ID

32156

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.10.18 22.10.18 -
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GlaxoSmithKline

Hochgeladen am

22. Oktober 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

Englisch

Unscheduled Assessment of Symptomatic DVT

1 Formulare  
Unscheduled Assessment of Symptomatic DVT
Beschreibung

Unscheduled Assessment of Symptomatic DVT

Alias
UMLS CUI-1
C0149871
UMLS CUI-2
C0220825
Date of first clinical signs/symptoms of DVT
Beschreibung

Deep Vein Thrombosis; Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0574845
Side
Beschreibung

Deep Vein Thrombosis; Side

Datentyp

text

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0441987
Ultrasonography
Beschreibung

Ultrasonography

Alias
UMLS CUI-1
C0041618
Not done
Beschreibung

Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1]
C0041618
Date performed
Beschreibung

Ultrasonography, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0011008
Result
Beschreibung

Ultrasonography, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1274040
left Leg, Common Femoral
Beschreibung

Ultrasonography, Common femoral vein, left

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205091
Left Leg, Popliteal
Beschreibung

Ultrasonography, Structure of popliteal vein, left

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205091
Right Leg, Common Femoral
Beschreibung

Ultrasonography; Common femoral vein, Right

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205090
Right Leg, Popliteal
Beschreibung

Ultrasonography; Structure of popliteal vein, Right

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205090
Venography
Beschreibung

Venography

Alias
UMLS CUI-1
C0031545
Not done
Beschreibung

Venography

Datentyp

boolean

Alias
UMLS CUI [1]
C0031545
Bilateral
Beschreibung

Venography, Bilateral

Datentyp

boolean

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

Venography, Bilateral, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0011008
Left Leg
Beschreibung

Venography, Structure of left lower leg

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
Left Leg, Date performed
Beschreibung

Venography, Structure of left lower leg, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
UMLS CUI [1,3]
C0011008
Right Leg
Beschreibung

Venography, Structure of right lower leg

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230442
Right Leg, Date performed
Beschreibung

Venography, Structure of right lower leg, Date in time

Datentyp

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.
Beschreibung

Venography; Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C3146298
Treatment
Beschreibung

Treatment

Alias
UMLS CUI-1
C0149871
UMLS CUI-2
C0013227
Based on signs and symptoms, ultrasound and/or venogram results, was medication given to treat DVT?
Beschreibung

Deep vein thrombosis; Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0013227
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Ähnliche Modelle

Unscheduled Assessment of Symptomatic DVT

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unscheduled Assessment of Symptomatic DVT
C0149871 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Deep Vein Thrombosis; Date of onset
Item
Date of first clinical signs/symptoms of DVT
date
C0149871 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Side
text
C0149871 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Ultrasonography, Common femoral vein, right
Code List
Side
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
Ultrasonography
C0041618 (UMLS CUI-1)
Ultrasonography
Item
Not done
boolean
C0041618 (UMLS CUI [1])
Ultrasonography, Date in time
Item
Date performed
date
C0041618 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Ultrasonography, Structure of popliteal vein, left
Code List
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, Common Femoral
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Ultrasonography, Common femoral vein, left
Code List
left Leg, Common Femoral
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
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Ultrasonography, Structure of popliteal vein, left
Code List
Left Leg, Popliteal
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
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Ultrasonography; Common femoral vein, Right
Code List
Right Leg, Common Femoral
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
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Ultrasonography; Common femoral vein, Right
Code List
Right Leg, Popliteal
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
Item
Not done
boolean
C0031545 (UMLS CUI [1])
Venography, Bilateral
Item
Bilateral
boolean
C0031545 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Venography, Bilateral, Date in time
Item
Bilateral, 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
Left Leg, 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
Right Leg, 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
Treatment
C0149871 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Deep vein thrombosis; Pharmaceutical Preparations
Item
Based on signs and symptoms, ultrasound and/or venogram results, was medication given to treat DVT?
boolean
C0149871 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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