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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00496769




Registration number
NCT00496769
Ethics application status
Date submitted
2/07/2007
Date registered
4/07/2007
Date last updated
15/06/2018

Titles & IDs
Public title
A Phase III Study of Apixaban in Patients With Atrial Fibrillation
Scientific title
Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial
Secondary ID [1] 0 0
CV185-048
Universal Trial Number (UTN)
Trial acronym
AVERROES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Apixaban -

Active comparator: Acetylasalicylic acid -


Treatment: Drugs: Apixaban
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

Treatment: Drugs: Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

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

Outcomes
Primary outcome [1] 0 0
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
Timepoint [1] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [1] 0 0
Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
Timepoint [1] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [2] 0 0
Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
Timepoint [2] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [3] 0 0
Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
Timepoint [3] 0 0
First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Secondary outcome [4] 0 0
Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
Timepoint [4] 0 0
Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
Timepoint [5] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [6] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality
Timepoint [6] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [7] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
Timepoint [7] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [8] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
Timepoint [8] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

Eligibility
Key inclusion criteria
Key

* Male and female
* Age of 50 years or older
* Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
* At least 1 of the following risk factors for stroke:

* Prior stroke or transient ischemic attack
* Age of 75 years or older
* Arterial hypertension on treatment
* Diabetes mellitus
* Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
* Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
* Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
* Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

* Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
* Vitamin K antagonist therapy not previously used but expected unsuitable

Key
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breast feeding
* Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
* Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
* Valvular disease requiring surgery
* Planned ablation procedure for atrial fibrillation to be performed within 3 months
* Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
* Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

* Active peptic ulcer disease
* Platelet count <100,000/mm^3 or hemoglobin <10g/dL
* Recent stroke (within 10 days)
* Documented hemorrhagic tendencies or blood dyscrasias
* Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
* Severe comorbid condition with life expectancy <1 year
* Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
* Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
* Allergy or adverse reaction to acetylsalicylic acid
* Required treatment with a thienopyridine (clopidogrel or ticlopidine)
* Prisoners or participants who are compulsory detained (involuntarily incarcerated)
* Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
* Patients who are compulsorily detained for treatment for a psychiatric or physical illness

