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ID

10171

Beschrijving

E1609 Adverse Event Form (CTCAE v4) - Arm A Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery NCT01274338 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97ED76E3-6554-CD9F-E040-BB89AD430E2E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97ED76E3-6554-CD9F-E040-BB89AD430E2E

Trefwoorden

Versies (5)
  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
  4. 09-01-15 09-01-15 - Martin Dugas
  5. 21-04-15 21-04-15 - Martin Dugas
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21 april 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    Melanoma Adverse Event E1609 NCT01274338

    Engels

    No Instruction available.

    1 Formulieren  
    1. StudyEvent: E1609 Adverse Event Form (CTCAE v4) - Arm A
      1. No Instruction available.
    Header
    Beschrijving

    Header

    Alias
    UMLS CUI-1
    C1320722
    ECOG Protocol Number
    Beschrijving

    Protocol Number ECOG

    Datatype

    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
    Beschrijving

    Patient ID ECOG

    Datatype

    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
    Beschrijving

    Generic drug form

    Datatype

    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)
    Beschrijving

    Registration Number

    Datatype

    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)
    Beschrijving

    Patient Initials

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participating Group Protocol Number
    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
    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
    Please mark an 'X' if data have been amended.
    Beschrijving

    Data amended

    Datatype

    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)
    Beschrijving

    Data amended date

    Datatype

    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
    Investigator Signature
    Beschrijving

    Investigator Signature

    Datatype

    text

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

    Investigator Signature Date

    Datatype

    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
    On Treatment
    Beschrijving

    On Treatment

    Alias
    UMLS CUI-1
    C3538994
    On Treatment Report Period
    Beschrijving

    Cycle number

    Datatype

    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 Report Period (Choose one)
    Beschrijving

    PersonOff-TreatmentTimePeriodType

    Datatype

    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
    Beschrijving

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Were adverse events assessed during this report period (cycle)
    Beschrijving

    AdverseEventCurrentAssessmentInd

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    NCI Thesaurus Property
    C20989
    NCI Thesaurus Property-2
    C25471
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-1
    C2826795
    CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y)
    Beschrijving

    Adverse Event Start Date

    Datatype

    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 (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y - mm/dd/yyyy)
    Beschrijving

    Adverse Event End Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697886
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass
    C49704
    Adverse event hematologic or metabolic
    Beschrijving

    Adverse event hematologic or metabolic

    Alias
    UMLS CUI-1
    C0877248
    CTC Adverse Event Term
    Beschrijving

    CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    NCI Thesaurus Property
    C49704
    NCI Thesaurus Property-2
    C45559
    NCI Thesaurus ValueDomain
    C45255
    NCI Thesaurus ValueDomain-2
    C49704
    NCI Thesaurus ValueDomain-3
    C42614
    NCI Thesaurus ValueDomain-4
    C45559
    NCI Thesaurus ValueDomain-5
    C25714
    UMLS CUI-1
    C2347090
    CTC Adverse Event Grade (v4.0 - this cycle/report period)
    Beschrijving

    AdverseEventSeverityGrade

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C48309
    UMLS 2011AA Property
    C0441800
    NCI Thesaurus Property-2
    C49705
    UMLS 2011AA Property-2
    C1710065
    NCI Thesaurus Property-3
    C25676
    UMLS 2011AA Property-3
    C0439793
    NCI Thesaurus ValueDomain
    C41331
    UMLS 2011AA ValueDomain
    C0877248
    NCI Thesaurus ValueDomain-2
    C48309
    UMLS 2011AA ValueDomain-2
    C0441800
    NCI Thesaurus ValueDomain-3
    C25676
    UMLS 2011AA ValueDomain-3
    C0439793
    CTC AE Attribution Code (v4.0)
    Beschrijving

    CTC AE Attribution Code (v4.0)

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    UMLS CUI-1
    C1706735
    Was this attributed to investigational protocol treatment
    Beschrijving

    AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41331
    NCI Thesaurus Property
    C15368
    NCI Thesaurus Property-2
    C28041
    NCI Thesaurus Property-3
    C15206
    NCI Thesaurus Property-4
    C25358
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0596130
    UMLS CUI-3
    C1517586
    AE Expedited report filed?
    Beschrijving

    AdverseDrugExperienceReportText

    Datatype

    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
    Mark 'X' if likely to be immune-related
    Beschrijving

    ImmuneSystemAdverseEventPresentText

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25704
    NCI Thesaurus Property
    C25626
    NCI Thesaurus ObjectClass
    C41331
    NCI Thesaurus ObjectClass-2
    C12735
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0020962
    III. Other Adverse Events (INCLUDING INFECTIONS)
    Beschrijving

    III. Other Adverse Events (INCLUDING INFECTIONS)

    Alias
    UMLS CUI-1
    C0877248
    Other, specify (specific infection or AE CTC Adverse Event Term not listed)
    Beschrijving

    CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermOtherSpecifyText

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    NCI Thesaurus Property
    C49704
    NCI Thesaurus Property-2
    C45559
    NCI Thesaurus ValueDomain
    C25685
    NCI Thesaurus ValueDomain-2
    C25704
    NCI Thesaurus ValueDomain-3
    C17649
    NCI Thesaurus ValueDomain-4
    C45255
    NCI Thesaurus ValueDomain-5
    C49704
    NCI Thesaurus ValueDomain-6
    C45559
    NCI Thesaurus ValueDomain-7
    C25714
    UMLS CUI-1
    C2347090
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    1 Formulieren
    1. StudyEvent: E1609 Adverse Event Form (CTCAE v4) - Arm A
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    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 (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)
    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 (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)
    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)
    Item Group
    On Treatment
    C3538994 (UMLS CUI-1)
    Item
    On Treatment Report Period
    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
    CL Item
    Week 1 (Week 1)
    CL Item
    Week 4 (Week 4)
    CL Item
    Week 7 (Week 7)
    CL Item
    Week 10 (Week 10)
    CL Item
    Week 12 (Week 12)
    CL Item
    Week 18 (Week 18)
    CL Item
    Week 24 (Week 24)
    CL Item
    Week 30 (Week 30)
    CL Item
    Week 36 (Week 36)
    CL Item
    Week 42 (Week 42)
    CL Item
    Week 48 (Week 48)
    CL Item
    Week 54 (Week 54)
    CL Item
    Week 60 (Week 60)
    Item
    Off Treatment Report Period (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)
    CL.2
    Code List
    Off Treatment Report Period (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)
    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)
    CL Item
    11 Years Post Registration (132 Months Post Registration)
    CL Item
    12 Years Post Registration (144 Months Post Registration)
    CL Item
    13 Years Post Registration (156 Months Post Registration)
    CL Item
    14 Years Post Registration (168 Months Post Registration)
    CL Item
    15 Years Post Registration (180 Months Post Registration)
    CL Item
    16 Years Post Registration (192 Months Post Registration)
    CL Item
    17 Years Post Registration (204 Months Post Registration)
    CL Item
    18 Years Post Registration (216 Months Post Registration)
    CL Item
    19 Years Post Registration (228 Months Post Registration)
    CL Item
    20 Years Post Registration (240 Months Post Registration)
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Item
    Were adverse events assessed during this report period (cycle)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C20989 (NCI Thesaurus Property)
    C25471 (NCI Thesaurus Property-2)
    C41331 (NCI Thesaurus ObjectClass)
    C2826795 (UMLS CUI-1)
    CL.3
    Code List
    Were adverse events assessed during this report period (cycle)
    CL Item
    No (0)
