0 Bewertungen

ID

42681

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01171417

Link

http://clinicaltrials.gov/show/NCT01171417

Stichworte

  1. 06.12.13 06.12.13 - Martin Dugas
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility NCT01171417 Postmenopause

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschreibung

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Signed written informed consent
    Beschreibung

    Signed written informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1519316
    UMLS CUI 2011AA
    C1576874
    HL7 V3 2006_05
    WRITTEN
    UMLS CUI 2011AA
    C0021430
    Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
    Beschreibung

    Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    C0029936
    SNOMED CT 2011_0131
    83152002
    MedDRA 14.1
    10061889
    UMLS CUI 2011AA
    C0206159
    MedDRA 14.1
    10051775
    UMLS CUI 2011AA
    C1704788
    Age >= 60 years and natural menopause with menses > 1year ago or
    Beschreibung

    Age >= 60 years and natural menopause with menses > 1year ago or

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    UMLS CUI 2011AA
    C0856856
    MedDRA 14.1
    10028812
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    C0025344
    SNOMED CT 2011_0131
    248957007
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    FSH and E2 levels in the postmenopausal range or
    Beschreibung

    FSH and E2 levels in the postmenopausal range or

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0202022
    SNOMED CT 2011_0131
    31003009
    MedDRA 14.1
    10016911
    UMLS CUI 2011AA
    C0337434
    SNOMED CT 2011_0131
    37538009
    MedDRA 14.1
    10030227
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C1514721
    Patients who had bilateral ovariectomy (NCCN V.I. 2009)
    Beschreibung

    Patients who had bilateral ovariectomy (NCCN V.I. 2009)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0278321
    SNOMED CT 2011_0131
    76876009
    MedDRA 14.1
    10030339
    ICD-9-CM Version 2011
    65.51
    UMLS CUI 2011AA
    C1513893
    Histologically confirmed ER+ locally advanced or metastatic breast cancer
    Beschreibung

    Histologically confirmed ER+ locally advanced or metastatic breast cancer

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    CL415116
    UMLS CUI 2011AA
    C0205179
    SNOMED CT 2011_0131
    86005002
    UMLS CUI 2011AA
    C0036525
    SNOMED CT 2011_0131
    77879006
    MedDRA 14.1
    10027474
    UMLS CUI 2011AA
    C2938924
    MedDRA 14.1
    10070575
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    Not eligible for curative therapy
    Beschreibung

    Not eligible for curative therapy

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1555471
    HL7 V3 2006_05
    NELG
    UMLS CUI 2011AA
    C1880198
    UMLS CUI 2011AA
    C0039798
    Prior treatment with tamoxifen
    Beschreibung

    Prior treatment with tamoxifen

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0039286
    SNOMED CT 2011_0131
    373345002
    LOINC Version 232
    MTHU003102
    Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
    Beschreibung

    Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0814634
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0279025
    SNOMED CT 2011_0131
    309542002, 169413002
    MedDRA 14.1
    10065646
    UMLS CUI 2011AA
    C0205179
    SNOMED CT 2011_0131
    86005002
    UMLS CUI 2011AA
    C2938924
    MedDRA 14.1
    10070575
    UMLS CUI 2011AA
    C1519228
    UMLS CUI 2011AA
    C1707391
    UMLS CUI 2011AA
    C0593802
    SNOMED CT 2011_0131
    108775004
    Patient is able to read and understand German
    Beschreibung

    Patient is able to read and understand German

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0586740
    SNOMED CT 2011_0131
    309251006
    UMLS CUI 2011AA
    C1273101
    SNOMED CT 2011_0131
    395659009
    UMLS CUI 2011AA
    C0017477
    SNOMED CT 2011_0131
    297490002
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
    Beschreibung

    Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0935916
    SNOMED CT 2011_0131
    385519002
    UMLS CUI 2011AA
    C0851344
    SNOMED CT 2011_0131
    387017005
    UMLS CUI 2011AA
    C0205198
    SNOMED CT 2011_0131
    62105006
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
    Beschreibung

    Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0935916
    SNOMED CT 2011_0131
    385519002
    UMLS CUI 2011AA
    C0699792
    SNOMED CT 2011_0131
    263498003
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0935916
    SNOMED CT 2011_0131
    385519002
    Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
    Beschreibung

    Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0851344
    SNOMED CT 2011_0131
    387017005
    UMLS CUI 2011AA
    C0699792
    SNOMED CT 2011_0131
    263498003
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0851344
    SNOMED CT 2011_0131
    387017005
    Acutely life threatening disease
    Beschreibung

    Acutely life threatening disease

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205178
    SNOMED CT 2011_0131
    272118002
    UMLS CUI 2011AA
    C2826244
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    Treatment with Faslodex 250 mg/month (previously approved dose)
    Beschreibung

    Treatment with Faslodex 250 mg/month (previously approved dose)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0935916
    SNOMED CT 2011_0131
    385519002
    UMLS CUI 2011AA
    C0332177
    SNOMED CT 2011_0131
    259036001
    Prior palliative chemotherapy
    Beschreibung

    Prior palliative chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1285530
    SNOMED CT 2011_0131
    363676003
    UMLS CUI 2011AA
    C1514457