Study design
Purpose of the study
Prevention
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)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Gosford
Recruitment hospital [4] 0 0
Local Institution - Kingswood
Recruitment hospital [5] 0 0
Local Institution - Auchenflower
Recruitment hospital [6] 0 0
Local Institution - Kippa Ring
Recruitment hospital [7] 0 0
Local Institution - Milton
Recruitment hospital [8] 0 0
Local Institution - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - Geelong
Recruitment hospital [10] 0 0
Local Institution - Joondalup
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
6027 - Joondalup
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
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Argentina
State/province [31] 0 0
Jujuy
Country [32] 0 0
Argentina
State/province [32] 0 0
Provincia Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa FE
Country [34] 0 0
Argentina
State/province [34] 0 0
Tucuman
Country [35] 0 0
Argentina
State/province [35] 0 0
Corrientes
Country [36] 0 0
Argentina
State/province [36] 0 0
Salta
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Austria
State/province [38] 0 0
Graz
Country [39] 0 0
Austria
State/province [39] 0 0
Linz
Country [40] 0 0
Austria
State/province [40] 0 0
Oberpullendorf
Country [41] 0 0
Austria
State/province [41] 0 0
Salzburg
Country [42] 0 0
Belgium
State/province [42] 0 0
Aalst
Country [43] 0 0
Belgium
State/province [43] 0 0
Brasschaat
Country [44] 0 0
Belgium
State/province [44] 0 0
Brussel
Country [45] 0 0
Belgium
State/province [45] 0 0
Bruxelles
Country [46] 0 0
Belgium
State/province [46] 0 0
De Pinte
Country [47] 0 0
Belgium
State/province [47] 0 0
Genk
Country [48] 0 0
Belgium
State/province [48] 0 0
Huy
Country [49] 0 0
Belgium
State/province [49] 0 0
Roeselare
Country [50] 0 0
Belgium
State/province [50] 0 0
Turnhout
Country [51] 0 0
Brazil
State/province [51] 0 0
Bahia
Country [52] 0 0
Brazil
State/province [52] 0 0
Minas Gerais
Country [53] 0 0
Brazil
State/province [53] 0 0
Parana
Country [54] 0 0
Brazil
State/province [54] 0 0
Para
Country [55] 0 0
Brazil
State/province [55] 0 0
Rio Grande Do Norte
Country [56] 0 0
Brazil
State/province [56] 0 0
Rio Grande Do Sul
Country [57] 0 0
Brazil
State/province [57] 0 0
Santa Catarina
Country [58] 0 0
Brazil
State/province [58] 0 0
Sao Paulo
Country [59] 0 0
Brazil
State/province [59] 0 0
Rio De Janeiro
Country [60] 0 0
Canada
State/province [60] 0 0
British Columbia
Country [61] 0 0
Canada
State/province [61] 0 0
Manitoba
Country [62] 0 0
Canada
State/province [62] 0 0
Ontario
Country [63] 0 0
Canada
State/province [63] 0 0
Quebec
Country [64] 0 0
Canada
State/province [64] 0 0
Saskatchewan
Country [65] 0 0
Chile
State/province [65] 0 0
Araucania
Country [66] 0 0
Chile
State/province [66] 0 0
LOS Lagos
Country [67] 0 0
Chile
State/province [67] 0 0
Los Rios
Country [68] 0 0
Chile
State/province [68] 0 0
Metropolitana
Country [69] 0 0
Chile
State/province [69] 0 0
Valparaiso
Country [70] 0 0
China
State/province [70] 0 0
Beijing
Country [71] 0 0
China
State/province [71] 0 0
Guangdong
Country [72] 0 0
China
State/province [72] 0 0
Hebei
Country [73] 0 0
China
State/province [73] 0 0
Hubei
Country [74] 0 0
China
State/province [74] 0 0
Jiangsu
Country [75] 0 0
China
State/province [75] 0 0
Liaoning
Country [76] 0 0
China
State/province [76] 0 0
Shandong
Country [77] 0 0
China
State/province [77] 0 0
Shanghai
Country [78] 0 0
China
