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ID

9420

Descrizione

SOUTHWEST ONCOLOGY GROUP S0347 TREATMENT FORM Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DDB236B7-9161-179E-E034-0003BA12F5E7

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DDB236B7-9161-179E-E034-0003BA12F5E7

Keywords

  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
Caricato su

9 gennaio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT00103233 Treatment - SOUTHWEST ONCOLOGY GROUP S0347 TREATMENT FORM - 2285534v3.0

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0347 TREATMENT FORM
      1. No Instruction available.
    Header
    Descrizione

    Header

    SWOG Patient ID
    Descrizione

    Trial subject ID SWOG

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    SWOG Study No.
    Descrizione

    Protocol ID SWOG

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    Registration Step
    Descrizione

    Registration Number

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C1514821 (Registration)
    NCI Thesaurus ObjectClass
    C25646 (undefined)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus Property
    C16154 (undefined)
    NCI Thesaurus ValueDomain-2
    C16154 (undefined)
    Cycle Number (see instructions)
    Descrizione

    Cycle Number Chemotherapeutics

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2045829 (chemotherapeutics regimen status cycle number)
    NCI Thesaurus Property
    C25471 (undefined)
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property-2
    C25379 (undefined)
    Patient Initials (L, F M)
    Descrizione

    Patient Initials

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Institution/Affiliate
    Descrizione

    Institution Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454 (undefined)
    UMLS CUI-1
    C1301943 (Institution name)
    SNOMED
    398321007
    NCI Thesaurus ObjectClass-2
    C21541 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    NCI Thesaurus ValueDomain-2
    C21541 (undefined)
    Physician
    Descrizione

    Investigator Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2826892 (Investigator Name)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    NCI Thesaurus ObjectClass-2
    C25644 (undefined)
    Participating Group Name
    Descrizione

    Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus ObjectClass
    C25608 (undefined)
    NCI Thesaurus ObjectClass-2
    C17005 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Participating Study No.
    Descrizione

    Study Number Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Participating Patient ID (Instructions: Please complete this form after each cycle 1 cycle = 4 weeks. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.)
    Descrizione

    Trial subject ID Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Status
    Descrizione

    Status

    Date of Last Contact or Death
    Descrizione

    Date last contact

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus ValueDomain-2
    C25367 (undefined)
    NCI Thesaurus Property
    C25461 (undefined)
    Vital Status
    Descrizione

    Patient Status

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-1
    C3846084 (undefined)
    NCI Thesaurus ValueDomain
    C18003 (undefined)
    NCI Thesaurus ValueDomain-2
    C25688 (undefined)
    NCI Thesaurus Property
    C25365 (undefined)
    Has the patient progressed per the definition in Section 10.0 of the protocol?
    Descrizione

    Tumor Progression

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS CUI-1
    C0178874 (Tumor Progression)
    SNOMED
    419835002
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25320 (undefined)
    NCI Thesaurus Property-2
    C19987 (undefined)
    Treatment For This Cycle
    Descrizione

    Treatment For This Cycle

    Assigned Treatment Arm
    Descrizione

    Protocol Treatment Arm

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ObjectClass-2
    C42651 (undefined)
    UMLS CUI-1
    C1522541 (Protocol Treatment Arm)
    NCI Thesaurus Property
    C32141 (undefined)
    NCI Thesaurus Property-2
    C25426 (undefined)
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    Cycle start date
    Descrizione

    Chemotherapy Cycle Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ValueDomain-2
    C25431 (undefined)
    UMLS CUI-2
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    NCI Thesaurus Property
    C25379 (undefined)
    Weight first day this cycle
    Descrizione

    Patient Weight

    Tipo di dati

    float

    Unità di misura
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209 (undefined)
    UMLS CUI-1
    C0005910 (Body Weight)
    SNOMED
    27113001
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25208 (undefined)
    Kg
    Date of last treatment for this cycle
    Descrizione

    TreatmentCycleEndDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus Property
    C25472 (undefined)
    UMLS 2011AA Property
    C1511572 (event cycle)
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    BSA first day this cycle
    Descrizione

    Body Surface Area

    Tipo di dati

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209 (undefined)
    UMLS CUI-1
    C0005902 (Body Surface Area)
    SNOMED
    301898006
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25157 (undefined)
    Were there any dose modifications or additions/omissions to protocol treatment?
    Descrizione

