrame: From randomization up to 3 days after last study drug injection
measure: Percentage of Participants Who Experienced Clinically Relevant Bleedings
timeFrame: From first study drug injection up to 3 days after last study drug injection
measure: Overall survival [OS]
timeFrame: From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first
Other outcomes:
measure: Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
timeFrame: From first study drug injection up to 3 days after last study drug injection
measure: Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
timeFrame: From first study drug injection up to 3 days after last study drug injection
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840006
state: Alabama
city: Casa Grande
country: United States
facility: Investigational Site Number 840007
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840060
state: Arizona
city: Fountain Valley
country: United States
facility: Investigational Site Number 840050
state: California
city: Fullerton
country: United States
facility: Investigational Site Number 840072
state: California
city: Indian Wells
country: United States
facility: Investigational Site Number 840037
state: California
city: La Verne
country: United States
facility: Investigational Site Number 840069
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840009
state: California
city: Oceanside
country: United States
facility: Investigational Site Number 840001
state: California
city: Rancho Mirage
country: United States
facility: Investigational Site Number 840011
state: California
city: West Covina
country: United States
facility: Investigational Site Number 840029
state: California
city: Norwich
country: United States
facility: Investigational Site Number 840005
state: Connecticut
city: Torrington
country: United States
facility: Investigational Site Number 840064
state: Connecticut
city: Woodbridge
country: United States
facility: Investigational Site Number 840038
state: Connecticut
city: Washington
country: United States
facility: Investigational Site Number 840052
state: District of Columbia
city: Washington
country: United States
facility: Investigational Site Number 840025
state: District of Columbia
city: Clearwater
country: United States
facility: Investigational Site Number 840074
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840019
state: Florida
city: Rockledge
country: United States
facility: Investigational Site Number 840051
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840073
state: Florida
city: Roswell
country: United States
facility: Investigational Site Number 840070
state: Georgia
city: Park Ridge
country: United States
facility: Investigational Site Number 840016
state: Illinois
city: Quincy
country: United States
facility: Investigational Site Number 840028
state: Illinois
city: Skokie
country: United States
facility: Investigational Site Number 840008
state: Illinois
city: Goshen
country: United States
facility: Investigational Site Number 840033
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840010
state: Indiana
city: Louisville
country: United States
facility: Investigational Site Number 840014
state: Kentucky
city: Mount Sterling
country: United States
facility: Investigational Site Number 840048
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site Number 840047
state: Louisiana
city: Ruston
country: United States
facility: Investigational Site Number 840032
state: Louisiana
city: Bethesda
country: United States
facility: Investigational Site Number 840042
state: Maryland
city: Easton
country: United States
facility: Investigational Site Number 840066
state: Maryland
city: Tupelo
country: United States
facility: Investigational Site Number 840059
state: Mississippi
city: Rochester
country: United States
facility: Investigational Site Number 840024
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number 840031
state: New York
city: Durham
country: United States
facility: Investigational Site Number 840020
state: North Carolina
city: Durham
country: United States
facility: Investigational Site Number 840021
state: North Carolina
city: High Point
country: United States
facility: Investigational Site Number 840026
state: North Carolina
city: Bismarck
country: United States
facility: Investigational Site Number 840046
state: North Dakota
city: Middletown
country: United States
facility: Investigational Site Number 840003
state: Ohio
city: Sylvania
country: United States
facility: Investigational Site Number 840022
state: Ohio
city: East Providence
country: United States