State/province [78] 0 0
Sichuan
Country [79] 0 0
Colombia
State/province [79] 0 0
Antioquia
Country [80] 0 0
Colombia
State/province [80] 0 0
Atlantico
Country [81] 0 0
Colombia
State/province [81] 0 0
Santander
Country [82] 0 0
Colombia
State/province [82] 0 0
Valle DEL Cauca
Country [83] 0 0
Colombia
State/province [83] 0 0
Bogota
Country [84] 0 0
Czechia
State/province [84] 0 0
Brno
Country [85] 0 0
Czechia
State/province [85] 0 0
Havirov - Mesto
Country [86] 0 0
Czechia
State/province [86] 0 0
Jindrichuv Hradec
Country [87] 0 0
Czechia
State/province [87] 0 0
Kladno
Country [88] 0 0
Czechia
State/province [88] 0 0
Kromeriz
Country [89] 0 0
Czechia
State/province [89] 0 0
Mestec Kralove
Country [90] 0 0
Czechia
State/province [90] 0 0
Ostrava
Country [91] 0 0
Czechia
State/province [91] 0 0
Pisek
Country [92] 0 0
Czechia
State/province [92] 0 0
Praha 1
Country [93] 0 0
Czechia
State/province [93] 0 0
Praha 2
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 5
Country [95] 0 0
Czechia
State/province [95] 0 0
Prelouc
Country [96] 0 0
Czechia
State/province [96] 0 0
Pribram
Country [97] 0 0
Czechia
State/province [97] 0 0
Slany
Country [98] 0 0
Czechia
State/province [98] 0 0
Usti Nad Orlici
Country [99] 0 0
Denmark
State/province [99] 0 0
Arhus C
Country [100] 0 0
Denmark
State/province [100] 0 0
Esbjerg
Country [101] 0 0
Denmark
State/province [101] 0 0
Frederiksberg
Country [102] 0 0
Finland
State/province [102] 0 0
Espoo
Country [103] 0 0
Finland
State/province [103] 0 0
Helsinki
Country [104] 0 0
Finland
State/province [104] 0 0
Jyvaskyla
Country [105] 0 0
Finland
State/province [105] 0 0
Kuopio
Country [106] 0 0
Finland
State/province [106] 0 0
Tampere
Country [107] 0 0
France
State/province [107] 0 0
Abbeville Cedex
Country [108] 0 0
France
State/province [108] 0 0
Albi Cedex 09
Country [109] 0 0
France
State/province [109] 0 0
Cholet
Country [110] 0 0
France
State/province [110] 0 0
Grenoble Cedex 09
Country [111] 0 0
France
State/province [111] 0 0
Langres Cedex
Country [112] 0 0
France
State/province [112] 0 0
Paris Cedex 18
Country [113] 0 0
France
State/province [113] 0 0
Sisteron
Country [114] 0 0
France
State/province [114] 0 0
Toulon Cedex 09
Country [115] 0 0
Germany
State/province [115] 0 0
Berlin
Country [116] 0 0
Germany
State/province [116] 0 0
Bonn
Country [117] 0 0
Germany
State/province [117] 0 0
Essen
Country [118] 0 0
Germany
State/province [118] 0 0
Frankfurt Am Main
Country [119] 0 0
Germany
State/province [119] 0 0
Halle/saale
Country [120] 0 0
Germany
State/province [120] 0 0
Hamburg
Country [121] 0 0
Germany
State/province [121] 0 0
Heidelberg
Country [122] 0 0
Germany
State/province [122] 0 0
Kassel
Country [123] 0 0
Germany
State/province [123] 0 0
Koln
Country [124] 0 0
Germany
State/province [124] 0 0
Leipzig
Country [125] 0 0
Germany
State/province [125] 0 0
Magdeburg
Country [126] 0 0
Germany
State/province [126] 0 0
Mainz
Country [127] 0 0
Germany
State/province [127] 0 0
Mannheim
Country [128] 0 0
Germany
State/province [128] 0 0
Papenburg
Country [129] 0 0
Germany
State/province [129] 0 0
Regensburg
Country [130] 0 0
Germany
State/province [130] 0 0
Riesa
Country [131] 0 0
Germany
State/province [131] 0 0
Witten
Country [132] 0 0
Germany
State/province [132] 0 0
Wolmirstedt
Country [133] 0 0
Greece
State/province [133] 0 0
Athens
Country [134] 0 0
Greece
State/province [134] 0 0
Larissa
Country [135] 0 0
Greece
State/province [135] 0 0
Thiva