    Dose Modification

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS CUI-1
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25256 (undefined)
    NCI Thesaurus Property
    C25572 (undefined)
    NCI Thesaurus ValueDomain-2
    C25572 (undefined)
    Unnamed question 2
    Descrizione

    AdministeredAgentDayCourseType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C41161 (undefined)
    UMLS 2011AA ObjectClass
    C1521826 (Protocol Agent)
    NCI Thesaurus ObjectClass-2
    C25382 (undefined)
    UMLS 2011AA ObjectClass-2
    C1521801 (Having administered)
    NCI Thesaurus Property
    C25301 (undefined)
    UMLS 2011AA Property
    C0439228 (day)
    SNOMED
    258703001
    NCI Thesaurus Property-2
    C25379 (undefined)
    UMLS 2011AA Property-2
    C0750729 (Course)
    SNOMED
    288524001
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Unnamed question 3
    Descrizione

    Agent

    Tipo di dati

    text

    Alias
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS CUI-1
    C1521826 (Protocol Agent)
    NCI Thesaurus ObjectClass
    C1708 (undefined)
    NCI Thesaurus ValueDomain
    C1708 (undefined)
    NCI Thesaurus ValueDomain-2
    C42614 (undefined)
    Dose
    Descrizione

    Medication Dose

    Tipo di dati

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488 (undefined)
    UMLS CUI-1
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    NCI Thesaurus ObjectClass
    C1708 (undefined)
    NCI Thesaurus ValueDomain-2
    C1708 (undefined)
    NCI Thesaurus Property
    C25382 (undefined)
    Comments
    Descrizione

    Comments

    Comments
    Descrizione

    Research Comments

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    NCI Thesaurus ObjectClass
    C15319 (undefined)
    NCI Thesaurus Property
    C25393 (undefined)

    Similar models

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0347 TREATMENT FORM
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Protocol ID SWOG
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Registration Number
    Item
    Registration Step
    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)
    Cycle Number Chemotherapeutics
    Item
    Cycle Number (see instructions)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    Patient Initials
    Item
    Patient Initials (L, F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Investigator Name
    Item
    Physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Patient ID (Instructions: Please complete this form after each cycle 1 cycle = 4 weeks. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Status
    Date last contact
    Item
    Date of Last Contact or Death
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0805839 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25461 (NCI Thesaurus Property)
    Item
    Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25365 (NCI Thesaurus Property)
    Code List
    Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Tumor Progression
    Item
    Has the patient progressed per the definition in Section 10.0 of the protocol?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0178874 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25320 (NCI Thesaurus Property)
    C19987 (NCI Thesaurus Property-2)
    Item Group
    Treatment For This Cycle
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C25426 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    Code List
    Assigned Treatment Arm
    CL Item
    Arm 1 (Arm 1)
    CL Item
    Arm 2 (Arm 2)
    Chemotherapy Cycle Start Date
    Item
    Cycle start date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C3173309 (UMLS CUI-2)
    C25379 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight first day this cycle
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    TreatmentCycleEndDate
    Item
    Date of last treatment for this cycle
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25472 (NCI Thesaurus Property)
    C1511572 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    Body Surface Area
    Item
    BSA first day this cycle
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005902 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25157 (NCI Thesaurus Property)
    Item
    Were there any dose modifications or additions/omissions to protocol treatment?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
    Item
    Unnamed question 2
    text
    C41161 (NCI Thesaurus ObjectClass)
    C1521826 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus ObjectClass-2)
    C1521801 (UMLS 2011AA ObjectClass-2)
    C25301 (NCI Thesaurus Property)
    C0439228 (UMLS 2011AA Property)
    C25379 (NCI Thesaurus Property-2)
    C0750729 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Unnamed question 2
    CL Item
    Day 1 (Day 1)
    CL Item
    Day 8 (Day 8)
    CL Item
    Day 15 (Day 15)
    CL Item
    Day 22 (Day 22)
    Item
    Unnamed question 3
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Code List
    Unnamed question 3
    CL Item
    Vinorelbine (Vinorelbine)
    CL Item
    Trastuzumab (Trastuzumab)
    Medication Dose
    Item
    Dose
    float
    C25488 (NCI Thesaurus ValueDomain)
    C3174092 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain-2)
    C25382 (NCI Thesaurus Property)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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