ID

32568

Description

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Keywords

Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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Creative Commons BY-NC 3.0
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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

English

Assessment of Suspected Pulmonary Embolism

1 forms  
Pulmonary Embolism, Suspicion
Description

Pulmonary Embolism, Suspicion

Alias
UMLS CUI-1
C0034065
UMLS CUI-2
C0242114
Date of first clinical signs/symptoms of PE
Description

Pulmonary Embolism; first clinical symptoms, date

Data type

date

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0574845
Perfusion and/or Ventilation Lung Scan
Description

Perfusion and/or Ventilation Lung Scan

Alias
UMLS CUI-1
C0034065
UMLS CUI-2
C0024109
UMLS CUI-3
C0040405
Not Done
Description

Lung, X-ray Computed Tomography, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0040405
UMLS CUI [1,3]
C1272696
V/Q Scan
Description

V/Q Scan

Data type

boolean

Alias
UMLS CUI [1]
C0560738
Date performed
Description

V/Q Scan, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0560738
UMLS CUI [1,2]
C0011008
Perfusion scan
Description

Lung Perfusion scan

Data type

boolean

Alias
UMLS CUI [1]
C1518040
Date performed
Description

Lung Perfusion scan, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1518040
UMLS CUI [1,2]
C0011008
Ventilation Scan
Description

Bilateral Lung Ventilation, Scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0559315
UMLS CUI [1,2]
C0441633
Date performed
Description

Bilateral Lung Ventilation, Scanning, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0559315
UMLS CUI [1,2]
C0441633
UMLS CUI [1,3]
C0011008
Result
Description

Pulmonary Embolism; Lung; X-Ray Computed Tomography; Result

Data type

text

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C0040405
UMLS CUI [1,4]
C1274040
Ultrasonography
Description

Ultrasonography

Alias
UMLS CUI-1
C0041618
Not Done
Description

Ultrasonography, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1272696
Date performed
Description

Ultrasonography, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0011008
Left Leg, Common Femoral, Result
Description

Ultrasonography, Common Femoral vein, left, Result

Data type

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1274040
Left Leg, Popliteal, Result
Description

Ultrasonography, Structure of Popliteal vein, left, Result

Data type

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1274040
Right Leg, Common Femoral, Result
Description

Ultrasonography, Common Femoral vein, left, Result

Data type

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1274040
Right Leg, Popliteal, Result
Description

Ultrasonography, Structure of popliteal vein, right, Result

Data type

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1274040
Venography
Description

Venography

Alias
UMLS CUI-1
C0031545
Not Done
Description

Venography, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C1272696
Bilateral
Description

Venography, Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0238767
Date performed
Description

Venography, Bilateral, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0011008
Left leg
Description

Venography, Structure of left lower leg

Data type

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
Date performed
Description

Venography, Structure of left lower leg, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
UMLS CUI [1,3]
C0011008
Right leg
Description

Venography, Structure of right lower leg

Data type

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230442
Date performed
Description

Venography, Structure of right lower leg, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230442
UMLS CUI [1,3]
C0011008
If NOT BILATERAL or NOT DONE, tick the primary reason:
Description

Venography, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C3146298
Angiography
Description

Angiography

Alias
UMLS CUI-1
C0002978
Not Done
Description

Angiogram, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0002978
UMLS CUI [1,2]
C1272696
Date performed
Description

Angiogram, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0002978
UMLS CUI [1,2]
C0011008
Spiral CT Scan
Description

Spiral CT Scan

Alias
UMLS CUI-1
C0860888
Not Done
Description

Tomography, Spiral Computed, Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0860888
UMLS CUI [1,2]
C1272696
Date performed
Description

Tomography, Spiral Computed, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0860888
UMLS CUI [1,2]
C0011008
Other Tests
Description

Other Tests

Alias
UMLS CUI-1
C0392366
UMLS CUI-2
C0205394
Not Done
Description

Tests, Other, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0392366
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1272696
Specify
Description

Tests, Other

Data type

text

Alias
UMLS CUI [1,1]
C0392366
UMLS CUI [1,2]
C0205394
Date performed
Description

Tests, Other, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0392366
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011008
Treatment
Description

Treatment

Alias
UMLS CUI-1
C0087111
Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
Description

Pulmonary Embolism, Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0013227
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C0034065
UMLS CUI-2
C0871902
Was the suspected PE fatal?
Description

