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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004494-96 | EudraCT Number |
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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.
The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Experimental | Participants were to receive rivaroxaban 20 mg oral tablet once daily |
|
| Placebo | Placebo Comparator | Participants were to receive matching placebo oral tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. For definition of DVT/PE, kindly refer to the link in the Protocol section. | 6- or 12-month study treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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), or lung scintigraphy (for PE), and/or case summaries. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Death (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 autopsy, results/films/images of confirmatory testing, and/or case summaries. | 6- or 12-month study treatment period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22371186 | Result | Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28. | |
| 21128814 | Result | EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3. |
| Label | URL |
|---|---|
| Click here to find the definition for Deep Vein Thrombosis \[DVT\]. | View source |
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Out of 1200 participants screened, 3 failed screening (2 due to withdrawal of consent and 1 due to a protocol violation), and 1197 participants were randomized (602 to rivaroxaban and 595 to placebo).
Participants with confirmed symptomatic deep vein thrombosis or pulmonary embolism, who either had been treated for 6 or 12 months with warfarin or acenocoumarol or rivaroxaban in study NCT00440193, or who had been treated for 6 to 14 months with warfarin or acenocoumarol outside study NCT00440193, were recruited at specialized study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban (Xarelto, BAY59-7939) | Participants were to receive rivaroxaban 20 mg oral tablet once daily |
| FG001 | Placebo | Participants were to receive matching placebo oral tablet once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Placebo | Drug | Patients allocated to placebo will receive a matching placebo tablet once daily. |
|
| 6- or 12-month study treatment period |
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions 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), results/films/images of confirmatory testing, and/or case summaries. | 6- or 12-month study treatment period |
| Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events 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. | 6- or 12-month study treatment period |
| Percentage of Participants With Recurrent VTE (PE or 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 (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), results/films/images of confirmatory testing, and/or case summaries. | 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. | 6- or 12-month study treatment period |
| Percentage of Participants With Major Bleeding | All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 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. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported. | 6- or 12-month study treatment period |
| Percentage of Participants With Clinically Relevant Bleeding | All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) 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 daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported | 6- or 12-month study treatment period |
| Percentage of Participants With All Death | 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. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days) | 6- or 12-month study treatment period |
| Percentage of Participants With Other Vascular Events | All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day) | 6- or 12-month study treatment period |
| Percentage of Participants With Death (PE Cannot be Excluded) 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 unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. | 6- or 12-month study treatment period |
| Percentage of Participants With Symptomatic 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 either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. | 6- or 12-month study treatment period |
| 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]) 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), results/films/images of confirmatory testing, and/or case summaries. | 30 days observational period after last intake of study medication |
| Percentage of Participants With Symptomatic Recurrent 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 spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. | 30 days observational period after 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. | 30 days observational period after last intake of study medication |
| Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions 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), results/films/images of confirmatory testing, and/or case summaries. | 30 days observational period after last intake of study medication |
| Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period | Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT 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 or more units, occurring in a critical site or contributing to death. | 30 days observational period after last intake of study medication |
| Percentage of Participants With Recurrent VTE (PE or 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 (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), results/films/images of confirmatory testing, and/or case summaries. | 30 days observational period after 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 or venography, results/films/images of confirmatory testing, and/or case summaries. | 30 days observational period after last intake of study medication |
