Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

NCT ID: NCT00694382

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-11-30

Brief Summary

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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

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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).

Conditions

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Venous Thromboembolism Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Semuloparin

Semuloparin sodium 20 mg once daily until change in chemotherapy regimen

Group Type EXPERIMENTAL

Semuloparin sodium

Intervention Type DRUG

0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Placebo

Placebo (for semuloparin) once daily until change in chemotherapy regimen

Group Type PLACEBO_COMPARATOR

Placebo (for semuloparin)

Intervention Type DRUG

0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component

Subcutaneous injection

Interventions

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Semuloparin sodium

0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Intervention Type DRUG

Placebo (for semuloparin)

0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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AVE5026

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Turpie, MD

Role: STUDY_CHAIR

HHS-General Hospital, Hamilton, Canada

Giancarlo Agnelli, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Perugia

Locations

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Investigational Site Number 840066

Easton, Maryland, United States

Site Status

Investigational Site Number 840059

Tupelo, Mississippi, United States

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Investigational Site Number 840006

Birmingham, Alabama, United States

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Investigational Site Number 840007

Casa Grande, Arizona, United States

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Investigational Site Number 840060

Tucson, Arizona, United States

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Investigational Site Number 840050

Fountain Valley, California, United States

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Investigational Site Number 840072

Fullerton, California, United States

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Investigational Site Number 840037

Indian Wells, California, United States

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Investigational Site Number 840069

La Verne, California, United States

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Investigational Site Number 840009

Long Beach, California, United States

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Investigational Site Number 840001

Oceanside, California, United States

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Investigational Site Number 840011

Rancho Mirage, California, United States

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Investigational Site Number 840029

West Covina, California, United States

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Investigational Site Number 840005

Norwich, Connecticut, United States

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Investigational Site Number 840064

Torrington, Connecticut, United States

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Investigational Site Number 840038

Woodbridge, Connecticut, United States

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Investigational Site Number 840052

Washington D.C., District of Columbia, United States

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Investigational Site Number 840025

Washington D.C., District of Columbia, United States

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Investigational Site Number 840074

Clearwater, Florida, United States

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Investigational Site Number 840019

Jacksonville, Florida, United States

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Investigational Site Number 840051

Rockledge, Florida, United States

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Investigational Site Number 840073

Sarasota, Florida, United States

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Investigational Site Number 840070

Roswell, Georgia, United States

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Investigational Site Number 840016

Park Ridge, Illinois, United States

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Investigational Site Number 840028

Quincy, Illinois, United States

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Investigational Site Number 840008

Skokie, Illinois, United States

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Investigational Site Number 840033

Goshen, Indiana, United States

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Investigational Site Number 840010

Indianapolis, Indiana, United States

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Investigational Site Number 840014

Louisville, Kentucky, United States

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Investigational Site Number 840048

Mount Sterling, Kentucky, United States

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Investigational Site Number 840047

Metairie, Louisiana, United States

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Investigational Site Number 840032

Ruston, Louisiana, United States

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Investigational Site Number 840042

Bethesda, Maryland, United States

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Investigational Site Number 840024

Rochester, New York, United States

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Investigational Site Number 840031

Syracuse, New York, United States

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Investigational Site Number 840020

Durham, North Carolina, United States

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Investigational Site Number 840021

Durham, North Carolina, United States

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Investigational Site Number 840026

High Point, North Carolina, United States

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Investigational Site Number 840046

Bismarck, North Dakota, United States

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Investigational Site Number 840003

Middletown, Ohio, United States

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Investigational Site Number 840022

Sylvania, Ohio, United States

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Investigational Site Number 840075

East Providence, Rhode Island, United States

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Investigational Site Number 840067

Beaumont, Texas, United States

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Investigational Site Number 840004

El Paso, Texas, United States

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Investigational Site Number 840034

Houston, Texas, United States

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Investigational Site Number 840035

Sugar Land, Texas, United States

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Investigational Site Number 840063

Kennewick, Washington, United States

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Investigational Site Number 840018

