ID

7822

Beschrijving

CALGB: 90401 TREATMENT FORM Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy NCT00110214 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF49A3AB-7EC3-51E0-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF49A3AB-7EC3-51E0-E034-0003BA3F9857

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    TREATMENT FORM Prostate Cancer (NCT00110214)

    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

    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
    Patient Initials
    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
    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 has withdrawn consent for clinical follow-up.
    Beschrijving

    PatientWithdrawnConsentClinicalInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus Property-2
    C38061
    UMLS 2011AA Property-2
    C2349954
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ValueDomain-2
    C25398
    UMLS 2011AA ValueDomain-2
    C0205210
    Patient has withdrawn consent for survival follow-up.
    Beschrijving

    PatientWithdrawnConsentSurvivalInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus Property-2
    C38061
    UMLS 2011AA Property-2
    C2349954
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ValueDomain-2
    C17177
    UMLS 2011AA ValueDomain-2
    C0038952
    Withdrawn consent date
    Beschrijving

    PatientWithdrawConsentDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus Property-2
    C38061
    UMLS 2011AA Property-2
    C2349954
    Completed by
    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
    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
    Clinical Data
    Beschrijving

    Clinical Data

    Alias
    UMLS CUI-1
    C1516606
    Currrent cycle number
    Beschrijving

    Cycle Number Chemotherapeutics

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Cycle start date
    Beschrijving

    Chemotherapy Cycle Start Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C3173309
    NCI Thesaurus Property
    C25379
    Cycle end date
    Beschrijving

    Chemotherapy Cycle End Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    UMLS CUI-2
    C0806020
    Height
    Beschrijving

    Patient Height

    Datatype

    float

    Maateenheden
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight
    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
    Beschrijving

    Body Surface Area

    Datatype

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005902
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25157
    Agent name
    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
    Dose
    Beschrijving

    Medication Dose

    Datatype

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488
    UMLS CUI-1
    C3174092
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain-2
    C1708
    NCI Thesaurus Property
    C25382
    No. of days administered
    Beschrijving

    AgentAdministeredDayDuration

    Datatype

    float

    Alias
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain-2
    C25330
    UMLS 2011AA ValueDomain-2
    C0449238
    Administered?
    Beschrijving

    AgentPlaceboAdministeredInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C753
    UMLS 2011AA Property
    C0032042
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    Dose modification (^1)
    Beschrijving

    Dose Modification Status

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose modification reason (^2)
    Beschrijving

    Dose Modification Reason

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    If dose modification = 99, specify
    Beschrijving

    Dose Modification Reason, other

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Concomitant medications received this cycle (Mark all that apply with an X.)
    Beschrijving

    ConcomitantMedicationReceivedType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C459
    UMLS 2011AA ObjectClass
    C0013227
    NCI Thesaurus Property
    C25639
    UMLS 2011AA Property
    C1514756
    NCI Thesaurus ObjectClass-2
    C25730
    UMLS 2011AA ObjectClass-2
    C0521115
    Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
    Beschrijving

    GrowthFactorAgentCurrentReportPeriodAdministeredType

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C20424
    UMLS 2011AA ObjectClass
    C0018284
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus Property-2
    C25471
    UMLS 2011AA Property-2
    C0521116
    NCI Thesaurus Property-3
    C25375
    UMLS 2011AA Property-3
    C0684224
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-4
    C1521801
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Other, specify
    Beschrijving

    GrowthFactorAgentCurrentReportPeriodAdministeredSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C20424
    UMLS 2011AA ObjectClass
    C0018284
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus Property-2
    C25471
    UMLS 2011AA Property-2
    C0521116
    NCI Thesaurus Property-3
    C25375
    UMLS 2011AA Property-3
    C0684224
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-4
    C1521801
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Aspirin (Mark one with an X.)
    Beschrijving

    AcetylsalicylicAcidAdministeredDailyAmount

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25473
    UMLS 2011AA ValueDomain
    C0332173
    NCI Thesaurus ObjectClass
    C287
    UMLS 2011AA ObjectClass
    C0004057
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain-2
    C25417
    Agent code (*)
    Beschrijving