| Los Angeles |
| California |
| 90095 |
| United States |
| Redlands | California | 92373 | United States |
| Bay Pines | Florida | 33744 | United States |
| Melbourne | Florida | 32901 | United States |
| Miami | Florida | 33136-1096 | United States |
| Miami | Florida | 33136 | United States |
| Decatur | Georgia | 30033 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Covington | Louisiana | 70433 | United States |
| Baltimore | Maryland | 21215-5271 | United States |
| Boston | Massachusetts | 02215 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Chapel Hill | North Carolina | 27599-7035 | United States |
| Greensboro | North Carolina | 27401 | United States |
| Greensboro | North Carolina | 27403 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Pittsburgh | Pennsylvania | 15224 | United States |
| Corsicana | Texas | 75110 | United States |
| San Antonio | Texas | 78229 | United States |
| Murray | Utah | 84107 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Burlington | Vermont | 05401 | United States |
| Fredericksburg | Virginia | 22401 | United States |
| Spokane | Washington | 99204 | United States |
| Garran | Australian Capital Territory | 2605 | Australia |
| Gosford | New South Wales | 2250 | Australia |
| Kogarah | New South Wales | 2217 | Australia |
| Lismore | New South Wales | 2480 | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| Sydney | New South Wales | 2010 | Australia |
| Sydney | New South Wales | 2031 | Australia |
| Sydney | New South Wales | 2139 | Australia |
| Sydney | New South Wales | 2229 | Australia |
| Brisbane | Queensland | 4029 | Australia |
| Redcliffe | Queensland | 4020 | Australia |
| Southport | Queensland | 4215 | Australia |
| Woolloongabba | Queensland | 4102 | Australia |
| Adelaide | South Australia | 5011 | Australia |
| Adelaide | South Australia | 5042 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Melbourne | Victoria | 3135 | Australia |
| Melbourne | Victoria | 3181 | Australia |
| Prahran | Victoria | 3181 | Australia |
| Fremantle | Western Australia | 6160 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Salzburg | State of Salzburg | 5020 | Austria |
| Vienna | State of Vienna | 1090 | Austria |
| Vienna | State of Vienna | 1140 | Austria |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Feldkirch | Vorarlberg | 6807 | Austria |
| Bruxelles - Brussel | 1070 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Duffel | 2570 | Belgium |
| Genk | 3600 | Belgium |
| Ghent | 9000 | Belgium |
| Hasselt | 3500 | Belgium |
| Leuven | 3000 | Belgium |
| Lier | 2500 | Belgium |
| Liège | 4000 | Belgium |
| Namur | 5000 | Belgium |
| Sint-Truiden | 3800 | Belgium |
| Yvoir | 5530 | Belgium |
| Zottegem | 9620 | Belgium |
| Uberaba | Minas Gerais | 38010 380 | Brazil |
| Curitiba | Paraná | 80050-350 | Brazil |
| Londrina | Paraná | 86038440 | Brazil |
| Porto Alegre | Rio Grande do Sul | Brazil |
| Botucatu | São Paulo | 18618 000 | Brazil |
| São Paulo | São Paulo | 01323-001 | Brazil |
| São Paulo | São Paulo | 01509-900 | Brazil |
| São Paulo | São Paulo | 04023-061 | Brazil |
| São Paulo | São Paulo | 04039-004 | Brazil |
| Sorocaba | São Paulo | 18031-000 | Brazil |
| Rio de Janeiro | Brazil |
| Winnipeg | Manitoba | R2H 2A6 | Canada |
| Toronto | Ontario | M6R 1B5 | Canada |
| Guangzhou | Guangdong | 510080 | China |
| Harbin | Heilongjiang | 150086 | China |
| Wuhan | Hubei | 430022 | China |
| Suzhou | Jiangsu | 215004 | China |
| Shenyang | Liaoning | 110016 | China |
| Beijing | 100020 | China |
| Beijing | 100029 | China |
| Beijing | 100037 | China |
| Beijing | 100038 | China |
| Beijing | 100044 | China |
| Beijing | 100730 | China |
| Beijing | 100853 | China |
| Shanghai | 200001 | China |
| Shanghai | 200032 | China |
| Shanghai | 200433 | China |
| Brno | 65691 | Czechia |
| Karlovy Vary | 360 00 | Czechia |
| Kladno | 27259 | Czechia |
| Ostrava | 728 80 | Czechia |
| Ostrava-Poruba | 708 52 | Czechia |
| Prague | 110 00 | Czechia |
| Prague | 12800 | Czechia |
| Prague | 140 21 | Czechia |
| Prague | 150 00 | Czechia |
| Usti Nad Lebem | 401 13 | Czechia |
| Aarhus C | 8000 | Denmark |
| Brædstrup | 8740 | Denmark |
| Frederiksberg | 2000F | Denmark |
| Hellerup | 2900 | Denmark |
| Seinäjoki | 60220 | Finland |
| Agen | 47923 | France |
| Amiens | 80000 | France |
| Angers | 49033 | France |
| Arras | 62000 | France |
| Bordeaux | 33075 | France |
| Brest | 29609 | France |
| Castelnau-le-Lez | 34170 | France |
| Clamart | 92141 | France |
| Clermont-Ferrand | 63000 | France |
| Colombes | 92700 | France |
| Créteil | 94000 | France |
| Dijon | 21000 | France |
| Grenoble | 38028 | France |
| Grenoble | 38043 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Montpellier | 34295 | France |
| Nantes | 44000 | France |
| Nîmes | 30029 | France |
| Orthez | 64300 | France |
| Paris | 75004 | France |
| Paris | 75475 | France |
| Paris | 75877 | France |
| Paris | 75908 | France |
| Pierre-Bénite | 69495 | France |
| Roanne | 42328 | France |
| Rouen | 76031 | France |
| Saint-Etienne | 42055 | France |
| Strasbourg | 67091 | France |
| Toulon | 83000 | France |
| Toulouse | 31403 | France |
| Tours | 37044 | France |
| Valenciennes | 59322 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Vernon | 27200 | France |
| Bruchsal | Baden-Wurttemberg | 76646 | Germany |
| Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Karlsbad | Baden-Wurttemberg | 76307 | Germany |
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Neckargemünd | Baden-Wurttemberg | 69151 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Augsburg | Bavaria | 86156 | Germany |
| München | Bavaria | 80331 | Germany |
| München | Bavaria | 81377 | Germany |
| Würzburg | Bavaria | 97080 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
