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Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy (SAVE-ONCO)

Primary Purpose

Venous Thromboembolism, Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semuloparin sodium
Placebo (for semuloparin)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy

Exclusion Criteria:

  • Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
  • High risk of bleeding;
  • Severe renal impairment (estimated creatinine clearance <30 mL/min);
  • ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4;
  • Major surgery within 4 weeks before randomization;
  • Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin [LMWH].

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Sites / Locations

  • Investigational Site Number 840006
  • Investigational Site Number 840007
  • Investigational Site Number 840060
  • Investigational Site Number 840050
  • Investigational Site Number 840072
  • Investigational Site Number 840037
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  • Investigational Site Number 826004
  • Investigational Site Number 826009
  • Investigational Site Number 826011
  • Investigational Site Number 826001
  • Investigational Site Number 826014

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semuloparin

Placebo

Arm Description

Semuloparin sodium 20 mg once daily until change in chemotherapy regimen

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

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
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".
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
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.

Secondary Outcome Measures

Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
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.
Percentage of Participants Who Experienced Clinically Relevant Bleedings
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).
Overall survival [OS]
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.

Full Information

First Posted
May 7, 2008
Last Updated
January 14, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00694382
Brief Title
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Acronym
SAVE-ONCO
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). The study period per participant was variable depending on the duration of chemotherapy. It included: a screening period up to 3 weeks, a double-blind treatment period, a follow-up period of 1 month. Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Cancer
Keywords
chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semuloparin
Arm Type
Experimental
Arm Description
Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for semuloparin) once daily until change in chemotherapy regimen
Intervention Type
Drug
Intervention Name(s)
Semuloparin sodium
Other Intervention Name(s)
AVE5026
Intervention Description
0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo (for semuloparin)
Intervention Description
0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
Description
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".
Time Frame
From randomization up to 3 days after last study drug injection
Title
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
Description
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.
Time Frame
From randomization up to 3 days after last study drug injection
Secondary Outcome Measure Information:
Title
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Description
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.
Time Frame
From randomization up to 3 days after last study drug injection
Title
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Description
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).
Time Frame
From first study drug injection up to 3 days after last study drug injection
Title
Overall survival [OS]
Description
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.
Time Frame
From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first
Other Pre-specified Outcome Measures:
Title
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
Description
PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Thresholds for platelet counts were defined as follows: Platelets count <50 Giga/L; Platelets count ≥50 and <100 Giga/L;
Time Frame
From first study drug injection up to 3 days after last study drug injection
Title
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
Description
Thresholds were defined as follows: Alanine Aminotransferase [ALAT] >3 Upper Normal Limit [ULN]; Total Bilirubin [TB] >2 ULN; ALAT >3 ULN and TB >2 ULN; Cases with ALAT >3 ULN and TB >2 ULN (not necessarily concomitant) were evaluated by blinded independent adjudicator to determine if they met Hy's law criteria.
Time Frame
From first study drug injection up to 3 days after last study drug injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy Exclusion Criteria: Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; High risk of bleeding; Severe renal impairment (estimated creatinine clearance <30 mL/min); ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4; Major surgery within 4 weeks before randomization; Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin [LMWH]. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Turpie, MD
Organizational Affiliation
HHS-General Hospital, Hamilton, Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giancarlo Agnelli, MD
Organizational Affiliation
University Of Perugia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site Number 840006
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Investigational Site Number 840007
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
Investigational Site Number 840060
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Investigational Site Number 840050
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigational Site Number 840072
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Investigational Site Number 840037
City
Indian Wells
State/Province
California
ZIP/Postal Code
92210
Country
United States
Facility Name
Investigational Site Number 840069
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Investigational Site Number 840009
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigational Site Number 840001
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Investigational Site Number 840011
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Investigational Site Number 840029
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Investigational Site Number 840005
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Investigational Site Number 840064
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Investigational Site Number 840038
City
Woodbridge
State/Province
Connecticut
ZIP/Postal Code
06525
Country
United States
Facility Name
Investigational Site Number 840052
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Investigational Site Number 840025
