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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00633893




Registration number
NCT00633893
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
25/11/2013

Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Secondary ID [1] 0 0
EUDRACT: 2007-004953-27
Secondary ID [2] 0 0
CV185-057
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Placebo

Experimental: 1 - 2.5 mg

Experimental: 2 - 5.0 mg

Active comparator: 3 - 0 mg


Treatment: Drugs: Apixaban
Tablets, Oral, twice daily, 12 months

Treatment: Drugs: Placebo
Tablets, Oral, twice daily, 12 months

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [1] 0 0
Day 1 up to 12 Months
Primary outcome [2] 0 0
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [2] 0 0
Day 1 up to 12 months
Secondary outcome [1] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [1] 0 0
Day 1 up to 12 Months
Secondary outcome [2] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [2] 0 0
Day 1 up to 12 Months
Secondary outcome [3] 0 0
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [3] 0 0
Day 1 up to 12 Months
Secondary outcome [4] 0 0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [4] 0 0
Day 1 up to 12 Months
Secondary outcome [5] 0 0
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [5] 0 0
Day 1 up to 12 Months
Secondary outcome [6] 0 0
Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [6] 0 0
Day 1 up to 12 Months
Secondary outcome [7] 0 0
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [7] 0 0
Day 1 up to 12 Months
Secondary outcome [8] 0 0
Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
Timepoint [8] 0 0
Day 1 up to 12 Months
Secondary outcome [9] 0 0
Adjudicated Major Bleeding During the Treatment Period - Treated Population
Timepoint [9] 0 0
Day 1 up to 12 Months
Secondary outcome [10] 0 0
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Timepoint [10] 0 0
Day 1 up to 12 Months
Secondary outcome [11] 0 0
Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Timepoint [11] 0 0
Day 1 up to 12 months
Secondary outcome [12] 0 0
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
Timepoint [12] 0 0
Day 1 up to 12 months
Secondary outcome [13] 0 0
Adjudicated Total Bleeding During the Treatment Period - Treated Participants
Timepoint [13] 0 0
Day 1 up to 12 months
Secondary outcome [14] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [14] 0 0
Day 1 up to 12 Months
Secondary outcome [15] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [15] 0 0
Day 1 up to 12 Months
Secondary outcome [16] 0 0
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [16] 0 0
Day 1 up to 12 Months
Secondary outcome [17] 0 0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [17] 0 0
Day 1 up to 12 Months
Secondary outcome [18] 0 0
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [18] 0 0
Day 1 up to 12 Months
Secondary outcome [19] 0 0
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [19] 0 0
Day 1 up to 12 Months
Secondary outcome [20] 0 0
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [20] 0 0
Day 1 up to 12 Months

Eligibility
Key inclusion criteria
* Men and women = 18 years of age;
* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
* Anticoagulant treatment completed
* No recurrence of Venous Thromboembolism (VTE)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with indications for long-term treatment with a vitamin K antagonist
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Impaired kidney or liver function