Country [136] 0 0
Hong Kong
State/province [136] 0 0
NEW Territories
Country [137] 0 0
Hong Kong
State/province [137] 0 0
Chai Wan
Country [138] 0 0
Hong Kong
State/province [138] 0 0
Hong Kong
Country [139] 0 0
India
State/province [139] 0 0
Andhra Pradesh
Country [140] 0 0
India
State/province [140] 0 0
Karnataka
Country [141] 0 0
India
State/province [141] 0 0
Maharashtra
Country [142] 0 0
India
State/province [142] 0 0
Nagpur
Country [143] 0 0
India
State/province [143] 0 0
Tamil Nadu
Country [144] 0 0
India
State/province [144] 0 0
Uttar Pradesh
Country [145] 0 0
India
State/province [145] 0 0
Ahmedabad
Country [146] 0 0
India
State/province [146] 0 0
Bangalore
Country [147] 0 0
India
State/province [147] 0 0
Bikaner
Country [148] 0 0
India
State/province [148] 0 0
Indore
Country [149] 0 0
India
State/province [149] 0 0
Jaipur
Country [150] 0 0
India
State/province [150] 0 0
Kottayam
Country [151] 0 0
India
State/province [151] 0 0
Pune
Country [152] 0 0
Indonesia
State/province [152] 0 0
Jawa-timur
Country [153] 0 0
Indonesia
State/province [153] 0 0
Bandung
Country [154] 0 0
Indonesia
State/province [154] 0 0
Denpasar
Country [155] 0 0
Indonesia
State/province [155] 0 0
Jakarta Timur
Country [156] 0 0
Indonesia
State/province [156] 0 0
Jakarta
Country [157] 0 0
Indonesia
State/province [157] 0 0
Padang
Country [158] 0 0
Indonesia
State/province [158] 0 0
Palembang
Country [159] 0 0
Indonesia
State/province [159] 0 0
Surabaya
Country [160] 0 0
Indonesia
State/province [160] 0 0
Yogyakarta
Country [161] 0 0
Israel
State/province [161] 0 0
Afula
Country [162] 0 0
Israel
State/province [162] 0 0
Ashkelon
Country [163] 0 0
Israel
State/province [163] 0 0
Givatayim
Country [164] 0 0
Israel
State/province [164] 0 0
Hadera
Country [165] 0 0
Israel
State/province [165] 0 0
Haifa
Country [166] 0 0
Israel
State/province [166] 0 0
Holon
Country [167] 0 0
Israel
State/province [167] 0 0
Nazareth
Country [168] 0 0
Israel
State/province [168] 0 0
Petach-tikva
Country [169] 0 0
Israel
State/province [169] 0 0
Safed
Country [170] 0 0
Israel
State/province [170] 0 0
Tel Aviv
Country [171] 0 0
Italy
State/province [171] 0 0
Ascoli Piceno
Country [172] 0 0
Italy
State/province [172] 0 0
Chieti
Country [173] 0 0
Italy
State/province [173] 0 0
Genova
Country [174] 0 0
Italy
State/province [174] 0 0
Isernia
Country [175] 0 0
Italy
State/province [175] 0 0
Lido Di Camaiore
Country [176] 0 0
Italy
State/province [176] 0 0
Palermo
Country [177] 0 0
Italy
State/province [177] 0 0
Perugia
Country [178] 0 0
Italy
State/province [178] 0 0
San Daniele De Friuli (ud)
Country [179] 0 0
Italy
State/province [179] 0 0
Sassari
Country [180] 0 0
Korea, Republic of
State/province [180] 0 0
Gyeonggi-do
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Kyunggi-do
Country [182] 0 0
Korea, Republic of
State/province [182] 0 0
Busan
Country [183] 0 0
Korea, Republic of
State/province [183] 0 0
Daegu
Country [184] 0 0
Korea, Republic of
State/province [184] 0 0
Daejeon
Country [185] 0 0
Korea, Republic of
State/province [185] 0 0
Gwangju
Country [186] 0 0
Korea, Republic of
State/province [186] 0 0
Seoul
Country [187] 0 0
Malaysia
State/province [187] 0 0
Johor
Country [188] 0 0
Malaysia
State/province [188] 0 0
Kuala Lumpur
Country [189] 0 0
Malaysia
State/province [189] 0 0
Pinang
Country [190] 0 0
Malaysia
State/province [190] 0 0
Sarawak
Country [191] 0 0
Mexico
State/province [191] 0 0
Distrito Federal
Country [192] 0 0
