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ID

11580

Descrição

E2805 Adverse Event Form - (CTCAE v3) NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0538F350-3C05-47A5-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0538F350-3C05-47A5-E044-0003BA3F9857

Palavras-chave

Versões (5)
  1. 19/09/2012 19/09/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 09/01/2015 09/01/2015 - Martin Dugas
  5. 08/07/2015 08/07/2015 -
Transferido a

8 de julho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    E2805 Adverse Event Form - (CTCAE v3) NCT00326898

    Inglês

    INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

    1 Formulários  
    Header
    Descrição

    Header

    ECOG Protocol Number
    Descrição

    Protocol Number ECOG

    Tipo de dados

    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
    Descrição

    Patient ID ECOG

    Tipo de dados

    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
    Descrição

    Generic drug form

    Tipo de dados

    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
    Descrição

    Registration Number

    Tipo de dados

    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 demographics
    Descrição

    Patient demographics

    ECOG Protocol Number
    Descrição

    Protocol Number ECOG

    Tipo de dados

    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
    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Patient ID
    Descrição

    Patient ID ECOG

    Tipo de dados

    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
    Participating Group Protocol Number
    Descrição

    Study Number Participating Group

    Tipo de dados

    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
    Institution/Affiliate
    Descrição

    Institution Name

    Tipo de dados

    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 Patient ID
    Descrição

    Trial subject ID Participating Group

    Tipo de dados

    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
    Data amendment
    Descrição

    Data amendment

    Please mark an 'X' if data have been amended.
    Descrição

    Data amended

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended
    Descrição

    Data amended date

    Tipo de dados

    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
    On Treatment
    Descrição

    On Treatment

    On Treatment Report Period (Choose one)
    Descrição

    Cycle number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Off Treatment
    Descrição

    Off Treatment

    Off Treatment Report Period (since registration)
    Descrição

    PersonOff-TreatmentTimePeriodType

    Tipo de dados

    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
    Adverse Event Current Assessment
    Descrição

    Adverse Event Current Assessment

    Were adverse events assessed during this report period (cycle)
    Descrição

    AdverseEventCurrentAssessmentInd

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C25471
    UMLS 2011AA Property-2
    C0521116
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    CTC Adverse Event Report Begin Date
    Descrição

    Adverse Event Start Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC Adverse Event Report End Date
    Descrição

    Adverse Event End Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697886
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass
    C49704
    Blood/bone Marrow/metabolic - Labs
    Descrição

    Blood/bone Marrow/metabolic - Labs

    CTC Adverse Event Term
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    Adverse Event Start Date
    Descrição

    AdverseEventSymptomBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Adverse Event End Date
    Descrição

    AdverseEventSymptomEndDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Mark an 'X' if continuing from prior cycle.
    Descrição

    PriorAdverseEventContinuedText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Metathesaurus Property
    C0750536
    CTC Adverse Event Grade (v3.0)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Action Taken at Time of Adverse Event
    Descrição

    AdverseEventActionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Outcome of Adverse Event
    Descrição

    AdverseEventOutcomeType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    AE Expedited report filed? (Check box if yes)
    Descrição

    AdverseDrugExperienceReportText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Metathesaurus ObjectClass
    C0085425
    NCI Thesaurus Property
    C25175
    UMLS 2011AA Property
    C1522646
    NON-HEMATOLOGIC
    Descrição

    NON-HEMATOLOGIC

    CTC Adverse Event Term
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    Adverse Event Start Date
    Descrição

    AdverseEventSymptomBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Adverse Event End Date
    Descrição

    AdverseEventSymptomEndDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Mark an 'X' if continuing from prior cycle.
    Descrição

    PriorAdverseEventContinuedText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Metathesaurus Property
    C0750536
    CTC Adverse Event Grade (v3.0)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Action Taken at Time of Adverse Event
    Descrição

    AdverseEventActionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Outcome of Adverse Event
    Descrição

    AdverseEventOutcomeType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    AE Expedited report filed? (Check box if yes)
    Descrição

    AdverseDrugExperienceReportText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Metathesaurus ObjectClass
    C0085425
    NCI Thesaurus Property
    C25175
    UMLS 2011AA Property
    C1522646
    Ii. Infections
    Descrição

    Ii. Infections

    CommonToxicity --CTC Adverse Event Short Name (Specify site for each event)
    Descrição

    CommonToxicity --CTC Adverse Event Short Name (Specify site for each event)

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C49704
    NCI Metathesaurus ValueDomain
    C0332307
    NCI Thesaurus Property-2
    C25249
    UMLS CUI-1
    C0600091
    UMLS CUI-2
    C1516728
    UMLS CUI-3
    C1806781
    CTC Select AE
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C38024
    NCI Thesaurus Property-2
    C45559
    CTC Adverse Event Grade (v3.0)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Action Taken at Time of Adverse Event
    Descrição

    AdverseEventActionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Outcome of Adverse Event
    Descrição

    AdverseEventOutcomeType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    AE Expedited report filed? (Check box if yes)
    Descrição

    AdverseDrugExperienceReportText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Metathesaurus ObjectClass
    C0085425
    NCI Thesaurus Property
    C25175
    UMLS 2011AA Property
    C1522646
    Other Adverse Events
    Descrição

    Other Adverse Events

    Other CTC Adverse Event Term not listed
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    Other, Specify (site/sub-term)
    Descrição

    CTC Adverse Event Reported Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2699044
    NCI Thesaurus Property
    C25161
    CTC Adverse Event Grade (v3.0)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Action Taken at Time of Adverse Event
    Descrição

    AdverseEventActionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Outcome of Adverse Event
    Descrição

    AdverseEventOutcomeType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    AE Expedited report filed? (Check box if yes)
    Descrição

    AdverseDrugExperienceReportText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Metathesaurus ObjectClass
    C0085425
    NCI Thesaurus Property
    C25175
    UMLS 2011AA Property
    C1522646
    Comments
    Descrição

    Comments

    Investigator Signature
    Descrição

    Investigator Signature

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Descrição

    Investigator Signature Date

    Tipo de dados

    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
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    Similar models

    INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    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)
    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
    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)
    Item Group
    Patient demographics
    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 Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    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)
    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)
    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)
    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
    Data amendment
    Data amended
    Item
    Please mark an 'X' if data have been amended.
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended
    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
    On Treatment
    Item
    On Treatment Report Period (Choose one)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    CL.1
    Code List
    On Treatment Report Period (Choose one)
    CL Item
    Cycle 1 (Cycle 1)
    CL Item
    Cycle 2 (Cycle 2)
    CL Item
    Cycle 3 (Cycle 3)
    CL Item
    Cycle 4 (Cycle 4)
    CL Item
    Cycle 5 (Cycle 5)
    CL Item
    Cycle 6 (Cycle 6)
    CL Item
    Cycle 7 (Cycle 7)
    CL Item
    Cycle 8 (Cycle 8)
    CL Item
    Cycle 9 (Cycle 9)
    Item Group
    Off Treatment
    Item
    Off Treatment Report Period (since registration)
    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)
    CL.2
    Code List
    Off Treatment Report Period (since registration)
    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)
    CL Item
    6 Years (72 months post registration)
    CL Item
    84 Months Post Registration (84 months post registration)
    CL Item
    8 Years (96 months post registration)
    CL Item
    9 Years (108 months post registration)
    CL Item
    10 Years (120 months post registration)
    Item Group
    Adverse Event Current Assessment
    Item
    Were adverse events assessed during this report period (cycle)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    CL.3
    Code List
    Were adverse events assessed during this report period (cycle)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
    CL Item
    Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
    Adverse Event Start Date
    Item
    CTC Adverse Event Report Begin Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Adverse Event End Date
    Item
    CTC Adverse Event Report End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697886 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    Item Group
    Blood/bone Marrow/metabolic - Labs
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CL.9
    Code List
    CTC Adverse Event Term
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Constipation (Constipation)
    C37930 (NCI Thesaurus)
    C0009806 (UMLS 2011AA)
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Fatigue (Fatigue (asthenia, lethargy, malaise))
    C3036 (NCI Thesaurus)
    C0015672 (UMLS 2011AA)
    CL Item
    Dyspepsia (Heartburn/dyspepsia)
    C26756 (NCI Thesaurus)
    C0013395 (UMLS 2011AA)
    CL Item
    Hypopigmentation (Hypopigmentation)
    CL Item
    Hypertension Nos (Hypertension)
    CL Item
    Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Localised Exfoliation (Rash: hand-foot skin reaction)
    CL Item
    Hypothyroidism (Thyroid function, low (hypothyroidism))
    C26800 (NCI Thesaurus)
    C0020676 (UMLS 2011AA)
    CL Item
    Vomiting Nos (Vomiting)
    AdverseEventSymptomBeginDate
    Item
    Adverse Event Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    AdverseEventSymptomEndDate
    Item
    Adverse Event End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    PriorAdverseEventContinuedText
    Item
    Mark an 'X' if continuing from prior cycle.
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C0750536 (NCI Metathesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (v3.0)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.20
    Code List
    CTC AE Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    CL.21
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    There Was No Action Taken Based On The Adverse Event (none)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.22
