0 Évaluations

ID

3766

Description

ODM derived from http://clinicaltrials.gov/show/NCT01335399

Lien

http://clinicaltrials.gov/show/NCT01335399

Mots-clés

  1. 21/03/2013 21/03/2013 - Martin Dugas
Téléchargé le

21 mars 2013

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility NCT01335399 Multiple Myeloma

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Description

    Einschlusskriterien

    Alter mindestens 18 Jahre
    Description

    age at least 18 Years

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
    Description

    Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C2585997
    SNOMED CT 2011_0131
    441308009
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C0026764
    SNOMED CT 2011_0131
    109989006
    MedDRA 14.1
    10028228
    ICD-10-CM Version 2010
    C90.0
    ICD-9-CM Version 2011
    203.0
    have not received any prior systemic anti-myeloma therapy AND
    Description

    have not received any prior systemic anti-myeloma therapy AND

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1515119
    UMLS CUI 2011AA
    C0521124
    SNOMED CT 2011_0131
    65897001
    UMLS CUI 2011AA
    CL324441
    Measurable Disease
    Description

    have measurable disease AND

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1513041
    are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
    Description

    are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1555471
    HL7 V3 2006_05
    NELG
    UMLS CUI 2011AA
    C0444956
    SNOMED CT 2011_0131
    261829003
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0332287
    SNOMED CT 2011_0131
    20401003
    UMLS CUI 2011AA
    C1504389
    MedDRA 14.1
    10063581
    UMLS CUI 2011AA
    CL420107
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    UMLS CUI 2011AA
    C0243086
    Ausschlusskriterien
    Description

    Ausschlusskriterien

    Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
    Description

    Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0456845
    SNOMED CT 2011_0131
    277580004
    MedDRA 14.1
    10029662
    UMLS CUI 2011AA
    C0205251
    SNOMED CT 2011_0131
    62482003
    UMLS CUI 2011AA
    C0036536
    UMLS CUI 2011AA
    CL324441
    UMLS CUI 2011AA
    C0332296
    SNOMED CT 2011_0131
    37837009
    UMLS CUI 2011AA
    C0456844
    SNOMED CT 2011_0131
    277579002
    Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
    Description

    Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1531608
    SNOMED CT 2011_0131
    413587002
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C2585107
    SNOMED CT 2011_0131
    440422002
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0221204
    monoklonale Gammopathie unbestimmter Signifikanz (MGUS)
    Description

    Monoclonal Gammopathy of Undetermined Significance (MGUS)

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0026470
    SNOMED CT 2011_0131
    277577000
    MedDRA 14.1
    10027863
    ICD-10-CM Version 2010
    D47.2
    Active plasma cell leukemia
    Description

    Active plasma cell leukemia

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0023484
    SNOMED CT 2011_0131
    95210003
    MedDRA 14.1
    10035222
    ICD-10-CM Version 2010
    C90.1
    ICD-9-CM Version 2011
    203.1
    Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
    Description

    Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0856706
    MedDRA 14.1
    10019738
    UMLS CUI 2011AA
    C1112419
    MedDRA 14.1
    10057394
    UMLS CUI 2011AA
    C0019699
    SNOMED CT 2011_0131
    165816005
    MedDRA 14.1
    10020188
    ICD-10-CM Version 2010
    Z21

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Einschlusskriterien
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
    Item
    Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
    boolean
    C2585997 (UMLS CUI 2011AA)
    441308009 (SNOMED CT 2011_0131)
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C0026764 (UMLS CUI 2011AA)
    109989006 (SNOMED CT 2011_0131)
    10028228 (MedDRA 14.1)
    C90.0 (ICD-10-CM Version 2010)
    203.0 (ICD-9-CM Version 2011)
    have not received any prior systemic anti-myeloma therapy AND
    Item
    have not received any prior systemic anti-myeloma therapy AND
    boolean
    C1518422 (UMLS CUI 2011AA)
    C1514756 (UMLS CUI 2011AA)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1515119 (UMLS CUI 2011AA)
    C0521124 (UMLS CUI 2011AA)
    65897001 (SNOMED CT 2011_0131)
    CL324441 (UMLS CUI 2011AA)
    have measurable disease AND
    Item
    Measurable Disease
    boolean
    C1513041 (UMLS CUI 2011AA)
    are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
    Item
    are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
    boolean
    C1555471 (UMLS CUI 2011AA)
    NELG (HL7 V3 2006_05)
    C0444956 (UMLS CUI 2011AA)
    261829003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0332287 (UMLS CUI 2011AA)
    20401003 (SNOMED CT 2011_0131)
    C1504389 (UMLS CUI 2011AA)
    10063581 (MedDRA 14.1)
    CL420107 (UMLS CUI 2011AA)
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    C0243086 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
    Item
    Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
    boolean
    C0456845 (UMLS CUI 2011AA)
    277580004 (SNOMED CT 2011_0131)
    10029662 (MedDRA 14.1)
    C0205251 (UMLS CUI 2011AA)
    62482003 (SNOMED CT 2011_0131)
    C0036536 (UMLS CUI 2011AA)
    CL324441 (UMLS CUI 2011AA)
    C0332296 (UMLS CUI 2011AA)
    37837009 (SNOMED CT 2011_0131)
    C0456844 (UMLS CUI 2011AA)
    277579002 (SNOMED CT 2011_0131)
    Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
    Item
    Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
    boolean
    C1531608 (UMLS CUI 2011AA)
    413587002 (SNOMED CT 2011_0131)
    C1704788 (UMLS CUI 2011AA)
    C2585107 (UMLS CUI 2011AA)
    440422002 (SNOMED CT 2011_0131)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0221204 (UMLS CUI 2011AA)
    Monoclonal Gammopathy of Undetermined Significance (MGUS)
    Item
    monoklonale Gammopathie unbestimmter Signifikanz (MGUS)
    boolean
    C0026470 (UMLS CUI 2011AA)
    277577000 (SNOMED CT 2011_0131)
    10027863 (MedDRA 14.1)
    D47.2 (ICD-10-CM Version 2010)
    Active plasma cell leukemia
    Item
    Active plasma cell leukemia
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0023484 (UMLS CUI 2011AA)
    95210003 (SNOMED CT 2011_0131)
    10035222 (MedDRA 14.1)
    C90.1 (ICD-10-CM Version 2010)
    203.1 (ICD-9-CM Version 2011)
    Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
    Item
    Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
    boolean
    C0856706 (UMLS CUI 2011AA)
    10019738 (MedDRA 14.1)
    C1112419 (UMLS CUI 2011AA)
    10057394 (MedDRA 14.1)
    C0019699 (UMLS CUI 2011AA)
    165816005 (SNOMED CT 2011_0131)
    10020188 (MedDRA 14.1)
    Z21 (ICD-10-CM Version 2010)

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