Mexico
State/province [192] 0 0
Estado De Mexico
Country [193] 0 0
Mexico
State/province [193] 0 0
Guerrero
Country [194] 0 0
Mexico
State/province [194] 0 0
Jalisco
Country [195] 0 0
Mexico
State/province [195] 0 0
Nuevo Leon
Country [196] 0 0
Mexico
State/province [196] 0 0
San Luis Potosi
Country [197] 0 0
Mexico
State/province [197] 0 0
Sinaloa
Country [198] 0 0
Mexico
State/province [198] 0 0
Sonora
Country [199] 0 0
Mexico
State/province [199] 0 0
Veracruz
Country [200] 0 0
Mexico
State/province [200] 0 0
Aguascalientes
Country [201] 0 0
Mexico
State/province [201] 0 0
Chihuahua
Country [202] 0 0
Mexico
State/province [202] 0 0
Durango
Country [203] 0 0
Mexico
State/province [203] 0 0
Queretaro
Country [204] 0 0
Norway
State/province [204] 0 0
Fyllingsdal
Country [205] 0 0
Norway
State/province [205] 0 0
Kongsberg
Country [206] 0 0
Norway
State/province [206] 0 0
Oslo
Country [207] 0 0
Philippines
State/province [207] 0 0
Camarines SUR
Country [208] 0 0
Philippines
State/province [208] 0 0
Laguna
Country [209] 0 0
Philippines
State/province [209] 0 0
Lanao DEL Norte
Country [210] 0 0
Philippines
State/province [210] 0 0
Cagayan De Oro City
Country [211] 0 0
Philippines
State/province [211] 0 0
Cavite
Country [212] 0 0
Philippines
State/province [212] 0 0
Laoag City
Country [213] 0 0
Philippines
State/province [213] 0 0
Manila
Country [214] 0 0
Philippines
State/province [214] 0 0
Muntinlupa City
Country [215] 0 0
Poland
State/province [215] 0 0
Czestochowa
Country [216] 0 0
Poland
State/province [216] 0 0
Elblag
Country [217] 0 0
Poland
State/province [217] 0 0
Gdynia
Country [218] 0 0
Poland
State/province [218] 0 0
Gliwice
Country [219] 0 0
Poland
State/province [219] 0 0
Gniewkowo
Country [220] 0 0
Poland
State/province [220] 0 0
Grodzisk Mazowiecki
Country [221] 0 0
Poland
State/province [221] 0 0
Inowroclaw
Country [222] 0 0
Poland
State/province [222] 0 0
Kielce
Country [223] 0 0
Poland
State/province [223] 0 0
Krakow
Country [224] 0 0
Poland
State/province [224] 0 0
Lodz
Country [225] 0 0
Poland
State/province [225] 0 0
Piotrkow Trybunalski
Country [226] 0 0
Poland
State/province [226] 0 0
Plock
Country [227] 0 0
Poland
State/province [227] 0 0
Poznan
Country [228] 0 0
Poland
State/province [228] 0 0
Pulawy
Country [229] 0 0
Poland
State/province [229] 0 0
Siemianowice Slaskie
Country [230] 0 0
Poland
State/province [230] 0 0
Skierniewice
Country [231] 0 0
Poland
State/province [231] 0 0
Tarnow
Country [232] 0 0
Poland
State/province [232] 0 0
Warsaw
Country [233] 0 0
Poland
State/province [233] 0 0
Warszawa
Country [234] 0 0
Poland
State/province [234] 0 0
Wegrow
Country [235] 0 0
Poland
State/province [235] 0 0
Zabrze
Country [236] 0 0
Poland
State/province [236] 0 0
Zarow
Country [237] 0 0
Russian Federation
State/province [237] 0 0
Anenki
Country [238] 0 0
Russian Federation
State/province [238] 0 0
Barnaul
Country [239] 0 0
Russian Federation
State/province [239] 0 0
Chelyabinsk
Country [240] 0 0
Russian Federation
State/province [240] 0 0
Ekaterinburg
Country [241] 0 0
Russian Federation
State/province [241] 0 0
Kazan
Country [242] 0 0
Russian Federation
State/province [242] 0 0
Kemerovo
Country [243] 0 0
Russian Federation
State/province [243] 0 0
Krasnodar
Country [244] 0 0
Russian Federation
State/province [244] 0 0
Moscow
Country [245] 0 0
Russian Federation
State/province [245] 0 0
Nizhniy Novgorod
Country [246] 0 0
Russian Federation
State/province [246] 0 0
