A Phase 3 interventional study of Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin overlapping with and followed by VKA in Pulmonary Embolism, sponsored by Bayer. Completed at 305 sites in 39 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-27.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 4,833 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Drug: Enoxaparin overlapping with and followed by VKA
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Time frame: 3-, 6-, or 12-month study treatment period
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6-, or 12-month study treatment period
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6-, or 12-month study treatment period
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With All Deaths
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Time frame: 3-, 6- or 12-month study treatment period
Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Time frame: Up to 30 days after the last intake of study medication
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Time frame: Up to 30 days after the last intake of study medication
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time frame: Up to 30 days after the last intake of study medication
Percentage of Participants With Recurrent DVT During Observational Period
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Time frame: Up to 30 days after the last intake of study medication
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Time frame: Up to 30 days after the last intake of study medication
Participants with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT) were recruited at specialized study sites.
| Milestone | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Started | 2420 | 2413 |
| Participants received treatment | 2412 | 2405 |
| Completed | 2001 | 1954 |
| Not completed | 419 | 459 |
| Withdrew: Death | 29 | 21 |
| Withdrew: Study terminated by sponsor | 125 | 132 |
| Withdrew: Site closed by investigator | 0 | 1 |
| Withdrew: Did not take study treatment | 7 | 8 |
| Withdrew: Adverse event | 111 | 92 |
| Withdrew: Protocol violation | 23 | 30 |
| Withdrew: Withdrawal by subject | 66 | 118 |
| Withdrew: Lack of efficacy | 1 | 4 |
| Withdrew: Lost to follow-up | 8 | 10 |
| Withdrew: Protocol driven decision point | 1 | 3 |
| Withdrew: Physician decision | 7 | 18 |
| Withdrew: Clinical endpoint reached | 26 | 13 |
| Withdrew: Technical problems | 3 | 1 |
| Withdrew: Participant convenience | 12 | 8 |
| Milestone | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Started | 2206 | 2197 |
| Completed | 2165 | 2156 |
| Not completed | 41 | 41 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Withdrawal by subject | 9 | 5 |
| Withdrew: Lost to follow-up | 1 | 11 |
| Withdrew: Death | 27 | 20 |
| Withdrew: Study terminated by sponsor | 3 | 1 |
| Withdrew: Protocol driven decision point | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Technical problems | 0 | 1 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment | 2.1 | 1.8 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment | 4.0 | 3.4 |
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment | 3.4 | 4.0 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment | 1.4 | 1.2 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment | 0.7 | 0.8 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) | 10.3 | 11.4 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| All post-randomization | 2.6 | 2.1 |
| Treatment-emergent (time window: 2 days) | 1.2 | 0.8 |
| Treatment-emergent (time window: 7 days) | 1.5 | 1.1 |
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) | 1.5 | 1.5 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Death (PE) | 0.1 | 0.04 |
| Death (PE cannot be excluded) | 0.3 | 0.2 |
| Symptomatic PE and DVT | 0.0 | 0.1 |
| Symptomatic recurrent PE only | 1.0 | 0.8 |
| Symptomatic recurrent DVT only | 0.7 | 0.7 |
| Death (bleeding) | 0.2 | 0.2 |
| Death (cardiovascular) | 0.4 | 0.1 |
| Death (other) | 1.3 | 1.5 |
| Major bleeding | 1.4 | 2.4 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period | 0.9 | 0.7 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period | 2.1 | 1.5 |
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period | 1.2 | 1.2 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With Recurrent DVT During Observational Period | 0.3 | 0.1 |
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Death (PE) | 0.09 | 0 |
| Death (PE cannot be excluded) | 0 | 0.05 |
| Symptomatic PE and DVT | 0.09 | 0 |
| Symptomatic recurrent PE only | 0.5 | 0.5 |
| Symptomatic recurrent DVT only | 0.2 | 0.1 |
| Death (bleeding) | 0.09 | 0.09 |
| Death (cardiovascular) | 0.3 | 0.05 |
| Death (other) | 0.8 | 0.7 |
| Major bleeding | 0.3 | 0.5 |
Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment | 4.5 | 4.8 |
Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
| Percentage of participants | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period | 1.5 | 1.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | — | 504/2,412 (20.9%) | 1,053/2,412 (43.7%) |
| Enoxaparin/VKA | — | 495/2,405 (20.6%) | 1,065/2,405 (44.3%) |
| Event | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| Chest painGeneral disorders | 21/2412 | 27/2405 |
| PneumoniaInfections and infestations | 22/2412 | 21/2405 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 17/2412 | 13/2405 |
| AnaemiaBlood and lymphatic system disorders | 14/2412 | 6/2405 |
| SepsisInfections and infestations | 13/2412 | 2/2405 |
| Ischaemic strokeNervous system disorders | 13/2412 | 5/2405 |
| Atrial fibrillationCardiac disorders | 8/2412 | 11/2405 |
| HaematuriaRenal and urinary disorders | 8/2412 | 11/2405 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 9/2412 | 11/2405 |
| Acute myocardial infarctionCardiac disorders | 6/2412 | 10/2405 |
| Event | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA |
|---|---|---|
| EpistaxisRespiratory, thoracic and mediastinal disorders | 229/2412 | 205/2405 |
| HeadacheNervous system disorders | 196/2412 | 177/2405 |
| NasopharyngitisInfections and infestations | 188/2412 | 195/2405 |
| Chest painGeneral disorders | 179/2412 | 181/2405 |
| CoughRespiratory, thoracic and mediastinal disorders | 160/2412 | 179/2405 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 172/2412 | 162/2405 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 156/2412 | 147/2405 |
| ConstipationGastrointestinal disorders | 146/2412 | 141/2405 |
| Back painMusculoskeletal and connective tissue disorders | 87/2412 | 134/2405 |
| ContusionInjury, poisoning and procedural complications | 95/2412 | 133/2405 |
| Age, Continuous(Years) | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA | Total |
|---|---|---|---|
| Mean | 57.9 ± 17.3 | 57.5 ± 17.2 | 57.7 ± 17.3 |
| Age, Customized(Participants) | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA | Total |
|---|---|---|---|
| 18 - < 40 years | 410 | 432 | 842 |
| 40 - < 60 years | 794 | 779 | 1573 |
| 60 - < 75 years | 740 | 754 | 1494 |
| ≥ 75 years | 475 | 448 | 923 |
| Sex: Female, Male(Participants) | Rivaroxaban (Xarelto, BAY59-7939) | Enoxaparin/VKA | Total |
|---|---|---|---|
| Female | 1309 | 1247 | 2556 |
| Male | 1110 | 1166 | 2276 |
Showing the first 100 of 305 sites across 39 countries.
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