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Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Primary Purpose

Venous Thrombosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Enoxaparin

warfarin

Placebo for apixaban

Placebo for enoxaparin

Placebo for warfarin

apixaban

About this trial

This is an interventional treatment trial for Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women ≥ 18 years of age
Clinical diagnosis of DVT or PE

Exclusion Criteria:

Contraindications for enoxaparin or warfarin
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Significantly impaired kidney or liver function

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Apixaban

Enoxaparin + Warfarin

Arm Description

apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.

Outcomes

Primary Outcome Measures

Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment

VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).

Secondary Outcome Measures

Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death

VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death

VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding

VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding

VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).

Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period

DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period

PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period

VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period

VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

Incidence of All-Cause Death During the Intended Treatment Period

Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).

Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants

All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants

Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).

Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants

Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests

Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.

Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests

Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.

Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests

Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.

Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests

Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.

Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests

All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.

Full Information

NCT ID

NCT00643201

First Posted

March 20, 2008

Last Updated

April 17, 2014

Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00643201

Brief Title

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Official Title

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5614 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apixaban

Arm Type

Active Comparator

Arm Description

apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Arm Title

Enoxaparin + Warfarin

Arm Type

Experimental

Arm Description

Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

Intervention Type

Drug

Intervention Name(s)

warfarin

Other Intervention Name(s)

Coumadin, BMS-565793

Intervention Description

tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo for apixaban

Intervention Description

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo for enoxaparin

Intervention Description

solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

Intervention Type

Drug

Intervention Name(s)

Placebo for warfarin

Intervention Description

tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

Intervention Type

Drug

Intervention Name(s)

apixaban

Other Intervention Name(s)

BMS-562247

Intervention Description

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Primary Outcome Measure Information:

Title

Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)

Secondary Outcome Measure Information:

Title

Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death

Description

Time Frame

Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death

Description

VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.

Time Frame

Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding

Description

Time Frame

Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding

Description

Time Frame

Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period

Description

Time Frame

Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period

Description

Time Frame

Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of All-Cause Death During the Intended Treatment Period

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants

Description

Time Frame

First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued

Title

Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Title

Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests

Description

Time Frame

Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women ≥ 18 years of age Clinical diagnosis of DVT or PE Exclusion Criteria: Contraindications for enoxaparin or warfarin Active bleeding or high risk for serious bleeding Short life expectancy Uncontrolled high blood pressure Significantly impaired kidney or liver function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Clinical Therapeutics, Llc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

Horizon Research Group, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Fort Smith Lung Center

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72901

Country

United States

Facility Name

University Of Arkansas For Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Beaver Medical Group

City

Banning

State/Province

California

ZIP/Postal Code

92220

Country

United States

Facility Name

University Of California San Francisco-Fresno

City

Fresno

State/Province

California

ZIP/Postal Code

93701

Country

United States

Facility Name

University Of California, Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Chest Medicine & Critical Care Medical Gr. Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Harbor Ucla Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90509

Country

United States

Facility Name

New West Physicians

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Drogue Medical, Llc

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Bridgeport Hospital

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06610

Country

United States

Facility Name

Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

George Washington University Medical Faculty Associates

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Bay Pines Va Healthcare Systems

City

Bay Pines

State/Province

Florida

ZIP/Postal Code

33744

Country

United States

Facility Name

Daniel G. Lorch, Jr, Md, Cpi

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Research Alliance, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

River City Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Pasadena Center For Medical Research

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

Tampa Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Office Of Michele S. Maholtz Md

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Facility Name

Atlanta Pulmonary Group

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Atlanta Institute For Medical Research, Inc

