Neoplasms
Conditions
Keywords
Cancer, Rivaroxaban, Venous thromboembolism
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.
Interventions
DRUGRivaroxaban
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
DRUGPlacebo
Placebo tablet will be administered orally once daily for 180 days.
Sponsors
Bayer
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Up to Day 180 | 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) | From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE) | Up to Day 180 | 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 | Up to Day 180 | 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 | Up to Day 180 | 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 | Up to Day 180 | 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 the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths | Up to Day 180 | 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 Time to First Occurrence of Composite Efficacy Endpoint 4 | Up to Day 180 | 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 | 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 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 | 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 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 | 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 event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding. |
| Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3 | Up to Day 180 | 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 All-Cause Mortality | Up to Day 180 | 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. |
Countries
Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Russia, United Kingdom, United States
Participant flow
Recruitment details
A total of 841 participants were enrolled in the study to receive either of the 2 treatments: rivaroxaban or matching placebo.
Pre-assignment details
Deaths which were primary cause of treatment discontinuation (up to Day 180) are reported in participant flow excluding deaths which occurred after discontinuation.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days. | 421 |
| Rivaroxaban 10 mg Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days. | 420 |
| Total | 841 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 8 |
| Overall Study | Death | 74 | 59 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Other | 17 | 17 |
| Overall Study | Physician Decision | 12 | 13 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 48 | 48 |
Baseline characteristics
| Characteristic | Rivaroxaban 10 mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 11.22 | 62 years STANDARD_DEVIATION 11.2 | 61.9 years STANDARD_DEVIATION 11.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 132 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 314 Participants | 626 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 43 Participants | 83 Participants | 40 Participants |
| Race/Ethnicity, Customized Asian | 6 Count of Participants | 11 Count of Participants | 5 Count of Participants |
| Race/Ethnicity, Customized Black | 13 Count of Participants | 31 Count of Participants | 18 Count of Participants |
| Race/Ethnicity, Customized Not reported | 39 Count of Participants | 70 Count of Participants | 31 Count of Participants |
| Race/Ethnicity, Customized Other | 10 Count of Participants | 31 Count of Participants | 21 Count of Participants |
| Race/Ethnicity, Customized White | 352 Count of Participants | 698 Count of Participants | 346 Count of Participants |
| Region of Enrollment Belgium | 10 Participants | 13 Participants | 3 Participants |
| Region of Enrollment Brazil | 48 Participants | 103 Participants | 55 Participants |
| Region of Enrollment Bulgaria | 19 Participants | 34 Participants | 15 Participants |
| Region of Enrollment Canada | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment Czech Republic | 12 Participants | 37 Participants | 25 Participants |
| Region of Enrollment France | 34 Participants | 63 Participants | 29 Participants |
| Region of Enrollment Germany | 53 Participants | 113 Participants | 60 Participants |
| Region of Enrollment Italy | 15 Participants | 32 Participants | 17 Participants |
| Region of Enrollment Russian Federation | 61 Participants | 120 Participants | 59 Participants |
| Region of Enrollment United Kingdom | 19 Participants | 49 Participants | 30 Participants |
| Region of Enrollment United States of America | 146 Participants | 274 Participants | 128 Participants |
| Sex: Female, Male Female | 198 Participants | 413 Participants | 215 Participants |
| Sex: Female, Male Male | 222 Participants | 428 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 106 / 404 | 85 / 405 |
| other Total, other adverse events | 145 / 404 | 138 / 405 |
| serious Total, serious adverse events | 128 / 404 | 134 / 405 |
Outcome results
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).
Time frame: Up to Day 180
Population: The Intent-to-treat (ITT) population consisted of all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Primary efficacy composite endpoint | 8.79 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic lower extremity proximal DVT | 1.90 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic lower extremity distal DVT | 1.19 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic upper extremity DVT | 1.43 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic non-fatal PE | 1.19 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Asymptomatic lower extremity proximal DVT | 2.61 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Incidental PE | 2.38 Percentage of participants |
| Placebo | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | VTE-related death | 0.71 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | VTE-related death | 0.24 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Primary efficacy composite endpoint | 5.95 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic non-fatal PE | 1.19 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic lower extremity proximal DVT | 2.14 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Incidental PE | 1.43 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic lower extremity distal DVT | 0.48 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Asymptomatic lower extremity proximal DVT | 0.95 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) | Symptomatic upper extremity DVT | 0.95 Percentage of participants |
Comparison: Statistical analysis for primary efficacy composite endpoint.p-value: =0.10195% CI: [0.4, 1.09]Log Rank
Comparison: Statistical analysis for Symptomatic lower extremity proximal DVT.p-value: =0.81495% CI: [0.43, 2.91]Log Rank
Comparison: Statistical analysis for symptomatic lower extremity distal DVT.p-value: =0.2695% CI: [0.08, 2.07]Log Rank
Comparison: Statistical analysis for symptomatic upper extremity DVT.p-value: =0.53895% CI: [0.19, 2.39]Log Rank
Comparison: Statistical analysis for symptomatic non-fatal PE.p-value: =0.97795% CI: [0.29, 3.52]Log Rank
Comparison: Statistical analysis for asymptomatic lower extremity proximal DVT.p-value: =0.06395% CI: [0.11, 1.11]Log Rank
Comparison: Statistical analysis for incidental PE.p-value: =0.30195% CI: [0.21, 1.62]Log Rank
Comparison: Statistical analysis for VTE-related death.p-value: =0.31495% CI: [0.03, 3.18]Log Rank
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.
Time frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) | 0.99 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) | 1.98 Percentage of participants |
p-value: =0.26595% CI: [0.59, 6.49]Log Rank
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With All-Cause Mortality | 23.8 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With All-Cause Mortality | 20.0 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2 | 5.23 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2 | 3.81 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3 | 10.7 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3 | 6.90 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4 | 6.89 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4 | 5.71 Percentage of participants |
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.
Time frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Any Bleeding | 6.44 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Any Bleeding | 11.1 Percentage of participants |
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.
Time frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding | 1.98 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding | 2.72 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1 | 29.5 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1 | 23.1 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE) | 1.66 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE) | 0.95 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE | 0.48 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE | 0.24 Percentage of participants |
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.
Time frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Minor Bleeding | 3.96 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Minor Bleeding | 6.91 Percentage of participants |
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.
Time frame: Up to Day 180
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths | 5.23 Percentage of participants |
| Rivaroxaban 10 mg | Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths | 3.81 Percentage of participants |