0 Evaluaciones
ID

43500

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00876031

Link

http://clinicaltrials.gov/show/NCT00876031

Palabras clave

Versiones (3)
  1. 9/12/13 9/12/13 - Martin Dugas
  2. 17/4/14 17/4/14 - Julian Varghese
  3. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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    Eligibility NCT00876031 Soft Tissue Sarcoma

    Alemán Inglés

    Eligibility

    1 formularios  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descripción

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter 6 Monate bis 21 Jahre
    Descripción

    age 6 Months to 21 Years

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
    Descripción

    written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
    Descripción

    pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1521733
    SNOMED CT 2011_0131
    29458008
    UMLS CUI 2011AA
    C1979599
    LOINC Version 232
    MTHU000098
    UMLS CUI 2011AA
    C0456369
    SNOMED CT 2011_0131
    277025001
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C2348205
    UMLS CUI 2011AA
    CL353068
    SNOMED CT 2011_0131
    2424003
    Rhabdomyosarcoma of the High Risk Group, i.e.:
    Descripción

    Rhabdomyosarcoma of the High Risk Group, i.e.:

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C0332167
    SNOMED CT 2011_0131
    15508007
    UMLS CUI 2011AA
    CL415249
    HL7 V3 2006_05
    RGRP
    RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
    Descripción

    RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0206656
    SNOMED CT 2011_0131
    404051002
    MedDRA 14.1
    10065868
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C0441959
    SNOMED CT 2011_0131
    62455006
    UMLS CUI 2011AA
    C0445034
    SNOMED CT 2011_0131
    30893008
    UMLS CUI 2011AA
    C1320617
    SNOMED CT 2011_0131
    405916000
    UMLS CUI 2011AA
    C0439069
    SNOMED CT 2011_0131
    257470002
    UMLS CUI 2011AA
    C0439070
    SNOMED CT 2011_0131
    257471003
    RME, N1, M0, any IRS-group, any size or age
    Descripción

    RME, N1, M0, any IRS-group, any size or age

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0206656
    SNOMED CT 2011_0131
    404051002
    MedDRA 14.1
    10065868
    UMLS CUI 2011AA
    C0441962
    SNOMED CT 2011_0131
    53623008
    UMLS CUI 2011AA
    C0445034
    SNOMED CT 2011_0131
    30893008
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C1320617
    SNOMED CT 2011_0131
    405916000
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C0456389
    SNOMED CT 2011_0131
    246115007
    LOINC Version 232
    MTHU010347
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
    Descripción

    RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0206655
    SNOMED CT 2011_0131
    404053004
    MedDRA 14.1
    10065867
    UMLS CUI 2011AA
    C0441959
    SNOMED CT 2011_0131
    62455006
    UMLS CUI 2011AA
    C0445034
    SNOMED CT 2011_0131
    30893008
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C1320617
    SNOMED CT 2011_0131
    405916000
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C0456389
    SNOMED CT 2011_0131
    246115007
    LOINC Version 232
    MTHU010347
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C1562297
    SNOMED CT 2011_0131
    415990002
    UMLS CUI 2011AA
    C0206655
    SNOMED CT 2011_0131
    404053004
    MedDRA 14.1
    10065867
    Rhabdomyosarcoma of the Very High Risk Group, i.e.:
    Descripción

    Rhabdomyosarcoma of the Very High Risk Group, i.e.:

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C0442824
    SNOMED CT 2011_0131
    260358002
    UMLS CUI 2011AA
    C0332167
    SNOMED CT 2011_0131
    15508007
    UMLS CUI 2011AA
    CL415249
    HL7 V3 2006_05
    RGRP
    RMA, N1, MO, IRS II&III, any size or age or
    Descripción