Tacoma, Washington, United States

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Investigational Site Number 032006

Buenos Aires, , Argentina

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Investigational Site Number 032003

Capital Federal, , Argentina

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Investigational Site Number 032004

Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Investigational Site Number 032005

San Miguel de Tucumán, , Argentina

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Investigational Site Number 036004

Adelaide, , Australia

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Bedford Park, , Australia

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Box Hill, , Australia

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Lismore, , Australia

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Perth, , Australia

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Ringwood East, , Australia

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Westmead, , Australia

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Woodville, , Australia

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Woolloongabba, , Australia

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Graz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Homyel, , Belarus

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Minsk, , Belarus

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Minsk, , Belarus

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Vitebsk, , Belarus

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Bonheiden, , Belgium

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Brussels, , Belgium

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Investigational Site Number 056005

Ghent, , Belgium

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Investigational Site Number 056010

Haine-Saint-Paul, , Belgium

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Kortrijk, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Ostend, , Belgium

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Ottignies, , Belgium

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Sint-Niklaas, , Belgium

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Belo Horizonte, , Brazil

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Curitiba, , Brazil

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Curitiba, , Brazil

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Florianópolis, , Brazil

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Fortaleza, , Brazil

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Goiânia, , Brazil

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Goiânia, , Brazil

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Goiânia, , Brazil

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Ijuí, , Brazil

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Joinville, , Brazil

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Londrina, , Brazil

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Passo Fundo, , Brazil

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Passo Fundo, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Salvador, , Brazil

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Salvador, , Brazil

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Santo André, , Brazil

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São José dos Campos, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Taguatinga, , Brazil

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Investigational Site Number 100001

Rousse, , Bulgaria

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Varna, , Bulgaria

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Investigational Site Number 124008

Greenfield Park, , Canada

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Kelowna, , Canada

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Moncton, , Canada

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Montreal, , Canada

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Ottawa, , Canada

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Owen Sound, , Canada

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Rimouski, , Canada

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Saint John, , Canada

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Sherbrooke, , Canada

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Victoria, , Canada

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Weston, , Canada

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Temuco, , Chile

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Chengdu, , China

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Chongqing, , China

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Dalian, , China

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Guangzhou, , China

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Hangzhou, , China

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Nanning, , China

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Qingdao, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shantou, , China

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Suzhou, , China

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Xi'an, , China

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Xi'an, , China

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Yinchuan, , China

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Bogotá, , Colombia

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Manizales, , Colombia

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Medellín, , Colombia

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Medellín, , Colombia

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Medellín, , Colombia

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Montería, , Colombia

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Pereira, , Colombia

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Pula, , Croatia

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Rijeka, , Croatia

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Varaždin, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Hradec Králové, , Czechia

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Kolín, , Czechia

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Nová Ves pod Pleší, , Czechia

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Prague, , Czechia

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Herlev, , Denmark

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Tallinn, , Estonia

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Turku, , Finland

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Antibes, , France

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Colmar, , France

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Gap, , France

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Lille, , France

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Lille, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Reims, , France

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Rouen, , France

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Saint-Grégoire, , France

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Vandœuvre-lès-Nancy, , France

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Investigational Site Number 276012

Augsburg, , Germany

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Investigational Site Number 276025

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Investigational Site Number 276004

Bochum, , Germany

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Investigational Site Number 276006

Cologne, , Germany

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Investigational Site Number 276014

Dresden, , Germany

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Investigational Site Number 276009

Dresden, , Germany

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Investigational Site Number 276030

Essen, , Germany

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Frankfurt am Main, , Germany

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Investigational Site Number 276032

Gauting, , Germany

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Investigational Site Number 276034

Halle, , Germany

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Investigational Site Number 276038

Halle, , Germany

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Investigational Site Number 276037

Hamburg, , Germany

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Investigational Site Number 276007

Hanover, , Germany

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Investigational Site Number 276020

Leer, , Germany

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Investigational Site Number 276010

Leipzig, , Germany

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Investigational Site Number 276017

Magdeburg, , Germany

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Investigational Site Number 276011