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Kogarah
Recruitment hospital [3] 0 0
Local Institution - Lismore
Recruitment hospital [4] 0 0
Local Institution - St Leonards
Recruitment hospital [5] 0 0
Local Institution - Herston
Recruitment hospital [6] 0 0
Local Institution - Kippa Ring
Recruitment hospital [7] 0 0
Local Institution - Woolloongabba
Recruitment hospital [8] 0 0
Local Institution - Adelaide
Recruitment hospital [9] 0 0
Local Institution - Bedford Park
Recruitment hospital [10] 0 0
Local Institution - Launceston
Recruitment hospital [11] 0 0
Local Institution - Box Hill
Recruitment hospital [12] 0 0
Local Institution - Clayton
Recruitment hospital [13] 0 0
Local Institution - Footscray
Recruitment hospital [14] 0 0
Local Institution - Parkville
Recruitment hospital [15] 0 0
Local Institution - Richmond
Recruitment hospital [16] 0 0
Local Institution - Ringwood East
Recruitment hospital [17] 0 0
Local Institution - Windsor
Recruitment hospital [18] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
7250 - Launceston
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3011 - Footscray
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
3121 - Richmond
Recruitment postcode(s) [16] 0 0
3135 - Ringwood East
Recruitment postcode(s) [17] 0 0
3181 - Windsor
Recruitment postcode(s) [18] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Cordoba
Country [36] 0 0
Argentina
State/province [36] 0 0
Corrientes
Country [37] 0 0
Austria
State/province [37] 0 0
Graz
Country [38] 0 0
Austria
State/province [38] 0 0
Innsbruck
Country [39] 0 0
Austria
State/province [39] 0 0
Vienna
Country [40] 0 0
Austria
State/province [40] 0 0
Wien
Country [41] 0 0
Brazil
State/province [41] 0 0
Bahia
Country [42] 0 0
Brazil
State/province [42] 0 0
Distrito Federal
Country [43] 0 0
Brazil
State/province [43] 0 0
Minas Gerais
Country [44] 0 0
Brazil
State/province [44] 0 0
Parana
Country [45] 0 0
Brazil
State/province [45] 0 0
Rio De Janeiro
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio Grande Do Sul
Country [47] 0 0
Brazil
State/province [47] 0 0
Sao Paulo
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
Araucania
Country [53] 0 0
Chile
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Magallanes Antartica
Country [54] 0 0
Chile
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Metropolitana
Country [55] 0 0
Chile
State/province [55] 0 0
Valparaiso
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Kladno
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Czech Republic
State/province [57] 0 0
Litomysl
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Czech Republic
State/province [58] 0 0
Mestec Kralove
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Ostrava Vitkovice
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Plzen
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Praha 13
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Praha 1
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Czech Republic
State/province [63] 0 0
Praha 2
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Praha 4
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Usti Nad Orlici
Country [66] 0 0
Denmark
State/province [66] 0 0
Arhus C
Country [67] 0 0
Denmark
State/province [67] 0 0
Braedstrup
Country [68] 0 0
Denmark
State/province [68] 0 0
Esbjerg
Country [69] 0 0
Denmark
State/province [69] 0 0
Frederiksberg
Country [70] 0 0
Denmark
State/province [70] 0 0
Hellerup
Country [71] 0 0
Denmark
State/province [71] 0 0
Herning
Country [72] 0 0
Denmark
State/province [72] 0 0
Hilleroed
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Denmark
State/province [73] 0 0
Naestved
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Denmark
State/province [74] 0 0
Silkeborg
Country [75] 0 0
France
State/province [75] 0 0
Arras
Country [76] 0 0
France
State/province [76] 0 0
Besancon
Country [77] 0 0
France
State/province [77] 0 0
Brest Cedex
Country [78] 0 0
France
State/province [78] 0 0
Clamart
Country [79] 0 0
France
State/province [79] 0 0
Clermont-Ferrand Cedex 01
Country [80] 0 0
France
State/province [80] 0 0
Dijon
Country [81] 0 0
France
State/province [81] 0 0
Grenoble
Country [82] 0 0
France
State/province [82] 0 0
Le Kremlin-Bicetre
Country [83] 0 0
France
State/province [83] 0 0
Lille Cedex
Country [84] 0 0
France
State/province [84] 0 0
Limoges Cedex
Country [85] 0 0
France
State/province [85] 0 0
Lyon Cedex 03
Country [86] 0 0
France
State/province [86] 0 0
Nantes
Country [87] 0 0
France
State/province [87] 0 0
Saint-Priest En Jarez
Country [88] 0 0
France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
France
State/province [89] 0 0
Vernon
Country [90] 0 0
Germany
State/province [90] 0 0
Berlin
Country [91] 0 0
Germany
State/province [91] 0 0
Bochum
Country [92] 0 0
Germany
State/province [92] 0 0
Bonn
Country [93] 0 0
Germany
State/province [93] 0 0
Cologne
Country [94] 0 0
Germany
State/province [94] 0 0
Dortmund
Country [95] 0 0
Germany
State/province [95] 0 0
Dresden
Country [96] 0 0
Germany
State/province [96] 0 0
Erfurt
Country [97] 0 0
Germany
State/province [97] 0 0
Frankfurt
Country [98] 0 0
Germany
State/province [98] 0 0
Gottingen
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Germany
State/province [99] 0 0
Karlsbad
Country [100] 0 0
Germany
State/province [100] 0 0
Krefeld
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Germany
State/province [101] 0 0
Ludwigshafen
Country [102] 0 0
Germany
State/province [102] 0 0
Mannheim
Country [103] 0 0
Germany
State/province [103] 0 0
Munchen
Country [104] 0 0
Germany
State/province [104] 0 0
Munich
Country [105] 0 0
