Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

December 7, 2015 updated by: Bristol-Myers Squibb

A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6758

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1181ACH
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
      • Cordoba, Argentina, X5006IKK
        • Local Institution
      • Corrientes, Argentina, 3400
        • Local Institution
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Local Institution
      • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
        • Local Institution
      • Derqui-Pilar, Buenos Aires, Argentina, B1629ODT
        • Local Institution
      • La Plata, Buenos Aires, Argentina, 1900
        • Local Institution
      • Munro, Buenos Aires, Argentina, B1605DSX
        • Local Institution
      • San Martin, Buenos Aires, Argentina, B1650CSQ
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution
      • Rosario, Santa Fe, Argentina, S2002KDS
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
        • Local Institution
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Local Institution
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • Local Institution
      • Woolloongabba, Queensland, Australia, 4102
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Local Institution
      • Woodville, South Australia, Australia, 5011
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution
      • Parkville, Victoria, Australia, 3050
        • Local Institution
      • Ringwood East, Victoria, Australia, 3135
        • Local Institution
      • Graz, Austria, 8036
        • Local Institution
      • Wien, Austria, 1090
        • Local Institution
      • Antwerpen, Belgium, 2060
        • Local Institution
      • Brasschaat, Belgium, 2930
        • Local Institution
      • Bruxelles, Belgium, 1070
        • Local Institution
      • Huy, Belgium, 4500
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
    • Waals-Brabant
      • Ottignies, Waals-Brabant, Belgium, 1340
        • Local Institution
      • Sao Paulo, Brazil, 05403
        • Local Institution
      • Sao Paulo, Brazil, 04025
        • Local Institution
      • Sao Paulo, Brazil, 04012
        • Local Institution
      • Sao Paulo, Brazil, 04020
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150
        • Local Institution
    • Parana
      • Curitiba, Parana, Brazil, 80810
        • Local Institution
      • Curitiba, Parana, Brazil, 80010
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91430
        • Local Institution
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618
        • Local Institution
      • Campinas, Sao Paulo, Brazil, 13059
        • Local Institution
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15091
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • Local Institution
      • Hamilton, Ontario, Canada, L8N 4A6
        • Local Institution
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Local Institution
      • Windsor, Ontario, Canada, N8X 5A6
        • Local Institution
      • Windsor, Ontario, Canada, N9A 1C9
        • Local Institution
    • Quebec
      • Granby, Quebec, Canada, J2G 1T7
        • Local Institution
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Local Institution
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution
      • Montreal, Quebec, Canada, H2L 4M1
        • Local Institution
    • Araucania
      • Temuco, Araucania, Chile, - - - - -
        • Local Institution
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7500922
        • Local Institution
      • Santiago, Metropolitana, Chile, 8207257
        • Local Institution
    • Valparaiso
      • Rancagua, Valparaiso, Chile
        • Local Institution
      • Bogota, Colombia
        • Local Institution
      • Bucaramanga, Colombia
        • Local Institution
      • Medellin, Colombia
        • Local Institution
      • Brno, Czech Republic, 656 91
        • Local Institution
      • Jindrichuv Hradec, Czech Republic, 377 38
        • Local Institution
      • Kladno, Czech Republic, 272 59
        • Local Institution
      • Kyjov, Czech Republic, 697 01
        • Local Institution
      • Ostrava, Czech Republic, 728 80
        • Local Institution
      • Prague 2, Czech Republic, 128 08
        • Local Institution
      • Praha 1, Czech Republic, 110 00
        • Local Institution
      • Praha 5, Czech Republic, 150 06
        • Local Institution
      • Usti Nad Labem, Czech Republic, 401 13
        • Local Institution
      • Aalborg, Denmark, 9100
        • Local Institution
      • Aarhus N, Denmark, 8200
        • Local Institution
      • Arhus C, Denmark, 8000
        • Local Institution
      • Frederiksberg, Denmark, 2000
        • Local Institution
      • Glostrup, Denmark, 2600
        • Local Institution
      • Hellerup, Denmark, 2900
        • Local Institution
      • Herlev, Denmark, 2730
        • Local Institution
      • Herning, Denmark, 7400
        • Local Institution
      • Hvidovre, Denmark, 2650
        • Local Institution
      • Odense, Denmark, 5000
        • Local Institution
      • Randers No, Denmark, 8930
        • Local Institution
      • Silkeborg, Denmark, 8600
        • Local Institution
      • Bordeaux, France, 33075
        • Local Institution
      • Brest, France, 29200
        • Local Institution
      • Brest Cedex, France, 29609
        • Local Institution
      • Dijon Cedex, France, 21079
        • Local Institution
      • Grenoble Cedex 9, France, 38043
        • Local Institution
      • Lille Cedex, France, 59020
        • Local Institution
      • Nancy, France, 54035
        • Local Institution
      • Nimes Cedex 9, France, 30029
        • Local Institution
      • Paris Cedex 10, France, 75475
        • Local Institution
      • Paris Cedex 15, France, 75908
        • Local Institution
      • Saint Etienne Cedex 02, France, 42055
        • Local Institution
      • Vernon, France, 27207
        • Local Institution
      • Bonn, Germany, 53127
        • Local Institution
      • Coburg, Germany, 96450
        • Local Institution
      • Darmstadt, Germany, 64283
        • Local Institution