    CL Item
    Yes, But No Reportable Adverse Events Occurred (1)
    CL Item
    Yes, And Reportable Adverse Events Occurred (2)
    Adverse Event Start Date
    Item
    CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y)
    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 (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. M D Y - mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697886 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    Item Group
    Adverse event hematologic or metabolic
    C0877248 (UMLS CUI-1)
    Meddra Low Level Term
    Item
    CTC Adverse Event Term
    text
    C41331 (NCI Thesaurus ObjectClass)
    C49704 (NCI Thesaurus Property)
    C45559 (NCI Thesaurus Property-2)
    C45255 (NCI Thesaurus ValueDomain)
    C49704 (NCI Thesaurus ValueDomain-2)
    C42614 (NCI Thesaurus ValueDomain-3)
    C45559 (NCI Thesaurus ValueDomain-4)
    C25714 (NCI Thesaurus ValueDomain-5)
    C2347090 (UMLS CUI-1)
    Item
    CTC Adverse Event Grade (v4.0 - this cycle/report period)
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C48309 (NCI Thesaurus Property)
    C0441800 (UMLS 2011AA Property)
    C49705 (NCI Thesaurus Property-2)
    C1710065 (UMLS 2011AA Property-2)
    C25676 (NCI Thesaurus Property-3)
    C0439793 (UMLS 2011AA Property-3)
    C41331 (NCI Thesaurus ValueDomain)
    C0877248 (UMLS 2011AA ValueDomain)
    C48309 (NCI Thesaurus ValueDomain-2)
    C0441800 (UMLS 2011AA ValueDomain-2)
    C25676 (NCI Thesaurus ValueDomain-3)
    C0439793 (UMLS 2011AA ValueDomain-3)
    CL.12
    Code List
    CTC Adverse Event Grade (v4.0 - this cycle/report period)
    CL Item
    Mild Adverse Event (1)
    C84263 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C84264 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C84265 (NCI Thesaurus)
    C2919019 (UMLS 2011AA)
    CL Item
    Life Threatening Adverse Event (4)
    C84266 (NCI Thesaurus)
    C1517874 (UMLS 2011AA)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item
    CTC AE Attribution Code (v4.0)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    C1706735 (UMLS CUI-1)
    CL.13
    Code List
    CTC AE Attribution Code (v4.0)
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS CUI-1)
    CL Item
    Unlikely (unlikely)
    C0750558 (UMLS CUI-1)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    C0332149 (UMLS CUI-1)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    C1709683 (UMLS CUI-1)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    C1704787 (UMLS CUI-1)
    Adverse event attributed to investigational treatment
    Item
    Was this attributed to investigational protocol treatment
    boolean
    C41331 (NCI Thesaurus ObjectClass)
    C15368 (NCI Thesaurus Property)
    C28041 (NCI Thesaurus Property-2)
    C15206 (NCI Thesaurus Property-3)
    C25358 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C0877248 (UMLS CUI-1)
    C0596130 (UMLS CUI-2)
    C1517586 (UMLS CUI-3)
    AdverseDrugExperienceReportText
    Item
    AE Expedited report filed?
    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)
    Adverse event, immune-related
    Item
    Mark 'X' if likely to be immune-related
    boolean
    C25704 (NCI Thesaurus ValueDomain)
    C25626 (NCI Thesaurus Property)
    C41331 (NCI Thesaurus ObjectClass)
    C12735 (NCI Thesaurus ObjectClass-2)
    C0877248 (UMLS CUI-1)
    C0020962 (UMLS CUI-2)
    Item Group
    III. Other Adverse Events (INCLUDING INFECTIONS)
    C0877248 (UMLS CUI-1)
    CTC Adverse Event Low Level Term
    Item
    Other, specify (specific infection or AE CTC Adverse Event Term not listed)
    text
    C41331 (NCI Thesaurus ObjectClass)
    C49704 (NCI Thesaurus Property)
    C45559 (NCI Thesaurus Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C25704 (NCI Thesaurus ValueDomain-2)
    C17649 (NCI Thesaurus ValueDomain-3)
    C45255 (NCI Thesaurus ValueDomain-4)
    C49704 (NCI Thesaurus ValueDomain-5)
    C45559 (NCI Thesaurus ValueDomain-6)
    C25714 (NCI Thesaurus ValueDomain-7)
    C2347090 (UMLS CUI-1)
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