Hong Kong
State/province [105] 0 0
Hong Kong
Country [106] 0 0
Hong Kong
State/province [106] 0 0
Shatin, N.T
Country [107] 0 0
India
State/province [107] 0 0
Andhra Pradesh
Country [108] 0 0
India
State/province [108] 0 0
Gujarat
Country [109] 0 0
India
State/province [109] 0 0
Haryana
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India
State/province [110] 0 0
Karnataka
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India
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Kerala
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India
State/province [112] 0 0
Maharashtra
Country [113] 0 0
India
State/province [113] 0 0
Punjab
Country [114] 0 0
India
State/province [114] 0 0
Tagore Nagar
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India
State/province [115] 0 0
Tamil Nadu
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India
State/province [116] 0 0
Ahmedabad
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India
State/province [117] 0 0
Bangalore, Karnataka
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India
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Bangalore
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India
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Chennai
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India
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Israel
State/province [121] 0 0
Afula
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Israel
State/province [122] 0 0
Givataim
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Israel
State/province [123] 0 0
Hadera
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Israel
State/province [124] 0 0
Haifa
Country [125] 0 0
Israel
State/province [125] 0 0
Holon
Country [126] 0 0
Israel
State/province [126] 0 0
Jerusalem
Country [127] 0 0
Israel
State/province [127] 0 0
Kfar Saba
Country [128] 0 0
Israel
State/province [128] 0 0
Kiryat Hadassah
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Israel
State/province [129] 0 0
Nahariya
Country [130] 0 0
Israel
State/province [130] 0 0
Petach-Tikva
Country [131] 0 0
Israel
State/province [131] 0 0
Safed
Country [132] 0 0
Israel
State/province [132] 0 0
Tel Aviv
Country [133] 0 0
Israel
State/province [133] 0 0
Tel Hashomer
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Italy
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Bollate
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Italy
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Bologna
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Italy
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Chieti Scalo
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Italy
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Cosenza
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Italy
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Ferrara
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Firenze
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Genova
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Milano
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Padova
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Italy
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Palermo
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Italy
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Pavia
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Italy
State/province [145] 0 0
Perugia
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Italy
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Piacenza
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Italy
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Pisa
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Roma
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Italy
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Rozzano (Mi)
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Italy
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San Daniele Del Friuli (Ud)
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Italy
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Udine
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Italy
State/province [152] 0 0
Venezia
Country [153] 0 0
Italy
State/province [153] 0 0
Vicenza
Country [154] 0 0
Italy
State/province [154] 0 0
Vittorio Veneto (Tv)
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Korea, Republic of
State/province [155] 0 0
Busan
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Korea, Republic of
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Jongno-Gu
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Korea, Republic of
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Mexico
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Mexico
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Sinaloa
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Mexico
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Veracruz
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
State/province [167] 0 0
Durango
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Mexico
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Puebla
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Mexico
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Queretaro
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Mexico
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San Luis Potosi
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Norway
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Alesund
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Norway
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Fredrikstad