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Chatham Hospitalists

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Gateway Cardiology. P.C

City

Jerseyville

State/Province

Illinois

ZIP/Postal Code

62052

Country

United States

Facility Name

West Suburban Medical Center

City

Oak Park

State/Province

Illinois

ZIP/Postal Code

60302

Country

United States

Facility Name

Infectious Disease Of Indiana Psc

City

Carmel

State/Province

Indiana

ZIP/Postal Code

46032

Country

United States

Facility Name

Heartland Vascular Medicine And Surgery

City

Windsor Heights

State/Province

Iowa

ZIP/Postal Code

50324

Country

United States

Facility Name

Kentucky Lung Clinic

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

Univ. Of Kentucky Dept. Of Surgery

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Research Integrity, Llc

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Pen Bay Medical Center

City

Rockport

State/Province

Maine

ZIP/Postal Code

04856

Country

United States

Facility Name

Anne Arundel Medical Center

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

R Adams Cowley Shock Trauma Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Medstar Research Health Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Mississippi Medical Research, Llc

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

University Of Missouri-Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Veterans Affairs Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Washington University School Of Medicine

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

St. John'S Mercy Medical Center

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Mercury Street Medical Group, Pllc

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Great Falls Clinic, Llp

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Internal Medical Associates Of Grand Island, P.C

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68803

Country

United States

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Morristown Memorial Hospital

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Pulmonary & Critical Care Services, Pc

City

Albany

State/Province

New York

ZIP/Postal Code

12205

Country

United States

Facility Name

Kaleida Health System

City

Buffalo

State/Province

New York

ZIP/Postal Code

14209

Country

United States

Facility Name

Richmond University Medical Center

City

Staten Island

State/Province

New York

ZIP/Postal Code

10310

Country

United States

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Rex Healthcare

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Piedmont Healthcare/Research

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Wilmington Medical Research

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Clinical Trials Of America, Inc.

City

Winston Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Altru Health System Clinic

City

Grand Forks

State/Province

North Dakota

ZIP/Postal Code

58201

Country

United States

Facility Name

Huron Hospital

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44112

Country

United States

Facility Name

Remington Davis Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Oregon Health Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Greenville Hospital System

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Palmetto Clinical Research

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Holston Medical Group

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Kore Cv Research

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Primecare Medical Group

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Cancer Care Centers Of South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

University Of Utah Medical Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Lake Washington Vascular, Pllc

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

Franciscan Research Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Local Institution