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Investigational Site Number 840074
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Site Number 840019
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Investigational Site Number 840051
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Investigational Site Number 840073
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number 840070
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site Number 840016
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Investigational Site Number 840028
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Investigational Site Number 840008
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Investigational Site Number 840033
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Investigational Site Number 840010
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Investigational Site Number 840014
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Investigational Site Number 840048
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Investigational Site Number 840047
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Facility Name
Investigational Site Number 840032
City
Ruston
State/Province
Louisiana
ZIP/Postal Code
71270
Country
United States
Facility Name
Investigational Site Number 840042
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Investigational Site Number 840066
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
Investigational Site Number 840059
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Investigational Site Number 840024
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Investigational Site Number 840031
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Investigational Site Number 840020
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Site Number 840021
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Site Number 840026
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigational Site Number 840046
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Investigational Site Number 840003
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Investigational Site Number 840022
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Investigational Site Number 840075
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Investigational Site Number 840067
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Investigational Site Number 840004
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Investigational Site Number 840034
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 840035
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Investigational Site Number 840063
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Investigational Site Number 840018
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Investigational Site Number 032006
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Investigational Site Number 032003
City
Capital Federal
ZIP/Postal Code
1264
Country
Argentina
Facility Name
Investigational Site Number 032004
City
Rosario
ZIP/Postal Code
S200PBJ
Country
Argentina
Facility Name
Investigational Site Number 032005
City
San Miguel De Tucuman
ZIP/Postal Code
T4000NIL
Country
Argentina
Facility Name
Investigational Site Number 032007
City
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Investigational Site Number 036004
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Investigational Site Number 036002
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Investigational Site Number 036001
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number 036009
City
Lismore
ZIP/Postal Code
2480
Country
Australia
Facility Name
Investigational Site Number 036007
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Investigational Site Number 036006
City
Ringwood East
ZIP/Postal Code
3135
Country
Australia
Facility Name
Investigational Site Number 036008
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Investigational Site Number 036003
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Investigational Site Number 036005
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Investigational Site Number 040002
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 040003
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number 040004
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Investigational Site Number 112002
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Investigational Site Number 112003
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Investigational Site Number 112001
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Investigational Site Number 112004
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Investigational Site Number 056008
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Investigational Site Number 056011
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Investigational Site Number 056005
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number 056010
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Investigational Site Number 056006
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Investigational Site Number 056009
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number 056004
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Investigational Site Number 056003
City
Oostende
Country
Belgium
Facility Name
Investigational Site Number 056012
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Investigational Site Number 056002
City
Sint Niklaas
Country
Belgium
Facility Name
Investigational Site Number 076002
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Investigational Site Number 076022
City
Curitiba
ZIP/Postal Code
80730 170
Country
Brazil
Facility Name
Investigational Site Number 076015
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Investigational Site Number 076012
City
Florianopolis
ZIP/Postal Code
88015-240
Country
Brazil
Facility Name
Investigational Site Number 076001
City
Fortaleza
ZIP/Postal Code
60336-550
Country
Brazil
Facility Name
Investigational Site Number 076009
City
Goiania
ZIP/Postal Code
74070-040
Country
Brazil
Facility Name
Investigational Site Number 076007
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Investigational Site Number 076016
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Investigational Site Number 076024
City
Ijui
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Investigational Site Number 076003
City
Joinville
ZIP/Postal Code
89202-000
Country
Brazil
Facility Name
Investigational Site Number 076010
City
Londrina
ZIP/Postal Code
86050-190
Country
Brazil
Facility Name
Investigational Site Number 076026
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Investigational Site Number 076027
City
Passo Fundo
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Investigational Site Number 076023
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Investigational Site Number 076020
