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ID

44597

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01026142

Länk

http://clinicaltrials.gov/show/NCT01026142

Nyckelord

  1. 2013-12-07 2013-12-07 - Martin Dugas
  2. 2014-04-17 2014-04-17 - Julian Varghese
  3. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

DOI

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Creative Commons BY 4.0

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    Eligibility DRKS00007744 NCT01026142 Breast Cancer

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beskrivning

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Beskrivning

    age at least 18 Years

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Erwachsener, erwachsen
    Beskrivning

    Adult patients >/=18 years of age

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001675
    SNOMED CT 2011_0131
    133936004
    Metastatic HER2 positive breast cancer
    Beskrivning

    Metastatic HER2 positive breast cancer

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0036525
    SNOMED CT 2011_0131
    77879006
    MedDRA 14.1
    10027474
    UMLS CUI 2011AA
    CL412284
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    ECOG performance status 0 or 1
    Beskrivning

    ECOG performance status 0 or 1

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
    Beskrivning

    Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    UMLS CUI 2011AA
    C0728747
    SNOMED CT 2011_0131
    387003001
    UMLS CUI 2011AA
    C1705938
    UMLS CUI 2011AA
    C1708063
    UMLS CUI 2011AA
    C0278488
    Prior treatment with taxane-containing regimen
    Beskrivning

    Prior treatment with taxane-containing regimen

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0215136
    UMLS CUI 2011AA
    C0332256
    SNOMED CT 2011_0131
    42504009
    UMLS CUI 2011AA
    CL031856
    LVEF - Left ventricular ejection fraction
    Beskrivning

    LVEF >/=50 percent

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0428772
    SNOMED CT 2011_0131
    250908004
    MedDRA 14.1
    10069170
    For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
    Beskrivning

    For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0682323
    SNOMED CT 2011_0131
    262043009
    HL7 V3 2006_05
    SIGOTHR
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    CL424941
    Ausschlusskriterien
    Beskrivning

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Prior treatment with pertuzumab or capecitabine
    Beskrivning

    Prior treatment with pertuzumab or capecitabine

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C1328025
    UMLS CUI 2011AA
    C0671970
    SNOMED CT 2011_0131
    108761006
    Concurrent treatment with other experimental drug
    Beskrivning

    Concurrent treatment with other experimental drug

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0009429
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Concurrent immunotherapy or anticancer hormonal therapy
    Beskrivning

    Concurrent immunotherapy or anticancer hormonal therapy

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0021083
    SNOMED CT 2011_0131
    146638005
    UMLS CUI 2011AA
    C0279025
    SNOMED CT 2011_0131
    309542002, 169413002
    MedDRA 14.1
    10065646
    UMLS CUI 2011AA
    C0521124
    SNOMED CT 2011_0131
    65897001
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
    Beskrivning

    Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205404
    SNOMED CT 2011_0131
    42745003
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    UMLS CUI 2011AA
    C1868885
    MedDRA 14.1
    10066860
    UMLS CUI 2011AA
    C0007222
    SNOMED CT 2011_0131
    105980002
    MedDRA 14.1
    10007649
    ICD-9-CM Version 2011
    429.2
    CNS metastases, which are not well controlled
    Beskrivning

    CNS metastases, which are not well controlled

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0279130
    SNOMED CT 2011_0131
    261731003
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
    Beskrivning

    History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0332157
    SNOMED CT 2011_0131
    24932003
    UMLS CUI 2011AA
    C0282564
    SNOMED CT 2011_0131
    372540003
    UMLS CUI 2011AA
    CL426125
    UMLS CUI 2011AA
    CL415123
    UMLS CUI 2011AA
    C0013089
    SNOMED CT 2011_0131
    68444001
    LOINC Version 232
    MTHU004184
    History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
    Beskrivning

    History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0264722
    SNOMED CT 2011_0131
    42343007
    MedDRA 14.1
    10007559
    LOINC Version 232
    MTHU020787
    ICD-10-CM Version 2010
    I50
    ICD-9-CM Version 2011
    428
    UMLS CUI 2011AA
    C1275491
    SNOMED CT 2011_0131
    420816009
    UMLS CUI 2011AA
    CL414621
    UMLS CUI 2011AA
    C0003811
    SNOMED CT 2011_0131
    44808001
    MedDRA 14.1
    10003119
    ICD-9-CM Version 2011
    427.9
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0039798
    Past history of myocardial infarction
    Beskrivning

    History of myocardial infarction within 6 months prior to randomization

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1275835
    SNOMED CT 2011_0131
    399211009
    History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
    Beskrivning

    History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab

    Datatyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C1096403
    MedDRA 14.1
    10053222
    UMLS CUI 2011AA
    C0876994
    MedDRA 14.1
    10048610
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0728747
    SNOMED CT 2011_0131
    387003001

