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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00694382
Registration number
NCT00694382
Ethics application status
Date submitted
7/05/2008
Date registered
10/06/2008
Date last updated
23/01/2013
Titles & IDs
Public title
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
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Scientific 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
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Secondary ID [1]
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2007-007943-29
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Secondary ID [2]
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EFC6521
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Universal Trial Number (UTN)
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Trial acronym
SAVE-ONCO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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0
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Cancer
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
0
0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Semuloparin sodium
Treatment: Drugs - Placebo (for semuloparin)
Experimental: Semuloparin - Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
Placebo Comparator: Placebo - Placebo (for semuloparin) once daily until change in chemotherapy regimen
Treatment: Drugs: Semuloparin sodium
0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
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Assessment method [1]
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VTE included any symptomatic Deep Vein Thrombosis [DVT] of lower or upper limbs and any non-fatal Pulmonary Embolism [PE] as confirmed by a Central Independent Adjudication Committee [CIAC] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE.
VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
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Timepoint [1]
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From randomization up to 3 days after last study drug injection
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Primary outcome [2]
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Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
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Assessment method [2]
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Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
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Timepoint [2]
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From randomization up to 3 days after last study drug injection
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Secondary outcome [1]
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Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
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Assessment method [1]
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Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after diagnostic tests for suspected VTE and after lung imaging test for tumor evaluation.
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Timepoint [1]
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From randomization up to 3 days after last study drug injection
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Secondary outcome [2]
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Percentage of Participants Who Experienced Clinically Relevant Bleedings
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Assessment method [2]
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Clinically Relevant Bleedings included overt bleedings classified by the CIAC as:
"major" (fatal, in a critical area/organ, causing a drop in hemoglobin =2 g/dL or requiring transfusion =2 units of blood)
"clinically relevant non-major" (requiring medical intervention and not meeting criteria for major bleeding).
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Timepoint [2]
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From first study drug injection up to 3 days after last study drug injection
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Secondary outcome [3]
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Overall survival [OS]
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Assessment method [3]
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Survival status was collected for all participants either one year after randomization, or at the study end date, (ie, 7 months following randomization of the last patient), whichever came first.
OS was defined as the time from date of randomization to date of death due to any cause. Participants alive were censored at last date of contact that they were known to be alive.
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Timepoint [3]
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From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2010
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Sample size
Target
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Accrual to date
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Final
3212
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036004 - Adelaide
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Investigational Site Number 036002 - Bedford Park
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Investigational Site Number 036001 - Box Hill
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Investigational Site Number 036009 - Lismore
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Investigational Site Number 036007 - Perth
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Investigational Site Number 036006 - Ringwood East
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Investigational Site Number 036008 - Westmead
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Investigational Site Number 036003 - Woodville
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Investigational Site Number 036005 - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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3128 - Box Hill
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2480 - Lismore
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6000 - Perth
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Recruitment postcode(s) [6]
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3135 - Ringwood East
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
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5011 - Woodville
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
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0
0
Gauting
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Halle/Saale
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Halle
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Hamburg
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Hannover
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Köln
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Leer
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Leipzig
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Magdeburg
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Mannheim
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Minden
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
München
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Neumünster
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Oldenburg
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Paderborn
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Passau
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Rosenheim
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Singen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Westerstede
Query!
Country [140]
0
0
Greece
Query!
State/province [140]
0
0
Athens
Query!
Country [141]
0
0
Greece
Query!
State/province [141]
0
0
Heraklion
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Thessaloniki
Query!
Country [143]
0
0
Hong Kong
Query!
State/province [143]
0
0
Hong Kong
Query!
Country [144]
0
0
Hungary
Query!
State/province [144]
0
0
Budapest
Query!
Country [145]
0
0
Hungary
Query!
State/province [145]
0
0
Farkasgyepu
Query!
Country [146]
0
0
Hungary
Query!
State/province [146]
0
0
Gyula
Query!
Country [147]
0
0
Hungary
Query!
State/province [147]
0
0
Mátraháza
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Sopron
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Szikszó
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Szolnok
Query!
Country [151]
0
0
Hungary
Query!
State/province [151]
0
0
Zalaegerszeg
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Bangalore
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Bhopal
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Chennai
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Coimbatore
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Hyderabad
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
Jaipur
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
Kochi
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Kolkata
Query!