City
Porto Alegre
ZIP/Postal Code
90430-090
Country
Brazil
Facility Name
Investigational Site Number 076014
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Investigational Site Number 076018
City
Salvador
ZIP/Postal Code
41825-010
Country
Brazil
Facility Name
Investigational Site Number 076011
City
Santo Andre
ZIP/Postal Code
09090-780
Country
Brazil
Facility Name
Investigational Site Number 076006
City
Sao Jose Dos Campos
ZIP/Postal Code
12245-750
Country
Brazil
Facility Name
Investigational Site Number 076008
City
Sao Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Investigational Site Number 076017
City
Sao Paulo
ZIP/Postal Code
04122 000
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Taguatinga
ZIP/Postal Code
72115-700
Country
Brazil
Facility Name
Investigational Site Number 100001
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number 100003
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Investigational Site Number 124008
City
Greenfield Park
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Investigational Site Number 124007
City
Kelowna
Country
Canada
Facility Name
Investigational Site Number 124010
City
Moncton
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Investigational Site Number 124003
City
Montreal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Investigational Site Number 124002
City
Ottawa
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Investigational Site Number 124009
City
Owen Sound
ZIP/Postal Code
N4K 2J1
Country
Canada
Facility Name
Investigational Site Number 124006
City
Rimouski
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Investigational Site Number 124013
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Investigational Site Number 124001
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 124012
City
Victoria
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Investigational Site Number 124011
City
Weston
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Investigational Site Number 152002
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Investigational Site Number 156014
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Investigational Site Number 156008
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Investigational Site Number 156022
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Investigational Site Number 156031
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number 156021
City
Chengdu
ZIP/Postal Code
610083
Country
China
Facility Name
Investigational Site Number 156019
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Investigational Site Number 156003
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Investigational Site Number 156025
City
Guangzhou
ZIP/Postal Code
510405
Country
China
Facility Name
Investigational Site Number 156026
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Investigational Site Number 156030
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Investigational Site Number 156029
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Investigational Site Number 156024
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Investigational Site Number 156028
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Investigational Site Number 156020
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Investigational Site Number 156011
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Investigational Site Number 156013
City
Shantou
ZIP/Postal Code
515041
Country
China
Facility Name
Investigational Site Number 156012
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Investigational Site Number 156004
City
Xi'An
ZIP/Postal Code
710032
Country
China
Facility Name
Investigational Site Number 156009
City
Xi'An
ZIP/Postal Code
710038
Country
China
Facility Name
Investigational Site Number 156027
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Investigational Site Number 170010
City
Bogota
Country
Colombia
Facility Name
Investigational Site Number 170005
City
Manizales
Country
Colombia
Facility Name
Investigational Site Number 170002
City
Medellin
Country
Colombia
Facility Name
Investigational Site Number 170006
City
Medellin
Country
Colombia
Facility Name
Investigational Site Number 170007
City
Medellín
Country
Colombia
Facility Name
Investigational Site Number 170008
City
Monteria
Country
Colombia
Facility Name
Investigational Site Number 170004
City
Pereira
Country
Colombia
Facility Name
Investigational Site Number 191006
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Investigational Site Number 191005
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Investigational Site Number 191007
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Investigational Site Number 191003
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Investigational Site Number 191008
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number 191001
City
Zagreb
Country
Croatia
Facility Name
Investigational Site Number 191004
City
Zagreb
Country
Croatia
Facility Name
Investigational Site Number 203004
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Investigational Site Number 203008
City
Kolin
ZIP/Postal Code
28020
Country
Czech Republic
Facility Name
Investigational Site Number 203007
City
Nova Ves Pod Plesi
ZIP/Postal Code
26202
Country
Czech Republic
Facility Name
Investigational Site Number 203003
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Investigational Site Number 208001
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Investigational Site Number 233001
City
Tallinn
ZIP/Postal Code
10167
Country
Estonia
Facility Name
Investigational Site Number 246001
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Investigational Site Number 250002
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
Investigational Site Number 250010
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Investigational Site Number 250020
City
Gap
ZIP/Postal Code
5007
Country
France
Facility Name
Investigational Site Number 250005
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Investigational Site Number 250025
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Investigational Site Number 250012
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250003
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Investigational Site Number 250001
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Investigational Site Number 250024
City
Montpellier Cedex
ZIP/Postal Code
34094
Country
France
Facility Name
Investigational Site Number 250006
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Investigational Site Number 250027
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Investigational Site Number 250004
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Investigational Site Number 250021
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Investigational Site Number 250019
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Investigational Site Number 250017