    ReducedPlateletAgentAdministeredCode

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25640
    UMLS 2011AA ObjectClass
    C0392756
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus ObjectClass-3
    C12520
    UMLS 2011AA ObjectClass-3
    C0005821
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Other, specify generic name
    Beschrijving

    ReducedPlateletAgentSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25640
    UMLS 2011AA ObjectClass
    C0392756
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus ObjectClass-3
    C12520
    UMLS 2011AA ObjectClass-3
    C0005821
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Frequency (no. of daily doses)
    Beschrijving

    DailyDoseAdministeredCount

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25473
    UMLS 2011AA ObjectClass
    C0332173
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass-2
    C25488
    UMLS 2011AA ObjectClass-2
    C0178602
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Agent start date
    Beschrijving

    Concomitant Medication Start Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Agent end date
    Beschrijving

    Concomitant Medication End Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826744
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Agent code (**)
    Beschrijving

    AnticoagulantAgentAdministeredName

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C263
    UMLS 2011AA ObjectClass
    C0003280
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Other, specify generic name
    Beschrijving

    AnticoagulantAgentAdministeredSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C263
    UMLS 2011AA ObjectClass
    C0003280
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Agent code (***)
    Beschrijving

    ReducedLipidAgentAdministeredCode

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25640
    UMLS 2011AA ObjectClass
    C0392756
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus ObjectClass-3
    C616
    UMLS 2011AA ObjectClass-3
    C0023779
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Metathesaurus ValueDomain
    C0027365
    Other, specify generic name
    Beschrijving

    ReducedLipidAgentSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25640
    UMLS 2011AA ObjectClass
    C0392756
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus ObjectClass-3
    C616
    UMLS 2011AA ObjectClass-3
    C0023779
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Was treatment permanently discontinued during this cycle (bevacizumab/placebo)
    Beschrijving

    Drug treatment discontinued during chemotherapy cycle

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25471
    UMLS CUI-1
    C0558681
    NCI Thesaurus Property-2
    C25472
    UMLS CUI-2
    C0347984
    NCI Thesaurus Property-3
    C25484
    UMLS CUI-3
    C1302181
    NCI Thesaurus ValueDomain
    C38147
    Reason treatment ended (*)
    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
    If Other reason, specify:
    Beschrijving

    Off-TreatmentOtherReasonSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    Total number of cycles completed (bevacizumab/placebo)
    Beschrijving

    ChemotherapyTotalCycleCompleteCount

    Datatype

    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
    last dose date (bevacizumab/placebo)
    Beschrijving

    LastDoseDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25488
    UMLS 2011AA ObjectClass
    C0178602
    NCI Thesaurus ObjectClass-2
    C25551
    UMLS 2011AA ObjectClass-2
    C1517741
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
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    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