Mannheim, , Germany

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Investigational Site Number 276003

Minden, , Germany

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Investigational Site Number 276021

München, , Germany

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Investigational Site Number 276019

München, , Germany

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Investigational Site Number 276015

München, , Germany

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Investigational Site Number 276013

Neumünster, , Germany

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Investigational Site Number 276022

Oldenburg, , Germany

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Investigational Site Number 276035

Paderborn, , Germany

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Investigational Site Number 276031

Passau, , Germany

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Investigational Site Number 276023

Rosenheim, , Germany

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Investigational Site Number 276008

Singen, , Germany

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Investigational Site Number 276024

Westerstede, , Germany

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Investigational Site Number 300004

Athens, , Greece

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Investigational Site Number 300003

Heraklion, , Greece

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Investigational Site Number 300002

Thessaloniki, , Greece

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Investigational Site Number 344001

Hong Kong, , Hong Kong

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Investigational Site Number 348005

Budapest, , Hungary

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Investigational Site Number 348006

Budapest, , Hungary

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Investigational Site Number 348009

Budapest, , Hungary

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Investigational Site Number 348004

Budapest, , Hungary

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Investigational Site Number 348010

Farkasgyepű, , Hungary

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Investigational Site Number 348001

Gyula, , Hungary

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Investigational Site Number 348012

Mátraháza, , Hungary

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Investigational Site Number 348003

Sopron, , Hungary

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Investigational Site Number 348008

Szikszó, , Hungary

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Investigational Site Number 348011

Szolnok, , Hungary

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Investigational Site Number 348007

Zalaegerszeg, , Hungary

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Investigational Site Number 356006

Bangalore, , India

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Investigational Site Number 356008

Bangalore, , India

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Investigational Site Number 356009

Bhopal, , India

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Investigational Site Number 356018

Chennai, , India

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Investigational Site Number 356020

Chennai, , India

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Investigational Site Number 356019

Coimbatore, , India

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Investigational Site Number 356015

Hyderabad, , India

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Investigational Site Number 356025

Hyderabad, , India

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Investigational Site Number 356011

Jaipur, , India

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Kochi, , India

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Kolkata, , India

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Kolkata, , India

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Kolkata, , India

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Madurai, , India

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Miraj, , India

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Investigational Site Number 356001

Mumbai, , India

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Investigational Site Number 356023

Nagpur, , India

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Investigational Site Number 356002

New Delhi, , India

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Pune, , India

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Investigational Site Number 356024

Pune, , India

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Visakhapatnam, , India

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Investigational Site Number 360002

Bandung, , Indonesia

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Investigational Site Number 360001

Denpasar, , Indonesia

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Investigational Site Number 360004

Medan, , Indonesia

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Investigational Site Number 372003

Dublin, , Ireland

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Investigational Site Number 372002

Dublin, , Ireland

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Dublin, , Ireland

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Investigational Site Number 376003

Jerusalem, , Israel

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Kfar Saba, , Israel

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Investigational Site Number 376001

Nahariya, , Israel

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Petah Tikva, , Israel

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Investigational Site Number 376007

Tzrifin, , Israel

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Investigational Site Number 380005

Castellanza, , Italy

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Investigational Site Number 380014

Cattolica, , Italy

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Cesena, , Italy

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Cremona, , Italy

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Faenza, , Italy

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Lecce, , Italy

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Investigational Site Number 380006

Lugo, , Italy

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Investigational Site Number 380001

Meldola, , Italy

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Parma, , Italy

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Perugia, , Italy

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Ravenna, , Italy

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Rimini, , Italy

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Sondrio, , Italy

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Sora, , Italy

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Taormina, , Italy

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Investigational Site Number 380019

Terni, , Italy

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Treviglio, , Italy

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Udine, , Italy

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Investigational Site Number 428002

Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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George Town, , Malaysia

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George Town, , Malaysia

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Kota Kinabalu, , Malaysia

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Kuala Lumpur, , Malaysia

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Acapulco, , Mexico

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Aguascalientes, , Mexico

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Investigational Site Number 484007