City
Saint Gregoire
ZIP/Postal Code
35570
Country
France
Facility Name
Investigational Site Number 250014
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Investigational Site Number 276012
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Investigational Site Number 276025
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site Number 276016
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Investigational Site Number 276002
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site Number 276029
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
Investigational Site Number 276004
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigational Site Number 276014
City
Dresden
ZIP/Postal Code
01219
Country
Germany
Facility Name
Investigational Site Number 276009
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number 276030
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Investigational Site Number 276005
City
Frankfurt Am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Investigational Site Number 276032
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Investigational Site Number 276038
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany
Facility Name
Investigational Site Number 276034
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Investigational Site Number 276037
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Investigational Site Number 276007
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Investigational Site Number 276006
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Investigational Site Number 276020
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Investigational Site Number 276010
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Investigational Site Number 276017
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Investigational Site Number 276011
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Investigational Site Number 276003
City
Minden
ZIP/Postal Code
32427
Country
Germany
Facility Name
Investigational Site Number 276021
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Investigational Site Number 276019
City
München
ZIP/Postal Code
81545
Country
Germany
Facility Name
Investigational Site Number 276015
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Investigational Site Number 276013
City
Neumünster
ZIP/Postal Code
24634
Country
Germany
Facility Name
Investigational Site Number 276022
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Investigational Site Number 276035
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Investigational Site Number 276031
City
Passau
ZIP/Postal Code
94032
Country
Germany
Facility Name
Investigational Site Number 276023
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Investigational Site Number 276008
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Investigational Site Number 276024
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Investigational Site Number 300004
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Investigational Site Number 300003
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number 300002
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
Facility Name
Investigational Site Number 344001
City
Hong Kong
Country
Hong Kong
Facility Name
Investigational Site Number 348005
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Investigational Site Number 348006
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Investigational Site Number 348009
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Investigational Site Number 348010
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Investigational Site Number 348001
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigational Site Number 348012
City
Mátraháza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Sopron
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigational Site Number 348008
City
Szikszó
ZIP/Postal Code
3800
Country
Hungary
Facility Name
Investigational Site Number 348011
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Investigational Site Number 348007
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Investigational Site Number 356006
City
Bangalore
ZIP/Postal Code
560029
Country
India
Facility Name
Investigational Site Number 356008
City
Bangalore
Country
India
Facility Name
Investigational Site Number 356009
City
Bhopal
ZIP/Postal Code
462 001 (M.P)
Country
India
Facility Name
Investigational Site Number 356018
City
Chennai
Country
India
Facility Name
Investigational Site Number 356020
City
Chennai
Country
India
Facility Name
Investigational Site Number 356019
City
Coimbatore
ZIP/Postal Code
641037
Country
India
Facility Name
Investigational Site Number 356015
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Investigational Site Number 356025
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Investigational Site Number 356011
City
Jaipur
Country
India
Facility Name
Investigational Site Number 356014
City
Kochi
Country
India
Facility Name
Investigational Site Number 356003
City
Kolkata
ZIP/Postal Code
700026
Country
India
Facility Name
Investigational Site Number 356013
City
Kolkata
Country
India
Facility Name
Investigational Site Number 356017
City
Kolkata
Country
India
Facility Name
Investigational Site Number 356005
City
Madurai
Country
India
Facility Name
Investigational Site Number 356016
City
Miraj
Country
India
Facility Name
Investigational Site Number 356001
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Investigational Site Number 356023
City
Nagpur
Country
India
Facility Name
Investigational Site Number 356002
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Investigational Site Number 356004
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Investigational Site Number 356024
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Investigational Site Number 356012
City
Vishakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Name
Investigational Site Number 360002
City
Bandung
ZIP/Postal Code
40161
Country
Indonesia
Facility Name
Investigational Site Number 360001
City
Denpasar
ZIP/Postal Code
80114
Country
Indonesia
Facility Name
Investigational Site Number 360004
City
Medan
ZIP/Postal Code
20136
Country
Indonesia
Facility Name
Investigational Site Number 372004
City
Dublin 7
Country
Ireland
Facility Name
Investigational Site Number 372003
City
Dublin
ZIP/Postal Code
D24
Country
Ireland
Facility Name
Investigational Site Number 372002
City
Dublin
ZIP/Postal Code
D9
Country
Ireland
Facility Name
Investigational Site Number 376003
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Investigational Site Number 376004
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigational Site Number 376001
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Investigational Site Number 376006
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Investigational Site Number 376007
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Investigational Site Number 380005
