ID

38421

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 prior, concomitant and follow-up medication, and is to be filled in repeatedly starting one week prior to study start up to the end of the follow-up period.

Link

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

Stichworte

Versionen (1)
  1. 17.10.19 17.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Oktober 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

Medication Record

1 Formulare  
  1. StudyEvent: ODM
    1. Medication Record
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
None
Beschreibung

If no concomitant medication, skip the rest of the form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0549184
Concomitant Medication Record
Beschreibung

Concomitant Medication Record

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose/Units
Beschreibung

Concomitant Agent Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2826638
Route
Beschreibung

Concomitant Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Prior
Beschreibung

Prior Medication- Recording is limited to treatment with anti-platelet agents, anticoagulant agents, fibrinolytics starting within 1 week prior to first dose.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2826667
UMLS CUI [1,3]
C2963157
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C2826667
UMLS CUI [2,3]
C0003280
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C2826667
UMLS CUI [3,3]
C0016018
After
Beschreibung

Follow-up Medication- Recording limited to treatment with anti-platelet-agents, anti-coagulant-agents, fibrinolytics and medication given as corrective treatment foradverse events, starting with the day after the last dose of study drug or the day of venography, whichever occurs last, to the end of the follow-up period.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C2963157
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2347804
UMLS CUI [2,4]
C0003280
UMLS CUI [3,1]
C2347852
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C2347804
UMLS CUI [3,4]
C0016018
UMLS CUI [4,1]
C2347852
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C2347804
UMLS CUI [4,4]
C0392360
UMLS CUI [4,5]
C0877248
Duration Dates: Start
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Duration Dates: End
Beschreibung

Concomitant Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing at the end of the study
Beschreibung

Ongoing Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Indication
Beschreibung

Concomitant Medication Indication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
AE form number
Beschreibung

AE form number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0600091
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Ähnliche Modelle

Medication Record

1 Formulare
  1. StudyEvent: ODM
    1. Medication Record
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])
No Concomitant Medication
Item
None
boolean
C2347852 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item Group
Concomitant Medication Record
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Concomitant Agent Total Daily Dose
Item
Total Daily Dose/Units
text
C2826638 (UMLS CUI [1])
Concomitant Medication Route
Item
Route
text
C2826730 (UMLS CUI [1])
Recent prior concomitant medication (Anti-platelet agents, anticoagulants, fibrinolytics)
Item
Prior
boolean
C0332185 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
C2963157 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C2826667 (UMLS CUI [2,2])
C0003280 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C2826667 (UMLS CUI [3,2])
C0016018 (UMLS CUI [3,3])
Concomitant medication (anti-platelet agents, anti-coagulants, fibrinolytics or drugs for AEs) taken after study
Item
After
boolean
C2347852 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C2963157 (UMLS CUI [1,4])
C2347852 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0003280 (UMLS CUI [2,4])
C2347852 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C2347804 (UMLS CUI [3,3])
C0016018 (UMLS CUI [3,4])
C2347852 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C2347804 (UMLS CUI [4,3])
C0392360 (UMLS CUI [4,4])
C0877248 (UMLS CUI [4,5])
Concomitant Medication Start Date
Item
Duration Dates: Start
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Duration Dates: End
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing Concomitant Medication
Item
Ongoing at the end of the study
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication Indication
Item
Indication
text
C2826696 (UMLS CUI [1])
AE form number
Item
AE form number
integer
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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