Back to resultsA Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
Primary Purpose
Neoplasms
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Neoplasms focused on measuring Cancer, Rivaroxaban, Venous thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
- Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
- Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
Exclusion Criteria:
- Diagnosis of primary brain tumors
- Known history of brain metastases
- Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
- Hematologic malignancies with the exception of lymphoma
- Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rivaroxaban
Placebo
Arm Description
Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Participants will be administered matching placebo tablet orally once daily for 180 days.
Outcomes
Primary Outcome Measures
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
Secondary Outcome Measures
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
Percentage of participants with time to first occurrence of the composite endpoint of symptomatic VTE events (symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, or symptomatic non-fatal PE) or VTE related deaths as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With All-Cause Mortality
Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here.
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2
Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3
Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4
Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding
Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.
Percentage of Participants With Time to the First Occurrence of Minor Bleeding
Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event.
Percentage of Participants With Time to the First Occurrence of Any Bleeding
Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding.
Full Information
NCT ID
NCT02555878
First Posted
September 18, 2015
Last Updated
August 22, 2019
Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT02555878
Brief Title
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
Official Title
Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2015 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, superiority study comparing the efficacy and safety of rivaroxaban with placebo for primary prophylaxis of venous thromboembolism (VTE) in ambulatory adult participants, with various cancer types who are scheduled to initiate systemic cancer therapy. The study consists of 3 Phases: Screening Phase (14 Days), double-blind treatment Phase (180 Days) and follow up Phase (30 Days). The duration of participation in the study for each participant is approximately 32 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Cancer, Rivaroxaban, Venous thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
841 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will be administered matching placebo tablet orally once daily for 180 days.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet will be administered orally once daily for 180 days.
Primary Outcome Measure Information:
Title
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
Description
Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
Description
Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
Description
Percentage of participants with time to first occurrence of the composite endpoint of symptomatic VTE events (symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, or symptomatic non-fatal PE) or VTE related deaths as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With All-Cause Mortality
Description
Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Description
Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Description
Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
Description
Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2
Description
Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3
Description
Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4
Description
Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Time Frame
Up to Day 180
Title
Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding
Description
Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.
Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Title
Percentage of Participants With Time to the First Occurrence of Minor Bleeding
Description
Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event.
Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Title
Percentage of Participants With Time to the First Occurrence of Any Bleeding
Description
Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding.
Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
Exclusion Criteria:
Diagnosis of primary brain tumors
Known history of brain metastases
Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
Hematologic malignancies with the exception of lymphoma
Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Martinez
State/Province
California
Country
United States
City
Santa Barbara
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Upland
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Norwich
State/Province
Connecticut
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Miami Shores
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Joliet
State/Province
Illinois
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Rockford
State/Province