Durango, , Mexico

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Mérida, , Mexico

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Puebla City, , Mexico

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Toluca, , Mexico

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Xalapa, , Mexico

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Investigational Site Number 528004

Groningen, , Netherlands

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Helmond, , Netherlands

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Hoofddorp, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Investigational Site Number 578001

Oslo, , Norway

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Investigational Site Number 604012

Arequipa, , Peru

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Callao, , Peru

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Callao, , Peru

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Cercado, , Peru

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Chiclayo, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Bialystok, , Poland

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Bielsko-Biala, , Poland

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Gliwice, , Poland

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Krakow, , Poland

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Lubin, , Poland

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Olsztyn, , Poland

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Otwock, , Poland

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Poznan, , Poland

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Prabuty, , Poland

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Rybnik, , Poland

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Rzeszów, , Poland

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Torun, , Poland

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Warsaw, , Poland

Site Status

Investigational Site Number 616002

Warsaw, , Poland

Site Status

Investigational Site Number 616015

Wroclaw, , Poland

Site Status

Investigational Site Number 620003

Aveiro, , Portugal

Site Status

Investigational Site Number 620009

Guimarães, , Portugal

Site Status

Investigational Site Number 620004

Lisbon, , Portugal

Site Status

Investigational Site Number 620008

Matosinhos Municipality, , Portugal

Site Status

Investigational Site Number 620007

Porto, , Portugal

Site Status

Investigational Site Number 620002

Setúbal, , Portugal

Site Status

Investigational Site Number 642004

Brasov, , Romania

Site Status

Investigational Site Number 642002

Bucharest, , Romania

Site Status

Investigational Site Number 642001

Cluj-Napoca, , Romania

Site Status

Investigational Site Number 642006

Cluj-Napoca, , Romania

Site Status

Investigational Site Number 642010

Iași, , Romania

Site Status

Investigational Site Number 642003

Suceava, , Romania

Site Status

Investigational Site Number 642008

Timișoara, , Romania

Site Status

Investigational Site Number 643024

Berdsk, , Russia

Site Status

Investigational Site Number 643006

Chelyabinsk, , Russia

Site Status

Investigational Site Number 643001

Kazan', , Russia

Site Status

Investigational Site Number 643004

Krasnoyarsk, , Russia

Site Status

Investigational Site Number 643010

Obninsk, , Russia

Site Status

Investigational Site Number 643005

Omsk, , Russia

Site Status

Investigational Site Number 643022

Pyatigorsk, , Russia

Site Status

Investigational Site Number 643023

Rostov-on-Don, , Russia

Site Status

Investigational Site Number 643009

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643014

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643015

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643011

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643020

Saratov, , Russia

Site Status

Investigational Site Number 643019

Smolensk, , Russia

Site Status

Investigational Site Number 643021

Sochi, , Russia

Site Status

Investigational Site Number 643008

Tomsk, , Russia

Site Status

Investigational Site Number 643016

Tula, , Russia

Site Status

Investigational Site Number 643018

Tyumen, , Russia

Site Status

Investigational Site Number 643012

Ufa, , Russia

Site Status

Investigational Site Number 643007

Vladivostok, , Russia

Site Status

Investigational Site Number 643017

Voronezh, , Russia

Site Status

Investigational Site Number 643003

Yaroslavl, , Russia

Site Status

Investigational Site Number 688002

Belgrade, , Serbia

Site Status

Investigational Site Number 688004

Belgrade, , Serbia

Site Status

Investigational Site Number 688007

Kragujevac, , Serbia

Site Status

Investigational Site Number 688005