facility: Investigational Site Number 840075
state: Rhode Island
city: Beaumont
country: United States
facility: Investigational Site Number 840067
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840004
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840034
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840035
state: Texas
city: Kennewick
country: United States
facility: Investigational Site Number 840063
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840018
state: Washington
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032006
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032003
city: Rosario
country: Argentina
facility: Investigational Site Number 032004
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032005
city: Tucuman
country: Argentina
facility: Investigational Site Number 032007
city: Adelaide
country: Australia
facility: Investigational Site Number 036004
city: Bedford Park
country: Australia
facility: Investigational Site Number 036002
city: Box Hill
country: Australia
facility: Investigational Site Number 036001
city: Lismore
country: Australia
facility: Investigational Site Number 036009
city: Perth
country: Australia
facility: Investigational Site Number 036007
city: Ringwood East
country: Australia
facility: Investigational Site Number 036006
city: Westmead
country: Australia
facility: Investigational Site Number 036008
city: Woodville
country: Australia
facility: Investigational Site Number 036003
city: Woolloongabba
country: Australia
facility: Investigational Site Number 036005
city: Graz
country: Austria
facility: Investigational Site Number 040002
city: Wien
country: Austria
facility: Investigational Site Number 040003
city: Wien
country: Austria
facility: Investigational Site Number 040004
city: Gomel
country: Belarus
facility: Investigational Site Number 112002
city: Minsk
country: Belarus
facility: Investigational Site Number 112003
city: Minsk
country: Belarus
facility: Investigational Site Number 112001
city: Vitebsk
country: Belarus
facility: Investigational Site Number 112004
city: Bonheiden
country: Belgium
facility: Investigational Site Number 056008
city: Brussels
country: Belgium
facility: Investigational Site Number 056011
city: Gent
country: Belgium
facility: Investigational Site Number 056005
city: Haine-Saint-Paul
country: Belgium
facility: Investigational Site Number 056010
city: Kortrijk
country: Belgium
facility: Investigational Site Number 056006
city: Liège
country: Belgium
facility: Investigational Site Number 056009
city: Merksem
country: Belgium
facility: Investigational Site Number 056004
city: Oostende
country: Belgium
facility: Investigational Site Number 056003
city: Ottignies
country: Belgium
facility: Investigational Site Number 056012
city: Sint Niklaas
country: Belgium
facility: Investigational Site Number 056002
city: Belo Horizonte
country: Brazil
facility: Investigational Site Number 076002
city: Curitiba
country: Brazil
facility: Investigational Site Number 076022
city: Curitiba
country: Brazil
facility: Investigational Site Number 076015
city: Florianopolis
country: Brazil
facility: Investigational Site Number 076012
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076001
city: Goiania
country: Brazil
facility: Investigational Site Number 076009
city: Goiania
country: Brazil
facility: Investigational Site Number 076007
city: Goiania
country: Brazil
facility: Investigational Site Number 076016
city: Ijui
country: Brazil
facility: Investigational Site Number 076024
city: Joinville
country: Brazil
facility: Investigational Site Number 076003
city: Londrina
country: Brazil
facility: Investigational Site Number 076010
city: Passo Fundo
country: Brazil
facility: Investigational Site Number 076026
city: Passo Fundo
country: Brazil
facility: Investigational Site Number 076027
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076023
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076020
city: Salvador
country: Brazil
facility: Investigational Site Number 076014
city: Salvador
country: Brazil
facility: Investigational Site Number 076018
city: Santo Andre
country: Brazil
facility: Investigational Site Number 076011
city: Sao Jose Dos Campos
country: Brazil
facility: Investigational Site Number 076006
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076008
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076017
city: Taguatinga
country: Brazil
facility: Investigational Site Number 076004
city: Rousse
country: Bulgaria
facility: Investigational Site Number 100001
city: Varna
country: Bulgaria
