ID

38086

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 death occuring during the study.

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

Death Adjudication

1 forms  
  1. StudyEvent: ODM
    1. Death Adjudication
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
Death Adjudication Form
Description

Death Adjudication Form

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0011065
CRF page number
Description

CRF page number

Data type

float

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

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Classification Status
Description

Classification Status

Alias
UMLS CUI-1
C0008902
Death Classification
Description

Death Classification

Data type

text

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0011065
Comment
Description

Death Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011065
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

Death Adjudication

1 forms
  1. StudyEvent: ODM
    1. Death Adjudication
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
Death Adjudication Form
C0680730 (UMLS CUI-1)
C0011065 (UMLS CUI-2)
CRF page number
Item
CRF page number
float
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item Group
Classification Status
C0008902 (UMLS CUI-1)
Item
Death Classification
text
C0008902 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Bleeding Classification
Code List
Death Classification
CL Item
Fatal PE (Fatal PE)
CL Item
Fatal Bleed (Fatal Bleed)
CL Item
Death not associated with VTE or bleeding (Death not associated with VTE or bleeding)
Death Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0011065 (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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