ID

38390

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 whether and when the study drug has been given, and is to be filled in from Day 1 (Visit 1) possibly up to Day 9 (Visit 2), as well as the Randomization/Treatment Assignment, which is applicable to Day 1 (Visit 1) only (prior to the first injection).

Link

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

Keywords

Versions (1)
  1. 10/15/19 10/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 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

Study Drug Dosing and Treatment Assignment

1 forms  
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
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Study Drug Dosing
Description

Study Drug Dosing

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C0304229
Was study drug given?
Description

If no, specify reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1533734
Specify reason study drug not given
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1533734
UMLS CUI [1,5]
C1272696
Study Drug Dosing - per Day
Description

Study Drug Dosing - per Day

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C0304229
UMLS CUI-3
C2826182
Study Day
Description

Fill in entire itemgroup for each Day. Note: Day 1 = day of anesthesia induction The first post-operative dose will be 6 hours following surgical closure provided that hemostasis is achieved.Timing of the first post-operative injection of study drug requires strict adherence in patients ≥ 75years, and/or with a body weight < 50 kg and/or a creatinine clearance (cockroft formula) < 50 mLper minute. In these patients the first injection of study drug should be more than 6 hours after surgical closure.The first injection must be performed at least 4 hours after removing of indwelling intrathecal or epidural catheter.The second study drug injection will be 16 to 28 hours after the first injection.The third injection and the following will be once daily at 8:00 a.m. ±2.

Data type

integer

Alias
UMLS CUI [1]
C2826182
Dosing of study drug not done?
Description

If no, give date/time of dose in next item; if yes, specify reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C1272696
Date and Time of Dosing
Description

Select either "Not done" in previous item or give date/time of dose. The first post-operative dose will be 6 hours following surgical closure provided that hemostasis is achieved.Timing of the first post-operative injection of study drug requires strict adherence in patients ≥ 75years, and/or with a body weight < 50 kg and/or a creatinine clearance (cockroft formula) < 50 mLper minute. In these patients the first injection of study drug should be more than 6 hours after surgical closure.The first injection must be performed at least 4 hours after removing of indwelling intrathecal or epidural catheter.The second study drug injection will be 16 to 28 hours after the first injection.The third injection and the following will be once daily at 8:00 a.m. ±2.

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0304229
Treatment Number
Description

Must be completed only once, but, in case of error in treatment allocation, it must be recorded for each Day.

Data type

integer

Alias
UMLS CUI [1]
C1522541
Indicate reason if dosing not done or outside time window
Description

Reason dosing not done or outside requested time

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0678766
UMLS CUI [1,4]
C1272696
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C0678766
UMLS CUI [2,4]
C3242146
Treatment Assignment
Description

Treatment Assignment

Alias
UMLS CUI-1
C1522541
Date of randomization
Description

Date of randomization

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Local time of randomization
Description

Time of randomization

Data type

time

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0040223
Treatment Number
Description

Treatment Number

Data type

integer

Alias
UMLS CUI [1]
C1522541
Place Drug Label Here
Description

Drug Label

Data type

text

Alias
UMLS CUI [1]
C0013191
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Similar models

Study Drug Dosing and Treatment Assignment

1 forms
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])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Drug Dosing
C0678766 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Study drug given?
Item
Was study drug given?
boolean
C0304229 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Specify reason study drug not given
Item
Specify reason study drug not given
text
C1521902 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C1272696 (UMLS CUI [1,5])
Item Group
Study Drug Dosing - per Day
C0678766 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C2826182 (UMLS CUI-3)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 1 (Post Op) (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Day 7 (7)
CL Item
Day 8 (8)
CL Item
Day 9 (9)
CL Item
Extra-Injection (10)
Dosing of study drug not done?
Item
Dosing of study drug not done?
boolean
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Date and Time of Dosing
Item
Date and Time of Dosing
datetime
C1264639 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1])
Reason dosing not done or outside requested time
Item
Indicate reason if dosing not done or outside time window
text
C0566251 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0566251 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C3242146 (UMLS CUI [2,4])
Item Group
Treatment Assignment
C1522541 (UMLS CUI-1)
Date of randomization
Item
Date of randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of randomization
Item
Local time of randomization
time
C0034656 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1])
Drug Label
Item
Place Drug Label Here
text
C0013191 (UMLS CUI [1])
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