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ID

6770

Description

E5508 Long-Term Follow-up Form Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6D41D0A3-AEE4-13D4-E040-BB89AD430599

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6D41D0A3-AEE4-13D4-E040-BB89AD430599

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
Uploaded on

January 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Lung Cancer NCT01107626 Follow-Up - E5508 Long-Term Follow-up Form - 2905089v1.0

    INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule). Submit original to the ECOG Coordinating Center. Keep a copy for your files.

    Header
    Description

    Header

    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

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

    Patient ID ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    text

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

    Generic drug form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step (Place ID Label Here)
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient Initials (Last, First)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participating Group Protocol Number
    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
    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
    Off Treatment Report Period (since registration Choose one)
    Description

    PersonOff-TreatmentTimePeriodType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus Property-2
    C25601
    UMLS 2011AA Property-2
    C1518544
    NCI Thesaurus Property-3
    C25207
    UMLS 2011AA Property-3
    C0040223
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Unnamed2
    Description

    Unnamed2

    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    Description

    Data amended

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended (s M D Y)
    Description

    Data amended date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25416
    NCI Thesaurus ValueDomain-2
    C25367
    Vital Status
    Description

    Vital Status

    Patient's Vital Status
    Description

    Patient Status

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3846084
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25717
    Date of Last Contact or Death (M D Y)
    Description

    Date last contact

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C0805839
    NCI Thesaurus Property
    C25461
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Primary Cause of Death
    Description

    Primary Cause of Death

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C28554
    NCI Thesaurus ValueDomain-2
    C25251
    Describe cause of death
    Description

    Cause of Death, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Section Ii - Reporting Period
    Description

    Section Ii - Reporting Period

    Reporting Period Start Date (M D Y)
    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 (M D Y)
    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
    Section Iv - Notice Of New Primary
    Description

    Section Iv - Notice Of New Primary

    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    Description

    NewCancerDiagnosisInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Site of new primary (s)
    Description

    NewCancerSiteText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    Section Iii - Disease Follow-up Status
    Description

    Section Iii - Disease Follow-up Status

    Has the patient had a documented clinical assessment for this cancer (this reporting period)
    Description

    Documented clinical assessment for this cancer

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1522577
    NCI Thesaurus Property
    C16033
    UMLS CUI-2
    C0006826
    NCI Thesaurus ObjectClass
    C9305
    NCI Thesaurus Property-2
    C25365
    If unknown, please explain
    Description

    CancerUnknownFollow-upAssessmentSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C17998
    UMLS 2011AA Property-2
    C0439673
    NCI Thesaurus Property-3
    C16033
    UMLS 2011AA Property-3
    C1522577
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Date of last clinical assessment (If yes M D Y Submit E5508 Follow-up Disease Evaluation Form RECIST)
    Description

    Follow-Up Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS CUI-1
    C3694716
    NCI Thesaurus Property
    C16033
    NCI Thesaurus Property-2
    C25365
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Has the patient developed a first progression that has not been previously reported? (or relapse)
    Description

    DiseaseProgressionInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    If unknown, please explain
    Description

    ProgressiveDiseaseUnknownAssessmentSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C25254
    UMLS 2011AA ObjectClass-2
    C0205329
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C17998
    UMLS 2011AA Property-2
    C0439673
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Date of progression (If yes, relapse M D Y Submit E5508 Follow-up Disease Evaluation Form RECIST)
    Description

    DiseaseProgressionDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Site(s) of progression
    Description

    Progression Sites

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0280457
    NCI Thesaurus Property
    C25341
    NCI Thesaurus ObjectClass
    C25331
    Did a physician make a formal diagnosis of progressive disease?
    Description

    PhysicianProgressiveDiagnosisInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25741
    UMLS 2011AA ObjectClass
    C0031831
    NCI Thesaurus Property
    C25254
    UMLS 2011AA Property
    C0205329
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    Specify basis of progression (If no or unknown)
    Description

    ProgressionDiagnosisSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Section V - Adverse Events
    Description

    Section V - Adverse Events

    Has the patient experienced any severe (Grade = 3) long term toxicity that has not been previously reported? (prior to diagnosis of progression/relapse)
    Description

    RadiationTherapyOncologyGroupAdverseEventRelapseReportInd-3

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C19778
    UMLS 2011AA ObjectClass
    C1514695
    NCI Thesaurus ObjectClass-2
    C41331
    UMLS 2011AA ObjectClass-2
    C0877248
    NCI Thesaurus Property
    C18265
    NCI Thesaurus Property-2
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Section Vi - Non-protocol Therapy Prior To Progression
    Description

    Section Vi - Non-protocol Therapy Prior To Progression

    Has the patient received any non-protocol cancer therapy prior to first recurrence (not previously reported)
    Description

    Non-ProtocolTherapyFirstRecurrenceInd-3

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C3352
    UMLS 2011AA Property
    C0034897
    NCI Thesaurus Property-2
    C25509
    UMLS 2011AA Property-2
    C1279901
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Comments
    Description

    Comments

    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date (M D Y)
    Description

    Investigator Signature Date

    Data type

    date

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

    Similar models

    INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule). Submit original to the ECOG Coordinating Center. Keep a copy for your files.