Illinois
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
Urbana
State/Province
Illinois
Country
United States
City
Anderson
State/Province
Indiana
Country
United States
City
Cedar Rapids
State/Province
Iowa
Country
United States
City
Brewer
State/Province
Maine
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Silver Spring
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Saint Cloud
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Grand Island
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
East Syracuse
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Erie
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
North Charleston
State/Province
South Carolina
Country
United States
City
Rapid City
State/Province
South Dakota
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Abilene
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Beaumont
State/Province
Texas
Country
United States
City
Bedford
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Denton
State/Province
Texas
Country
United States
City
Flower Mound
State/Province
Texas
Country
United States
City
Garland
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Paris
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Sugar Land
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
The Woodlands
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
City
Waco
State/Province
Texas
Country
United States
City
Roanoke
State/Province
Virginia
Country
United States
City
Winchester
State/Province
Virginia
Country
United States
City
Green Bay
State/Province
Wisconsin
Country
United States
City
Weston
State/Province
Wisconsin
Country
United States
City
Amberloup
Country
Belgium
City
Bonheiden
Country
Belgium
City
Brussel
Country
Belgium
City
Bruxelles
Country
Belgium
City
Edegem
Country
Belgium
City
Laken (brussel)
Country
Belgium
City
Turnhout
Country
Belgium
City
Wilrijk
Country
Belgium
City
Barretos
Country
Brazil
City
Caxias do Sul
Country
Brazil
City
Curitiba
Country
Brazil
City
Itajai
Country
Brazil
City
Lajeado
Country
Brazil
City
Londrina
Country
Brazil
City
Mogi das Cruzes
Country
Brazil
City
Porto Alegre, Rs
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Santo André
Country
Brazil
City
Sao Jose do Rio Preto
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Sorocaba
Country
Brazil
City
São Paulo
Country
Brazil
City
Plovdiv N/a
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Toronto
State/Province
Ontario
Country
Canada
City
Saint-Jerome
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
City
Benesov Nad Cernou
Country
Czechia
City
Brno
Country
Czechia
City
Jindrichuv Hradec
Country
Czechia
City
Kladno
Country
Czechia
City
Liberec
Country
Czechia
City
Novy Jicin
Country
Czechia
City
Olomouc
Country
Czechia
City
Pardubice
Country
Czechia
City
Praha 4
Country
Czechia
City
Praha 5
Country
Czechia
City
Tabor
Country
Czechia
City
Angers Cedex 9
Country
France
City
Angers
Country
France
City
Avignon Cedex 9
Country
France
City
Dijon Cedex
Country
France
City
Hyers
Country
France
City
Le Mans Cedex 2
Country
France
City
Le Mans cedex 9
Country
France
City
Paris
Country
France
City
Rennes Cedex
Country
France
City
Saint Herblain
Country
France
City
Valenciennes
Country
France
City
Berlin
Country
Germany
City
Brandenburg
Country
Germany
City
Dortmund
Country
Germany
City
Dresden
Country
Germany
City
Esslingen
Country
Germany
City
Gauting
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Herne
Country
Germany
City
Kiel
Country
Germany
City
Koeln
Country
Germany
City
Leipzig
Country
Germany
City
Luebeck
Country
Germany
City
Magdeburg
Country
Germany
City
Merseburg
Country
Germany
City
Minden
Country
Germany
City
München
Country
Germany
City
Paderborn
Country
Germany
City
Recklinghausen
Country
Germany
City
Weiden
Country
Germany
City
Arkhangelsk
Country
Russian Federation
City
Chelyabinsk
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Yaroslavi
Country
Russian Federation
City
Bournemouth
Country
United Kingdom
City
Cheltenham
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
Swindon
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34807979
Citation
Khorana AA, Barnard J, Wun T, Vijapurkar U, Damaraju CV, Moore KT, Wildgoose P, McCrae KR. Biomarker signatures in cancer patients with and without venous thromboembolism events: a substudy of CASSINI. Blood Adv. 2022 Feb 22;6(4):1212-1221. doi: 10.1182/bloodadvances.2021005710.
Results Reference
derived
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
PubMed Identifier
32663379
Citation
Vadhan-Raj S, McNamara MG, Venerito M, Riess H, O'Reilly EM, Overman MJ, Zhou X, Vijapurkar U, Kaul S, Wildgoose P, Khorana AA. Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study. Cancer Med. 2020 Sep;9(17):6196-6204. doi: 10.1002/cam4.3269. Epub 2020 Jul 14.
Results Reference
derived
PubMed Identifier
30786186
Citation
Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
Results Reference
derived
PubMed Identifier
28933799
Citation
Khorana AA, Vadhan-Raj S, Kuderer NM, Wun T, Liebman H, Soff G, Belani C, O'Reilly EM, McBane R, Eikelboom J, Damaraju CV, Beyers K, Dietrich F, Kakkar AK, Riess H, Peixoto RD, Lyman GH. Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial. Thromb Haemost. 2017 Nov 1;117(11):2135-2145. doi: 10.1160/TH17-03-0171. Epub 2017 Sep 21.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
We'll reach out to this number within 24 hrs