    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)
    Patient Initials
    Item
    Patient Initials
    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)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    PatientWithdrawnConsentClinicalInd-2
    Item
    Patient has withdrawn consent for clinical follow-up.
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38061 (NCI Thesaurus Property-2)
    C2349954 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25398 (NCI Thesaurus ValueDomain-2)
    C0205210 (UMLS 2011AA ValueDomain-2)
    PatientWithdrawnConsentSurvivalInd-2
    Item
    Patient has withdrawn consent for survival follow-up.
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38061 (NCI Thesaurus Property-2)
    C2349954 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C17177 (NCI Thesaurus ValueDomain-2)
    C0038952 (UMLS 2011AA ValueDomain-2)
    PatientWithdrawConsentDate
    Item
    Withdrawn consent date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38061 (NCI Thesaurus Property-2)
    C2349954 (UMLS 2011AA Property-2)
    Person Completing Form
    Item
    Completed by
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date form completed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Clinical Data
    C1516606 (UMLS CUI-1)
    Cycle Number Chemotherapeutics
    Item
    Currrent cycle number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-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)
    Chemotherapy Cycle End Date
    Item
    Cycle end date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0806020 (UMLS CUI-2)
    Patient Height
    Item
    Height
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    BSA
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005902 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25157 (NCI Thesaurus Property)
    Agent
    Item
    Agent name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    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)
    AgentAdministeredDayDuration
    Item
    No. of days administered
    float
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25330 (NCI Thesaurus ValueDomain-2)
    C0449238 (UMLS 2011AA ValueDomain-2)
    AgentPlaceboAdministeredInd-2
    Item
    Administered?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C753 (NCI Thesaurus Property)
    C0032042 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    Item
    Dose modification (^1)
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.3
    Code List
    Dose modification (^1)
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Dose Delayed And Reduced (Dose delayed and reduced)
    CL Item
    Drug Discontinued (Drug discontinued)
    Item
    Dose modification reason (^2)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    CL.4
    Code List
    Dose modification reason (^2)
    CL Item
    Hypersensitivity (Hypersensitivity)
    C3114 (NCI Thesaurus)
    C0020517 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Change In Bsa (Change in BSA)
    CL Item
    Hematologic Toxicity (Hematologic toxicity)
    CL Item
    Hepatic Dysfunction (Hepatic dysfunction)
    CL Item
    Pns Toxicity (PNS toxicity)
    CL Item
    Cns Toxicity (CNS toxicity)
    CL Item
    Gi Toxicity (GI toxicity)
    CL Item
    Cardiotoxicity (Cardiotoxicity)
    C27994 (NCI Thesaurus)
    C0876994 (UMLS 2011AA)
    CL Item
    Pulmonary Toxicity (Pulmonary toxicity)
    CL Item
    Renal Toxicity (Renal toxicity)
    CL Item
    Infection/fever (Infection/fever)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Dose Modification Reason, other
    Item
    If dose modification = 99, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item
    Concomitant medications received this cycle (Mark all that apply with an X.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C459 (NCI Thesaurus ObjectClass)
    C0013227 (UMLS 2011AA ObjectClass)
    C25639 (NCI Thesaurus Property)
    C1514756 (UMLS 2011AA Property)
    C25730 (NCI Thesaurus ObjectClass-2)
    C0521115 (UMLS 2011AA ObjectClass-2)
    CL.5
    Code List
    Concomitant medications received this cycle (Mark all that apply with an X.)
    CL Item
    Growth Factor (Growth factor)
    C20424 (NCI Thesaurus)
    C0018284 (UMLS 2011AA)
    CL Item
    Anti-platelet Agents (Anti-platelet agents)
    CL Item
    Aspirin (Aspirin)
    CL Item
    Anti-coagulant Agents (Anti-coagulant agents)
    CL Item
    Lipid-lowering Drugs (Lipid-lowering drugs)
    Item
    Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
    text
    C20424 (NCI Thesaurus ObjectClass)
    C0018284 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C25375 (NCI Thesaurus Property-3)
    C0684224 (UMLS 2011AA Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-4)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
    CL Item
    Epoetin Alfa (Epoetin)
    C2695 (NCI Thesaurus)
    C0357126 (UMLS 2011AA)
    CL Item
    Granulocyte-macrophage Colony-stimulating Factor (G-CSF)
    CL Item
    Oprelvekin (Neumega)
    C1303 (NCI Thesaurus)
    C0537668 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    GrowthFactorAgentCurrentReportPeriodAdministeredSpecify
    Item
    Other, specify
    text
    C20424 (NCI Thesaurus ObjectClass)
    C0018284 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C25375 (NCI Thesaurus Property-3)