    RMA, N1, MO, IRS II&III, any size or age or

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0206655
    SNOMED CT 2011_0131
    404053004
    MedDRA 14.1
    10065867
    UMLS CUI 2011AA
    C0441962
    SNOMED CT 2011_0131
    53623008
    UMLS CUI 2011AA
    C0445034
    SNOMED CT 2011_0131
    30893008
    UMLS CUI 2011AA
    C1320617
    SNOMED CT 2011_0131
    405916000
    UMLS CUI 2011AA
    C0439069
    SNOMED CT 2011_0131
    257470002
    UMLS CUI 2011AA
    C0439070
    SNOMED CT 2011_0131
    257471003
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C0456389
    SNOMED CT 2011_0131
    246115007
    LOINC Version 232
    MTHU010347
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
    Descripción

    localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0392752
    SNOMED CT 2011_0131
    255471002
    UMLS CUI 2011AA
    C0332167
    SNOMED CT 2011_0131
    15508007
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C2348205
    UMLS CUI 2011AA
    CL353068
    SNOMED CT 2011_0131
    2424003
    EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
    Descripción

    EES, pPNET, UDS: any N, M0, any IRS-group, any size or age

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0279980
    MedDRA 14.1
    10015759
    UMLS CUI 2011AA
    C0206663
    SNOMED CT 2011_0131
    39781001
    MedDRA 14.1
    10057846
    UMLS CUI 2011AA
    CL364379
    Synovial(is)sarkom
    Descripción

    SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0039101
    SNOMED CT 2011_0131
    63211008
    MedDRA 14.1
    10042863
    no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
    Descripción

    no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C2347662
    UMLS CUI 2011AA
    C0221423
    SNOMED CT 2011_0131
    39104002
    MedDRA 14.1
    10040658
    ICD-10-CM Version 2010
    R69
    UMLS CUI 2011AA
    CL414898
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1522601
    UMLS CUI 2011AA
    C0311400
    UMLS CUI 2011AA
    C0277785
    SNOMED CT 2011_0131
    386585008
    UMLS CUI 2011AA
    C0086565
    SNOMED CT 2011_0131
    75183008
    MedDRA 14.1
    10019670
    UMLS CUI 2011AA
    C0151746
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    no previous malignant tumours
    Descripción

    no previous malignant tumours

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    available for long term follow up through the treating centre
    Descripción

    available for long term follow up through the treating centre

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0470187
    SNOMED CT 2011_0131
    103328004
    UMLS CUI 2011AA
    C1517942
    in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
    Descripción

    in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0544452
    SNOMED CT 2011_0131
    277022003
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0034656
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    C2828392
    UMLS CUI 2011AA
    C0009429
    Ausschlusskriterien
    Descripción

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    pregnant or lactating women
    Descripción

    pregnant or lactating women

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C2828358
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
    Descripción

    other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C2348563
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0019682
    SNOMED CT 2011_0131
    19030005
    UMLS CUI 2011AA
    C0004936
    SNOMED CT 2011_0131
    74732009
    MedDRA 14.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
    Descripción

    for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0241028
    SNOMED CT 2011_0131
    228453005
    MedDRA 14.1
    10066098
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C1527415
    SNOMED CT 2011_0131
    26643006
    HL7 V3 2006_05
    _OralRoute
    UMLS CUI 2011AA
    C0077375
    UMLS CUI 2011AA
    C0020789
    SNOMED CT 2011_0131
    372539000
    UMLS CUI 2011AA
    C0015133
    SNOMED CT 2011_0131
    56928005
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1705116
    SNOMED CT 2011_0131
    443390004
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0009905
    SNOMED CT 2011_0131
    59261009
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
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    Similar models

