Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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
Query!
Secondary ID [1]
0
0
2007-007943-29
Query!
Secondary ID [2]
0
0
EFC6521
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SAVE-ONCO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
0
0
Query!
Cancer
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
Query!
Assessment method [1]
0
0
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".
Query!
Timepoint [1]
0
0
From randomization up to 3 days after last study drug injection
Query!
Primary outcome [2]
0
0
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From randomization up to 3 days after last study drug injection
Query!
Secondary outcome [1]
0
0
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomization up to 3 days after last study drug injection
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
From first study drug injection up to 3 days after last study drug injection
Query!
Secondary outcome [3]
0
0
Overall survival [OS]
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3212
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site Number 036004 - Adelaide
Query!
Recruitment hospital [2]
0
0
Investigational Site Number 036002 - Bedford Park
Query!
Recruitment hospital [3]
0
0
Investigational Site Number 036001 - Box Hill
Query!
Recruitment hospital [4]
0
0
Investigational Site Number 036009 - Lismore
Query!
Recruitment hospital [5]
0
0
Investigational Site Number 036007 - Perth
Query!
Recruitment hospital [6]
0
0
Investigational Site Number 036006 - Ringwood East
Query!
Recruitment hospital [7]
0
0
Investigational Site Number 036008 - Westmead
Query!
Recruitment hospital [8]
0
0
Investigational Site Number 036003 - Woodville
Query!
Recruitment hospital [9]
0
0
Investigational Site Number 036005 - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [4]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [5]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [6]
0
0
3135 - Ringwood East
Query!
Recruitment postcode(s) [7]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [8]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [9]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Dakota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Rhode Island
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Capital Federal
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Rosario
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
San Miguel De Tucuman
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Tucuman
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Graz
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Wien
Query!
Country [28]
0
0
Belarus
Query!
State/province [28]
0
0
Gomel
Query!
Country [29]
0
0
Belarus
Query!
State/province [29]
0
0
Minsk
Query!
Country [30]
0
0
Belarus
Query!
State/province [30]
0
0
Vitebsk
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Bonheiden
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Brussels
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Gent
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Haine-Saint-Paul
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Kortrijk
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Liège
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Merksem
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Oostende
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Ottignies
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Sint Niklaas
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Belo Horizonte
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Curitiba
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Florianopolis
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Fortaleza
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Goiania
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Ijui
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Joinville
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Londrina
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Passo Fundo
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Porto Alegre
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Salvador
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Santo Andre
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Sao Jose Dos Campos
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Sao Paulo
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Taguatinga
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Rousse
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Varna
Query!
Country [58]
0
0
Canada
Query!
State/province [58]
0
0
Greenfield Park
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
Kelowna
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
Moncton
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Montreal
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Ottawa
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Owen Sound
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
Rimouski
Query!
Country [65]
0
0
Canada
Query!
State/province [65]
0
0
Saint John
Query!
Country [66]
0
0
Canada
Query!
State/province [66]
0
0
Sherbrooke
Query!
Country [67]
0
0
Canada
Query!
State/province [67]
0
0
Victoria
Query!
Country [68]
0
0
Canada
Query!
State/province [68]
0
0
Weston
Query!
Country [69]
0
0
Chile
Query!
State/province [69]
0
0
Temuco
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Beijing
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Changchun
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Chengdu
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Chongqing
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Dalian
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Guangzhou
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Hangzhou
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Nanning
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Qingdao
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Shanghai
Query!
Country [80]
0
0
China
Query!
State/province [80]
0
0
Shantou
Query!
Country [81]
0
0
China
Query!
State/province [81]
0
0
Suzhou
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Xi'An
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Yinchuan
Query!
Country [84]
0
0
Colombia
Query!
State/province [84]
0
0
Bogota
Query!
Country [85]
0
0
Colombia
Query!
State/province [85]
0
0
Manizales
Query!
Country [86]
0
0
Colombia
Query!
State/province [86]
0
0
Medellin
Query!
Country [87]
0
0
Colombia
Query!
State/province [87]
0
0
Medellín
Query!
Country [88]
0
0
Colombia
Query!
State/province [88]
0
0
Monteria
Query!
Country [89]
0
0
Colombia
Query!
State/province [89]
0
0
Pereira
Query!
Country [90]
0
0
Croatia
Query!
State/province [90]
0
0
Pula
Query!
Country [91]
0
0
Croatia
Query!
State/province [91]
0
0
Rijeka
Query!
Country [92]
0
0
Croatia
Query!
State/province [92]
0
0
Varazdin
Query!
Country [93]
0
0
Croatia
Query!
State/province [93]
0
0
Zadar
Query!
Country [94]
0
0
Croatia
Query!
State/province [94]
0
0
Zagreb
Query!
Country [95]
0
0
Czech Republic
Query!
State/province [95]
0
0
Hradec Kralove
Query!
Country [96]
0
0
Czech Republic
Query!
State/province [96]
0
0
Kolin
Query!
Country [97]
0
0
Czech Republic
Query!
State/province [97]
0
0
Nova Ves Pod Plesi
Query!
Country [98]
0
0
Czech Republic
Query!
State/province [98]
0
0
Praha 5
Query!
Country [99]
0
0
Denmark
Query!
State/province [99]
0
0
Herlev
Query!
Country [100]
0
0
Estonia
Query!
State/province [100]
0
0
Tallinn
Query!
Country [101]
0
0
Finland
Query!
State/province [101]
0
0
Turku
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Antibes
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Colmar
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Gap
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Lille Cedex
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Lyon
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Marseille
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Montpellier Cedex
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Paris Cedex 10
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Paris Cedex 14
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Reims
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Rouen
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Saint Gregoire
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Vandoeuvre Les Nancy
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Augsburg
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Berlin
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Bochum
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Dresden
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Essen
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Frankfurt Am Main
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
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]
0
0
United Kingdom
Query!
State/province [307]
0
0
Manchester
Query!
Country [308]
0
0
United Kingdom
Query!
State/province [308]
0
0
Norwich
Query!
Country [309]
0
0
United Kingdom
Query!
State/province [309]
0
0
Peterborough
Query!
Country [310]
0
0
United Kingdom
Query!
State/province [310]
0
0
Portsmouth
Query!
Country [311]
0
0
United Kingdom
Query!
State/province [311]
0
0
Shrewsbury
Query!
Country [312]
0
0
United Kingdom
Query!
State/province [312]
0
0
Wirral
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00694382
Query!
Trial related presentations / publications
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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Alexander Turpie, MD
Query!
Address
0
0
HHS-General Hospital, Hamilton, Canada
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00694382
Download to PDF