ID

38349

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 end of treatment and is to be filled in on Day 9 (or earlier if the treatment has been stopped earlier), which belongs to Visit 2.

Link

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

Keywords

Versions (2)
  1. 9/16/19 9/16/19 -
  2. 10/11/19 10/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 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

End of Treatment

1 forms  
  1. StudyEvent: ODM
    1. End of Treatment
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
End of Treatment
Description

End of Treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0444930
Date of last administration
Description

Date of last administration

Data type

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1533734
Main reason for stopping treatment
Description

Select lack of efficacy in case of suspicion of DVT and/or PE, even if not confirmed, and complete appropriate forms. For Adverse Events, complete AE/SAE forms as well as Bleeding or Death Forms, if appropriate. Specify other main reason in next item.

Data type

integer

Alias
UMLS CUI [1,1]
C1542147
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0444930
Specify other main reason for stopping treatment
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C3840932
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0444930
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

End of Treatment

1 forms
  1. StudyEvent: ODM
    1. End of Treatment
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
End of Treatment
C0087111 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of last administration
Item
Date of last administration
date
C1762893 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Item
Main reason for stopping treatment
integer
C1542147 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
Main reason for stopping treatment
Code List
Main reason for stopping treatment
CL Item
Completed study treatment period (1)
CL Item
Lack of efficacy (2)
CL Item
Adverse event (3)
CL Item
Poor compliance to protocol (4)
CL Item
Subject's request (5)
CL Item
Subject lost to follow-up (6)
CL Item
Other reason (7)
Specify other main reason for stopping treatment
Item
Specify other main reason for stopping treatment
text
C1521902 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0444930 (UMLS CUI [1,5])
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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