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step (Place ID Label Here)
    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)
    Patient Initials
    Item
    Patient Initials (Last, First)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    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)
    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)
    Item
    Off Treatment Report Period (since registration Choose one)
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25601 (NCI Thesaurus Property-2)
    C1518544 (UMLS 2011AA Property-2)
    C25207 (NCI Thesaurus Property-3)
    C0040223 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Off Treatment Report Period (since registration Choose one)
    CL Item
    3 Months (3 Months Post Registration)
    CL Item
    6 Months (6 Months Post Registration)
    CL Item
    9 Months (9 Months Post Registration)
    CL Item
    12 Months (12 Months Post Registration)
    CL Item
    15 Months (15 Months Post Registration)
    CL Item
    18 Months (18 Months Post Registration)
    CL Item
    21 Months Post Registration (21 Months Post Registration)
    CL Item
    2 Years (24 Months Post Registration)
    CL Item
    30 Months (30 Months Post Registration)
    CL Item
    3 Years (36 Months Post Registration)
    CL Item
    42 Months (42 Months Post Registration)
    CL Item
    4 Years (48 Months Post Registration)
    CL Item
    54 Months (54 Months Post Registration)
    CL Item
    5 Years (60 Months Post Registration)
    Item Group
    Unnamed2
    Data amended
    Item
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended (s M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Vital Status
    Item
    Patient's Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Date last contact
    Item
    Date of Last Contact or Death (M D Y)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0805839 (UMLS CUI-1)
    C25461 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Primary Cause of Death
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    Code List
    Primary Cause of Death
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Cause of Death, specify
    Item
    Describe cause of death
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1521902 (UMLS CUI-2)
    C28554 (NCI Thesaurus Property)
    Item Group
    Section Ii - Reporting Period
    Reporting Period Start Date
    Item
    Reporting Period Start Date (M D Y)
    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 (M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Item Group
    Section Iv - Notice Of New Primary
    Item
    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Code List
    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    NewCancerSiteText
    Item
    Site of new primary (s)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    Item Group
    Section Iii - Disease Follow-up Status
    Item
    Has the patient had a documented clinical assessment for this cancer (this reporting period)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1522577 (UMLS CUI-1)
    C16033 (NCI Thesaurus Property)
    C0006826 (UMLS CUI-2)
    C9305 (NCI Thesaurus ObjectClass)
    C25365 (NCI Thesaurus Property-2)
    Code List
    Has the patient had a documented clinical assessment for this cancer (this reporting period)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CancerUnknownFollow-upAssessmentSpecify
    Item
    If unknown, please explain
    text
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C17998 (NCI Thesaurus Property-2)
    C0439673 (UMLS 2011AA Property-2)
    C16033 (NCI Thesaurus Property-3)
    C1522577 (UMLS 2011AA Property-3)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Follow-Up Date
    Item
    Date of last clinical assessment (If yes M D Y Submit E5508 Follow-up Disease Evaluation Form RECIST)
    date
    C9305 (NCI Thesaurus ObjectClass)
    C3694716 (UMLS CUI-1)
    C16033 (NCI Thesaurus Property)
    C25365 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Has the patient developed a first progression that has not been previously reported? (or relapse)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Code List
    Has the patient developed a first progression that has not been previously reported? (or relapse)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    ProgressiveDiseaseUnknownAssessmentSpecify
    Item
    If unknown, please explain
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25254 (NCI Thesaurus ObjectClass-2)
    C0205329 (UMLS 2011AA ObjectClass-2)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C17998 (NCI Thesaurus Property-2)
    C0439673 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    DiseaseProgressionDate
    Item
    Date of progression (If yes, relapse M D Y Submit E5508 Follow-up Disease Evaluation Form RECIST)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25331 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Progression Sites
    Item
    Site(s) of progression
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0280457 (UMLS CUI-1)
    C25341 (NCI Thesaurus Property)
    C25331 (NCI Thesaurus ObjectClass)
    Item
    Did a physician make a formal diagnosis of progressive disease?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C25254 (NCI Thesaurus Property)
    C0205329 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    Code List
    Did a physician make a formal diagnosis of progressive disease?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    ProgressionDiagnosisSpecify
    Item
    Specify basis of progression (If no or unknown)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Item Group
    Section V - Adverse Events
    Item
    Has the patient experienced any severe (Grade = 3) long term toxicity that has not been previously reported? (prior to diagnosis of progression/relapse)
    text
    C19778 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS 2011AA ObjectClass)
    C41331 (NCI Thesaurus ObjectClass-2)
    C0877248 (UMLS 2011AA ObjectClass-2)
    C18265 (NCI Thesaurus Property)
    C25375 (NCI Thesaurus Property-2)
    C0684224 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Has the patient experienced any severe (Grade = 3) long term toxicity that has not been previously reported? (prior to diagnosis of progression/relapse)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Section Vi - Non-protocol Therapy Prior To Progression
    Item
    Has the patient received any non-protocol cancer therapy prior to first recurrence (not previously reported)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass)
    C3352 (NCI Thesaurus Property)
    C0034897 (UMLS 2011AA Property)
    C25509 (NCI Thesaurus Property-2)
    C1279901 (UMLS 2011AA Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Has the patient received any non-protocol cancer therapy prior to first recurrence (not previously reported)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Comments
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date (M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)

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