ID

4437

Beschreibung

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).

Stichworte

Versionen (1)
  1. 09.12.13 09.12.13 - Martin Dugas
Hochgeladen am

9. Dezember 2013

DOI

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00439725 Deep Vein Thrombosis

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschreibung

Inclusion criteria

18 Years and older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Beschreibung

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

Datentyp

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
Exclusion criteria
Beschreibung

Exclusion criteria

Legal lower age limitations (country specific)
Beschreibung

Legal lower age limitations (country specific)

Datentyp

boolean

Alias
UMLS CUI
C0680135
UMLS CUI
C0682055
Indication for VKA other than DVT and/or PE
Beschreibung

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

Datentyp

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
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Beschreibung

Anticoagulation treatment should be continued

Datentyp

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
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Beschreibung

No contraception, No pregnancy or breast feeding

Datentyp

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
Medical Concepts
Beschreibung

Medical Concepts

Age
Beschreibung

Age

Datentyp

string

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

Pulmonary Embolism

Datentyp

string

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

Deep Vein Thrombosis

Datentyp

string

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

Vitamin K antagonist

Datentyp

string

Alias
UMLS CUI
C1096489
MDR
10053755
Rivaroxaban
Beschreibung

Rivaroxaban

Datentyp

string

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

age restriction in context

Datentyp

string

Alias
UMLS CUI
C0680135
age subdivision of legal significance
Beschreibung

age subdivision of legal significance

Datentyp

string

Alias
UMLS CUI
C0682055
Anticoagulant therapy
Beschreibung

Anticoagulant therapy

Datentyp

string

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

Contraceptive methods

Datentyp

string

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

Patient currently pregnant

Datentyp

string

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

Breast Feeding

Datentyp

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria
Age
Item
18 Years and older
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
Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
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
Exclusion criteria
Legal lower age limitations (country specific)
Item
Legal lower age limitations (country specific)
boolean
C0680135 (UMLS CUI)
C0682055 (UMLS CUI)
Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
Item
Indication for VKA other than DVT and/or PE
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
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
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
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
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
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Pulmonary Embolism
Item
Pulmonary Embolism
string
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
string
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
Vitamin K antagonist
Item
Vitamin K antagonist
string
C1096489 (UMLS CUI)
10053755 (MDR)
Rivaroxaban
Item
Rivaroxaban
string
C1739768 (UMLS CUI)
442031002 (SNOMED CT 2010_0731)
age restriction in context
Item
age restriction in context
string
C0680135 (UMLS CUI)
age subdivision of legal significance
Item
age subdivision of legal significance
string
C0682055 (UMLS CUI)
Anticoagulant therapy
Item
Anticoagulant therapy
string
C0150457 (UMLS CUI)
10053468 (MDR)
182764009 (SNOMED CT 2010_0731)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Patient currently pregnant
Item
Patient currently pregnant
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
Breast Feeding
Item
Breast Feeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
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