Novosibirsk
Country [247] 0 0
Russian Federation
State/province [247] 0 0
Perm
Country [248] 0 0
Russian Federation
State/province [248] 0 0
Ryazan
Country [249] 0 0
Russian Federation
State/province [249] 0 0
Saint Petersburg
Country [250] 0 0
Russian Federation
State/province [250] 0 0
Saint-petersburg
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Samara
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Saratov
Country [253] 0 0
Russian Federation
State/province [253] 0 0
St.petersburg
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Tomsk
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Tumen
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Tver
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Yaroslavl
Country [258] 0 0
Singapore
State/province [258] 0 0
Singapore
Country [259] 0 0
South Africa
State/province [259] 0 0
FREE State
Country [260] 0 0
South Africa
State/province [260] 0 0
Gauteng
Country [261] 0 0
South Africa
State/province [261] 0 0
Western CAPE
Country [262] 0 0
South Africa
State/province [262] 0 0
Pretoria
Country [263] 0 0
Spain
State/province [263] 0 0
Alicante
Country [264] 0 0
Spain
State/province [264] 0 0
Barcelona
Country [265] 0 0
Spain
State/province [265] 0 0
Galicia
Country [266] 0 0
Spain
State/province [266] 0 0
Albacete
Country [267] 0 0
Spain
State/province [267] 0 0
Madrid
Country [268] 0 0
Spain
State/province [268] 0 0
Valencia
Country [269] 0 0
Sweden
State/province [269] 0 0
Goteborg
Country [270] 0 0
Sweden
State/province [270] 0 0
Molndal
Country [271] 0 0
Sweden
State/province [271] 0 0
Stockholm
Country [272] 0 0
Sweden
State/province [272] 0 0
Uppsala
Country [273] 0 0
Taiwan
State/province [273] 0 0
Kaohsiung
Country [274] 0 0
Taiwan
State/province [274] 0 0
Taichung
Country [275] 0 0
Taiwan
State/province [275] 0 0
Tainan
Country [276] 0 0
Taiwan
State/province [276] 0 0
Taipei
Country [277] 0 0
Turkey
State/province [277] 0 0
Isparta
Country [278] 0 0
Turkey
State/province [278] 0 0
Istanbul
Country [279] 0 0
Turkey
State/province [279] 0 0
Kirikkale
Country [280] 0 0
Ukraine
State/province [280] 0 0
Dnipropetrovsk
Country [281] 0 0
Ukraine
State/province [281] 0 0
Donetsk
Country [282] 0 0
Ukraine
State/province [282] 0 0
Kharkiv
Country [283] 0 0
Ukraine
State/province [283] 0 0
Kyiv
Country [284] 0 0
United Kingdom
State/province [284] 0 0
Aberdeenshire
Country [285] 0 0
United Kingdom
State/province [285] 0 0
Derbyshire
Country [286] 0 0
United Kingdom
State/province [286] 0 0
Essex
Country [287] 0 0
United Kingdom
State/province [287] 0 0
Fife
Country [288] 0 0
United Kingdom
State/province [288] 0 0
Greater London
Country [289] 0 0
United Kingdom
State/province [289] 0 0
Lanarkshire
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Lancashire
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Northamptonshire
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Nottinghamshire
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Portadown
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Renfrewshire
Country [295] 0 0
United Kingdom
State/province [295] 0 0
South Yorkshire
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Stirlingshire
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Tyne And Wear
Country [298] 0 0
United Kingdom
State/province [298] 0 0
West Midlands
Country [299] 0 0
United Kingdom
State/province [299] 0 0
West Sussex

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.