Country [160]
0
0
India
Query!
State/province [160]
0
0
Madurai
Query!
Country [161]
0
0
India
Query!
State/province [161]
0
0
Miraj
Query!
Country [162]
0
0
India
Query!
State/province [162]
0
0
Mumbai
Query!
Country [163]
0
0
India
Query!
State/province [163]
0
0
Nagpur
Query!
Country [164]
0
0
India
Query!
State/province [164]
0
0
New Delhi
Query!
Country [165]
0
0
India
Query!
State/province [165]
0
0
Pune
Query!
Country [166]
0
0
India
Query!
State/province [166]
0
0
Vishakhapatnam
Query!
Country [167]
0
0
Indonesia
Query!
State/province [167]
0
0
Bandung
Query!
Country [168]
0
0
Indonesia
Query!
State/province [168]
0
0
Denpasar
Query!
Country [169]
0
0
Indonesia
Query!
State/province [169]
0
0
Medan
Query!
Country [170]
0
0
Ireland
Query!
State/province [170]
0
0
Dublin 7
Query!
Country [171]
0
0
Ireland
Query!
State/province [171]
0
0
Dublin
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Jerusalem
Query!
Country [173]
0
0
Israel
Query!
State/province [173]
0
0
Kfar Saba
Query!
Country [174]
0
0
Israel
Query!
State/province [174]
0
0
Nahariya
Query!
Country [175]
0
0
Israel
Query!
State/province [175]
0
0
Petah-Tikva
Query!
Country [176]
0
0
Israel
Query!
State/province [176]
0
0
Tzrifin
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Castellanza
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Cattolica
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Cesena
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Cremona
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Faenza
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Lecce
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Lugo
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Meldola
Query!
Country [185]
0
0
Italy
Query!
State/province [185]
0
0
Parma
Query!
Country [186]
0
0
Italy
Query!
State/province [186]
0
0
Perugia
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Ravenna
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Rimini
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Sondrio
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Sora
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Taormina
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Terni
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Treviglio
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Udine
Query!
Country [195]
0
0
Korea, Republic of
Query!
State/province [195]
0
0
Daegu
Query!
Country [196]
0
0
Korea, Republic of
Query!
State/province [196]
0
0
Seoul
Query!
Country [197]
0
0
Korea, Republic of
Query!
State/province [197]
0
0
Suwon
Query!
Country [198]
0
0
Latvia
Query!
State/province [198]
0
0
Liepaja
Query!
Country [199]
0
0
Latvia
Query!
State/province [199]
0
0
Riga
Query!
Country [200]
0
0
Lithuania
Query!
State/province [200]
0
0
Kaunas
Query!
Country [201]
0
0
Lithuania
Query!
State/province [201]
0
0
Vilnius
Query!
Country [202]
0
0
Malaysia
Query!
State/province [202]
0
0
Kota Kinabalu
Query!
Country [203]
0
0
Malaysia
Query!
State/province [203]
0
0
Kuala Lumpur
Query!
Country [204]
0
0
Malaysia
Query!
State/province [204]
0
0
Penang
Query!
Country [205]
0
0
Mexico
Query!
State/province [205]
0
0
Acapulco
Query!
Country [206]
0
0
Mexico
Query!
State/province [206]
0
0
Aguascalientes
Query!
Country [207]
0
0
Mexico
Query!
State/province [207]
0
0
Durango
Query!
Country [208]
0
0
Mexico
Query!
State/province [208]
0
0
Mérida
Query!
Country [209]
0
0
Mexico
Query!
State/province [209]
0
0
Puebla
Query!
Country [210]
0
0
Mexico
Query!
State/province [210]
0
0
Toluca
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
Xalapa
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Den Haag
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
Groningen
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Helmond
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Hoofddorp
Query!
Country [216]
0
0
Netherlands
Query!
State/province [216]
0
0
Rotterdam
Query!
Country [217]
0
0
Norway
Query!
State/province [217]
0
0
Oslo
Query!
Country [218]
0
0
Peru
Query!
State/province [218]
0
0
Arequipa
Query!
Country [219]
0
0
Peru
Query!
State/province [219]
0
0
Callao
Query!
Country [220]
0
0
Peru
Query!
State/province [220]
0
0
Cercado
Query!
Country [221]
0
0
Peru
Query!