facility: Investigational Site Number 100003
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124008
city: Kelowna
country: Canada
facility: Investigational Site Number 124007
city: Moncton
country: Canada
facility: Investigational Site Number 124010
city: Montreal
country: Canada
facility: Investigational Site Number 124003
city: Ottawa
country: Canada
facility: Investigational Site Number 124002
city: Owen Sound
country: Canada
facility: Investigational Site Number 124009
city: Rimouski
country: Canada
facility: Investigational Site Number 124006
city: Saint John
country: Canada
facility: Investigational Site Number 124013
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124001
city: Victoria
country: Canada
facility: Investigational Site Number 124012
city: Weston
country: Canada
facility: Investigational Site Number 124011
city: Temuco
country: Chile
facility: Investigational Site Number 152002
city: Beijing
country: China
facility: Investigational Site Number 156014
city: Beijing
country: China
facility: Investigational Site Number 156008
city: Beijing
country: China
facility: Investigational Site Number 156022
city: Changchun
country: China
facility: Investigational Site Number 156031
city: Chengdu
country: China
facility: Investigational Site Number 156021
city: Chongqing
country: China
facility: Investigational Site Number 156019
city: Dalian
country: China
facility: Investigational Site Number 156003
city: Guangzhou
country: China
facility: Investigational Site Number 156025
city: Hangzhou
country: China
facility: Investigational Site Number 156026
city: Nanning
country: China
facility: Investigational Site Number 156030
city: Qingdao
country: China
facility: Investigational Site Number 156029
city: Shanghai
country: China
facility: Investigational Site Number 156024
city: Shanghai
country: China
facility: Investigational Site Number 156028
city: Shanghai
country: China
facility: Investigational Site Number 156020
city: Shanghai
country: China
facility: Investigational Site Number 156011
city: Shantou
country: China
facility: Investigational Site Number 156013
city: Suzhou
country: China
facility: Investigational Site Number 156012
city: Xi'An
country: China
facility: Investigational Site Number 156004
city: Xi'An
country: China
facility: Investigational Site Number 156009
city: Yinchuan
country: China
facility: Investigational Site Number 156027
city: Bogota
country: Colombia
facility: Investigational Site Number 170010
city: Manizales
country: Colombia
facility: Investigational Site Number 170005
city: Medellin
country: Colombia
facility: Investigational Site Number 170002
city: Medellin
country: Colombia
facility: Investigational Site Number 170006
city: Medellín
country: Colombia
facility: Investigational Site Number 170007
city: Monteria
country: Colombia
facility: Investigational Site Number 170008
city: Pereira
country: Colombia
facility: Investigational Site Number 170004
city: Pula
country: Croatia
facility: Investigational Site Number 191006
city: Rijeka
country: Croatia
facility: Investigational Site Number 191005
city: Varazdin
country: Croatia
facility: Investigational Site Number 191007
city: Zadar
country: Croatia
facility: Investigational Site Number 191003
city: Zagreb
country: Croatia
facility: Investigational Site Number 191008
city: Zagreb
country: Croatia
facility: Investigational Site Number 191001
city: Zagreb
country: Croatia
facility: Investigational Site Number 191004
city: Hradec Kralove
country: Czech Republic
facility: Investigational Site Number 203004
city: Kolin
country: Czech Republic
facility: Investigational Site Number 203008
city: Nova Ves Pod Plesi
country: Czech Republic
facility: Investigational Site Number 203007
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203003
city: Herlev
country: Denmark
facility: Investigational Site Number 208001
city: Tallinn
country: Estonia
facility: Investigational Site Number 233001
city: Turku
country: Finland
facility: Investigational Site Number 246001
city: Antibes
country: France
facility: Investigational Site Number 250002
city: Colmar
country: France
facility: Investigational Site Number 250010
city: Gap
country: France
facility: Investigational Site Number 250020
city: Lille Cedex
country: France
facility: Investigational Site Number 250005
city: Lille Cedex
country: France
facility: Investigational Site Number 250025
city: Lille Cedex
country: France
facility: Investigational Site Number 250012
city: Lyon
country: France
facility: Investigational Site Number 250003
city: Marseille
country: France