Pulmonary Embolism, Fatal

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C1302234
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Similar models

Assessment of Suspected Pulmonary Embolism

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pulmonary Embolism, Suspicion
C0034065 (UMLS CUI-1)
C0242114 (UMLS CUI-2)
Pulmonary Embolism; first clinical symptoms, date
Item
Date of first clinical signs/symptoms of PE
date
C0034065 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Item Group
Perfusion and/or Ventilation Lung Scan
C0034065 (UMLS CUI-1)
C0024109 (UMLS CUI-2)
C0040405 (UMLS CUI-3)
Lung, X-ray Computed Tomography, Not Done
Item
Not Done
boolean
C0024109 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
V/Q Scan
Item
V/Q Scan
boolean
C0560738 (UMLS CUI [1])
V/Q Scan, Date in time
Item
Date performed
date
C0560738 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lung Perfusion scan
Item
Perfusion scan
boolean
C1518040 (UMLS CUI [1])
Lung Perfusion scan, Date in time
Item
Date performed
date
C1518040 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Bilateral Lung Ventilation, Scanning
Item
Ventilation Scan
boolean
C0559315 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
Bilateral Lung Ventilation, Scanning, Date in time
Item
Date performed
date
C0559315 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0034065 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Results
Code List
Result
CL Item
High probability defect(s) (High probability defect(s))
CL Item
Non high probability defect(s) (Non high probability defect(s))
CL Item
No defect(s) (No defect(s))
Item Group
Ultrasonography
C0041618 (UMLS CUI-1)
Ultrasonography, Not Done
Item
Not Done
boolean
C0041618 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Ultrasonography, Date in time
Item
Date performed
date
C0041618 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Left Leg, Common Femoral, Result
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Left Leg, Common Femoral, Result
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Left Leg, Popliteal, Result
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Left Leg, Popliteal, Result
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Right Leg, Common Femoral, Result
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Right Leg, Common Femoral, Result
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Right Leg, Popliteal, Result
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Right Leg, Popliteal, Result
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item Group
Venography
C0031545 (UMLS CUI-1)
Venography, Not Done
Item
Not Done
boolean
C0031545 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Venography, Bilateral
Item
Bilateral
boolean
C0031545 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Venography, Bilateral, Date in time
Item
Date performed
date
C0031545 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Venography, Structure of left lower leg
Item
Left leg
boolean
C0031545 (UMLS CUI [1,1])
C0230443 (UMLS CUI [1,2])
Venography, Structure of left lower leg, Date in time
Item
Date performed
date
C0031545 (UMLS CUI [1,1])
C0230443 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Venography, Structure of right lower leg
Item
Right leg
boolean
C0031545 (UMLS CUI [1,1])
C0230442 (UMLS CUI [1,2])
Venography, Structure of right lower leg, Date in time
Item
Date performed
date
C0031545 (UMLS CUI [1,1])
C0230442 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If NOT BILATERAL or NOT DONE, tick the primary reason:
text
C0031545 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Venography, Indication
Code List
If NOT BILATERAL or NOT DONE, tick the primary reason:
CL Item
Failed venous access (Failed venous access)
CL Item
Subject refused/withdrew consent (Subject refused/withdrew consent)
CL Item
Subject amputee (Subject amputee)
CL Item
Other, specify (Other, specify)
Item Group
Angiography
C0002978 (UMLS CUI-1)
Angiogram, Not Done
Item
Not Done
boolean
C0002978 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Angiogram, Date in time
Item
Date performed
date
C0002978 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Spiral CT Scan
C0860888 (UMLS CUI-1)
Tomography, Spiral Computed, Not Done
Item
Not Done
boolean
C0860888 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Tomography, Spiral Computed, Date in time
Item
Date performed
date
C0860888 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Other Tests
C0392366 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Tests, Other, Not done
Item
Not Done
boolean
C0392366 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Tests, Other
Item
Specify
text
C0392366 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Tests, Other, Date in time
Item
Date performed
date
C0392366 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Treatment
C0087111 (UMLS CUI-1)
Pulmonary Embolism, Pharmaceutical Preparations
Item
Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
boolean
C0034065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Seriousness
C0034065 (UMLS CUI-1)
C0871902 (UMLS CUI-2)
Pulmonary Embolism, Fatal
Item
Was the suspected PE fatal?
boolean
C0034065 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
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