ID

4437

Description

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study).

Mots-clés

  1. 09/12/2013 09/12/2013 - Martin Dugas
Téléchargé le

9 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00439725 Deep Vein Thrombosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Age
Description

Age

Type de données

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
Description

Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban

Type de données

boolean

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
UMLS CUI
C1096489
MDR
10053755
UMLS CUI
C1739768
SNOMED CT 2010_0731
442031002
Ausschlusskriterien
Description

Ausschlusskriterien

Legal lower age limitations (country specific)
Description

Legal lower age limitations (country specific)

Type de données

boolean

Alias
UMLS CUI
C0680135
UMLS CUI
C0682055
Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
Description

Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis

Type de données

boolean

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
UMLS CUI
C1096489
MDR
10053755
Anticoagulation treatment should be continued
Description

Anticoagulation treatment should be continued

Type de données

boolean

Alias
UMLS CUI
C0150457
MDR
10053468
SNOMED CT 2010_0731
182764009
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
No contraception, No pregnancy or breast feeding
Description

No contraception, No pregnancy or breast feeding

Type de données

boolean

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Medizinische Konzepte
Description

Medizinische Konzepte

Age
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Pulmonary Embolism
Description

Pulmonary Embolism

Type de données

string

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
Deep Vein Thrombosis
Description

Deep Vein Thrombosis

Type de données

string

Alias
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
Vitamin K antagonist
Description

Vitamin K antagonist

Type de données

string

Alias
UMLS CUI
C1096489
MDR
10053755
Rivaroxaban
Description

Rivaroxaban

Type de données

string

Alias
UMLS CUI
C1739768
SNOMED CT 2010_0731
442031002
age restriction in context
Description

age restriction in context

Type de données

string

Alias
UMLS CUI
C0680135
age subdivision of legal significance
Description

age subdivision of legal significance

Type de données

string

Alias
UMLS CUI
C0682055
Anticoagulant therapy
Description

Anticoagulant therapy

Type de données

string

Alias
UMLS CUI
C0150457
MDR
10053468
SNOMED CT 2010_0731
182764009
Contraceptive methods
Description

Contraceptive methods

Type de données

string

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Patient currently pregnant
Description

Patient currently pregnant

Type de données

string

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
Breast Feeding
Description

Breast Feeding

Type de données

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
Age
Item
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
Item
boolean
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C1096489 (UMLS CUI)
10053755 (MDR)
C1739768 (UMLS CUI)
442031002 (SNOMED CT 2010_0731)
Item Group
Ausschlusskriterien
Legal lower age limitations (country specific)
Item
boolean
C0680135 (UMLS CUI)
C0682055 (UMLS CUI)
Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
Item
boolean
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C1096489 (UMLS CUI)
10053755 (MDR)
Anticoagulation treatment should be continued
Item
boolean
C0150457 (UMLS CUI)
10053468 (MDR)
182764009 (SNOMED CT 2010_0731)
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
No contraception, No pregnancy or breast feeding
Item
boolean
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
Item Group
Medizinische Konzepte
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Pulmonary Embolism
Item
string
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
Deep Vein Thrombosis
Item
string
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
Vitamin K antagonist
Item
string
C1096489 (UMLS CUI)
10053755 (MDR)
Rivaroxaban
Item
string
C1739768 (UMLS CUI)
442031002 (SNOMED CT 2010_0731)
age restriction in context
Item
string
C0680135 (UMLS CUI)
age subdivision of legal significance
Item
string
C0682055 (UMLS CUI)
Anticoagulant therapy
Item
string
C0150457 (UMLS CUI)
10053468 (MDR)
182764009 (SNOMED CT 2010_0731)
Contraceptive methods
Item
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Patient currently pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
Breast Feeding
Item
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)

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