Niš, , Serbia

Site Status

Investigational Site Number 703003

Trnava, , Slovakia

Site Status

Investigational Site Number 705003

Golnik, , Slovenia

Site Status

Investigational Site Number 705002

Maribor, , Slovenia

Site Status

Investigational Site Number 710003

Durban, , South Africa

Site Status

Investigational Site Number 710002

Durban, , South Africa

Site Status

Investigational Site Number 410008

Daegu, , South Korea

Site Status

Investigational Site Number 410007

Seoul, , South Korea

Site Status

Investigational Site Number 410001

Seoul, , South Korea

Site Status

Investigational Site Number 410002

Seoul, , South Korea

Site Status

Investigational Site Number 410006

Seoul, , South Korea

Site Status

Investigational Site Number 410005

Seoul, , South Korea

Site Status

Investigational Site Number 410003

Seoul, , South Korea

Site Status

Investigational Site Number 410009

Seoul, , South Korea

Site Status

Investigational Site Number 410004

Suwon, , South Korea

Site Status

Investigational Site Number 724008

Barakaldo, , Spain

Site Status

Investigational Site Number 724010

Barakaldo, , Spain

Site Status

Investigational Site Number 724004

Barcelona, , Spain

Site Status

Investigational Site Number 724006

Islas Baleares, , Spain

Site Status

Investigational Site Number 724011

Lleida, , Spain

Site Status

Investigational Site Number 724001

Madrid, , Spain

Site Status

Investigational Site Number 724007

Madrid, , Spain

Site Status

Investigational Site Number 724013

Madrid, , Spain

Site Status

Investigational Site Number 724012

Madrid, , Spain

Site Status

Investigational Site Number 724005

Ourense, , Spain

Site Status

Investigational Site Number 724003

Port de Sagunt, , Spain

Site Status

Investigational Site Number 724002

Valencia, , Spain

Site Status

Investigational Site Number 752003

Gothenburg, , Sweden

Site Status

Investigational Site Number 752005

Mora, , Sweden

Site Status

Investigational Site Number 752002

Uppsala, , Sweden

Site Status

Investigational Site Number 752001

Vaxjo, , Sweden

Site Status

Investigational Site Number 756006

Aarau, , Switzerland

Site Status

Investigational Site Number 756004

Winterthur, , Switzerland

Site Status

Investigational Site Number 158004

Changhua, , Taiwan

Site Status

Investigational Site Number 804008

Cherkasy, , Ukraine

Site Status

Investigational Site Number 804009

Chernivtsi, , Ukraine

Site Status

Investigational Site Number 804002

Dnipropetrovsk, , Ukraine

Site Status

Investigational Site Number 804006

Donetsk, , Ukraine

Site Status

Investigational Site Number 804005

Kryvyi Rih, , Ukraine

Site Status

Investigational Site Number 804001

Lutsk, , Ukraine

Site Status

Investigational Site Number 804010

Lviv, , Ukraine

Site Status

Investigational Site Number 804011

Sumy, , Ukraine

Site Status

Investigational Site Number 804004

Ternopil, , Ukraine

Site Status

Investigational Site Number 826016

Bangor, , United Kingdom

Site Status

Investigational Site Number 826010

Brighton, , United Kingdom

Site Status

Investigational Site Number 826015

Coventry, , United Kingdom

Site Status

Investigational Site Number 826013

Dundee, , United Kingdom

Site Status

Investigational Site Number 826007

Hull, , United Kingdom

Site Status

Investigational Site Number 826002

Lincoln, , United Kingdom

Site Status

Investigational Site Number 826017

Lincoln, , United Kingdom

Site Status

Investigational Site Number 826005

Manchester, , United Kingdom

Site Status

Investigational Site Number 826014

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Investigational Site Number 826004

Norwich, , United Kingdom

Site Status

Investigational Site Number 826009

Peterborough, , United Kingdom

Site Status

Investigational Site Number 826011

Portsmouth, , United Kingdom

Site Status

Investigational Site Number 826001

Shrewsbury, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada Chile China Colombia Croatia Czechia Denmark Estonia Finland France Germany Greece Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Norway Peru Poland Portugal Romania Russia Serbia Slovakia Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Ukraine United Kingdom

References

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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.

Reference Type RESULT
PMID: 22335737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33337539 (View on PubMed)

Other Identifiers

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2007-007943-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC6521

Identifier Type: -

Identifier Source: org_study_id

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