facility: Investigational Site Number 250001
city: Montpellier Cedex
country: France
facility: Investigational Site Number 250024
city: Paris Cedex 10
country: France
facility: Investigational Site Number 250006
city: Paris Cedex 10
country: France
facility: Investigational Site Number 250027
city: Paris Cedex 14
country: France
facility: Investigational Site Number 250004
city: Reims
country: France
facility: Investigational Site Number 250021
city: Rouen
country: France
facility: Investigational Site Number 250019
city: Saint Gregoire
country: France
facility: Investigational Site Number 250017
city: Vandoeuvre Les Nancy
country: France
facility: Investigational Site Number 250014
city: Augsburg
country: Germany
facility: Investigational Site Number 276012
city: Berlin
country: Germany
facility: Investigational Site Number 276025
city: Berlin
country: Germany
facility: Investigational Site Number 276016
city: Berlin
country: Germany
facility: Investigational Site Number 276002
city: Berlin
country: Germany
facility: Investigational Site Number 276029
city: Bochum
country: Germany
facility: Investigational Site Number 276004
city: Dresden
country: Germany
facility: Investigational Site Number 276014
city: Dresden
country: Germany
facility: Investigational Site Number 276009
city: Essen
country: Germany
facility: Investigational Site Number 276030
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276005
city: Gauting
country: Germany
facility: Investigational Site Number 276032
city: Halle/Saale
country: Germany
facility: Investigational Site Number 276038
city: Halle
country: Germany
facility: Investigational Site Number 276034
city: Hamburg
country: Germany
facility: Investigational Site Number 276037
city: Hannover
country: Germany
facility: Investigational Site Number 276007
city: Köln
country: Germany
facility: Investigational Site Number 276006
city: Leer
country: Germany
facility: Investigational Site Number 276020
city: Leipzig
country: Germany
facility: Investigational Site Number 276010
city: Magdeburg
country: Germany
facility: Investigational Site Number 276017
city: Mannheim
country: Germany
facility: Investigational Site Number 276011
city: Minden
country: Germany
facility: Investigational Site Number 276003
city: München
country: Germany
facility: Investigational Site Number 276021
city: München
country: Germany
facility: Investigational Site Number 276019
city: München
country: Germany
facility: Investigational Site Number 276015
city: Neumünster
country: Germany
facility: Investigational Site Number 276013
city: Oldenburg
country: Germany
facility: Investigational Site Number 276022
city: Paderborn
country: Germany
facility: Investigational Site Number 276035
city: Passau
country: Germany
facility: Investigational Site Number 276031
city: Rosenheim
country: Germany
facility: Investigational Site Number 276023
city: Singen
country: Germany
facility: Investigational Site Number 276008
city: Westerstede
country: Germany
facility: Investigational Site Number 276024
city: Athens
country: Greece
facility: Investigational Site Number 300004
city: Heraklion
country: Greece
facility: Investigational Site Number 300003
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300002
city: Hong Kong
country: Hong Kong
facility: Investigational Site Number 344001
city: Budapest
country: Hungary
facility: Investigational Site Number 348005
city: Budapest
country: Hungary
facility: Investigational Site Number 348006
city: Budapest
country: Hungary
facility: Investigational Site Number 348009
city: Budapest
country: Hungary
facility: Investigational Site Number 348004
city: Farkasgyepu
country: Hungary
facility: Investigational Site Number 348010
city: Gyula
country: Hungary
facility: Investigational Site Number 348001
city: Mátraháza
country: Hungary
facility: Investigational Site Number 348012
city: Sopron
country: Hungary
facility: Investigational Site Number 348003
city: Szikszó
country: Hungary
facility: Investigational Site Number 348008
city: Szolnok
country: Hungary
facility: Investigational Site Number 348011
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 348007
city: Bangalore
country: India
facility: Investigational Site Number 356006
city: Bangalore
country: India
facility: Investigational Site Number 356008
city: Bhopal
country: India
facility: Investigational Site Number 356009
city: Chennai
country: India
facility: Investigational Site Number 356018
city: Chennai
country: India
facility: Investigational Site Number 356020
city: Coimbatore
country: India
facility: Investigational Site Number 356019