    Ähnliche Modelle

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    Signed written informed consent
    Item
    Signed written informed consent
    boolean
    C1519316 (UMLS CUI 2011AA)
    C1576874 (UMLS CUI 2011AA)
    WRITTEN (HL7 V3 2006_05)
    C0021430 (UMLS CUI 2011AA)
    Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
    Item
    Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    C0029936 (UMLS CUI 2011AA)
    83152002 (SNOMED CT 2011_0131)
    10061889 (MedDRA 14.1)
    C0206159 (UMLS CUI 2011AA)
    10051775 (MedDRA 14.1)
    C1704788 (UMLS CUI 2011AA)
    Age >= 60 years and natural menopause with menses > 1year ago or
    Item
    Age >= 60 years and natural menopause with menses > 1year ago or
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    C0856856 (UMLS CUI 2011AA)
    10028812 (MedDRA 14.1)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    C0025344 (UMLS CUI 2011AA)
    248957007 (SNOMED CT 2011_0131)
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    FSH and E2 levels in the postmenopausal range or
    Item
    FSH and E2 levels in the postmenopausal range or
    boolean
    C0202022 (UMLS CUI 2011AA)
    31003009 (SNOMED CT 2011_0131)
    10016911 (MedDRA 14.1)
    C0337434 (UMLS CUI 2011AA)
    37538009 (SNOMED CT 2011_0131)
    10030227 (MedDRA 14.1)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C1514721 (UMLS CUI 2011AA)
    Patients who had bilateral ovariectomy (NCCN V.I. 2009)
    Item
    Patients who had bilateral ovariectomy (NCCN V.I. 2009)
    boolean
    C0278321 (UMLS CUI 2011AA)
    76876009 (SNOMED CT 2011_0131)
    10030339 (MedDRA 14.1)
    65.51 (ICD-9-CM Version 2011)
    C1513893 (UMLS CUI 2011AA)
    Histologically confirmed ER+ locally advanced or metastatic breast cancer
    Item
    Histologically confirmed ER+ locally advanced or metastatic breast cancer
    boolean
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    CL415116 (UMLS CUI 2011AA)
    C0205179 (UMLS CUI 2011AA)
    86005002 (SNOMED CT 2011_0131)
    C0036525 (UMLS CUI 2011AA)
    77879006 (SNOMED CT 2011_0131)
    10027474 (MedDRA 14.1)
    C2938924 (UMLS CUI 2011AA)
    10070575 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    Not eligible for curative therapy
    Item
    Not eligible for curative therapy
    boolean
    C1555471 (UMLS CUI 2011AA)
    NELG (HL7 V3 2006_05)
    C1880198 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    Prior treatment with tamoxifen
    Item
    Prior treatment with tamoxifen
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0039286 (UMLS CUI 2011AA)
    373345002 (SNOMED CT 2011_0131)
    MTHU003102 (LOINC Version 232)
    Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
    Item
    Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
    boolean
    C0814634 (UMLS CUI 2011AA)
    C1514756 (UMLS CUI 2011AA)
    C0279025 (UMLS CUI 2011AA)
    309542002, 169413002 (SNOMED CT 2011_0131)
    10065646 (MedDRA 14.1)
    C0205179 (UMLS CUI 2011AA)
    86005002 (SNOMED CT 2011_0131)
    C2938924 (UMLS CUI 2011AA)
    10070575 (MedDRA 14.1)
    C1519228 (UMLS CUI 2011AA)
    C1707391 (UMLS CUI 2011AA)
    C0593802 (UMLS CUI 2011AA)
    108775004 (SNOMED CT 2011_0131)
    Patient is able to read and understand German
    Item
    Patient is able to read and understand German
    boolean
    C0586740 (UMLS CUI 2011AA)
    309251006 (SNOMED CT 2011_0131)
    C1273101 (UMLS CUI 2011AA)
    395659009 (SNOMED CT 2011_0131)
    C0017477 (UMLS CUI 2011AA)
    297490002 (SNOMED CT 2011_0131)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
    Item
    Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
    boolean
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0935916 (UMLS CUI 2011AA)
    385519002 (SNOMED CT 2011_0131)
    C0851344 (UMLS CUI 2011AA)
    387017005 (SNOMED CT 2011_0131)
    C0205198 (UMLS CUI 2011AA)
    62105006 (SNOMED CT 2011_0131)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
    Item
    Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0935916 (UMLS CUI 2011AA)
    385519002 (SNOMED CT 2011_0131)
    C0699792 (UMLS CUI 2011AA)
    263498003 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0935916 (UMLS CUI 2011AA)
    385519002 (SNOMED CT 2011_0131)
    Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
    Item
    Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0851344 (UMLS CUI 2011AA)
    387017005 (SNOMED CT 2011_0131)
    C0699792 (UMLS CUI 2011AA)
    263498003 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0851344 (UMLS CUI 2011AA)
    387017005 (SNOMED CT 2011_0131)
    Acutely life threatening disease
    Item
    Acutely life threatening disease
    boolean
    C0205178 (UMLS CUI 2011AA)
    272118002 (SNOMED CT 2011_0131)
    C2826244 (UMLS CUI 2011AA)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    Treatment with Faslodex 250 mg/month (previously approved dose)
    Item
    Treatment with Faslodex 250 mg/month (previously approved dose)
    boolean
    C0039798 (UMLS CUI 2011AA)
    C0935916 (UMLS CUI 2011AA)
    385519002 (SNOMED CT 2011_0131)
    C0332177 (UMLS CUI 2011AA)
    259036001 (SNOMED CT 2011_0131)
    Prior palliative chemotherapy
    Item
    Prior palliative chemotherapy
    boolean
    C1285530 (UMLS CUI 2011AA)
    363676003 (SNOMED CT 2011_0131)
    C1514457 (UMLS CUI 2011AA)

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video