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ID

6661

Description

CALGB 40503 Supplemental Adverse Event (AE) Form Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=604DB84A-54BF-38D2-E040-BB89AD43495E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=604DB84A-54BF-38D2-E040-BB89AD43495E

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
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January 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT00601900 Toxicity - CALGB 40503 Supplemental Adverse Event (AE) Form - 2823361v1.0

    English

    If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

    1 forms  
    Header
    Description

    Header

    CALGB Form
    Description

    Form ID CALGB

    Data type

    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
    Description

    Protocol ID CALGB

    Data type

    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
    Description

    Trial subject ID CALGB

    Data type

    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
    Reporting Period Start Date (MM DD YYYY)
    Description

    Reporting Period Start Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25616
    UMLS CUI-1
    C2361257
    NCI Thesaurus Property-2
    C25651
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period End Date (MM DD YYYY)
    Description

    Reporting Period End Date

    Data type

    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
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Unnamed2
    Description

    Unnamed2

    Patient Initials
    Description

    Patient Initials

    Data type

    text

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

    Medical Record Number

    Data type

    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
    Description

    Institution Name

    Data type

    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 (Country name for International sites)
    Description

    Participating Group

    Data type

    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.
    Description

    Study Number Participating Group

    Data type

    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
    Description

    Trial subject ID Participating Group

    Data type

    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
    Expected Adverse Events
    Description

    Expected Adverse Events

    MedDRA Code
    Description

    MedDRACode

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    MedDRA Code
    Description

    MedDRACode

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC adverse event term
    Description

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC adverse event term
    Description

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC AE grade (^1)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC AE grade (^1)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Duration (in days of highest grade during assessment period)
    Description

    AdverseEventWorstSymptomDayDuration

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    NCI Thesaurus Property-2
    C25719
    UMLS 2011AA Property-2
    C1522166
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ValueDomain-2
    C25330
    UMLS 2011AA ValueDomain-2
    C0449238
    Duration (in days of highest grade during assessment period)
    Description

    AdverseEventWorstSymptomDayDuration

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    NCI Thesaurus Property-2
    C25719
    UMLS 2011AA Property-2
    C1522166
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ValueDomain-2
    C25330
    UMLS 2011AA ValueDomain-2
    C0449238
    Attributable to which medication (Mark all that apply)
    Description

    AgentAdverseEventAttributionName

    Data type

    text

    Alias
    NCI Thesaurus Property
    C41331
    UMLS 2011AA Property
    C0877248
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property-2
    C25358
    UMLS 2011AA Property-2
    C0596130
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Attributable to which medication (Mark all that apply)
    Description

    AgentAdverseEventAttributionName

    Data type

    text

    Alias
    NCI Thesaurus Property
    C41331
    UMLS 2011AA Property
    C0877248
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property-2
    C25358
    UMLS 2011AA Property-2
    C0596130
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Completed by (Last name, First name)
    Description

    Person Completing Form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date form completed (MM DD YYYY)
    Description

    Date Form Completed

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367
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    Similar models

    If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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)
    Reporting Period Start Date
    Item
    Reporting Period Start Date (MM DD YYYY)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (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
    Unnamed2
    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 (Country name for International sites)
    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
    Expected Adverse Events
    MedDRACode
    Item
    MedDRA Code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    MedDRACode
    Item
    MedDRA Code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC adverse event term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC adverse event term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC AE grade (^1)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC AE grade (^1)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    AdverseEventWorstSymptomDayDuration
    Item
    Duration (in days of highest grade during assessment period)
    float
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    C25719 (NCI Thesaurus Property-2)
    C1522166 (UMLS 2011AA Property-2)
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C25330 (NCI Thesaurus ValueDomain-2)
    C0449238 (UMLS 2011AA ValueDomain-2)
    AdverseEventWorstSymptomDayDuration
    Item
    Duration (in days of highest grade during assessment period)
    float
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    C25719 (NCI Thesaurus Property-2)
    C1522166 (UMLS 2011AA Property-2)
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C25330 (NCI Thesaurus ValueDomain-2)
    C0449238 (UMLS 2011AA ValueDomain-2)
    Item
    Attributable to which medication (Mark all that apply)
    text
    C41331 (NCI Thesaurus Property)
    C0877248 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property-2)
    C0596130 (UMLS 2011AA Property-2)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Attributable to which medication (Mark all that apply)
    CL Item
    Tamoxifen Letrozole (Letrozole/Tamoxifen)
    C1527 (NCI Thesaurus)
    C0246421 (UMLS 2011AA)
    C855 (NCI Thesaurus-3)
    C0039286 (UMLS 2011AA-4)
    CL Item
    Placebo Bevacizumab (Bevacizumab/Placebo)
    C753 (NCI Thesaurus)
    C0032042 (UMLS 2011AA)
    C2039 (NCI Thesaurus-3)
    C0796392 (UMLS 2011AA-4)
    Item
    Attributable to which medication (Mark all that apply)
    text
    C41331 (NCI Thesaurus Property)
    C0877248 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property-2)
    C0596130 (UMLS 2011AA Property-2)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Attributable to which medication (Mark all that apply)
    CL Item
    Tamoxifen Letrozole (Letrozole/Tamoxifen)
    C1527 (NCI Thesaurus)
    C0246421 (UMLS 2011AA)
    C855 (NCI Thesaurus-3)
    C0039286 (UMLS 2011AA-4)
    CL Item
    Placebo Bevacizumab (Bevacizumab/Placebo)
    C753 (NCI Thesaurus)
    C0032042 (UMLS 2011AA)
    C2039 (NCI Thesaurus-3)
    C0796392 (UMLS 2011AA-4)
    Person Completing Form
    Item
    Completed by (Last name, First 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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