City
Castellanza
ZIP/Postal Code
21053
Country
Italy
Facility Name
Investigational Site Number 380014
City
Cattolica
ZIP/Postal Code
47861
Country
Italy
Facility Name
Investigational Site Number 380007
City
Cesena
ZIP/Postal Code
47023
Country
Italy
Facility Name
Investigational Site Number 380015
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Investigational Site Number 380009
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Investigational Site Number 380012
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Investigational Site Number 380006
City
Lugo
ZIP/Postal Code
48022
Country
Italy
Facility Name
Investigational Site Number 380001
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Investigational Site Number 380011
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Investigational Site Number 380020
City
Perugia
ZIP/Postal Code
06128
Country
Italy
Facility Name
Investigational Site Number 380013
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Investigational Site Number 380016
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Investigational Site Number 380004
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Investigational Site Number 380010
City
Sora
ZIP/Postal Code
03039
Country
Italy
Facility Name
Investigational Site Number 380008
City
Taormina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Investigational Site Number 380019
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Investigational Site Number 380003
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Facility Name
Investigational Site Number 380017
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Investigational Site Number 410008
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Investigational Site Number 410007
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number 410005
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Investigational Site Number 410009
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Suwon
ZIP/Postal Code
442-060
Country
Korea, Republic of
Facility Name
Investigational Site Number 428002
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
Investigational Site Number 428003
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Investigational Site Number 428001
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number 440001
City
Kaunas
ZIP/Postal Code
06080
Country
Lithuania
Facility Name
Investigational Site Number 440002
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Investigational Site Number 458001
City
Kota Kinabalu
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Investigational Site Number 458003
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Investigational Site Number 458004
City
Penang
ZIP/Postal Code
11900
Country
Malaysia
Facility Name
Investigational Site Number 458005
City
Penang
ZIP/Postal Code
11900
Country
Malaysia
Facility Name
Investigational Site Number 484002
City
Acapulco
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Investigational Site Number 484006
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Investigational Site Number 484007
City
Durango
ZIP/Postal Code
34260
Country
Mexico
Facility Name
Investigational Site Number 484008
City
Mérida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigational Site Number 484012
City
Puebla
ZIP/Postal Code
72550
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Toluca
ZIP/Postal Code
50120
Country
Mexico
Facility Name
Investigational Site Number 484010
City
Xalapa
ZIP/Postal Code
91130
Country
Mexico
Facility Name
Investigational Site Number 528006
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Investigational Site Number 528004
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Investigational Site Number 528005
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Investigational Site Number 528001
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Investigational Site Number 528003
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Investigational Site Number 578001
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Investigational Site Number 604012
City
Arequipa
Country
Peru
Facility Name
Investigational Site Number 604004
City
Callao
ZIP/Postal Code
CALLAO 02
Country
Peru
Facility Name
Investigational Site Number 604011
City
Callao
ZIP/Postal Code
CALLAO 02
Country
Peru
Facility Name
Investigational Site Number 604001
City
Cercado
Country
Peru
Facility Name
Investigational Site Number 604002
City
Chiclayo
Country
Peru
Facility Name
Investigational Site Number 604008
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Investigational Site Number 604007
City
Lima
ZIP/Postal Code
LIMA 13
Country
Peru
Facility Name
Investigational Site Number 604009
City
Lima
ZIP/Postal Code
LIMA 13
Country
Peru
Facility Name
Investigational Site Number 604005
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Investigational Site Number 604006
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Investigational Site Number 604010
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Investigational Site Number 604003
City
Lima
Country
Peru
Facility Name
Investigational Site Number 616009
City
Bialystok
ZIP/Postal Code
15-069
Country
Poland
Facility Name
Investigational Site Number 616008
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Investigational Site Number 616006
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Investigational Site Number 616004
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Investigational Site Number 616003
City
Lubin
ZIP/Postal Code
59-300
Country
Poland
Facility Name
Investigational Site Number 616019
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Investigational Site Number 616021
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Investigational Site Number 616010
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Investigational Site Number 616001
City
Prabuty
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Investigational Site Number 616014
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Investigational Site Number 616005
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Investigational Site Number 616013
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 616018
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Investigational Site Number 616002
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigational Site Number 616015
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Investigational Site Number 620003
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Investigational Site Number 620009
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Investigational Site Number 620004
City
Lisboa
ZIP/Postal Code
1070
Country
Portugal
Facility Name
Investigational Site Number 620008
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
Investigational Site Number 620007
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Investigational Site Number 620002
