ID

38087

Description

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on the adjudication of any suspected DVT, information on which is recorded in a seperate form.

Link

https://clinicaltrials.gov/ct2/show/NCT00038961

Keywords

Versions (1)
  1. 9/16/19 9/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 16, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

English

Suspected DVT Adjudication

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Description

Country No.

Data type

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Description

Centre No.

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Suspected Deep Vein Thrombosis Adjudication Form
Description

Suspected Deep Vein Thrombosis Adjudication Form

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0149871
UMLS CUI-3
C0750491
CRF page number
Description

CRF page number

Data type

float

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Date of symptoms onset
Description

Date of DVT symptoms onset

Data type

date

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C1457887
Adjudication Results
Description

Adjudication Results

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0149871
UMLS CUI-3
C0750491
UMLS CUI-4
C0456984
Compression ultrasonography: Date
Description

Compression ultrasonography: Date

Data type

date

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0011008
Compression ultrasonography result: Left
Description

Compression ultrasonography result: Left

Data type

text

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205091
Compression ultrasonography result: Right
Description

Compression ultrasonography result: Right

Data type

text

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205090
Date of venography: bilateral
Description

Bilateral Venography Date

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0238767
Date of venography: Left leg
Description

Either left leg or right leg

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1140621
Date of venography: Right leg
Description

Either left leg or right leg

Data type

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1140621
Venography Adjudication Results
Description

Venography Adjudication Results

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0031545
UMLS CUI-3
C0456984
Venography site
Description

Fill in itemgroup for each of the four sites.

Data type

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C1515974
Venography adjudication result
Description

Venography adjudication result

Data type

text

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C0031545
UMLS CUI [1,3]
C0456984
Classification Status
Description

Classification Status

Alias
UMLS CUI-1
C0008902
Acute DVT
Description

Acute DVT

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0205178
Comment
Description

DVT Comment

Data type

text

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0947611
Adjudicators
Description

Adjudicators

Alias
UMLS CUI-1
C0401783
Adjudicator Signature 1
Description

Adjudicator Signature 1

Data type

text

Alias
UMLS CUI [1,1]
C0401783
UMLS CUI [1,2]
C1519316
Adjudicator Signature 2
Description

Adjudicator Signature 2

Data type

text

Alias
UMLS CUI [1,1]
C0401783
UMLS CUI [1,2]
C1519316
Date of adjudication
Description

Date of adjudication

Data type

text

Alias
UMLS CUI [1]
C4740194
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Similar models

Suspected DVT Adjudication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Item Group
Suspected Deep Vein Thrombosis Adjudication Form
C0680730 (UMLS CUI-1)
C0149871 (UMLS CUI-2)
C0750491 (UMLS CUI-3)
CRF page number
Item
CRF page number
float
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Date of DVT symptoms onset
Item
Date of symptoms onset
date
C0149871 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Adjudication Results
C0680730 (UMLS CUI-1)
C0149871 (UMLS CUI-2)
C0750491 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
Compression ultrasonography: Date
Item
Compression ultrasonography: Date
date
C2317107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Compression ultrasonography result: Left
text
C2317107 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Compression ultrasonography result: Left
Code List
Compression ultrasonography result: Left
CL Item
Compressible (Compressible)
CL Item
Non compressible (Non compressible)
CL Item
Indeterminate (Indeterminate)
CL Item
Not done (Not done)
Item
Compression ultrasonography result: Right
text
C2317107 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Compression ultrasonography result: Left
Code List
Compression ultrasonography result: Right
CL Item
Compressible (Compressible)
CL Item
Non compressible (Non compressible)
CL Item
Indeterminate (Indeterminate)
CL Item
Not done (Not done)
Bilateral Venography Date
Item
Date of venography: bilateral
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Left leg Venography Date
Item
Date of venography: Left leg
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
Right leg Venography Date
Item
Date of venography: Right leg
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
Item Group
Venography Adjudication Results
C0680730 (UMLS CUI-1)
C0031545 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Item
Venography site
text
C0031545 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Venography site
Code List
Venography site
CL Item
Left proximal (Left proximal)
CL Item
Left distal (Left distal)
CL Item
Right proximal (Right proximal)
CL Item
Right distal (Right distal)
Item
Venography adjudication result
text
C0680730 (UMLS CUI [1,1])
C0031545 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
Venography site
Code List
Venography adjudication result
CL Item
Normal (Normal)
CL Item
ILFD (ILFD)
CL Item
Indeterminate (Indeterminate)
CL Item
Not Done (Not Done)
Item Group
Classification Status
C0008902 (UMLS CUI-1)
Acute DVT
Item
Acute DVT
boolean
C0149871 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
DVT Comment
Item
Comment
text
C0149871 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Adjudicators
C0401783 (UMLS CUI-1)
Adjudicator Signature 1
Item
Adjudicator Signature 1
text
C0401783 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Adjudicator Signature 2
Item
Adjudicator Signature 2
text
C0401783 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of adjudication
Item
Date of adjudication
text
C4740194 (UMLS CUI [1])
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