ID

41987

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 serious adverse events, and is to be filled in as necessary during the study, in addition to the AE form, and consists of a complimentary part and a follow-up part.

Link

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

Keywords

Versions (2)
  1. 10/17/19 10/17/19 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2021

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

Serious Adverse Event

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Event
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
AE form No.
Description

The AE Form number from the A.E. form must be reported on the SAE complementary Form.

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0600091
Demographic Information
Description

Demographic Information

Alias
UMLS CUI-1
C1704791
Date of Birth
Description

Record Date of Birth or Age

Data type

date

Alias
UMLS CUI [1]
C0421451
Age
Description

Record Date of Birth or Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Detailed Description
Description

Detailed Description

Alias
UMLS CUI-1
C0678257
Detailed Description
Description

including complementary investigations Report the AE form verbatim (AE diagnosis) and give complete and detailed description and circumstances of the event. If relevant, give results of complementary investigation, laboratory tests, etc.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Study Drug
Description

Study Drug

Alias
UMLS CUI-1
C0304229
Treatment number
Description

Treatment number

Data type

integer

Alias
UMLS CUI [1]
C1522541
Date and time of the FIRST administration of Study Drug
Description

Date/Time first administration of study drug

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3899436
Date and time of the LAST administration of Study Drug prior to the event
Description

Date/Time last administration of study drug before SAE

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3899434
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C1519255
Study drug ongoing (at the time of report)
Description

If No, provide a copy of the end of treatment form

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0549178
In Case of Hospitalization
Description

In Case of Hospitalization

Alias
UMLS CUI-1
C0019993
Date of admission
Description

hospital report to be sent

Data type

date

Alias
UMLS CUI [1]
C1302393
In Case of Death
Description

In Case of Death

Alias
UMLS CUI-1
C0011065
Autopsy report
Description

If yes, provide copy

Data type

boolean

Alias
UMLS CUI [1]
C1548372
Previous and Concomitant Medication
Description

Previous and Concomitant Medication

Alias
UMLS CUI-1
C0205156
UMLS CUI-2
C0013227
UMLS CUI-3
C2347852
Previous and Concomitant Medication
Description

if yes, provide copy of appropriate forms

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C2347852
Medical History and Concomitant Disease
Description

Medical History and Concomitant Disease

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0243087
Medical History and Concomitant Disease
Description

if yes, provide copy of appropriate forms

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0243087
SAE Follow-Up Information Form
Description

SAE Follow-Up Information Form

Alias
UMLS CUI-1
C1533716
UMLS CUI-2
C1519255
UMLS CUI-3
C1522577
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Date of Evaluation
Description

Date of Evaluation

Data type

date

Alias
UMLS CUI [1]
C2985720
Additional information and Comments
Description

Additional information and Comments

Data type

text

Alias
UMLS CUI [1]
C1546922
UMLS CUI [2]
C0947611
Investigator & Monitor
Description

Investigator & Monitor

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1708968
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of report
Description

Date of report

Data type

date

Alias
UMLS CUI [1]
C1302584
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Monitor's name
Description

Monitor's name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Monitor date of receipt
Description

Monitor date of receipt

Data type

date

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C1708968
PV corporate date of receipt
Description

PV date of receipt

Data type

date

Alias
UMLS CUI [1,1]
C3178990
UMLS CUI [1,2]
C2985846
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Similar models

Serious Adverse Event

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Event
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])
AE form number
Item
AE form No.
integer
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Demographic Information
C1704791 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Caucasian (Caucasian)
CL Item
Black (Black)
CL Item
Asian, Oriental (Asian, Oriental)
CL Item
Other (Other)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Detailed Description
C0678257 (UMLS CUI-1)
SAE Description
Item
Detailed Description
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Study Drug
C0304229 (UMLS CUI-1)
Treatment number
Item
Treatment number
integer
C1522541 (UMLS CUI [1])
Date/Time first administration of study drug
Item
Date and time of the FIRST administration of Study Drug
datetime
C0304229 (UMLS CUI [1,1])
C3899436 (UMLS CUI [1,2])
Date/Time last administration of study drug before SAE
Item
Date and time of the LAST administration of Study Drug prior to the event
datetime
C0304229 (UMLS CUI [1,1])
C3899434 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Study drug ongoing
Item
Study drug ongoing (at the time of report)
boolean
C0304229 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
In Case of Hospitalization
C0019993 (UMLS CUI-1)
Date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
Item Group
In Case of Death
C0011065 (UMLS CUI-1)
Autopsy report
Item
Autopsy report
boolean
C1548372 (UMLS CUI [1])
Item Group
Previous and Concomitant Medication
C0205156 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
Previous and Concomitant Medication
Item
Previous and Concomitant Medication
boolean
C0205156 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item Group
Medical History and Concomitant Disease
C0262926 (UMLS CUI-1)
C0243087 (UMLS CUI-2)
Medical History and Concomitant Disease
Item
Medical History and Concomitant Disease
boolean
C0262926 (UMLS CUI [1])
C0243087 (UMLS CUI [2])
Item Group
SAE Follow-Up Information Form
C1533716 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Date of Evaluation
Item
Date of Evaluation
date
C2985720 (UMLS CUI [1])
Additional information and Comments
Item
Additional information and Comments
text
C1546922 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Item Group
Investigator & Monitor
C0008961 (UMLS CUI-1)
C1708968 (UMLS CUI-2)
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Monitor's name
Item
Monitor's name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Monitor date of receipt
Item
Monitor date of receipt
date
C2985846 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
PV date of receipt
Item
PV corporate date of receipt
date
C3178990 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
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