| Darmstadt | Hesse | 64297 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Wiesbaden | Hesse | 65183 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Rotenburg (Wümme) | Lower Saxony | 27342 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Essen | North Rhine-Westphalia | 45122 | Germany |
| Paderborn | North Rhine-Westphalia | 33098 | Germany |
| Soest | North Rhine-Westphalia | 59494 | Germany |
| Witten | North Rhine-Westphalia | 58455 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Homburg | Saarland | 66424 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04289 | Germany |
| Halle | Saxony-Anhalt | 06120 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Berlin | State of Berlin | 10713 | Germany |
| Berlin | State of Berlin | 12099 | Germany |
| Hong Kong | Hong Kong |
| Budapest | 1096 | Hungary |
| Budapest | 1115 | Hungary |
| Debrecen | 4032 | Hungary |
| Kecskemét | 6000 | Hungary |
| Kistarcsa | 2143 | Hungary |
| Miskolc | 3526 | Hungary |
| NyÃregyháza | 4400 | Hungary |
| Szentes | 6600 | Hungary |
| Szombathely | 9700 | Hungary |
| Kochi | Kerala | 682026 | India |
| Vellore | Kerala | 632004 | India |
| Mumbai | Maharashtra | 400008 | India |
| Mumbai | Maharashtra | 400016 | India |
| Mumbai | Maharashtra | 400022 | India |
| Hyderabad | 500082 | India |
| Kolkata | 700029 | India |
| New Delhi | 110060 | India |
| Pune | 411001 | India |
| Bandung | 40161 | Indonesia |
| Jakarta | 10430 | Indonesia |
| Medan | 20152 | Indonesia |
| Semarang | 50241 | Indonesia |
| Haifa | Israel | 34362 | Israel |
| Petah Tikva | Israel | 49100 | Israel |
| Afula | 18101 | Israel |
| Ashkelon | 78278 | Israel |
| Beersheba | 84101 | Israel |
| Haifa | 31048 | Israel |
| Haifa | 31096 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91120 | Israel |
| Kfar Saba | 44281 | Israel |
| Rehovot | 76100 | Israel |
| Safed | 13100 | Israel |
| Tel Aviv | 64239 | Israel |
| Bologna | 40138 | Italy |
| Chieti | 66013 | Italy |
| Milan | 20132 | Italy |
| Milan | 20142 | Italy |
| Naples | 80131 | Italy |
| Padova | 35128 | Italy |
| Palermo | 90127 | Italy |
| Parma | 43100 | Italy |
| Pavia | 27100 | Italy |
| Piacenza | 29100 | Italy |
| Venezia | 30122 | Italy |
| Kuala Selangor | 68000 | Malaysia |
| 's-Hertogenbosch | 5223 GZ | Netherlands |
| Amsterdam | 1105 AZ | Netherlands |
| Arnhem | 6815 AD | Netherlands |
| Dordrecht | 3318 AT | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Groningen | 9713 GZ | Netherlands |
| Hoofddorp | 2134 TM | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Rotterdam | 3083 AN | Netherlands |
| Zwijndrecht | 3331 LZ | Netherlands |
| Zwolle | 8025 AB | Netherlands |
| Auckland | 0622 | New Zealand |
| Auckland | 1023 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Palmerston North | 4414 | New Zealand |
| Wellington South | 6021 | New Zealand |
| Fredrikstad | 1603 | Norway |
| Oslo | 0407 | Norway |
| Oslo | 0514 | Norway |
| Rud | 1309 | Norway |
| Quezon City | 0850 | Philippines |
| Quezon City | 1102 | Philippines |
| Bialystok | 15-276 | Poland |
| Bydgoszcz | 85-168 | Poland |
| Gdansk | 80-952 | Poland |
| Katowice | 40-365 | Poland |
| Krakow | 31-066 | Poland |
| Lodz | 90-153 | Poland |
| Lublin | 20-081 | Poland |
| Poznan | 60-631 | Poland |
| Poznan | 61-848 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 01-138 | Poland |
| Warsaw | 02-097 | Poland |
| Warsaw | 04-479 | Poland |
| Wroclaw | 50-326 | Poland |
| Wroclaw | 51-124 | Poland |
| Singapore | 169608 | Singapore |
| Singapore | 308433 | Singapore |
| Cape Town | Cape | 7500 | South Africa |
| Johannesburg | Gauteng | 2132 | South Africa |
| Johannesburg | Gauteng | 2157 | South Africa |
| Johannesburg | Gauteng | 2191 | South Africa |
| Johannesburg | Gauteng | 2193 | South Africa |
| Pretoria | Gauteng | 0084 | South Africa |
| Pretoria | Gauteng | 0157 | South Africa |
| Pretoria | Gauteng | 0181 | South Africa |
| Roodepoort | Gauteng | 1724 | South Africa |
| Cape Town | Western Cape | 7460 | South Africa |
| Somerset West | Western Cape | 7130 | South Africa |
| Worcester | Western Cape | 6850 | South Africa |
| Daegu | Daegu Gwang'yeogsi | 700721 | South Korea |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Daegu | 705-718 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 137-701 | South Korea |
| Taegu | 700-712 | South Korea |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Terrassa | Barcelona | 08221 | Spain |
| Girona | Girona | 17007 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Fuenlabrada | Madrid | 28942 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| XÃ tiva | Valencia | 46800 | Spain |
| Borås | 501 82 | Sweden |
| Gothenburg | 413 45 | Sweden |
| Gothenburg | 416 85 | Sweden |
| Jönköping | 551 85 | Sweden |
| Sundsvall | 851 86 | Sweden |
| Västervik | 593 81 | Sweden |
| Bruderholz | Basel-Landschaft | 4101 | Switzerland |
| Zurich | Canton of Zurich | 8091 | Switzerland |
| Genéve 14 | Genève 14 | 1211 | Switzerland |
| Chur | Kanton Graubünden | 7000 | Switzerland |
| Brig | Valais | 3900 | Switzerland |
| Lucerne | 6000 | Switzerland |
| Lugano | 6903 | Switzerland |
| Kaohsiung City | 80756 | Taiwan |
| Tainan | 704 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taipei | 11217 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Bangkok | Bangkok | 10700 | Thailand |
| Pathumwan, Bangkok | Thailand | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Plymouth | Devon | PL6 8DH | United Kingdom |
| Chelmsford | Essex | CM1 5ET | United Kingdom |
| Romford | Essex | RM7 0AG | United Kingdom |
| Isleworth | London | TW7 6AF | United Kingdom |
| London | London | SE1 7EH | United Kingdom |
| London | London | SE5 9RS | United Kingdom |
| Edinburgh | Lothian | EH16 4SA | United Kingdom |
| Liverpool | Merseyside | L7 8XP | United Kingdom |
| London | W1T 4EU | United Kingdom |
| London | United Kingdom |
| 40163217 | Derived | Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31. |
| 38844941 | Derived | Yamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4. |
