ID

38586

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 is to be filled in if an autopsy has been performed.

Link

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

Keywords

Versions (2)
  1. 10/17/19 10/17/19 -
  2. 10/25/19 10/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 25, 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

Autopsy Form

1 forms  
  1. StudyEvent: ODM
    1. Autopsy Form
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
Autopsy Form
Description

Autopsy Form

Alias
UMLS CUI-1
C0004398
Was an autopsy performed?
Description

If yes, complete form.

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Date of Autopsy
Description

Date of Autopsy

Data type

date

Alias
UMLS CUI [1]
C3864942
Pulmonary Embolism
Description

If yes, specify location

Data type

boolean

Alias
UMLS CUI [1]
C0034065
Left pulmonary artery
Description

Pulmonary Embolism in Left pulmonary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0226069
Right pulmonary artery
Description

Pulmonary Embolism in Right pulmonary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0226054
Left lobar arteries
Description

Pulmonary Embolism in Left lobar arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0503867
UMLS CUI [1,3]
C0205091
Right lobar arteries
Description

Pulmonary Embolism in Right lobar arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0503867
UMLS CUI [1,3]
C0205090
Left segmental arteries
Description

Pulmonary Embolism in Left segmental arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0503402
UMLS CUI [1,3]
C0205091
Right segmental arteries
Description

Pulmonary Embolism in Right segmental arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0503402
UMLS CUI [1,3]
C0205090
Main pulmonary trunk
Description

Pulmonary Embolism in Main pulmonary trunk

Data type

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C2954153
Deep Vein Thrombosis
Description

If yes, specify location

Data type

boolean

Alias
UMLS CUI [1]
C0149871
Left calf vein
Description

Deep Vein Thrombosis in Left calf

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0230445
UMLS CUI [1,3]
C0205091
Right calf vein
Description

Deep Vein Thrombosis in Right calf

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0230445
UMLS CUI [1,3]
C0205090
Left popliteal vein
Description

Deep Vein Thrombosis in Left popliteal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0835016
Right popliteal vein
Description

Deep Vein Thrombosis in Right popliteal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0835015
Left femoral vein
Description

Deep Vein Thrombosis in Left femoral vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0739301
Right femoral vein
Description

Deep Vein Thrombosis in Right femoral vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0739300
Left iliac vein
Description

Deep Vein Thrombosis in Left iliac vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C4520258
Right iliac vein
Description

Deep Vein Thrombosis in Right iliac vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C4520257
Inferior vena cava
Description

Deep Vein Thrombosis in Inferior vena cava

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0042458
Other Thrombosis (venous and/or arterial)
Description

If yes, specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0042487
UMLS CUI [2,1]
C0151942
UMLS CUI [2,2]
C0205394
Specify other venous/arterial thrombosis
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0042487
UMLS CUI [2,1]
C1521902
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0151942
Hemorrhage(s)
Description

if yes specify

Data type

boolean

Alias
UMLS CUI [1]
C0019080
Specify Hemorrhage(s)
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1521902
Other Findings
Description

if yes specify

Data type

boolean

Alias
UMLS CUI [1]
C1335151
Specify other Findings
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C1335151
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

"I, the undersigned, certify that I have carefully examined all entries on the CRF for this subject.To the best of my knowledge, all information is correct."

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's signature date
Description

Investigator's signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Autopsy Form

1 forms
  1. StudyEvent: ODM
    1. Autopsy Form
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
Autopsy Form
C0004398 (UMLS CUI-1)
Autopsy?
Item
Was an autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Date of Autopsy
Item
Date of Autopsy
date
C3864942 (UMLS CUI [1])
Pulmonary Embolism
Item
Pulmonary Embolism
boolean
C0034065 (UMLS CUI [1])
Pulmonary Embolism in Left pulmonary artery
Item
Left pulmonary artery
boolean
C0034065 (UMLS CUI [1,1])
C0226069 (UMLS CUI [1,2])
Pulmonary Embolism in Right pulmonary artery
Item
Right pulmonary artery
boolean
C0034065 (UMLS CUI [1,1])
C0226054 (UMLS CUI [1,2])
Pulmonary Embolism in Left lobar arteries
Item
Left lobar arteries
boolean
C0034065 (UMLS CUI [1,1])
C0503867 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Pulmonary Embolism in Right lobar arteries
Item
Right lobar arteries
boolean
C0034065 (UMLS CUI [1,1])
C0503867 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Pulmonary Embolism in Left segmental arteries
Item
Left segmental arteries
boolean
C0034065 (UMLS CUI [1,1])
C0503402 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Pulmonary Embolism in Right segmental arteries
Item
Right segmental arteries
boolean
C0034065 (UMLS CUI [1,1])
C0503402 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Pulmonary Embolism in Main pulmonary trunk
Item
Main pulmonary trunk
boolean
C0034065 (UMLS CUI [1,1])
C2954153 (UMLS CUI [1,2])
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
boolean
C0149871 (UMLS CUI [1])
Deep Vein Thrombosis in Left calf
Item
Left calf vein
boolean
C0149871 (UMLS CUI [1,1])
C0230445 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
Deep Vein Thrombosis in Right calf
Item
Right calf vein
boolean
C0149871 (UMLS CUI [1,1])
C0230445 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
Deep Vein Thrombosis in Left popliteal vein
Item
Left popliteal vein
boolean
C0149871 (UMLS CUI [1,1])
C0835016 (UMLS CUI [1,2])
Deep Vein Thrombosis in Right popliteal vein
Item
Right popliteal vein
boolean
C0149871 (UMLS CUI [1,1])
C0835015 (UMLS CUI [1,2])
Deep Vein Thrombosis in Left femoral vein
Item
Left femoral vein
boolean
C0149871 (UMLS CUI [1,1])
C0739301 (UMLS CUI [1,2])
Deep Vein Thrombosis in Right femoral vein
Item
Right femoral vein
boolean
C0149871 (UMLS CUI [1,1])
C0739300 (UMLS CUI [1,2])
Deep Vein Thrombosis in Left iliac vein
Item
Left iliac vein
boolean
C0149871 (UMLS CUI [1,1])
C4520258 (UMLS CUI [1,2])
Deep Vein Thrombosis in Right iliac vein
Item
Right iliac vein
boolean
C0149871 (UMLS CUI [1,1])
C4520257 (UMLS CUI [1,2])
Deep Vein Thrombosis in Inferior vena cava
Item
Inferior vena cava
boolean
C0149871 (UMLS CUI [1,1])
C0042458 (UMLS CUI [1,2])
Other venous/arterial thrombosis
Item
Other Thrombosis (venous and/or arterial)
boolean
C0205394 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0151942 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Specify other venous/arterial thrombosis
Item
Specify other venous/arterial thrombosis
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0042487 (UMLS CUI [1,3])
C1521902 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0151942 (UMLS CUI [2,3])
Hemorrhage
Item
Hemorrhage(s)
boolean
C0019080 (UMLS CUI [1])
Specify Hemorrhage
Item
Specify Hemorrhage(s)
text
C0019080 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Other findings
Item
Other Findings
boolean
C1335151 (UMLS CUI [1])
Specify other findings
Item
Specify other Findings
text
C1521902 (UMLS CUI [1,1])
C1335151 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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