ID

38425

Beskrivning

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 Pulmonary Embolism (PE), information on which is recorded in a seperate form.

Länk

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

Nyckelord

Versioner (1)
  1. 2019-10-17 2019-10-17 -
Rättsinnehavare

GlaxoSmithKline

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17 oktober 2019

DOI

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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

Engelsk

Suspected Pulmonary Embolism Adjudication

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beskrivning

Country No.

Datatyp

integer

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

Centre No.

Datatyp

integer

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

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Suspected Pulmonary Embolism Adjudication Form
Beskrivning

Suspected Pulmonary Embolism Adjudication Form

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0034065
UMLS CUI-3
C0750491
CRF page number
Beskrivning

CRF page number

Datatyp

float

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

Date of PE symptoms onset

Datatyp

date

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C1457887
V/Q Lung Scan
Beskrivning

V/Q Lung Scan

Alias
UMLS CUI-1
C0560738
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
V/Q scan date
Beskrivning

V/Q scan date

Datatyp

date

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

Record perfusion scan OR ventilation scan date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1518040
Ventilation scan date
Beskrivning

Record perfusion scan OR ventilation scan date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2094576
V/Q Scan Result
Beskrivning

V/Q Scan Adjudication Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0560738
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
Spiral CT scan
Beskrivning

Spiral CT scan

Alias
UMLS CUI-1
C0860888
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Spiral CT Scan Date
Beskrivning

Spiral CT Scan Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0860888
Spiral CT Scan Result
Beskrivning

Spiral CT Scan Adjudication Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0860888
Pulmonary Angiogram
Beskrivning

Pulmonary Angiogram

Alias
UMLS CUI-1
C0202910
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Pulmonary Angiogram Date
Beskrivning

Pulmonary Angiogram Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0202910
UMLS CUI [1,2]
C0011008
Pulmonary Angiogram Result
Beskrivning

Pulmonary Angiogram Adjudication Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0202910
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
CUS
Beskrivning

CUS

Alias
UMLS CUI-1
C2317107
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Compression ultrasonography: Date
Beskrivning

Compression ultrasonography: Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0011008
CUS Result
Beskrivning

CUS Adjudication Result

Datatyp

text

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
Compression ultrasonography result: Left
Beskrivning

Compression ultrasonography adjudication result: Left

Datatyp

text

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205091
Compression ultrasonography result: Right
Beskrivning

Compression ultrasonography adjudication result: Right

Datatyp

text

Alias
UMLS CUI [1,1]
C2317107
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205090
Other test
Beskrivning

Other test

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0039593
UMLS CUI-3
C0680730
UMLS CUI-4
C1274040
Specify other test
Beskrivning

Specify other test

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1521902
Other test date
Beskrivning

Other test date

Datatyp

date

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0011008
Other test result
Beskrivning

Other test adjudication result

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0680730
UMLS CUI [1,4]
C1274040
Venogram
Beskrivning

Venogram

Alias
UMLS CUI-1
C0031545
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Bilateral Venogram Date
Beskrivning

Bilateral Venogram Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0238767
Left leg Venogram Date
Beskrivning

Record either left leg OR right leg

Datatyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1140621
Right leg Venogram Date
Beskrivning

Record either left leg OR right leg

Datatyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1140621
Venogram Result
Beskrivning

Also fill in the detailed repeating itemgroup below.

Datatyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
Venogram Results
Beskrivning

Venogram Results

Alias
UMLS CUI-1
C0031545
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Venogram site
Beskrivning

Fill in itemgroup for each of the four sites.

Datatyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C1515974
Venogram result
Beskrivning

Venogram adjudication result

Datatyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C1274040
Classification Status
Beskrivning

Classification Status

Alias
UMLS CUI-1
C0008902
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Pulmonary Embolism?
Beskrivning

Pulmonary Embolism?