| 27262225 | Derived | Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1. |
| 25698905 | Derived | Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014. |
| Click here to find the definition for Pulmonary Embolism \[PE\]. | View source |
| Click here and search for information of Bayer products for Europe | View source |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Observational Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban (Xarelto, BAY59-7939) | Participants were to receive rivaroxaban 20 mg oral tablet once daily |
| BG001 | Placebo | Participants were to receive matching placebo oral tablet once daily |
| 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 | Number of participants analyzed for Baseline is intention-to-treat (ITT) population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Number of participants analyzed for Baseline is intention-to-treat (ITT) population. | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Number of participants analyzed for Baseline is intention-to-treat (ITT) population. | Count of Participants | Participants |
|
| 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 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. For definition of DVT/PE, kindly refer to the link in the Protocol section. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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), or lung scintigraphy (for PE), and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions 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), results/films/images of confirmatory testing, and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events 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. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Recurrent VTE (PE or 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 (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), results/films/images of confirmatory testing, and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding | All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 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. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported. | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Relevant Bleeding | All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) 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 daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All Death | 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. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days) | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Other Vascular Events | All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day) | The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Death (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 autopsy, results/films/images of confirmatory testing, and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Death (PE Cannot be Excluded) 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 unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Symptomatic 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 either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. | The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 6- or 12-month study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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]) 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), results/films/images of confirmatory testing, and/or case summaries. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Symptomatic Recurrent 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 spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions 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), results/films/images of confirmatory testing, and/or case summaries. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period | Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT 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 or more units, occurring in a critical site or contributing to death. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Recurrent VTE (PE or 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 (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), results/films/images of confirmatory testing, and/or case summaries. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 or venography, results/films/images of confirmatory testing, and/or case summaries. | Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | 30 days observational period after last intake of study medication |
|
|
Not provided
Not provided
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 | Rivaroxaban (Xarelto, BAY59-7939) | Participants were to receive rivaroxaban 20 mg oral tablet once daily | 59 | 598 | 63 | 598 | ||
| EG001 | Placebo | Participants were to receive matching placebo oral tablet once daily | 52 | 590 | 65 | 590 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Antiphospholipid syndrome | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intestinal gangrene | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Benign vascular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vaginal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anal fistula excision | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bladder calculus removal | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| 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
| Death |
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| Study termination by sponsor |
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| Clinical endpoint reached |
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| Technical problems |
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| Participant convenience |
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| >40 - <65 years |
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| 65 - 75 years |
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| >75 years |
|
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