State/province [221]
0
0
Chiclayo
Query!
Country [222]
0
0
Peru
Query!
State/province [222]
0
0
Lima
Query!
Country [223]
0
0
Poland
Query!
State/province [223]
0
0
Bialystok
Query!
Country [224]
0
0
Poland
Query!
State/province [224]
0
0
Bielsko-Biala
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Gliwice
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Krakow
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Lubin
Query!
Country [228]
0
0
Poland
Query!
State/province [228]
0
0
Olsztyn
Query!
Country [229]
0
0
Poland
Query!
State/province [229]
0
0
Otwock
Query!
Country [230]
0
0
Poland
Query!
State/province [230]
0
0
Poznan
Query!
Country [231]
0
0
Poland
Query!
State/province [231]
0
0
Prabuty
Query!
Country [232]
0
0
Poland
Query!
State/province [232]
0
0
Rybnik
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Rzeszow
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Torun
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Warszawa
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Wroclaw
Query!
Country [237]
0
0
Portugal
Query!
State/province [237]
0
0
Aveiro
Query!
Country [238]
0
0
Portugal
Query!
State/province [238]
0
0
Guimarães
Query!
Country [239]
0
0
Portugal
Query!
State/province [239]
0
0
Lisboa
Query!
Country [240]
0
0
Portugal
Query!
State/province [240]
0
0
Matosinhos
Query!
Country [241]
0
0
Portugal
Query!
State/province [241]
0
0
Porto
Query!
Country [242]
0
0
Portugal
Query!
State/province [242]
0
0
Setúbal
Query!
Country [243]
0
0
Romania
Query!
State/province [243]
0
0
Brasov
Query!
Country [244]
0
0
Romania
Query!
State/province [244]
0
0
Bucuresti
Query!
Country [245]
0
0
Romania
Query!
State/province [245]
0
0
Cluj Napoca
Query!
Country [246]
0
0
Romania
Query!
State/province [246]
0
0
Cluj-Napoca
Query!
Country [247]
0
0
Romania
Query!
State/province [247]
0
0
Iasi
Query!
Country [248]
0
0
Romania
Query!
State/province [248]
0
0
Suceava
Query!
Country [249]
0
0
Romania
Query!
State/province [249]
0
0
Timisoara
Query!
Country [250]
0
0
Russian Federation
Query!
State/province [250]
0
0
Berdsk
Query!
Country [251]
0
0
Russian Federation
Query!
State/province [251]
0
0
Chelyabinsk
Query!
Country [252]
0
0
Russian Federation
Query!
State/province [252]
0
0
Kazan
Query!
Country [253]
0
0
Russian Federation
Query!
State/province [253]
0
0
Krasnoyarsk
Query!
Country [254]
0
0
Russian Federation
Query!
State/province [254]
0
0
Obninsk
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Omsk
Query!
Country [256]
0
0
Russian Federation
Query!
State/province [256]
0
0
Pyatigorsk
Query!
Country [257]
0
0
Russian Federation
Query!
State/province [257]
0
0
Rostov-On-Don
Query!
Country [258]
0
0
Russian Federation
Query!
State/province [258]
0
0
Saratov
Query!
Country [259]
0
0
Russian Federation
Query!
State/province [259]
0
0
Smolensk
Query!
Country [260]
0
0
Russian Federation
Query!
State/province [260]
0
0
Sochi
Query!
Country [261]
0
0
Russian Federation
Query!
State/province [261]
0
0
St-Petersburg
Query!
Country [262]
0
0
Russian Federation
Query!
State/province [262]
0
0
St.Petersburg
Query!
Country [263]
0
0
Russian Federation
Query!
State/province [263]
0
0
Tomsk
Query!
Country [264]
0
0
Russian Federation
Query!
State/province [264]
0
0
Tula
Query!
Country [265]
0
0
Russian Federation
Query!
State/province [265]
0
0
Tyumen
Query!
Country [266]
0
0
Russian Federation
Query!
State/province [266]
0
0
Ufa
Query!
Country [267]
0
0
Russian Federation
Query!
State/province [267]
0
0
Vladivostok
Query!
Country [268]
0
0
Russian Federation
Query!
State/province [268]
0
0
Voronezh
Query!
Country [269]
0
0
Russian Federation
Query!
State/province [269]
0
0
Yaroslavl
Query!