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Adult patients >/=18 years of age
    Item
    Erwachsener, erwachsen
    boolean
    C0001675 (UMLS CUI 2011AA)
    133936004 (SNOMED CT 2011_0131)
    Metastatic HER2 positive breast cancer
    Item
    Metastatic HER2 positive breast cancer
    boolean
    C0036525 (UMLS CUI 2011AA)
    77879006 (SNOMED CT 2011_0131)
    10027474 (MedDRA 14.1)
    CL412284 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    ECOG performance status 0 or 1
    Item
    ECOG performance status 0 or 1
    boolean
    C1520224 (UMLS CUI 2011AA)
    Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
    Item
    Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
    boolean
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    C0728747 (UMLS CUI 2011AA)
    387003001 (SNOMED CT 2011_0131)
    C1705938 (UMLS CUI 2011AA)
    C1708063 (UMLS CUI 2011AA)
    C0278488 (UMLS CUI 2011AA)
    Prior treatment with taxane-containing regimen
    Item
    Prior treatment with taxane-containing regimen
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0215136 (UMLS CUI 2011AA)
    C0332256 (UMLS CUI 2011AA)
    42504009 (SNOMED CT 2011_0131)
    CL031856 (UMLS CUI 2011AA)
    LVEF >/=50 percent
    Item
    LVEF - Left ventricular ejection fraction
    boolean
    C0428772 (UMLS CUI 2011AA)
    250908004 (SNOMED CT 2011_0131)
    10069170 (MedDRA 14.1)
    For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
    Item
    For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0682323 (UMLS CUI 2011AA)
    262043009 (SNOMED CT 2011_0131)
    SIGOTHR (HL7 V3 2006_05)
    C0680240 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    CL424941 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Prior treatment with pertuzumab or capecitabine
    Item
    Prior treatment with pertuzumab or capecitabine
    boolean
    C1514463 (UMLS CUI 2011AA)
    C1328025 (UMLS CUI 2011AA)
    C0671970 (UMLS CUI 2011AA)
    108761006 (SNOMED CT 2011_0131)
    Concurrent treatment with other experimental drug
    Item
    Concurrent treatment with other experimental drug
    boolean
    C0009429 (UMLS CUI 2011AA)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Concurrent immunotherapy or anticancer hormonal therapy
    Item
    Concurrent immunotherapy or anticancer hormonal therapy
    boolean
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0021083 (UMLS CUI 2011AA)
    146638005 (SNOMED CT 2011_0131)
    C0279025 (UMLS CUI 2011AA)
    309542002, 169413002 (SNOMED CT 2011_0131)
    10065646 (MedDRA 14.1)
    C0521124 (UMLS CUI 2011AA)
    65897001 (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)
    Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
    Item
    Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
    boolean
    C0205404 (UMLS CUI 2011AA)
    42745003 (SNOMED CT 2011_0131)
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    C1868885 (UMLS CUI 2011AA)
    10066860 (MedDRA 14.1)
    C0007222 (UMLS CUI 2011AA)
    105980002 (SNOMED CT 2011_0131)
    10007649 (MedDRA 14.1)
    429.2 (ICD-9-CM Version 2011)
    CNS metastases, which are not well controlled
    Item
    CNS metastases, which are not well controlled
    boolean
    C0279130 (UMLS CUI 2011AA)
    261731003 (SNOMED CT 2011_0131)
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
    Item
    History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0332157 (UMLS CUI 2011AA)
    24932003 (SNOMED CT 2011_0131)
    C0282564 (UMLS CUI 2011AA)
    372540003 (SNOMED CT 2011_0131)
    CL426125 (UMLS CUI 2011AA)
    CL415123 (UMLS CUI 2011AA)
    C0013089 (UMLS CUI 2011AA)
    68444001 (SNOMED CT 2011_0131)
    MTHU004184 (LOINC Version 232)
    History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
    Item
    History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
    boolean
    C0264722 (UMLS CUI 2011AA)
    42343007 (SNOMED CT 2011_0131)
    10007559 (MedDRA 14.1)
    MTHU020787 (LOINC Version 232)
    I50 (ICD-10-CM Version 2010)
    428 (ICD-9-CM Version 2011)
    C1275491 (UMLS CUI 2011AA)
    420816009 (SNOMED CT 2011_0131)
    CL414621 (UMLS CUI 2011AA)
    C0003811 (UMLS CUI 2011AA)
    44808001 (SNOMED CT 2011_0131)
    10003119 (MedDRA 14.1)
    427.9 (ICD-9-CM Version 2011)
    C1514873 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    History of myocardial infarction within 6 months prior to randomization
    Item
    Past history of myocardial infarction
    boolean
    C1275835 (UMLS CUI 2011AA)
    399211009 (SNOMED CT 2011_0131)
    History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
    Item
    History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C1096403 (UMLS CUI 2011AA)
    10053222 (MedDRA 14.1)
    C0876994 (UMLS CUI 2011AA)
    10048610 (MedDRA 14.1)
    C1514463 (UMLS CUI 2011AA)
    C0728747 (UMLS CUI 2011AA)
    387003001 (SNOMED CT 2011_0131)

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