    Eligibility

    1 formularios
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age 6 Months to 21 Years
    Item
    Alter 6 Monate bis 21 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
    Item
    written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
    boolean
    C0021430 (UMLS CUI 2011AA)
    pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
    Item
    pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
    boolean
    C1521733 (UMLS CUI 2011AA)
    29458008 (SNOMED CT 2011_0131)
    C1979599 (UMLS CUI 2011AA)
    MTHU000098 (LOINC Version 232)
    C0456369 (UMLS CUI 2011AA)
    277025001 (SNOMED CT 2011_0131)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0035412 (UMLS CUI 2011AA)
    302847003 (SNOMED CT 2011_0131)
    10039022 (MedDRA 14.1)
    C2348205 (UMLS CUI 2011AA)
    CL353068 (UMLS CUI 2011AA)
    2424003 (SNOMED CT 2011_0131)
    Rhabdomyosarcoma of the High Risk Group, i.e.:
    Item
    Rhabdomyosarcoma of the High Risk Group, i.e.:
    boolean
    C0035412 (UMLS CUI 2011AA)
    302847003 (SNOMED CT 2011_0131)
    10039022 (MedDRA 14.1)
    C0332167 (UMLS CUI 2011AA)
    15508007 (SNOMED CT 2011_0131)
    CL415249 (UMLS CUI 2011AA)
    RGRP (HL7 V3 2006_05)
    RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
    Item
    RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
    boolean
    C0206656 (UMLS CUI 2011AA)
    404051002 (SNOMED CT 2011_0131)
    10065868 (MedDRA 14.1)
    C0035412 (UMLS CUI 2011AA)
    302847003 (SNOMED CT 2011_0131)
    10039022 (MedDRA 14.1)
    C0441959 (UMLS CUI 2011AA)
    62455006 (SNOMED CT 2011_0131)
    C0445034 (UMLS CUI 2011AA)
    30893008 (SNOMED CT 2011_0131)
    C1320617 (UMLS CUI 2011AA)
    405916000 (SNOMED CT 2011_0131)
    C0439069 (UMLS CUI 2011AA)
    257470002 (SNOMED CT 2011_0131)
    C0439070 (UMLS CUI 2011AA)
    257471003 (SNOMED CT 2011_0131)
    RME, N1, M0, any IRS-group, any size or age
    Item
    RME, N1, M0, any IRS-group, any size or age
    boolean
    C0206656 (UMLS CUI 2011AA)
    404051002 (SNOMED CT 2011_0131)
    10065868 (MedDRA 14.1)
    C0441962 (UMLS CUI 2011AA)
    53623008 (SNOMED CT 2011_0131)
    C0445034 (UMLS CUI 2011AA)
    30893008 (SNOMED CT 2011_0131)
    CL407060 (UMLS CUI 2011AA)
    C1320617 (UMLS CUI 2011AA)
    405916000 (SNOMED CT 2011_0131)
    CL407060 (UMLS CUI 2011AA)
    C0456389 (UMLS CUI 2011AA)
    246115007 (SNOMED CT 2011_0131)
    MTHU010347 (LOINC Version 232)
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
    Item
    RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
    boolean
    C0206655 (UMLS CUI 2011AA)
    404053004 (SNOMED CT 2011_0131)
    10065867 (MedDRA 14.1)
    C0441959 (UMLS CUI 2011AA)
    62455006 (SNOMED CT 2011_0131)
    C0445034 (UMLS CUI 2011AA)
    30893008 (SNOMED CT 2011_0131)
    CL407060 (UMLS CUI 2011AA)
    C1320617 (UMLS CUI 2011AA)
    405916000 (SNOMED CT 2011_0131)
    CL407060 (UMLS CUI 2011AA)
    C0456389 (UMLS CUI 2011AA)
    246115007 (SNOMED CT 2011_0131)
    MTHU010347 (LOINC Version 232)
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C1562297 (UMLS CUI 2011AA)
    415990002 (SNOMED CT 2011_0131)
    C0206655 (UMLS CUI 2011AA)
    404053004 (SNOMED CT 2011_0131)
    10065867 (MedDRA 14.1)
    Rhabdomyosarcoma of the Very High Risk Group, i.e.:
    Item
    Rhabdomyosarcoma of the Very High Risk Group, i.e.:
    boolean
    C0035412 (UMLS CUI 2011AA)
    302847003 (SNOMED CT 2011_0131)
    10039022 (MedDRA 14.1)
    C0442824 (UMLS CUI 2011AA)
    260358002 (SNOMED CT 2011_0131)
    C0332167 (UMLS CUI 2011AA)
    15508007 (SNOMED CT 2011_0131)
    CL415249 (UMLS CUI 2011AA)
    RGRP (HL7 V3 2006_05)
    RMA, N1, MO, IRS II&III, any size or age or
    Item
    RMA, N1, MO, IRS II&III, any size or age or
    boolean
    C0206655 (UMLS CUI 2011AA)
    404053004 (SNOMED CT 2011_0131)
    10065867 (MedDRA 14.1)
    C0441962 (UMLS CUI 2011AA)
    53623008 (SNOMED CT 2011_0131)
    C0445034 (UMLS CUI 2011AA)
    30893008 (SNOMED CT 2011_0131)