City

Ciudad Autonoma De Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

C1180AAX

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CVB

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Local Institution

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

Local Institution

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Local Institution

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Local Institution

City

Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

Local Institution

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Local Institution

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Local Institution

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Local Institution

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Local Institution

City

Ringwood East

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

Local Institution

City

Windsor

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Local Institution

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6001

Country

Australia

Facility Name

Local Institution

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1100

Country

Austria

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1160

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Belo Horizonte - Mg

State/Province

Minas Gerais

ZIP/Postal Code

30150

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80035

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80050

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80810

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

81520

Country

Brazil

Facility Name

Local Institution

City

Rio Janeiro

State/Province

Rio De Janeiro

ZIP/Postal Code

22280

Country

Brazil

Facility Name

Local Institution

City

Port Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90020

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90110

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610

Country

Brazil

Facility Name

Local Institution

City

Botucatu

State/Province

Sao Paulo

ZIP/Postal Code

18618

Country

Brazil

Facility Name

Local Institution

City

Liberdade

State/Province

Sao Paulo

ZIP/Postal Code

01509

Country

Brazil

Facility Name

Local Institution

City

Sao Jose Do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15090

Country

Brazil

Facility Name

Local Institution

City

Sao Bernardo do Campo

State/Province

ZIP/Postal Code

09715

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

20551

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

01323

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04005

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04025

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

05403

Country

Brazil

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 4B9

Country

Canada

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

Local Institution

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 6R5

Country

Canada

Facility Name

Local Institution

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

Local Institution

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Local Institution

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Local Institution

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Local Institution

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Local Institution

City

St. Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 5T3

Country

Canada

Facility Name

Local Institution

City

Punta Arenas

State/Province

Magallanes Antartica

ZIP/Postal Code

6212296

Country

Chile

Facility Name

Local Institution

City

Independencia

State/Province

Metropolitana

ZIP/Postal Code

XXXXX

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7600448

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8330024

Country

Chile

Facility Name

Local Institution

City

Vina Del Mar

State/Province

Valparaiso

ZIP/Postal Code

2520000

Country

Chile

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100035

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100038

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Local Institution

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Local Institution

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

Local Institution

City

Shengyang

State/Province

Liaoning

ZIP/Postal Code

110004

Country

China

Facility Name

Local Institution

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Local Institution

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Facility Name

Local Institution

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

130016

Country

China

Facility Name

Local Institution

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

Facility Name

Local Institution

City

Xian

ZIP/Postal Code

710032

Country

China

Facility Name

Local Institution

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

Local Institution

City

Kladno

ZIP/Postal Code

272 59

Country

Czech Republic

Facility Name

Local Institution

City

Litomysl

ZIP/Postal Code

570 14

Country

Czech Republic

Facility Name

Local Institution

City

Mestec Kralove

ZIP/Postal Code

289 03

Country

Czech Republic

Facility Name

Local Institution

City

Ostrava Vitkovice

ZIP/Postal Code

703 84

Country

Czech Republic

Facility Name

Local Institution

City

Ostrava

ZIP/Postal Code

708 52

Country

Czech Republic

Facility Name

Local Institution

City

Praha 10

ZIP/Postal Code

100 34

Country

Czech Republic

Facility Name

Local Institution

City

Praha 1

ZIP/Postal Code

110 00

Country

Czech Republic

Facility Name

Local Institution

City

Praha 1

ZIP/Postal Code

118 33

Country

Czech Republic

Facility Name

Local Institution

City

Praha 2

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Local Institution

City

Usti Nad Labem

ZIP/Postal Code

401 13

Country

Czech Republic

Facility Name

Local Institution

City

Usti Nad Orlici

ZIP/Postal Code

562 18

Country

Czech Republic

Facility Name

Local Institution

City

Arhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Local Institution

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Local Institution

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Facility Name

Local Institution

City

Hilleroed

ZIP/Postal Code

3400

Country

Denmark

Facility Name

Local Institution

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

Facility Name

Local Institution

City

Naestved

ZIP/Postal Code

4700

Country

Denmark

Facility Name

Local Institution

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

Local Institution

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

Local Institution

City

Arras

ZIP/Postal Code

62022

Country

France

Facility Name

Local Institution

City

Besancon

ZIP/Postal Code

25000

Country

France

Facility Name

Local Institution

City

Clamart

ZIP/Postal Code

92141

Country

France

Facility Name

Local Institution

City

Clermont-Ferrand Cedex 01

ZIP/Postal Code

63003

Country

France

Facility Name

Local Institution

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Local Institution

City

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Local Institution

City

Langres Cedex

ZIP/Postal Code

52206

Country

France

Facility Name

Local Institution

City

Le Kremlin-Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Local Institution

City

Limoges Cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Local Institution

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75004

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Local Institution

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Local Institution

City

Saint-Priest En Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Local Institution