city: Hyderabad
country: India
facility: Investigational Site Number 356015
city: Hyderabad
country: India
facility: Investigational Site Number 356025
city: Jaipur
country: India
facility: Investigational Site Number 356011
city: Kochi
country: India
facility: Investigational Site Number 356014
city: Kolkata
country: India
facility: Investigational Site Number 356003
city: Kolkata
country: India
facility: Investigational Site Number 356013
city: Kolkata
country: India
facility: Investigational Site Number 356017
city: Madurai
country: India
facility: Investigational Site Number 356005
city: Miraj
country: India
facility: Investigational Site Number 356016
city: Mumbai
country: India
facility: Investigational Site Number 356001
city: Nagpur
country: India
facility: Investigational Site Number 356023
city: New Delhi
country: India
facility: Investigational Site Number 356002
city: Pune
country: India
facility: Investigational Site Number 356004
city: Pune
country: India
facility: Investigational Site Number 356024
city: Vishakhapatnam
country: India
facility: Investigational Site Number 356012
city: Bandung
country: Indonesia
facility: Investigational Site Number 360002
city: Denpasar
country: Indonesia
facility: Investigational Site Number 360001
city: Medan
country: Indonesia
facility: Investigational Site Number 360004
city: Dublin 7
country: Ireland
facility: Investigational Site Number 372004
city: Dublin
country: Ireland
facility: Investigational Site Number 372003
city: Dublin
country: Ireland
facility: Investigational Site Number 372002
city: Jerusalem
country: Israel
facility: Investigational Site Number 376003
city: Kfar Saba
country: Israel
facility: Investigational Site Number 376004
city: Nahariya
country: Israel
facility: Investigational Site Number 376001
city: Petah-Tikva
country: Israel
facility: Investigational Site Number 376006
city: Tzrifin
country: Israel
facility: Investigational Site Number 376007
city: Castellanza
country: Italy
facility: Investigational Site Number 380005
city: Cattolica
country: Italy
facility: Investigational Site Number 380014
city: Cesena
country: Italy
facility: Investigational Site Number 380007
city: Cremona
country: Italy
facility: Investigational Site Number 380015
city: Faenza
country: Italy
facility: Investigational Site Number 380009
city: Lecce
country: Italy
facility: Investigational Site Number 380012
city: Lugo
country: Italy
facility: Investigational Site Number 380006
city: Meldola
country: Italy
facility: Investigational Site Number 380001
city: Parma
country: Italy
facility: Investigational Site Number 380011
city: Perugia
country: Italy
facility: Investigational Site Number 380020
city: Ravenna
country: Italy
facility: Investigational Site Number 380013
city: Rimini
country: Italy
facility: Investigational Site Number 380016
city: Sondrio
country: Italy
facility: Investigational Site Number 380004
city: Sora
country: Italy
facility: Investigational Site Number 380010
city: Taormina
country: Italy
facility: Investigational Site Number 380008
city: Terni
country: Italy
facility: Investigational Site Number 380019
city: Treviglio
country: Italy
facility: Investigational Site Number 380003
city: Udine
country: Italy
facility: Investigational Site Number 380017
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410009
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Liepaja
country: Latvia
facility: Investigational Site Number 428002
city: Riga
country: Latvia
facility: Investigational Site Number 428003
city: Riga
country: Latvia
facility: Investigational Site Number 428001
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440001
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440002
city: Kota Kinabalu
country: Malaysia
facility: Investigational Site Number 458001
city: Kuala Lumpur
country: Malaysia
facility: Investigational Site Number 458003
city: Penang
country: Malaysia
facility: Investigational Site Number 458004
city: Penang
country: Malaysia
facility: Investigational Site Number 458005
city: Acapulco
country: Mexico
facility: Investigational Site Number 484002
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484006
city: Durango
country: Mexico
facility: Investigational Site Number 484007
city: Mérida
country: Mexico
facility: Investigational Site Number 484008
city: Puebla
country: Mexico
facility: Investigational Site Number 484012
city: Toluca
country: Mexico
facility: Investigational Site Number 484003
city: Xalapa
country: Mexico
facility: Investigational Site Number 484010
city: Den Haag