      • Dresden, Germany, 01307
        • Local Institution
      • Dresden, Germany, 01099
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Karlsbad, Germany, 76307
        • Local Institution
      • Luebeck, Germany, 23538
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Offenbach, Germany, 63069
        • Local Institution
      • Witten, Germany, 58455
        • Local Institution
      • Shatin, N.T., Hong Kong
        • Local Institution
      • Budapest, Hungary, 1135
        • Local Institution
      • Debrecen, Hungary, 4032
        • Local Institution
      • Dunaujvaros, Hungary, 2400
        • Local Institution
      • Eger, Hungary, 3300
        • Local Institution
      • Ahmedabad, India, 380054
        • Local Institution
      • Bangalore, India, 560017
        • Local Institution
      • Bangalore, India, 560054
        • Local Institution
      • Hyderabad, India, 500033
        • Local Institution
      • Mumbai, India, 400008
        • Local Institution
      • New Delhi, India, 110025
        • Local Institution
    • Andhra-Pradesh
      • Vishakapatnam, Andhra-Pradesh, India, 530002
        • Local Institution
    • Andra Pradesh
      • Hyderabad, Andra Pradesh, India, 500004
        • Local Institution
    • Gujarat
      • Ahemdabad, Gujarat, India, 380054
        • Local Institution
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Local Institution
    • Madhya Pardesh
      • Indore, Madhya Pardesh, India, 452018
        • Local Institution
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Local Institution
      • Pune, Maharashtra, India, 411004
        • Local Institution
    • Maharastra
      • Pune, Maharastra, India, 411001
        • Local Institution
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Local Institution
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641004
        • Local Institution
      • Madurai, Tamil Nadu, India, 625107
        • Local Institution
    • Tamil-Nadu
      • Chennai, Tamil-Nadu, India, 600096
        • Local Institution
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
        • Local Institution
      • Afula, Israel, 18101
        • Local Institution
      • Ashkelon, Israel, 78308
        • Local Institution
      • Beer Sheva, Israel, 84105
        • Local Institution
      • Haifa, Israel, 31096
        • Local Institution
      • Petach Tikva, Israel, 49100
        • Local Institution
      • Safed, Israel, 13110
        • Local Institution
      • Tel Hashomer, Israel, 52621
        • Local Institution
      • Tel-Aviv, Israel, 64239
        • Local Institution
      • Zerifin, Israel, 70300
        • Local Institution
      • Chieti Scalo, Italy, 66013
        • Local Institution
      • Cremona, Italy, 26100
        • Local Institution
      • Padua, Italy, 35128
        • Local Institution
      • Piacenza, Italy, 29100
        • Local Institution
      • Reggio Emilia, Italy, 42100
        • Local Institution
      • Treviso, Italy, 31100
        • Local Institution
      • Vicenza, Italy, 36100
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 137-040
        • Local Institution
      • Seoul, Korea, Republic of, 136-705
        • Local Institution
      • Suwon, Korea, Republic of, 443721
        • Local Institution
    • Gyeonggi-Do
      • Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
        • Local Institution
      • Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
        • Local Institution
      • Johor Bahru, Malaysia, 80100
        • Local Institution
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Local Institution
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Local Institution
      • Queretaro, Mexico, 76178
        • Local Institution
      • San Luis Potosi, Mexico, 78220
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06726
        • Local Institution
      • Mexico, Distrito Federal, Mexico, 07760
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91020
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97129
        • Local Institution
      • Den Helder, Netherlands, 1782 GZ
        • Local Institution
      • Kongsvinger, Norway, 2226
        • Local Institution
      • Arequipa, Peru, AREQUIPA54
        • Local Institution
      • Callao, Peru, CALLAO 2
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, LIMA 31
        • Local Institution
      • Lima, Peru, LIMA 01
        • Local Institution
      • Lima, Peru, LIMA 1
        • Local Institution
    • Lima
      • La Victoria, Lima, Peru, LIMA 13
        • Local Institution
      • Las Pinas, Philippines, 1742
        • Local Institution
      • Quezon City, Philippines, 1102
        • Local Institution
      • Quezon City, Philippines, 1100
        • Local Institution
      • Quezon City, Philippines, 1110
        • Local Institution
    • Misamis Oriental
      • Cagayan De Oro City, Misamis Oriental, Philippines, 9000
        • Local Institution
      • Bydgoszcz, Poland, 85-168
        • Local Institution
      • Krakow, Poland, 31-202
        • Local Institution
      • Lodz, Poland, 91-347
        • Local Institution
      • Nowa Sol, Poland, 67-100
        • Local Institution
      • Poznan, Poland, 61-833
        • Local Institution
      • Skierniewice, Poland, 96-100
        • Local Institution
      • Warszawa, Poland, 01-138
        • Local Institution
      • Warszawa, Poland, 03-737
        • Local Institution
      • Wejherowo, Poland, 84-200
        • Local Institution
      • Zielona Gora, Poland, 65-046
        • Local Institution
      • Moscow, Russian Federation, 121309
        • Local Institution
      • Moscow, Russian Federation, 119991
        • Local Institution
      • Moscow, Russian Federation, 111539
        • Local Institution
      • Moscow, Russian Federation, 115280
        • Local Institution
      • Moscow, Russian Federation, 117292
        • Local Institution
      • Moscow, Russian Federation, 117593
        • Local Institution
      • Moscow, Russian Federation, 127018
        • Local Institution
      • Moscow, Russian Federation, 129336
        • Local Institution
      • Odintsovo, Russian Federation, 143000