    C0684224 (UMLS 2011AA Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-4)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Item
    Aspirin (Mark one with an X.)
    text
    C25473 (NCI Thesaurus ValueDomain)
    C0332173 (UMLS 2011AA ValueDomain)
    C287 (NCI Thesaurus ObjectClass)
    C0004057 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25417 (NCI Thesaurus ValueDomain-2)
    CL.7
    Code List
    Aspirin (Mark one with an X.)
    CL Item
    81 Mg/daily (81 mg/daily)
    CL Item
    325 Mg/daily (325 mg/daily)
    Item
    Agent code (*)
    text
    C25640 (NCI Thesaurus ObjectClass)
    C0392756 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C12520 (NCI Thesaurus ObjectClass-3)
    C0005821 (UMLS 2011AA ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    CL.8
    Code List
    Agent code (*)
    CL Item
    Clopidogrel (clopidogrel)
    CL Item
    Ticlopidine (ticlopidine)
    CL Item
    Dipyridamole (dipyridamole)
    C445 (NCI Thesaurus)
    C0012582 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    ReducedPlateletAgentSpecify
    Item
    Other, specify generic name
    text
    C25640 (NCI Thesaurus ObjectClass)
    C0392756 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C12520 (NCI Thesaurus ObjectClass-3)
    C0005821 (UMLS 2011AA ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    DailyDoseAdministeredCount
    Item
    Frequency (no. of daily doses)
    float
    C25473 (NCI Thesaurus ObjectClass)
    C0332173 (UMLS 2011AA ObjectClass)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25488 (NCI Thesaurus ObjectClass-2)
    C0178602 (UMLS 2011AA ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Concomitant Medication Start Date
    Item
    Agent start date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Concomitant Medication End Date
    Item
    Agent end date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826744 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Item
    Agent code (**)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C263 (NCI Thesaurus ObjectClass)
    C0003280 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.9
    Code List
    Agent code (**)
    CL Item
    Low Molecular Weight Heparin (Low molecular weight heparin)
    CL Item
    Warfarin (Warfarin)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    AnticoagulantAgentAdministeredSpecify
    Item
    Other, specify generic name
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C263 (NCI Thesaurus ObjectClass)
    C0003280 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item
    Agent code (***)
    text
    C25640 (NCI Thesaurus ObjectClass)
    C0392756 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C616 (NCI Thesaurus ObjectClass-3)
    C0023779 (UMLS 2011AA ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C0027365 (NCI Metathesaurus ValueDomain)
    CL.10
    Code List
    Agent code (***)
    CL Item
    Atorvastatin (atorvastatin)
    C28837 (NCI Thesaurus)
    C0082029 (UMLS 2011AA)
    CL Item
    Fluvastatin (fluvastatin)
    CL Item
    Lovastatin (lovastatin)
    C620 (NCI Thesaurus)
    C0024027 (UMLS 2011AA)
    CL Item
    Pravastatin (pravastatin)
    CL Item
    Rosuvastatin (rosuvastatin)
    CL Item
    Simvastatin (simvastatin)
    CL Item
    Fenofibrate (fenofibrate)
    C29047 (NCI Thesaurus)
    C0033228 (UMLS 2011AA)
    CL Item
    Gemfibrozil (gemfibrozil)
    C29071 (NCI Thesaurus)
    C0017245 (UMLS 2011AA)
    CL Item
    Cholestyramine (cholestyramine)
    C28929 (NCI Thesaurus)
    C0008402 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    ReducedLipidAgentSpecify
    Item
    Other, specify generic name
    text
    C25640 (NCI Thesaurus ObjectClass)
    C0392756 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C616 (NCI Thesaurus ObjectClass-3)
    C0023779 (UMLS 2011AA ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Drug treatment discontinued during chemotherapy cycle
    Item
    Was treatment permanently discontinued during this cycle (bevacizumab/placebo)
    boolean
    C15368 (NCI Thesaurus ObjectClass)
    C25471 (NCI Thesaurus Property)
    C0558681 (UMLS CUI-1)
    C25472 (NCI Thesaurus Property-2)
    C0347984 (UMLS CUI-2)
    C25484 (NCI Thesaurus Property-3)
    C1302181 (UMLS CUI-3)
    C38147 (NCI Thesaurus ValueDomain)
    Item
    Reason treatment ended (*)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    CL.14
    Code List
    Reason treatment ended (*)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    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
    Death On Study (Death on study)
    CL Item
    Patient Withdrawal Or Refusal (Patient withdrawal or refusal prior to beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after 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)
    Off-TreatmentOtherReasonSpecify
    Item
    If Other reason, specify:
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    ChemotherapyTotalCycleCompleteCount
    Item
    Total number of cycles completed (bevacizumab/placebo)
    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)
    LastDoseDate
    Item
    last dose date (bevacizumab/placebo)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25488 (NCI Thesaurus ObjectClass)
    C0178602 (UMLS 2011AA ObjectClass)
    C25551 (NCI Thesaurus ObjectClass-2)
    C1517741 (UMLS 2011AA ObjectClass-2)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
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