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Norway
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Gjettum
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Norway
State/province [174] 0 0
Gjovik
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Norway
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Hamar
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Norway
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Oslo
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Philippines
State/province [177] 0 0
Cavite
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Philippines
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Davao City
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Philippines
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Pasig City
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Philippines
State/province [180] 0 0
Quezon City
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Poland
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Arkonska 4
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Bialystok
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Poland
State/province [183] 0 0
Bydgoszcz
Country [184] 0 0
Poland
State/province [184] 0 0
Gdansk
Country [185] 0 0
Poland
State/province [185] 0 0
Gdynia
Country [186] 0 0
Poland
State/province [186] 0 0
Lodz
Country [187] 0 0
Poland
State/province [187] 0 0
Lublin
Country [188] 0 0
Poland
State/province [188] 0 0
Poznan
Country [189] 0 0
Poland
State/province [189] 0 0
Przeworsk
Country [190] 0 0
Poland
State/province [190] 0 0
Szczecin
Country [191] 0 0
Poland
State/province [191] 0 0
Tarnobrzeg
Country [192] 0 0
Poland
State/province [192] 0 0
Warsawa
Country [193] 0 0
Poland
State/province [193] 0 0
Warsaw
Country [194] 0 0
Poland
State/province [194] 0 0
Warszawa
Country [195] 0 0
Poland
State/province [195] 0 0
Wroclaw
Country [196] 0 0
Portugal
State/province [196] 0 0
Guarda
Country [197] 0 0
Portugal
State/province [197] 0 0
Lisboa
Country [198] 0 0
Puerto Rico
State/province [198] 0 0
San Juan
Country [199] 0 0
Romania
State/province [199] 0 0
Baia Mare
Country [200] 0 0
Romania
State/province [200] 0 0
Bucharest
Country [201] 0 0
Romania
State/province [201] 0 0
Targu Mures
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Arkhangelsk
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Kemerovo
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Moscow
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Novosibirsk
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Rostov-On Don
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Ryazan
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Saint Petersburg
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Saint-Petersburg
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Samara
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Saratov
Country [212] 0 0
Russian Federation
State/province [212] 0 0
St Petersburg
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Tomsk
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Yaroslavl
Country [215] 0 0
Singapore
State/province [215] 0 0
Singapore
Country [216] 0 0
South Africa
State/province [216] 0 0
Free State
Country [217] 0 0
South Africa
State/province [217] 0 0
Gauteng
Country [218] 0 0
South Africa
State/province [218] 0 0
Kwa Zulu Natal
Country [219] 0 0
South Africa
State/province [219] 0 0
Western Cape
Country [220] 0 0
Spain
State/province [220] 0 0
Alicante
Country [221] 0 0
Spain
State/province [221] 0 0
Barcelona
Country [222] 0 0
Spain
State/province [222] 0 0
Madrid
Country [223] 0 0
Spain
State/province [223] 0 0
Cadiz
Country [224] 0 0
Spain
State/province [224] 0 0
Getafe
Country [225] 0 0
Spain
State/province [225] 0 0
Girona
Country [226] 0 0
Spain
State/province [226] 0 0
L'Hospitalet De Llobregat
Country [227] 0 0
Spain
State/province [227] 0 0
Leon
Country [228] 0 0
Spain
State/province [228] 0 0
Mourente
Country [229] 0 0
Spain
State/province [229] 0 0
Pamplona
Country [230] 0 0
Spain
State/province [230] 0 0
Salamanca
Country [231] 0 0
Spain
State/province [231] 0 0
Sant Boi De Llobregat
Country [232] 0 0
Spain
State/province [232] 0 0
Tarragona
Country [233] 0 0
Spain
State/province [233] 0 0
Toledo
Country [234] 0 0
Spain
State/province [234] 0 0
Valencia
Country [235] 0 0
Ukraine
State/province [235] 0 0
Chernihiv
Country [236] 0 0
Ukraine
State/province [236] 0 0
Dnipropetrovsk
Country [237] 0 0
Ukraine
State/province [237] 0 0
Donetsk
Country [238] 0 0
Ukraine
State/province [238] 0 0
Ivano-Frankivsk
Country [239] 0 0
Ukraine
State/province [239] 0 0
Kharkiv
Country [240] 0 0
Ukraine
State/province [240] 0 0
Kyiv
Country [241] 0 0
Ukraine
State/province [241] 0 0
Lviv
Country [242] 0 0
Ukraine
State/province [242] 0 0
Odesa
Country [243] 0 0
Ukraine
State/province [243] 0 0
Ternopil
Country [244] 0 0
Ukraine
State/province [244] 0 0
Vinnytsia
Country [245] 0 0
Ukraine
State/province [245] 0 0
Zaporizhzhia
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Aberdeenshire
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Essex
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Greater London
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Greater Manchester
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Humberside
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Nottinghamshire
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Suffolk
Country [253] 0 0
United Kingdom
State/province [253] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

No documents have been uploaded by study researchers.