        • Local Institution
      • Podolsk, Russian Federation, 142100
        • Local Institution
      • Ryazan, Russian Federation, 390005
        • Local Institution
      • Saint Petersburg, Russian Federation, 199106
        • Local Institution
      • Saint-Petersburg, Russian Federation, 198205
        • Local Institution
      • Saratov, Russian Federation, 410054
        • Local Institution
      • Saratov, Russian Federation, 410002
        • Local Institution
      • St Petersburg, Russian Federation, 195067
        • Local Institution
      • St. Petersburg, Russian Federation, 193312
        • Local Institution
      • St.Petersburg, Russian Federation, 192242
        • Local Institution
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 529889
        • Local Institution
      • Groenkloof, South Africa, 0181
        • Local Institution
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0044
        • Local Institution
    • Kwa Zulu Natal
      • Amanzimtoti, Kwa Zulu Natal, South Africa, 4120
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, South Africa, 7530
        • Local Institution
      • Alcorcon(Madrid), Spain, 28922
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28006
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Sevilla, Spain, 41013
        • Local Institution
      • Tarragona, Spain, 43007
        • Local Institution
    • Alicante
      • Torrevieja, Alicante, Spain, 03186
        • Local Institution
      • Goteborg, Sweden, 413 45
        • Local Institution
      • Lund, Sweden, 221 85
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
    • Tainan
      • Yung-Kang City, Tainan, Taiwan, 710
        • Local Institution
      • Istanbul, Turkey, 34390
        • Local Institution
    • Capa
      • Istanbul, Capa, Turkey, 34390
        • Local Institution
    • Dikimevi
      • Ankara, Dikimevi, Turkey, 06100
        • Local Institution
      • Donetsk, Ukraine, 83003
        • Local Institution
      • Kharkiv, Ukraine, 61018
        • Local Institution
      • Kharkiv, Ukraine, 61176
        • Local Institution
      • Kharkov, Ukraine, 61039
        • Local Institution
      • Kyiv, Ukraine, 03680
        • Local Institution
      • Kyiv, Ukraine, 02091
        • Local Institution
      • Kyiv, Ukraine, 01133
        • Local Institution
      • Kyiv, Ukraine, 03115
        • Local Institution
      • Kyiv, Ukraine, 03151
        • Local Institution
      • Kyiv, Ukraine, 04050
        • Local Institution
      • Kyiv, Ukraine, 04201
        • Local Institution
      • Lutsk, Ukraine, 43024
        • Local Institution
      • Lviv, Ukraine, 79010
        • Local Institution
      • Uzhgorod, Ukraine, 88000
        • Local Institution
      • Vinnitsa, Ukraine, 21029
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Local Institution
      • London, Greater London, United Kingdom, SW3 6LR
        • Local Institution
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB8 3NN
        • Local Institution
    • Tyne And Wear
      • Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
        • Local Institution
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Local Institution
    • Yorkshire
      • Hull, Yorkshire, United Kingdom, HU3 2JZ
        • Local Institution
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama At Birmingham Hospital
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Pulmonary Specialists, Ltd.
      • Scottsdale, Arizona, United States, 85258
        • Az Pulmonary Specialists Ltd
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Fort Smith Lung Center
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic/Scripps Health And Green Hospital
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States, 90033
        • Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
      • Oakland, California, United States, 94609
        • Dr. Felt Medical Office
      • Stanford, California, United States, 94305
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Florida
      • Celebration, Florida, United States, 34747
        • Florida Hospital Celebration Health
      • Clearwater, Florida, United States, 33756
        • Research Alliance, Inc.
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Pensacola, Florida, United States, 32504
        • Pensacola Lung Group
      • Vero Beach, Florida, United States, 32960
        • Indian River Med. Ctr.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pulmonary & Critical Care of Atlanta
      • Atlanta, Georgia, United States, 30030
        • Atlanta Institute For Medical Research, Inc
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls Infectious Diseases, PLLC
    • Illinois
      • Oak Park, Illinois, United States, 60302
        • West Suburban Hospital
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Infectious Disease Of Indiana Psc
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Cotton-O-Neil Clinical Research Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center-Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital
    • Michigan
      • Detriot, Michigan, United States, 48202
        • Henry Ford Hospital, Transplant Institute
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
    • New Jersey
      • Mornstown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, United States, 17033
        • The Milton S Hershey Medical Center Of Penn. State Univ.
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Palmetto Nephrology Pa
      • Spartanburg, South Carolina, United States, 29303
        • S. Carolina Pharmaceutical Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Health Presbyterian Dallas
      • Houston, Texas, United States, 77030
        • Michael E. De Bakey Veteran Affairs Medical Center
      • San Antonio, Texas, United States, 78258
        • Sonterra Clinical Research
      • San Antonio, Texas, United States, 78205
        • Sonterra Clinical Research
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • 40 years or older
  • hospitalized with congestive heart failure or acute respiratory failure
  • infection (without septic shock)
  • acute rheumatic disorder
  • inflammatory bowel disease