Datatyp

boolean

Alias
UMLS CUI [1]
C0034065
Comment
Beskrivning

PE Comment

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0034065
Adjudicators
Beskrivning

Adjudicators

Alias
UMLS CUI-1
C0401783
Adjudicator Signature 1
Beskrivning

Adjudicator Signature 1

Datatyp

text

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

Adjudicator Signature 2

Datatyp

text

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

Date of adjudication

Datatyp

text

Alias
UMLS CUI [1]
C4740194
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Similar models

Suspected Pulmonary Embolism Adjudication

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 Pulmonary Embolism Adjudication Form
C0680730 (UMLS CUI-1)
C0034065 (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 PE symptoms onset
Item
Date of symptoms onset
date
C0034065 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
V/Q Lung Scan
C0560738 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
V/Q scan date
Item
V/Q scan date
date
C0560738 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Perfusion scan date
Item
Perfusion scan date
date
C0011008 (UMLS CUI [1,1])
C1518040 (UMLS CUI [1,2])
Ventilation scan date
Item
Ventilation scan date
date
C0011008 (UMLS CUI [1,1])
C2094576 (UMLS CUI [1,2])
Item
V/Q Scan Result
text
C0560738 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
V/Q Scan Result
Code List
V/Q Scan Result
CL Item
Normal (Normal)
CL Item
High Probability (High Probability)
CL Item
Non-High Probability (Non-High Probability)
CL Item
Not done (Not done)
Item Group
Spiral CT scan
C0860888 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Spiral CT Scan Date
Item
Spiral CT Scan Date
date
C0011008 (UMLS CUI [1,1])
C0860888 (UMLS CUI [1,2])
Item
Spiral CT Scan Result
text
C0680730 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0860888 (UMLS CUI [1,3])
Spiral CT Scan Result
Code List
Spiral CT Scan Result
CL Item
Non-Diagnostic (Non-Diagnostic)
CL Item
ILFD (ILFD)
CL Item
Indeterminate (Indeterminate)
CL Item
Not done (Not done)
Item Group
Pulmonary Angiogram
C0202910 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Pulmonary Angiogram Date
Item
Pulmonary Angiogram Date
date
C0202910 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pulmonary Angiogram Result
text
C0202910 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Pulmonary Angiogram Result
Code List
Pulmonary Angiogram Result
CL Item
Normal (Normal)
CL Item
Diagnostic for PE (Diagnostic for PE)
CL Item
Indeterminate (Indeterminate)
CL Item
Not done (Not done)
Item Group
CUS
C2317107 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Compression ultrasonography: Date
Item
Compression ultrasonography: Date
date
C2317107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
CUS Result
text
C2317107 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CUS Result
Code List
CUS Result
CL Item
No Acute DVT (No Acute DVT)
CL Item
Acute DVT (Acute DVT)
CL Item
Non-Evaluable (Non-Evaluable)
CL Item
Not done (Not done)
Item
Compression ultrasonography result: Left
text
C2317107 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,4])
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])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205090 (UMLS CUI [1,4])
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)
Item Group
Other test
C0205394 (UMLS CUI-1)
C0039593 (UMLS CUI-2)
C0680730 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
Specify other test
Item
Specify other test
text
C0205394 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other test date
Item
Other test date
date
C0205394 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Other test result
text
C0205394 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Other test result
Code List
Other test result
CL Item
Normal (Normal)
CL Item
Diagnostic for PE (Diagnostic for PE)
CL Item
Indeterminate (Indeterminate)
CL Item
Not done (Not done)
Item Group
Venogram
C0031545 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Bilateral Venogram Date
Item
Bilateral Venogram Date
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Left leg Venogram Date
Item
Left leg Venogram Date
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
Right leg Venogram Date
Item
Right leg Venogram Date
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
Item
Venogram Result
text
C0031545 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Venogram Result
Code List
Venogram Result
CL Item
No Acute DVT (No Acute DVT)
CL Item
Acute DVT (Acute DVT)
CL Item
Non-Evaluable (Non-Evaluable)
CL Item
Not done (Not done)
Item Group
Venogram Results
C0031545 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Item
Venogram site
text
C0031545 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Venography site
Code List
Venogram 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
Venogram result
text
C0031545 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Venography site
Code List
Venogram 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)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Pulmonary Embolism?
Item
Pulmonary Embolism?
boolean
C0034065 (UMLS CUI [1])
PE Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0034065 (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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