ID

38421

Descrizione

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.

collegamento

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

Keywords

versioni (1)
  1. 17/10/19 17/10/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

17 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Medication Record

1 moduli  
  1. StudyEvent: ODM
    1. Medication Record
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Descrizione

Country No.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Inclusion Criteria
Descrizione

Inclusion Criteria

age at least 18 Years
Descrizione

age at least 18 Years

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
Descrizione

End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1261469
SNOMED CT 2011_0131
46177005
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0597409
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0745777
UMLS CUI 2011AA
C0018129
SNOMED CT 2011_0131
72627004
MedDRA 14.1
10044439
Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
Descrizione

Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0401176
SNOMED CT 2011_0131
175902000
UMLS CUI 2011AA
C0401177
SNOMED CT 2011_0131
175901007
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0344389
SNOMED CT 2011_0131
112143006
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
Descrizione

Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C1516879
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Descrizione

Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
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Medication Record

1 moduli
  1. StudyEvent: ODM
    1. Medication Record
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
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End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
boolean
C1261469 (UMLS CUI 2011AA)
46177005 (SNOMED CT 2011_0131)
585.6 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
CL414904 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0597409 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0745777 (UMLS CUI 2011AA)
C0018129 (UMLS CUI 2011AA)
72627004 (SNOMED CT 2011_0131)
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Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
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Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
boolean
C1514756 (UMLS CUI 2011AA)
C0401176 (UMLS CUI 2011AA)
175902000 (SNOMED CT 2011_0131)
C0401177 (UMLS CUI 2011AA)
175901007 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0344389 (UMLS CUI 2011AA)
112143006 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
Item
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Item
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
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C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
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