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution

City

Vernon

ZIP/Postal Code

27200

Country

France

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

12559

Country

Germany

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

14050

Country

Germany

Facility Name

Local Institution

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Local Institution

City

Cologne

ZIP/Postal Code

50937

Country

Germany

Facility Name

Local Institution

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Local Institution

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Local Institution

City

Karlsbad

ZIP/Postal Code

76307

Country

Germany

Facility Name

Local Institution

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Local Institution

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Local Institution

City

Mannheim

ZIP/Postal Code

68163

Country

Germany

Facility Name

Local Institution

City

Munchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Local Institution

City

Munich

ZIP/Postal Code

80336

Country

Germany

Facility Name

Local Institution

City

Pokfulman

ZIP/Postal Code

XXXXX

Country

Hong Kong

Facility Name

Local Institution

City

Shatin, N.T

Country

Hong Kong

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Local Institution

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Local Institution

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Local Institution

City

Miskolc

ZIP/Postal Code

3501

Country

Hungary

Facility Name

Local Institution

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Local Institution

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Local Institution

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Local Institution

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 082

Country

India

Facility Name

Local Institution

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500034

Country

India

Facility Name

Local Institution

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380006

Country

India

Facility Name

Local Institution

City

Gurgaon

State/Province

Haryana

ZIP/Postal Code

122001

Country

India

Facility Name

Local Institution

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

Local Institution

City

Bengaluru

State/Province

Karnataka

ZIP/Postal Code

560017

Country

India

Facility Name

Local Institution

City

Manipal

State/Province

Karnataka

ZIP/Postal Code

576104

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Local Institution

City

Mohali

State/Province

Punjab

ZIP/Postal Code

160062

Country

India

Facility Name

Local Institution

City

Ludhiana

State/Province

Tagore Nagar

ZIP/Postal Code

141001

Country

India

Facility Name

Local Institution

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 006

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560052

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560099

Country

India

Facility Name

Local Institution

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Local Institution

City

Tiberias

State/Province

Lower Galillee

ZIP/Postal Code

15208

Country

Israel

Facility Name

Local Institution

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Local Institution

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Local Institution

City

Hadera

ZIP/Postal Code

38101

Country

Israel

Facility Name

Local Institution

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

Local Institution

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Local Institution

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Local Institution

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Local Institution

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Local Institution

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Local Institution

City

Safed

ZIP/Postal Code

13100

Country

Israel

Facility Name

Local Institution

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution

City

Castelfranco Veneto (Tv)

ZIP/Postal Code

31033

Country

Italy

Facility Name

Local Institution

City

Chieti Scalo

ZIP/Postal Code

66013

Country

Italy

Facility Name

Local Institution

City

Cosenza

ZIP/Postal Code

87100

Country

Italy

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Local Institution

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution

City

Piacenza

ZIP/Postal Code

29100

Country

Italy

Facility Name

Local Institution

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Local Institution

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Local Institution

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution

City

Rozzano (Mi)

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution

City

San Daniele Del Friuli (Ud)

ZIP/Postal Code

33038

Country

Italy

Facility Name

Local Institution

City

Vicenza

ZIP/Postal Code

36100

Country

Italy

Facility Name

Local Institution

City

Vittorio Veneto (Tv)