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (resolved)
    CL Item
    Adverse Event Has Improved (improved)
    CL Item
    Adverse Event Is Unchanged (unchanged)
    CL Item
    Adverse Event Is Worse (worsened)
    CL Item
    Adverse Event Was Fatal (fatal)
    AdverseDrugExperienceReportText
    Item
    AE Expedited report filed? (Check box if yes)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C0085425 (NCI Metathesaurus ObjectClass)
    C25175 (NCI Thesaurus Property)
    C1522646 (UMLS 2011AA Property)
    Item Group
    NON-HEMATOLOGIC
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CL.9
    Code List
    CTC Adverse Event Term
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Constipation (Constipation)
    C37930 (NCI Thesaurus)
    C0009806 (UMLS 2011AA)
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Fatigue (Fatigue (asthenia, lethargy, malaise))
    C3036 (NCI Thesaurus)
    C0015672 (UMLS 2011AA)
    CL Item
    Dyspepsia (Heartburn/dyspepsia)
    C26756 (NCI Thesaurus)
    C0013395 (UMLS 2011AA)
    CL Item
    Hypopigmentation (Hypopigmentation)
    CL Item
    Hypertension Nos (Hypertension)
    CL Item
    Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Localised Exfoliation (Rash: hand-foot skin reaction)
    CL Item
    Hypothyroidism (Thyroid function, low (hypothyroidism))
    C26800 (NCI Thesaurus)
    C0020676 (UMLS 2011AA)
    CL Item
    Vomiting Nos (Vomiting)
    AdverseEventSymptomBeginDate
    Item
    Adverse Event Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    AdverseEventSymptomEndDate
    Item
    Adverse Event End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    PriorAdverseEventContinuedText
    Item
    Mark an 'X' if continuing from prior cycle.
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C0750536 (NCI Metathesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (v3.0)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.20
    Code List
    CTC AE Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    CL.21
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    There Was No Action Taken Based On The Adverse Event (none)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.22
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (resolved)
    CL Item
    Adverse Event Has Improved (improved)
    CL Item
    Adverse Event Is Unchanged (unchanged)
    CL Item
    Adverse Event Is Worse (worsened)
    CL Item
    Adverse Event Was Fatal (fatal)
    AdverseDrugExperienceReportText
    Item
    AE Expedited report filed? (Check box if yes)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C0085425 (NCI Metathesaurus ObjectClass)
    C25175 (NCI Thesaurus Property)
    C1522646 (UMLS 2011AA Property)
    Item Group
    Ii. Infections
    Item
    CommonToxicity --CTC Adverse Event Short Name (Specify site for each event)
    text
    C25364 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    C0332307 (NCI Metathesaurus ValueDomain)
    C25249 (NCI Thesaurus Property-2)
    C0600091 (UMLS CUI-1)
    C1516728 (UMLS CUI-2)
    C1806781 (UMLS CUI-3)
    CL.14
    Code List
    CommonToxicity --CTC Adverse Event Short Name (Specify site for each event)
    CL Item
    Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - select)
    CL Item
    Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - select)
    CL Item
    Infection With Unknown Anc (Infection with unknown ANC - select)
    CTC Adverse Event Term
    Item
    CTC Select AE
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C38024 (NCI Thesaurus Property)
    C45559 (NCI Thesaurus Property-2)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (v3.0)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.20
    Code List
    CTC AE Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    CL.21
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    There Was No Action Taken Based On The Adverse Event (none)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.22
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (resolved)
    CL Item
    Adverse Event Has Improved (improved)
    CL Item
    Adverse Event Is Unchanged (unchanged)
    CL Item
    Adverse Event Is Worse (worsened)
    CL Item
    Adverse Event Was Fatal (fatal)
    AdverseDrugExperienceReportText
    Item
    AE Expedited report filed? (Check box if yes)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C0085425 (NCI Metathesaurus ObjectClass)
    C25175 (NCI Thesaurus Property)
    C1522646 (UMLS 2011AA Property)
    Item Group
    Other Adverse Events
    CTC Adverse Event Term
    Item
    Other CTC Adverse Event Term not listed
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Reported Term
    Item
    Other, Specify (site/sub-term)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2699044 (UMLS CUI-2)
    C25161 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (v3.0)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.20
    Code List
    CTC AE Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    CL.21
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    There Was No Action Taken Based On The Adverse Event (none)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.22
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (resolved)
    CL Item
    Adverse Event Has Improved (improved)
    CL Item
    Adverse Event Is Unchanged (unchanged)
    CL Item
    Adverse Event Is Worse (worsened)
    CL Item
    Adverse Event Was Fatal (fatal)
    AdverseDrugExperienceReportText
    Item
    AE Expedited report filed? (Check box if yes)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C0085425 (NCI Metathesaurus ObjectClass)
    C25175 (NCI Thesaurus Property)
    C1522646 (UMLS 2011AA Property)
    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
    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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