ID

38426

Beschrijving

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 bleeding event, information on which is recorded in a seperate form.

Link

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

Trefwoorden

Versies (1)
  1. 17.10.19 17.10.19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17. Oktober 2019

DOI

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Licentie

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

Engels

Bleeding Adjudication

1 Formulieren  
  1. StudyEvent: ODM
    1. Bleeding Adjudication
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beschrijving

Country No.

Datatype

integer

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

Centre No.

Datatype

integer

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

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschrijving

Subject Initials

Datatype

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Bleeding Event Adjudication Form
Beschrijving

Bleeding Event Adjudication Form

Alias
UMLS CUI-1
C0680730
UMLS CUI-2
C0019080
CRF page number
Beschrijving

CRF page number

Datatype

float

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Date of onset
Beschrijving

Date of bleeding onset

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0019080
Adverse event reference number(s)
Beschrijving

Adverse event reference number(s)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0600091
Adverse event reference number
Beschrijving

Adverse event reference number

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0600091
This is the main AE reference number
Beschrijving

(only applicable if more than AE reference No. recorded)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1542147
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0877248
Provide a response to each of the following bleeding criteria:
Beschrijving

Provide a response to each of the following bleeding criteria:

Alias
UMLS CUI-1
C0019080
UMLS CUI-2
C0243161
Clinically overt
Beschrijving

Bleeding clinically overt?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205379
Non-surgical site bleeding at a critical site
Beschrijving

If yes, select locations in next 6 items.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1511545
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C1705847
UMLS CUI [1,5]
C0741556
Intracranial bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1]
C0151699
Retroperitoneal bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1]
C0151705
Intraocular bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1]
C0015402
Spinal bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1]
C0018949
Pericardial bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1]
C0019064
Adrenal glands bleeding
Beschrijving

Only applicable if non-surgical site bleeding at a critical site

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001625
UMLS CUI [1,2]
C0019080
Non-surgical site bleeding leading to an intervention
Beschrijving

Non-surgical site bleeding leading to intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0741556
Non-surgical site bleeding with a bleeding index ≥2.0
Beschrijving

Bleeding index = hemoglobin decrease (value determined before and after the bleeding episode) + number of units transfused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1709793
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0741556
Surgical bleeding leading to an intervention
Beschrijving

Surgical bleeding leading to intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C0741556
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0184661
Fatal bleed
Beschrijving

Fatal bleed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1302234
Classification Status
Beschrijving

Classification Status

Alias
UMLS CUI-1
C0008902
UMLS CUI-2
C0680730
UMLS CUI-3
C1274040
Bleeding Classification
Beschrijving

Bleeding Classification

Datatype

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0008902
Comment
Beschrijving

Bleeding Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0019080
Adjudicators
Beschrijving

Adjudicators

Alias
UMLS CUI-1
C0401783
Adjudicator Signature 1
Beschrijving

Adjudicator Signature 1

Datatype

text

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

Adjudicator Signature 2

Datatype

text

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

Date of adjudication

Datatype

text

Alias
UMLS CUI [1]
C4740194
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Similar models

Bleeding Adjudication

1 Formulieren
  1. StudyEvent: ODM
    1. Bleeding Adjudication
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Bleeding Event Adjudication Form
C0680730 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
CRF page number
Item
CRF page number
float
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Date of bleeding onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Item Group
Adverse event reference number(s)
C0877248 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
Adverse event reference number
Item
Adverse event reference number
integer
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Main AE reference number?
Item
This is the main AE reference number
boolean
C1542147 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Item Group
Provide a response to each of the following bleeding criteria:
C0019080 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Bleeding clinically overt?
Item
Clinically overt
boolean
C0019080 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
Non-surgical site bleeding at critical site?
Item
Non-surgical site bleeding at a critical site
boolean
C0019080 (UMLS CUI [1,1])
C1511545 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
C0741556 (UMLS CUI [1,5])
Intracranial bleeding
Item
Intracranial bleeding
boolean
C0151699 (UMLS CUI [1])
Retroperitoneal bleeding
Item
Retroperitoneal bleeding
boolean
C0151705 (UMLS CUI [1])
Intraocular bleeding
Item
Intraocular bleeding
boolean
C0015402 (UMLS CUI [1])
Spinal bleeding
Item
Spinal bleeding
boolean
C0018949 (UMLS CUI [1])
Pericardial bleeding
Item
Pericardial bleeding
boolean
C0019064 (UMLS CUI [1])
Adrenal glands bleeding
Item
Adrenal glands bleeding
boolean
C0001625 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Non-surgical site bleeding leading to intervention
Item
Non-surgical site bleeding leading to an intervention
boolean
C0019080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0741556 (UMLS CUI [2,2])
Non-surgical site bleeding by bleeding index
Item
Non-surgical site bleeding with a bleeding index ≥2.0
boolean
C0019080 (UMLS CUI [1,1])
C1709793 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0741556 (UMLS CUI [2,2])
Surgical bleeding leading to intervention
Item
Surgical bleeding leading to an intervention
boolean
C0741556 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Fatal bleed
Item
Fatal bleed
boolean
C0019080 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
Item Group
Classification Status
C0008902 (UMLS CUI-1)
C0680730 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Item
Bleeding Classification
text
C0019080 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Bleeding Classification
Code List
Bleeding Classification
CL Item
Major Bleed (Major Bleed)
CL Item
Minor Bleed (Minor Bleed)
CL Item
Criteria for Bleeding event not satisfied (Criteria for Bleeding event not satisfied)
Bleeding Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0019080 (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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