Exclusion Criteria:

  • patients with venous thromboembolism (VTE)
  • active bleeding or at high risk of bleeding
  • unable to take oral medication
  • with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1

While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Other Names:
  • BMS-562247
ACTIVE_COMPARATOR: Arm 2

While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)

Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
Time Frame: Intended Treatment Period
VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Major Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of All Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of drug to last dose of drug plus 2 days
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of drug to last dose of drug plus 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
Time Frame: Day 1 to last dose of parenteral study drug plus 1 day
Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
Day 1 to last dose of parenteral study drug plus 1 day
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
Time Frame: Day 1 to last dose of parenteral study drug plus 1 day
Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
Day 1 to last dose of parenteral study drug plus 1 day
Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated PE With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.
Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
Time Frame: Day 1 to last dose of study drug plus 2 days
Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.
Day 1 to last dose of study drug plus 2 days
Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
Time Frame: Day 1 to last dose of study drug plus 2 days
Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.
Day 1 to last dose of study drug plus 2 days
Mean Change From Baseline in Heart Rate in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.
Day 1 to last dose of study drug plus 2 days
Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
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). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Day 1 to last dose of study drug plus 2 days
Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Day 1 to last dose of study drug plus 2 days
Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 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. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Day 1 to last dose of study drug plus 2 days
Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.
Day 1 to last dose of study drug plus 2 days
Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.
Day 1 to last dose of study drug plus 2 days
Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
Time Frame: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.
Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.
Day 1 to last dose of study drug plus 2 days

Collaborators and Investigators

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Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (ESTIMATE)

April 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

May 1, 2014

More Information

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