country: Netherlands
facility: Investigational Site Number 528006
city: Groningen
country: Netherlands
facility: Investigational Site Number 528004
city: Helmond
country: Netherlands
facility: Investigational Site Number 528005
city: Hoofddorp
country: Netherlands
facility: Investigational Site Number 528001
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528003
city: Oslo
country: Norway
facility: Investigational Site Number 578001
city: Arequipa
country: Peru
facility: Investigational Site Number 604012
city: Callao
country: Peru
facility: Investigational Site Number 604004
city: Callao
country: Peru
facility: Investigational Site Number 604011
city: Cercado
country: Peru
facility: Investigational Site Number 604001
city: Chiclayo
country: Peru
facility: Investigational Site Number 604002
city: Lima
country: Peru
facility: Investigational Site Number 604008
city: Lima
country: Peru
facility: Investigational Site Number 604007
city: Lima
country: Peru
facility: Investigational Site Number 604009
city: Lima
country: Peru
facility: Investigational Site Number 604005
city: Lima
country: Peru
facility: Investigational Site Number 604006
city: Lima
country: Peru
facility: Investigational Site Number 604010
city: Lima
country: Peru
facility: Investigational Site Number 604003
city: Bialystok
country: Poland
facility: Investigational Site Number 616009
city: Bielsko-Biala
country: Poland
facility: Investigational Site Number 616008
city: Gliwice
country: Poland
facility: Investigational Site Number 616006
city: Krakow
country: Poland
facility: Investigational Site Number 616004
city: Lubin
country: Poland
facility: Investigational Site Number 616003
city: Olsztyn
country: Poland
facility: Investigational Site Number 616019
city: Otwock
country: Poland
facility: Investigational Site Number 616021
city: Poznan
country: Poland
facility: Investigational Site Number 616010
city: Prabuty
country: Poland
facility: Investigational Site Number 616001
city: Rybnik
country: Poland
facility: Investigational Site Number 616014
city: Rzeszow
country: Poland
facility: Investigational Site Number 616005
city: Torun
country: Poland
facility: Investigational Site Number 616013
city: Warszawa
country: Poland
facility: Investigational Site Number 616018
city: Warszawa
country: Poland
facility: Investigational Site Number 616002
city: Wroclaw
country: Poland
facility: Investigational Site Number 616015
city: Aveiro
country: Portugal
facility: Investigational Site Number 620003
city: Guimarães
country: Portugal
facility: Investigational Site Number 620009
city: Lisboa
country: Portugal
facility: Investigational Site Number 620004
city: Matosinhos
country: Portugal
facility: Investigational Site Number 620008
city: Porto
country: Portugal
facility: Investigational Site Number 620007
city: Setúbal
country: Portugal
facility: Investigational Site Number 620002
city: Brasov
country: Romania
facility: Investigational Site Number 642004
city: Bucuresti
country: Romania
facility: Investigational Site Number 642002
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642001
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642006
city: Iasi
country: Romania
facility: Investigational Site Number 642010
city: Suceava
country: Romania
facility: Investigational Site Number 642003
city: Timisoara
country: Romania
facility: Investigational Site Number 642008
city: Berdsk
country: Russian Federation
facility: Investigational Site Number 643024
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 643006
city: Kazan
country: Russian Federation
facility: Investigational Site Number 643001
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site Number 643004
city: Obninsk
country: Russian Federation
facility: Investigational Site Number 643010
city: Omsk
country: Russian Federation
facility: Investigational Site Number 643005
city: Pyatigorsk
country: Russian Federation
facility: Investigational Site Number 643022
city: Rostov-On-Don
country: Russian Federation
facility: Investigational Site Number 643023
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643020
city: Smolensk
country: Russian Federation
facility: Investigational Site Number 643019
city: Sochi
country: Russian Federation
facility: Investigational Site Number 643021
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643014
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643015
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643011
city: St.Petersburg
country: Russian Federation
facility: Investigational Site Number 643009
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 643008