    C1320617 (UMLS CUI 2011AA)
    405916000 (SNOMED CT 2011_0131)
    C0439069 (UMLS CUI 2011AA)
    257470002 (SNOMED CT 2011_0131)
    C0439070 (UMLS CUI 2011AA)
    257471003 (SNOMED CT 2011_0131)
    CL407060 (UMLS CUI 2011AA)
    C0456389 (UMLS CUI 2011AA)
    246115007 (SNOMED CT 2011_0131)
    MTHU010347 (LOINC Version 232)
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
    Item
    localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
    boolean
    C0392752 (UMLS CUI 2011AA)
    255471002 (SNOMED CT 2011_0131)
    C0332167 (UMLS CUI 2011AA)
    15508007 (SNOMED CT 2011_0131)
    C0035412 (UMLS CUI 2011AA)
    302847003 (SNOMED CT 2011_0131)
    10039022 (MedDRA 14.1)
    C2348205 (UMLS CUI 2011AA)
    CL353068 (UMLS CUI 2011AA)
    2424003 (SNOMED CT 2011_0131)
    EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
    Item
    EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
    boolean
    C0279980 (UMLS CUI 2011AA)
    10015759 (MedDRA 14.1)
    C0206663 (UMLS CUI 2011AA)
    39781001 (SNOMED CT 2011_0131)
    10057846 (MedDRA 14.1)
    CL364379 (UMLS CUI 2011AA)
    SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
    Item
    Synovial(is)sarkom
    boolean
    C0039101 (UMLS CUI 2011AA)
    63211008 (SNOMED CT 2011_0131)
    10042863 (MedDRA 14.1)
    no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
    Item
    no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
    boolean
    C1518422 (UMLS CUI 2011AA)
    C2347662 (UMLS CUI 2011AA)
    C0221423 (UMLS CUI 2011AA)
    39104002 (SNOMED CT 2011_0131)
    10040658 (MedDRA 14.1)
    R69 (ICD-10-CM Version 2010)
    CL414898 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C1522601 (UMLS CUI 2011AA)
    C0311400 (UMLS CUI 2011AA)
    C0277785 (UMLS CUI 2011AA)
    386585008 (SNOMED CT 2011_0131)
    C0086565 (UMLS CUI 2011AA)
    75183008 (SNOMED CT 2011_0131)
    10019670 (MedDRA 14.1)
    C0151746 (UMLS CUI 2011AA)
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    no previous malignant tumours
    Item
    no previous malignant tumours
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    available for long term follow up through the treating centre
    Item
    available for long term follow up through the treating centre
    boolean
    C0470187 (UMLS CUI 2011AA)
    103328004 (SNOMED CT 2011_0131)
    C1517942 (UMLS CUI 2011AA)
    in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
    Item
    in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
    boolean
    C0544452 (UMLS CUI 2011AA)
    277022003 (SNOMED CT 2011_0131)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    C2828392 (UMLS CUI 2011AA)
    C0009429 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    pregnant or lactating women
    Item
    pregnant or lactating women
    boolean
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C2828358 (UMLS CUI 2011AA)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
    Item
    other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    CL411789 (UMLS CUI 2011AA)
    C2348563 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0019682 (UMLS CUI 2011AA)
    19030005 (SNOMED CT 2011_0131)
    C0004936 (UMLS CUI 2011AA)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
    Item
    for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
    boolean
    C0241028 (UMLS CUI 2011AA)
    228453005 (SNOMED CT 2011_0131)
    10066098 (MedDRA 14.1)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C1527415 (UMLS CUI 2011AA)
    26643006 (SNOMED CT 2011_0131)
    _OralRoute (HL7 V3 2006_05)
    C0077375 (UMLS CUI 2011AA)
    C0020789 (UMLS CUI 2011AA)
    372539000 (SNOMED CT 2011_0131)
    C0015133 (UMLS CUI 2011AA)
    56928005 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C1705116 (UMLS CUI 2011AA)
    443390004 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0009905 (UMLS CUI 2011AA)
    59261009 (SNOMED CT 2011_0131)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
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