Country [270]
0
0
Serbia
Query!
State/province [270]
0
0
Belgrade
Query!
Country [271]
0
0
Serbia
Query!
State/province [271]
0
0
Kragujevac
Query!
Country [272]
0
0
Serbia
Query!
State/province [272]
0
0
Nis
Query!
Country [273]
0
0
Slovakia
Query!
State/province [273]
0
0
Trnava
Query!
Country [274]
0
0
Slovenia
Query!
State/province [274]
0
0
Golnik
Query!
Country [275]
0
0
Slovenia
Query!
State/province [275]
0
0
Maribor
Query!
Country [276]
0
0
South Africa
Query!
State/province [276]
0
0
Durban
Query!
Country [277]
0
0
Spain
Query!
State/province [277]
0
0
Barakaldo
Query!
Country [278]
0
0
Spain
Query!
State/province [278]
0
0
Barcelona
Query!
Country [279]
0
0
Spain
Query!
State/province [279]
0
0
Islas Baleares
Query!
Country [280]
0
0
Spain
Query!
State/province [280]
0
0
Lérida
Query!
Country [281]
0
0
Spain
Query!
State/province [281]
0
0
Madrid
Query!
Country [282]
0
0
Spain
Query!
State/province [282]
0
0
Orense
Query!
Country [283]
0
0
Spain
Query!
State/province [283]
0
0
Puerto De Sagunto
Query!
Country [284]
0
0
Spain
Query!
State/province [284]
0
0
Valencia
Query!
Country [285]
0
0
Sweden
Query!
State/province [285]
0
0
Göteborg
Query!
Country [286]
0
0
Sweden
Query!
State/province [286]
0
0
Mora
Query!
Country [287]
0
0
Sweden
Query!
State/province [287]
0
0
Uppsala
Query!
Country [288]
0
0
Sweden
Query!
State/province [288]
0
0
Växjö
Query!
Country [289]
0
0
Switzerland
Query!
State/province [289]
0
0
Aarau
Query!
Country [290]
0
0
Switzerland
Query!
State/province [290]
0
0
Winterthur
Query!
Country [291]
0
0
Taiwan
Query!
State/province [291]
0
0
Changhua
Query!
Country [292]
0
0
Ukraine
Query!
State/province [292]
0
0
Cherkasy
Query!
Country [293]
0
0
Ukraine
Query!
State/province [293]
0
0
Chernivtsi
Query!
Country [294]
0
0
Ukraine
Query!
State/province [294]
0
0
Dnipropetrovsk
Query!
Country [295]
0
0
Ukraine
Query!
State/province [295]
0
0
Donetsk
Query!
Country [296]
0
0
Ukraine
Query!
State/province [296]
0
0
Krivoy Rog
Query!
Country [297]
0
0
Ukraine
Query!
State/province [297]
0
0
Lutsk
Query!
Country [298]
0
0
Ukraine
Query!
State/province [298]
0
0
Lviv
Query!
Country [299]
0
0
Ukraine
Query!
State/province [299]
0
0
Sumy
Query!
Country [300]
0
0
Ukraine
Query!
State/province [300]
0
0
Ternopil
Query!
Country [301]
0
0
United Kingdom
Query!
State/province [301]
0
0
Bangor
Query!
Country [302]
0
0
United Kingdom
Query!
State/province [302]
0
0
Brighton
Query!
Country [303]
0
0
United Kingdom
Query!
State/province [303]
0
0
Coventry
Query!
Country [304]
0
0
United Kingdom
Query!
State/province [304]
0
0
Dundee
Query!
Country [305]
0
0
United Kingdom
Query!
State/province [305]
0
0
Hull
Query!
Country [306]
0
0
United Kingdom
Query!
State/province [306]
0
0
Lincoln
Query!
Country [307]
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United Kingdom
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Manchester
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United Kingdom
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State/province [308]
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Norwich
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Country [309]
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United Kingdom
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State/province [309]
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Peterborough
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Country [310]
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United Kingdom
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State/province [310]
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Portsmouth
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Country [311]
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United Kingdom
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State/province [311]
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Shrewsbury
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United Kingdom
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State/province [312]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00694382
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Public notes
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Contacts
Principal investigator
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Alexander Turpie, MD
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HHS-General Hospital, Hamilton, Canada
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00694382
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