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ID

10918

Beschrijving

CALGB 30506 Treatment And Response Form NCT00863512 Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5E92C67F-DAF6-CFB0-E040-BB89AD432DA1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5E92C67F-DAF6-CFB0-E040-BB89AD432DA1

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 12-06-15 12-06-15 -
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12 juni 2015

DOI

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    CALGB 30506 Treatment And Response Form NCT00863512

    Engels

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

    1 Formulieren  
    Header
    Beschrijving

    Header

    CALGB Form
    Beschrijving

    Form ID CALGB

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3262252
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25442
    CALGB Study No.
    Beschrijving

    Protocol ID CALGB

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CALGB Patient ID
    Beschrijving

    Trial subject ID CALGB

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Date of First dose for this reporting period (MM DD YYYY)
    Beschrijving

    Treatment Start Date

    Datatype

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25509
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25256
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period End Date (MM DD YYYY)
    Beschrijving

    Reporting Period End Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Are data amended
    Beschrijving

    Data amended

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Patient demographics
    Beschrijving

    Patient demographics

    Patient Initials (Last, First Middle)
    Beschrijving

    Patient Initials

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No.
    Beschrijving

    Medical Record Number

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Institution/Affiliate
    Beschrijving

    Institution Name

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group
    Beschrijving

    Participating Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Beschrijving

    Study Number Participating Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Beschrijving

    Trial subject ID Participating Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Patient Data
    Beschrijving

    Patient Data

    Cycle Number
    Beschrijving

    Cycle Number

    Datatype

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    Weight (kg)
    Beschrijving

    Patient Weight

    Datatype

    float

    Maateenheden
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    BSA (m^2)
    Beschrijving

    Body Surface Area

    Datatype

    float

    Maateenheden
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    First Treatment (cycles 1 ¿ 6)
    Beschrijving

    First Treatment (cycles 1 ¿ 6)

    Agent
    Beschrijving

    Agent

    Datatype

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Total Dose of Agents/Drugs for this Cycle
    Beschrijving

    Agent Total Dose

    Datatype

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Dose Modifications
    Beschrijving

    Dose Modifications

    Were there any dose modifications or additions/omissions to protocol treatment?
    Beschrijving

    Dose Modification

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    Reason Treatment Ended
    Beschrijving

    Reason Treatment Ended

    Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
    Beschrijving

    Off Treatment Reason

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    Alternative therapy, specify
    Beschrijving

    Off Treatment Reason

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C25415
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25382
    NCI Thesaurus ValueDomain
    C25638
    Other specify
    Beschrijving

    Off Treatment Reason, specify

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902
    Was growth factor support employed? (during this reporting period)
    Beschrijving

    Growth factor administered

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0018284
    NCI Thesaurus ObjectClass
    C20424
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Total No. of Doses (if yes, specify)
    Beschrijving

    Number of Doses, Total

    Datatype

    float

    Alias
    NCI Thesaurus Property
    C25304
    UMLS CUI-1
    C0178602
    NCI Thesaurus ValueDomain
    C25463
    UMLS CUI-2
    C0750480
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property-2
    C25256
    Footer Module
    Beschrijving

    Footer Module

    Completed by (print or type name)
    Beschrijving

    Person Completing Form

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed (MM DD YYYY)
    Beschrijving

    Date Form Completed

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367
    Terug naar het begin van de pagina

    Similar models

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3262252 (UMLS CUI-1)
    C19464 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus ObjectClass-2)
    Protocol ID CALGB
    Item
    CALGB Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Treatment Start Date
    Item
    Date of First dose for this reporting period (MM DD YYYY)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25256 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Reporting Period End Date
    Item
    Reporting Period End Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Patient demographics
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    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)
    Participating Group
    Item
    Participating Group
    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 Group 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 Group Patient ID
    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
    Patient Data
    Cycle Number
    Item
    Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    BSA (m^2)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item Group
    First Treatment (cycles 1 ¿ 6)
    Agent
    Item
    Agent
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Item Group
    Dose Modifications
    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)
    CL.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 Group
    Reason Treatment Ended
    Item
    Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    CL.3
    Code List
    Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item
    Alternative therapy, specify
    text
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C25415 (NCI Thesaurus ObjectClass-3)
    C0566251 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    C25638 (NCI Thesaurus ValueDomain)
    CL.4
    Code List
    Alternative therapy, specify
    CL Item
    Removed To Undergo Surgical Resection (Removed to undergo surgical resection)
    CL Item
    Removed To Receive Non-protocol Chemotherapy And/or Biologic Therapy (Removed to receive non-protocol chemotherapy and/or biologic therapy)
    Off Treatment Reason, specify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)
    Growth factor administered
    Item
    Was growth factor support employed? (during this reporting period)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0018284 (UMLS CUI-1)
    C20424 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Number of Doses, Total
    Item
    Total No. of Doses (if yes, specify)
    float
    C25304 (NCI Thesaurus Property)
    C0178602 (UMLS CUI-1)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25256 (NCI Thesaurus Property-2)
    Item Group
    Footer Module
    Person Completing Form
    Item
    Completed by (print or type name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
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