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| ID | Type | Description | Link |
|---|---|---|---|
| 39039039STM4001 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-001630-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental | Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days. |
|
| Placebo | Experimental | Participants will be administered matching placebo tablet orally once daily for 180 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to Day 180 |
| 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. | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34807979 | Derived | 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. | |
| 33337539 | Derived | 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. |
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Deaths which were primary cause of treatment discontinuation (up to Day 180) are reported in participant flow excluding deaths which occurred after discontinuation.
A total of 841 participants were enrolled in the study to receive either of the 2 treatments: rivaroxaban or matching placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days. |
| FG001 | Rivaroxaban 10 mg | Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2018 | Aug 22, 2019 |
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| Placebo | Drug | Placebo tablet will be administered orally once daily for 180 days. |
|
| Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | Up to Day 180 |
| 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. | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
| 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. | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
| 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. | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
| Tucson |
| Arizona |
| United States |
| Little Rock | Arkansas | United States |
| Los Angeles | California | United States |
| Martinez | California | United States |
| Santa Barbara | California | United States |
| Torrance | California | United States |
| Upland | California | United States |
| Denver | Colorado | United States |
| Norwich | Connecticut | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Miami Shores | Florida | United States |
| New Port Richey | Florida | United States |
| Atlanta | Georgia | United States |
| Evanston | Illinois | United States |
| Joliet | Illinois | United States |
| Peoria | Illinois | United States |
| Rockford | Illinois | United States |
| Skokie | Illinois | United States |
| Urbana | Illinois | United States |
| Anderson | Indiana | United States |
| Cedar Rapids | Iowa | United States |
| Brewer | Maine | United States |
| Baltimore | Maryland | United States |
| Silver Spring | Maryland | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Rochester | Minnesota | United States |
| Saint Cloud | Minnesota | United States |
| Kansas City | Missouri | United States |
| Grand Island | Nebraska | United States |
| Las Vegas | Nevada | United States |
| Lebanon | New Hampshire | United States |
| Albany | New York | United States |
| East Syracuse | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| The Bronx | New York | United States |
| Charlotte | North Carolina | United States |
| High Point | North Carolina | United States |
| Cleveland | Ohio | United States |
| Eugene | Oregon | United States |
| Portland | Oregon | United States |
| Erie | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Greenville | South Carolina | United States |
| North Charleston | South Carolina | United States |
| Rapid City | South Dakota | United States |
| Nashville | Tennessee | United States |
| Abilene | Texas | United States |
| Austin | Texas | United States |
| Beaumont | Texas | United States |
| Bedford | Texas | United States |
| Dallas | Texas | United States |
| Denton | Texas | United States |
| Flower Mound | Texas | United States |
| Garland | Texas | United States |
| Houston | Texas | United States |
| Paris | Texas | United States |
| San Antonio | Texas | United States |
| Sugar Land | Texas | United States |
| Temple | Texas | United States |
| The Woodlands | Texas | United States |
| Tyler | Texas | United States |
| Waco | Texas | United States |
| Roanoke | Virginia | United States |
| Winchester | Virginia | United States |
| Green Bay | Wisconsin | United States |
| Weston | Wisconsin | United States |
| Amberloup | Belgium |
| Bonheiden | Belgium |
| Brussels | Belgium |
| Edegem | Belgium |
| Laken (brussel) | Belgium |
| Turnhout | Belgium |
| Wilrijk | Belgium |
| Barretos | Brazil |
| Caxias do Sul | Brazil |
| Curitiba | Brazil |
| Itajaí | Brazil |
| Lajeado | Brazil |
| Londrina | Brazil |
| Mogi das Cruzes | Brazil |
| Porto Alegre | Brazil |
| Porto Alegre, Rs | Brazil |
| Rio de Janeiro | Brazil |
| Santo André | Brazil |
| São José do Rio Preto | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Plovdiv | Bulgaria |
| Sofia | Bulgaria |
| Toronto | Ontario | Canada |
| Saint-Jérôme | Quebec | Canada |
| Québec | Canada |
| Benešov nad Černou | Czechia |
| Brno | Czechia |
| Jindřichův Hradec | Czechia |
| Kladno | Czechia |
| Liberec | Czechia |
| Nový Jičín | Czechia |
| Olomouc | Czechia |
| Pardubice | Czechia |
| Prague | Czechia |
| Tábor | Czechia |
| Angers | France |
| Avignon | France |
| Dijon | France |
| Hyers | France |
| Le Mans | France |
| Paris | France |
| Rennes | France |
| Saint-Herblain | France |
| Valenciennes | France |
| Berlin | Germany |