ZIP/Postal Code

31029

Country

Italy

Facility Name

Local Institution

City

Busan

ZIP/Postal Code

602-702

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

120752

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

138736

Country

Korea, Republic of

Facility Name

Local Institution

City

Georgetown

State/Province

Penang

ZIP/Postal Code

10350

Country

Malaysia

Facility Name

Local Institution

City

Ipoh

State/Province

Perak

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

Local Institution

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Local Institution

City

Melaka

ZIP/Postal Code

75400

Country

Malaysia

Facility Name

Local Institution

City

Tijuana

State/Province

Baja California

ZIP/Postal Code

22500

Country

Mexico

Facility Name

Local Institution

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37320

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Local Institution

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45170

Country

Mexico

Facility Name

Local Institution

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45200

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Local Institution

City

Xalapa

State/Province

Veracruz

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Local Institution

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Local Institution

City

Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Local Institution

City

Alesund

ZIP/Postal Code

6017

Country

Norway

Facility Name

Local Institution

City

Fredrikstad

ZIP/Postal Code

1606

Country

Norway

Facility Name

Local Institution

City

Gjettum

ZIP/Postal Code

1346

Country

Norway

Facility Name

Local Institution

City

Gjovik

ZIP/Postal Code

2819

Country

Norway

Facility Name

Local Institution

City

Hamar

ZIP/Postal Code

2318

Country

Norway

Facility Name

Local Institution

City

Oslo

ZIP/Postal Code

0319

Country

Norway

Facility Name

Local Institution

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Local Institution

City

Oslo

ZIP/Postal Code

0456

Country

Norway

Facility Name

Local Institution

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Local Institution

City

Tynset

ZIP/Postal Code

2500

Country

Norway

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Local Institution

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Local Institution

City

Bydgoszcz

ZIP/Postal Code

85-681

Country

Poland

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Local Institution

City

Gdynia

ZIP/Postal Code

81-348

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Local Institution

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Local Institution

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

61-848

Country

Poland

Facility Name

Local Institution

City

Przeworsk

ZIP/Postal Code

37-200

Country

Poland

Facility Name

Local Institution

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Local Institution

City

Warsawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Local Institution

City

Warsaw

ZIP/Postal Code

02-005

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

50-981

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Local Institution

City

Coimbra

ZIP/Postal Code

3004-548

Country

Portugal

Facility Name

Local Institution

City

Guarda

ZIP/Postal Code

6301-857

Country

Portugal

Facility Name

Local Institution

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Facility Name

Local Institution

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

Local Institution

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Local Institution

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

030171

Country

Romania

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Local Institution

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Local Institution

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Local Institution

City

Chelyabinsk

ZIP/Postal Code

454136

Country

Russian Federation

Facility Name

Local Institution

City

Kazan

ZIP/Postal Code

420101

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

109386

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Local Institution

City

Novosibirsk

ZIP/Postal Code

630090

Country

Russian Federation

Facility Name

Local Institution

City

Rostov-On Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Local Institution

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Local Institution

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Local Institution

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Local Institution

City

Bioemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Local Institution

City

Centurion

State/Province

Gauteng

ZIP/Postal Code

0157

Country

South Africa

Facility Name

Local Institution

City

Parktown

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Local Institution

City

Durban

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Local Institution

City

Pietermaritzburg

State/Province

Kwa Zulu Natal

ZIP/Postal Code

3201

Country

South Africa

Facility Name

Local Institution

City

Bellville

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Local Institution

City

George

State/Province

Western Cape

ZIP/Postal Code

6529

Country

South Africa

Facility Name

Local Institution

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Local Institution

City

Worcester

State/Province

Western Cape

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Local Institution

City

Torrevieja

State/Province

Alicante

ZIP/Postal Code

03186

Country

Spain

Facility Name

Local Institution

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

Local Institution

City

L'Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Local Institution

City

Leon

ZIP/Postal Code

24008

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Local Institution

City

Mourente

ZIP/Postal Code

36071

Country

Spain

Facility Name

Local Institution

City

Tarragona

ZIP/Postal Code

43007

Country

Spain

Facility Name

Local Institution

City

Chernihiv

ZIP/Postal Code

14034

Country

Ukraine

Facility Name

Local Institution

City

Dnipropetrovsk

ZIP/Postal Code

49000

Country

Ukraine

Facility Name

Local Institution

City

Donetsk

ZIP/Postal Code

83045

Country

Ukraine

Facility Name

Local Institution

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Local Institution

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Local Institution

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Local Institution

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Local Institution

City

Odesa

ZIP/Postal Code

65117

Country

Ukraine

Facility Name

Local Institution

City

Ternopil

ZIP/Postal Code

46000

Country

Ukraine

Facility Name

Local Institution

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Local Institution

City

Zaporizhzhia

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Local Institution

City

Livingston

State/Province

West Lothian

ZIP/Postal Code

EH54 7BH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35570249

Citation

Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

Results Reference

derived

PubMed Identifier

33890242

Citation

Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22. Erratum In: Adv Ther. 2021 Aug;38(8):4596-4597.

Results Reference

derived

PubMed Identifier

30650446

Citation

Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.

Results Reference

derived

PubMed Identifier

26627879

Citation

Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.

Results Reference

derived

PubMed Identifier

23808982

Citation

Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

Results Reference

derived

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

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Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Venous Thrombosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial