A Phase 3 interventional study of Rivaroxaban and Placebo in Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 151 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 841 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.
Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.
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Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Drug: Rivaroxaban
Participants will be administered matching placebo tablet orally once daily for 180 days.
Drug: Placebo
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
Placebo tablet will be administered orally once daily for 180 days.
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
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)
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
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
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
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
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
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
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
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
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)
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)
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)
A total of 841 participants were enrolled in the study to receive either of the 2 treatments: rivaroxaban or matching placebo.
| Milestone | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Started | 421 | 420 |
| Treated | 404 | 405 |
| Completed | 255 | 270 |
| Not completed | 166 | 150 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Withdrawal by subject | 48 | 48 |
| Withdrew: Adverse event | 12 | 8 |
| Withdrew: Death | 74 | 59 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Physician decision | 12 | 13 |
| Withdrew: Other | 17 | 17 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Primary efficacy composite endpoint | 8.79 | 5.95 |
| Symptomatic lower extremity proximal DVT | 1.90 | 2.14 |
| Symptomatic lower extremity distal DVT | 1.19 | 0.48 |
| Symptomatic upper extremity DVT | 1.43 | 0.95 |
| Symptomatic non-fatal PE | 1.19 | 1.19 |
| Asymptomatic lower extremity proximal DVT | 2.61 | 0.95 |
| Incidental PE | 2.38 | 1.43 |
| VTE-related death | 0.71 | 0.24 |
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.
| Percentage of participants | Placebo | 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) | 0.99 | 1.98 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths | 5.23 | 3.81 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With All-Cause Mortality | 23.8 | 20.0 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE) | 1.66 | 0.95 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE | 0.48 | 0.24 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1 | 29.5 | 23.1 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2 | 5.23 | 3.81 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3 | 10.7 | 6.90 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4 | 6.89 | 5.71 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding | 1.98 | 2.72 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Minor Bleeding | 3.96 | 6.91 |
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 | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Percentage of Participants With Time to the First Occurrence of Any Bleeding | 6.44 | 11.1 |
Collected over Up to 32 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 106/404 (26.2%) | 128/404 (31.7%) | 145/404 (35.9%) |
| Rivaroxaban 10 mg | 85/405 (21%) | 134/405 (33.1%) | 138/405 (34.1%) |
| Event | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| Malignant Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 33/404 | 29/405 |
| PneumoniaInfections and infestations | 4/404 | 10/405 |
| PyrexiaGeneral disorders | 8/404 | 8/405 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 4/404 | 6/405 |
| SepsisInfections and infestations | 4/404 | 6/405 |
| DehydrationMetabolism and nutrition disorders | 5/404 | 3/405 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/404 | 3/405 |
| Abdominal PainGastrointestinal disorders | 3/404 | 5/405 |
| General Physical Health DeteriorationGeneral disorders | 4/404 | 5/405 |
| DysphagiaGastrointestinal disorders | 4/404 | 1/405 |
| Event | Placebo | Rivaroxaban 10 mg |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 59/404 | 46/405 |
| NauseaGastrointestinal disorders | 55/404 | 55/405 |
| FatigueGeneral disorders | 32/404 | 44/405 |
| DiarrhoeaGastrointestinal disorders | 36/404 | 34/405 |
| ConstipationGastrointestinal disorders | 12/404 | 29/405 |
| VomitingGastrointestinal disorders | 17/404 | 28/405 |
| Decreased AppetiteMetabolism and nutrition disorders | 25/404 | 21/405 |
| NeutropeniaBlood and lymphatic system disorders | 24/404 | 25/405 |
| Age, Continuous(years) | Placebo | Rivaroxaban 10 mg | Total |
|---|---|---|---|
| Mean | 61.9 ± 11.19 | 62.1 ± 11.22 | 62 ± 11.2 |
| Sex: Female, Male(Participants) | Placebo | Rivaroxaban 10 mg | Total |
|---|---|---|---|
| Female | 215 | 198 | 413 |
| Male | 206 | 222 | 428 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Rivaroxaban 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 69 | 63 | 132 |
| Not Hispanic or Latino | 312 | 314 | 626 |
| Unknown or Not Reported | 40 | 43 | 83 |
| Race/Ethnicity, Customized(Count of Participants) | Placebo | Rivaroxaban 10 mg | Total |
|---|---|---|---|
| White | 346 | 352 | 698 |
| Black | 18 | 13 | 31 |
| Asian | 5 | 6 | 11 |
| Other | 21 | 10 | 31 |
| Not reported | 31 | 39 | 70 |
| Region of Enrollment(Participants) | Placebo | Rivaroxaban 10 mg | Total |
|---|---|---|---|
| Belgium | 3 | 10 | 13 |
| Brazil | 55 | 48 | 103 |
| Bulgaria | 15 | 19 | 34 |
| Canada | 0 | 3 | 3 |
| Czech Republic | 25 | 12 | 37 |
| France | 29 | 34 | 63 |
| Germany | 60 | 53 | 113 |
| Italy | 17 | 15 | 32 |
| Russian Federation | 59 | 61 | 120 |
| United Kingdom | 30 | 19 | 49 |
| United States of America | 128 | 146 | 274 |
Showing the first 100 of 151 sites across 10 countries.
Documents are hosted by the registry — open the source record to download them.
Ran from Sep 2015 to primary completion in Aug 2018, 35 months.
Results were first posted in Sep 2019, 1 year after primary completion.
Of 92 industry-sponsored phase 3 interventional studies under Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 78. This study's 35 months is below that.
Counting every sponsor, half of 191 studies reached it within 55 months; a quarter within 40 and three quarters within 96.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivaroxaban
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