city: Tula
country: Russian Federation
facility: Investigational Site Number 643016
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 643018
city: Ufa
country: Russian Federation
facility: Investigational Site Number 643012
city: Vladivostok
country: Russian Federation
facility: Investigational Site Number 643007
city: Voronezh
country: Russian Federation
facility: Investigational Site Number 643017
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643003
city: Belgrade
country: Serbia
facility: Investigational Site Number 688002
city: Belgrade
country: Serbia
facility: Investigational Site Number 688004
city: Kragujevac
country: Serbia
facility: Investigational Site Number 688007
city: Nis
country: Serbia
facility: Investigational Site Number 688005
city: Trnava
country: Slovakia
facility: Investigational Site Number 703003
city: Golnik
country: Slovenia
facility: Investigational Site Number 705003
city: Maribor
country: Slovenia
facility: Investigational Site Number 705002
city: Durban
country: South Africa
facility: Investigational Site Number 710003
city: Durban
country: South Africa
facility: Investigational Site Number 710002
city: Barakaldo
country: Spain
facility: Investigational Site Number 724008
city: Barakaldo
country: Spain
facility: Investigational Site Number 724010
city: Barcelona
country: Spain
facility: Investigational Site Number 724004
city: Islas Baleares
country: Spain
facility: Investigational Site Number 724006
city: Lérida
country: Spain
facility: Investigational Site Number 724011
city: Madrid
country: Spain
facility: Investigational Site Number 724001
city: Madrid
country: Spain
facility: Investigational Site Number 724007
city: Madrid
country: Spain
facility: Investigational Site Number 724013
city: Madrid
country: Spain
facility: Investigational Site Number 724012
city: Orense
country: Spain
facility: Investigational Site Number 724005
city: Puerto De Sagunto
country: Spain
facility: Investigational Site Number 724003
city: Valencia
country: Spain
facility: Investigational Site Number 724002
city: Göteborg
country: Sweden
facility: Investigational Site Number 752003
city: Mora
country: Sweden
facility: Investigational Site Number 752005
city: Uppsala
country: Sweden
facility: Investigational Site Number 752002
city: Växjö
country: Sweden
facility: Investigational Site Number 752001
city: Aarau
country: Switzerland
facility: Investigational Site Number 756006
city: Winterthur
country: Switzerland
facility: Investigational Site Number 756004
city: Changhua
country: Taiwan
facility: Investigational Site Number 158004
city: Cherkasy
country: Ukraine
facility: Investigational Site Number 804008
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804009
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 804002
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804006
city: Krivoy Rog
country: Ukraine
facility: Investigational Site Number 804005
city: Lutsk
country: Ukraine
facility: Investigational Site Number 804001
city: Lviv
country: Ukraine
facility: Investigational Site Number 804010
city: Sumy
country: Ukraine
facility: Investigational Site Number 804011
city: Ternopil
country: Ukraine
facility: Investigational Site Number 804004
city: Bangor
country: United Kingdom
facility: Investigational Site Number 826016
city: Brighton
country: United Kingdom
facility: Investigational Site Number 826010
city: Coventry
country: United Kingdom
facility: Investigational Site Number 826015
city: Dundee
country: United Kingdom
facility: Investigational Site Number 826013
city: Hull
country: United Kingdom
facility: Investigational Site Number 826007
city: Lincoln
country: United Kingdom
facility: Investigational Site Number 826002
city: Lincoln
country: United Kingdom
facility: Investigational Site Number 826017
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826005
city: Norwich
country: United Kingdom
facility: Investigational Site Number 826004
city: Peterborough
country: United Kingdom
facility: Investigational Site Number 826009
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number 826011
city: Shrewsbury
country: United Kingdom
facility: Investigational Site Number 826001
city: Wirral
country: United Kingdom
facility: Investigational Site Number 826014
Study officials:
affiliation: HHS-General Hospital, Hamilton, Canada
name: Alexander Turpie, MD
role: STUDY_CHAIR
affiliation: University Of Perugia
name: Giancarlo Agnelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.
citation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.