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ID

11074

Beskrivning

PACCT-1 TAILORx Chemotherapy Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DD92D7-B59A-692F-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DD92D7-B59A-692F-E044-0003BA3F9857

Nyckelord

  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-06-18 2015-06-18 -
Uppladdad den

18 juni 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    PACCT-1 TAILORx Chemotherapy Form NCT00310180

    No Instruction available.

    1. StudyEvent: PACCT-1 TAILORx Chemotherapy Form
      1. No Instruction available.
    Header
    Beskrivning

    Header

    ECOG Protocol Number
    Beskrivning

    Protocol Number ECOG

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Beskrivning

    Patient ID ECOG

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    DCI Name
    Beskrivning

    Generic drug form

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step Number
    Beskrivning

    Registration Number

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Reporting Period
    Beskrivning

    Clinical Trial Period

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Assessment of Chemotherapy
    Beskrivning

    Assessment of Chemotherapy

    Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
    Beskrivning

    ChemotherapyRegimenType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    specify study number and treatment arm (given as part of a CTSU adjuvant therapy protocol)
    Beskrivning

    AdjuvantChemotherapyRegimenSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C2140
    UMLS 2011AA ObjectClass-2
    C0001552
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    specify drugs and schedule (other chemotherapy regimen)
    Beskrivning

    ChemotherapyRegimenSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    Date Chemotherapy Began (date 1st cycle given m/d/y)
    Beskrivning

    Chemotherapy Start Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15632
    UMLS CUI-2
    C3173309
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus Property
    C25382
    Date Chemotherapy Ended (date last cycle given m/d/y)
    Beskrivning

    ChemotherapyAdministeredEndDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Taxane Use
    Beskrivning

    TaxaneCompoundAgentAdministeredType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ObjectClass-2
    C1490
    UMLS 2011AA ObjectClass-2
    C0796419
    Total number of chemotherapy cycles completed
    Beskrivning

    ChemotherapyTotalCycleCompleteCount

    Datatyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property-2
    C25304
    UMLS 2011AA Property-2
    C0439810
    NCI Thesaurus Property-3
    C25472
    UMLS 2011AA Property-3
    C1511572
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Footer Module
    Beskrivning

    Footer Module

    Investigator Signature
    Beskrivning

    Investigator Signature

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Beskrivning

    Investigator Signature Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089

    Similar models

    No Instruction available.

    1. StudyEvent: PACCT-1 TAILORx Chemotherapy Form
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    Code List
    Reporting Period
    CL Item
    Completion Of Chemotherapy (Completion of chemotherapy)
    Item Group
    Assessment of Chemotherapy
    Item
    Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    Code List
    Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
    CL Item
    Oral Cyclophosphamide, Methotrexate And 5-fluorouracil (cmf) (Oral CMF)
    CL Item
    Intravenous Cyclophosphamide, Methotrexate, And Fluorouracil (cmf) (IV CMF)
    CL Item
    Standard Anthracycline And Cyclophosphamide (ac) Therapy (standard AC)
    CL Item
    Dose Dense Anthracycline (doxorubicin) And Cyclophosphamide (ac) Therapy (dose dense AC)
    CL Item
    Standard Anthracycline (doxorubicin) And Cyclophosphamide (ac) Followed By A Taxane (standard AC followed by a taxane)
    CL Item
    Dose Dense Anthracycline (doxorubicin) And Cyclophosphamide (ac) Followed By A Taxane (dose dense AC followed by a taxane)
    CL Item
    5-fluorouracil, Epirubicin, Cyclophosphamide (fec) (FEC)
    CL Item
    Doxorubicin, Cyclophosphamide, And Docetaxel (tac) (TAC)
    CL Item
    Docetaxel And Cyclophosphamide (tc) Therapy (TC)
    CL Item
    Other Regimen Given As Part Of A Ctsu Adjuvant Therapy Protocol (other regimen given as part of a CTSU adjuvant therapy protocol)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Not Given (Chemotherapy not given)
    AdjuvantChemotherapyRegimenSpecify
    Item
    specify study number and treatment arm (given as part of a CTSU adjuvant therapy protocol)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C2140 (NCI Thesaurus ObjectClass-2)
    C0001552 (UMLS 2011AA ObjectClass-2)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    ChemotherapyRegimenSpecify
    Item
    specify drugs and schedule (other chemotherapy regimen)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    Chemotherapy Start Date
    Item
    Date Chemotherapy Began (date 1st cycle given m/d/y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15632 (NCI Thesaurus ObjectClass)
    C3173309 (UMLS CUI-2)
    C25431 (NCI Thesaurus ValueDomain-2)
    C25382 (NCI Thesaurus Property)
    ChemotherapyAdministeredEndDate
    Item
    Date Chemotherapy Ended (date last cycle given m/d/y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item
    Taxane Use
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C1490 (NCI Thesaurus ObjectClass-2)
    C0796419 (UMLS 2011AA ObjectClass-2)
    Code List
    Taxane Use
    CL Item
    None: C41132 (None)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    CL Item
    Paclitaxel (Paclitaxel)
    C1411 (NCI Thesaurus)
    C0144576 (UMLS 2011AA)
    CL Item
    Docetaxel (Docetaxel)
    C1526 (NCI Thesaurus)
    C0246415 (UMLS 2011AA)
    ChemotherapyTotalCycleCompleteCount
    Item
    Total number of chemotherapy cycles completed
    float
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25304 (NCI Thesaurus Property-2)
    C0439810 (UMLS 2011AA Property-2)
    C25472 (NCI Thesaurus Property-3)
    C1511572 (UMLS 2011AA Property-3)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    Item Group
    Footer Module
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)

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