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Investigational Site Number 642004
City
Brasov
ZIP/Postal Code
500117
Country
Romania
Facility Name
Investigational Site Number 642002
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Investigational Site Number 642001
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Investigational Site Number 642006
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Investigational Site Number 642010
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Investigational Site Number 642003
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Investigational Site Number 642008
City
Timisoara
ZIP/Postal Code
300041
Country
Romania
Facility Name
Investigational Site Number 643024
City
Berdsk
ZIP/Postal Code
633190
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
Krasnoyarsk
ZIP/Postal Code
660113
Country
Russian Federation
Facility Name
Investigational Site Number 643010
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Investigational Site Number 643022
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Investigational Site Number 643023
City
Rostov-On-Don
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Investigational Site Number 643020
City
Saratov
ZIP/Postal Code
410004
Country
Russian Federation
Facility Name
Investigational Site Number 643019
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
Investigational Site Number 643021
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Investigational Site Number 643014
City
St-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Investigational Site Number 643015
City
St-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Investigational Site Number 643011
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Investigational Site Number 643009
City
St.Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Investigational Site Number 643016
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Investigational Site Number 643018
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Investigational Site Number 643012
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Vladivostok
ZIP/Postal Code
690105
Country
Russian Federation
Facility Name
Investigational Site Number 643017
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Investigational Site Number 643003
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Investigational Site Number 688002
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number 688004
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Investigational Site Number 688007
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigational Site Number 688005
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Investigational Site Number 703003
City
Trnava
ZIP/Postal Code
91775
Country
Slovakia
Facility Name
Investigational Site Number 705003
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
Investigational Site Number 705002
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Investigational Site Number 710003
City
Durban
ZIP/Postal Code
400
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 724008
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Investigational Site Number 724010
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Investigational Site Number 724004
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724006
City
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Investigational Site Number 724011
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Investigational Site Number 724001
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number 724007
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number 724013
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Investigational Site Number 724012
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724005
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Investigational Site Number 724003
City
Puerto De Sagunto
ZIP/Postal Code
46520
Country
Spain
Facility Name
Investigational Site Number 724002
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Investigational Site Number 752003
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Investigational Site Number 752005
City
Mora
ZIP/Postal Code
792 85
Country
Sweden
Facility Name
Investigational Site Number 752002
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Investigational Site Number 752001
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Investigational Site Number 756006
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Investigational Site Number 756004
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Investigational Site Number 158004
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Investigational Site Number 804008
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Investigational Site Number 804009
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Investigational Site Number 804002
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Investigational Site Number 804006
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Investigational Site Number 804005
City
Krivoy Rog
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Investigational Site Number 804001
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Investigational Site Number 804010
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Investigational Site Number 804011
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Investigational Site Number 804004
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Investigational Site Number 826016
City
Bangor
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Investigational Site Number 826010
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Investigational Site Number 826015
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Investigational Site Number 826013
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Investigational Site Number 826007
City
Hull
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Investigational Site Number 826017
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Investigational Site Number 826005
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Investigational Site Number 826004
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Investigational Site Number 826009
City
Peterborough
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Investigational Site Number 826011
City
Portsmouth
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Investigational Site Number 826001
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Investigational Site Number 826014
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22335737
Citation
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.
Results Reference
result
PubMed Identifier
33337539
Citation
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.
Results Reference
derived

Learn more about this trial

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

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