Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

NCT00362232 | Completed Phase 3 Results DMC

• 2 other identifiers: 113552006-002402-60
• Study Type: interventional
• Target: 3,148
• Locations: 13 countries
• Sites: 124

Brief Summary

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Conditions

Venous Thromboembolism

Keywords

Prevention of venous thromboembolism

Outcome Measures

Primary Outcomes (2)

• Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population

  Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

  Up to 16 days after surgery

• Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.

  Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

  Up to 16 days after surgery

Secondary Outcomes (14)

• Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE

  Up to 16 days after surgery

• Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.

  Up to 16 days after surgery

• Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.

  Up to 16 days after surgery

• Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.

  Up to 16 days after surgery

• Incidence of DVT (Proximal, Distal) Per Protocol Population.

  Up to 16 days after surgery

Study Arms (2)

Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Placebo: syringes of Enoxaparin

Enoxaparin 30 mg twice a day (bid)

ACTIVE COMPARATOR

Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Drug: Enoxaparin; Drug: Placebo: tablet of Rivaroxaban

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.

Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

Enoxaparin DRUG

Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Enoxaparin 30 mg twice a day (bid)

Placebo: tablet of Rivaroxaban DRUG

Placebo tablet of rivaroxaban administered once daily in the evening.

Enoxaparin 30 mg twice a day (bid)

Placebo: syringes of Enoxaparin DRUG

Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 years or above
• Patients scheduled for elective total knee replacement

You may not qualify if:

• Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH)
• Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)
• Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Sponsors & Collaborators

• Bayer: lead

Study Sites (124)

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Birmingham, Alabama, 35209, United States

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Tuscaloosa, Alabama, 35406, United States

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Phoenix, Arizona, 85023, United States

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Little Rock, Arkansas, 72205, United States

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Bakersfield, California, 93309, United States

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Encinitas, California, 92024, United States

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Fountain Valley, California, 92708, United States

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La Jolla, California, 92037, United States

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Torrance, California, 90502-2004, United States

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Yuba City, California, 95991, United States

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Centennial, Colorado, 80112, United States

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Denver, Colorado, 80230, United States

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Englewood, Colorado, 80110, United States

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Boynton Beach, Florida, 33472-2952, United States

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Clearwater, Florida, 33756, United States

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DeLand, Florida, 32720, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32216, United States

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Pensacola, Florida, 32501, United States

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Pinellas Park, Florida, 33781, United States

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Decatur, Georgia, 30033, United States

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Boise, Idaho, 83702, United States

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Meridian, Idaho, 83642, United States

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Towson, Maryland, 21204, United States

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Missoula, Montana, 59802, United States

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Teaneck, New Jersey, 07666, United States

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Greensboro, North Carolina, 27401, United States

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Cincinnati, Ohio, 45242, United States

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Oklahoma City, Oklahoma, 73162, United States

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Johnstown, Pennsylvania, 15901, United States

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State College, Pennsylvania, 16801, United States

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Charleston, South Carolina, 29414, United States

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Dallas, Texas, 75231, United States

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Grapevine, Texas, 76051, United States

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Houston, Texas, 77030, United States

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Lubbock, Texas, 79410, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78233, United States

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Spokane, Washington, 99218, United States

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1431, Bulgaria

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Red Deer, Alberta, T4N 6V7, Canada

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Kelowna, British Columbia, V1W 4V5, Canada

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Penticton, British Columbia, V2A 5C8, Canada

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Fredericton, New Brunswick, E3B 5N5, Canada

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Ajax, Ontario, L1S 2J4, Canada

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Brantford, Ontario, N3R 1G9, Canada

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Greater Sudbury, Ontario, P3A 1Y8, Canada

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Oakville, Ontario, L6J 3M5, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Peterborough, Ontario, K9J 7C6, Canada

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Scarborough Village, Ontario, M1M 3W3, Canada

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Scarborough Village, Ontario, M1P 2V5, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Woodstock, Ontario, N4S 5B2, Canada

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Charlottetown, Prince Edward Island, C1A 8T5, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Hellerup, DK-2900, Denmark

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Herlev, 2730, Denmark

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Hvidovre, 2650, Denmark

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Hørsholm, 2970, Denmark

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Silkeborg, 8600, Denmark

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Viborg, 8800, Denmark

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Hyderabad, Andhra Pradesh, 500004, India

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Secunderabad, Andhra Pradesh, 500 003, India

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Secundrabad, Andhra Pradesh, 500003, India

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Ahmedabad, Gujarat, 380006, India

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Ahmedabad, Gujarat, 380054, India

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Pune, Maharashtra, 411001, India

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Pune, Maharashtra, 411009, India

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Ludhiana, Punjab, 141001, India

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Chennai, Tamil Nadu, 600 006, India

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Bangalore, 560001, India

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Bangalore, 560034, India

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Baroda, 390007, India

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Hyderabad, India

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New Delhi, 110029, India

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Petah Tikva, Israel, 49100, Israel

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Ẕerifin, Israel, 70300, Israel

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Beersheba, 85025, Israel

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Holon, 58100, Israel

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Kfar Saba, 44281, Israel

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Tel Aviv, 64239, Israel

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Kaunas, 44320, Lithuania

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Kaunas, LT-50009, Lithuania

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Klaipėda, 92288, Lithuania

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Panevezys, 35144, Lithuania

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Vilnius, LT-04130, Lithuania

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Guadalajara, Jalisco, 44200, Mexico

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Guadalajara, Jalisco, 44350, Mexico

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Zapopan, Jalisco, 45100, Mexico

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Monterrey, Nuevo León, 64000, Mexico

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Monterrey, Nuevo León, 64380, Mexico

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Mérida, Yucatán, 97150, Mexico

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Edo. de Mexico, 53120, Mexico

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Baerum Postterminal, 1306, Norway

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Gjøvik, 2819, Norway

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Kongsvinger, 2212, Norway

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Lillehammer, 2609, Norway

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Karachi, Sindh, 74800, Pakistan

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Karachi, Sindh, Pakistan

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Bydgoszcz, 85-094, Poland

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Elblag, 82-300, Poland

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Gdansk, 80-803, Poland

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Gmina Końskie, 26-200, Poland

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Kielce, Poland

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Krakow, 31-913, Poland

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Lublin, 20-718, Poland

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Sosnowiec, 41-200, Poland

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Warsaw, 02-005, Poland

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Warsaw, 02-507, Poland

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Colombo-80, Sri Lanka

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Ragama, Sri Lanka

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Sri Jayewardenepura Kotte, Sri Lanka

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Gothenburg, 416 85, Sweden

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Hässleholm, 281 25, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 112 81, Sweden

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Vaxjo, 351 85, Sweden

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Västervik, 593 81, Sweden

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Related Publications (1)

• Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.

  PMID: 19411100 RESULT

Related Links

• Click here and search for information of Bayer products for Europe

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 9, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2008
• Last Updated: November 4, 2014
• Results First Posted: June 13, 2012

Record last verified: 2014-10

Locations

ME (7); PL (10); DK (6); SR (3); IN (14); NO (4); IL (6); CA (18); SE (6); BU (3); LI (5); PA (2); US (40)