ID

38086

Beschreibung

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

Stichworte

Versionen (1)
  1. 16.09.19 16.09.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. September 2019

DOI

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Lizenz

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

Englisch

Death Adjudication

1 Formulare  
  1. StudyEvent: ODM
    1. Death Adjudication
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beschreibung

Country No.

Datentyp

integer

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

Centre No.

Datentyp

integer

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

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Death Adjudication Form
Beschreibung

Death Adjudication Form

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

CRF page number

Datentyp

float

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

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Classification Status
Beschreibung

Classification Status

Alias
UMLS CUI-1
C0008902
Death Classification
Beschreibung

Death Classification

Datentyp

text

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

Death Comment

Datentyp

text

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

Adjudicators

Alias
UMLS CUI-1
C0401783
Adjudicator Signature 1
Beschreibung

Adjudicator Signature 1

Datentyp

text

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

Adjudicator Signature 2

Datentyp

text

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

Date of adjudication

Datentyp

text

Alias
UMLS CUI [1]
C4740194
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Ähnliche Modelle

Death Adjudication

1 Formulare
  1. StudyEvent: ODM
    1. Death Adjudication
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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