| Brandenburg | Germany |
| Cologne | Germany |
| Dortmund | Germany |
| Dresden | Germany |
| Esslingen am Neckar | Germany |
| Gauting | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Herne | Germany |
| Kiel | Germany |
| Leipzig | Germany |
| Lübeck | Germany |
| Magdeburg | Germany |
| Merseburg | Germany |
| Minden | Germany |
| München | Germany |
| Paderborn | Germany |
| Recklinghausen | Germany |
| Weiden | Germany |
| Arkhangelsk | Russia |
| Chelyabinsk | Russia |
| Kursk | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Omsk | Russia |
| Saint Petersburg | Russia |
| Tomsk | Russia |
| Yaroslavi | Russia |
| Bournemouth | United Kingdom |
| Cheltenham | United Kingdom |
| Dundee | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Plymouth | United Kingdom |
| Swindon | United Kingdom |
| 32663379 | Derived | 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. |
| 30786186 | Derived | 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. |
| 28933799 | Derived | 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. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days. |
| BG001 | Rivaroxaban 10 mg | Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Count of Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The Intent-to-treat (ITT) population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
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| Primary | 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. | The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
|
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| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all randomized participants. | Posted | Number | Percentage of participants | Up to Day 180 |
|
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| Secondary | 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. | The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
|
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| Secondary | 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. | The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
|
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| Secondary | 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. | The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) |
|
|
Up to 32 weeks
The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days. | 106 | 404 | 128 | 404 | 145 | 404 |
| EG001 | Rivaroxaban 10 mg | Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days. | 85 | 405 | 134 | 405 | 138 | 405 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cardiotoxicity | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Duodenal Obstruction | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal Obstruction | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal Toxicity | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Intestinal Infarction | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Condition Aggravated | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Biliary Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Febrile Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Klebsiella Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aspiration Bronchial | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| General Physical Condition Abnormal | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Glomerular Filtration Rate Decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Feeding Intolerance | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Metastases to Lymph Nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Muscle Contractions Involuntary | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Transient Global Amnesia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Superior Vena Cava Syndrome | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Scientific Affairs, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 16, 2018 | Aug 22, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| Other |
|
| Not reported |
|
| Brazil |
|
| Bulgaria |
|
| Canada |
|
| Czech Republic |
|
| France |
|
| Germany |
|
| Italy |
|
| Russian Federation |
|
| United Kingdom |
|
| United States of America |
|
| Symptomatic lower extremity distal DVT |
|
| Symptomatic upper extremity DVT |
|
| Symptomatic non-fatal PE |
|
| Asymptomatic lower extremity proximal DVT |
|
| Incidental PE |
|
| VTE-related death |
|
| Log Rank |
| = 0.814 |
| Hazard Ratio (HR) |
| 1.12 |
| 2-Sided |
| 95 |
| 0.43 |
| 2.91 |
| Superiority |
| Statistical analysis for symptomatic lower extremity distal DVT. | Log Rank | = 0.260 | Hazard Ratio (HR) | 0.40 | 2-Sided | 95 | 0.08 | 2.07 | Superiority |
| Statistical analysis for symptomatic upper extremity DVT. | Log Rank | = 0.538 | Hazard Ratio (HR) | 0.67 | 2-Sided | 95 | 0.19 | 2.39 | Superiority |
| Statistical analysis for symptomatic non-fatal PE. | Log Rank | = 0.977 | Hazard Ratio (HR) | 1.02 | 2-Sided | 95 | 0.29 | 3.52 | Superiority |
| Statistical analysis for asymptomatic lower extremity proximal DVT. | Log Rank | = 0.063 | Hazard Ratio (HR) | 0.35 | 2-Sided | 95 | 0.11 | 1.11 | Superiority |
| Statistical analysis for incidental PE. | Log Rank | = 0.301 | Hazard Ratio (HR) | 0.59 | 2-Sided | 95 | 0.21 | 1.62 | Superiority |
| Statistical analysis for VTE-related death. | Log Rank | = 0.314 | Hazard Ratio (HR) | 0.33 | 2-Sided | 95 | 0.03 | 3.18 | Superiority |
|
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| Participants |
|
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