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9665

Description

RTOG 0848: Phase III Pancreas-Resected + Adjuvant Treatment Additional Systemic Treatment Summary Form (AT) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AFC2AE9-5C38-1FC0-E040-BB89AD4334D1

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AFC2AE9-5C38-1FC0-E040-BB89AD4334D1

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Pancreatic Cancer NCT01013649 Treatment - RTOG 0848: Phase III Pancreas-Resected + Adjuvant Treatment Additional Systemic Treatment Summary Form (AT) - 2891794v1.0

    English

    INSTRUCTIONS: Form is submitted 1 week after completion of final Gemcitiabine +/- Erlotinib after step 2 registration. All 4 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified.

    1 forms  
    Module 1
    Description

    Module 1

    RTOG Study No.
    Description

    Protocol ID RTOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Case #
    Description

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19778
    UMLS 2011AA ObjectClass-2
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C49152
    UMLS 2011AA Property-2
    C1706256
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Institution Name
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Institution No.
    Description

    Institution Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Patient Initials
    Description

    Patient Initials

    Data type

    text

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

    Trial subject ID RTOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    Description

    Data amended

    Data type

    boolean

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

    Header

    Assigned Treatment Arm First Randomization
    Description

    ProtocolTreatmentArmFirstRandomizationAssignmentType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    NCI Thesaurus Property-2
    C32141
    UMLS 2011AA Property-2
    C1140618
    NCI Thesaurus Property-3
    C25509
    UMLS 2011AA Property-3
    C1279901
    NCI Thesaurus Property-4
    C25426
    UMLS 2011AA Property-4
    C1516050
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Assessment
    Description

    Assessment

    Height (CM)
    Description

    Patient Height

    Data type

    float

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight (CM)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    BSA
    Description

    Body Surface Area

    Data type

    float

    Measurement units
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Unnamed 3
    Description

    Unnamed 3

    Agent Name
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Date Agent Started (MM DD YYYY)
    Description

    Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1521826
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C0808070
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Date Agent Ended (MM DD YYYY)
    Description

    Medication End Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25275
    Total Dose
    Description

    Cumulative Dose Agent

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C2986497
    NCI Thesaurus ObjectClass-2
    C25470
    UMLS CUI-2
    C1521826
    NCI Thesaurus Property
    C25304
    NCI Thesaurus Property-2
    C25256
    NCI Thesaurus ValueDomain
    C25304
    NCI Thesaurus ValueDomain-2
    C25488
    Dose Modification (Change)
    Description

    Dose Modification

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    Reason Treatment Ended
    Description

    Off Treatment Reason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    Alternative therapy, specify
    Description

    Alternative therapy, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0949216
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25415
    NCI Thesaurus Property
    C25382
    Other Complicating Disease specify
    Description

    Off Treatment Reason, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902
    NCI Thesaurus Property-2
    C25455
    Other specify
    Description

    Off Treatment Reason, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902
    Details of any treatment modification
    Description

    TherapyModificationText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    Dose modification
    Description

    Dose Modification Status

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Other, specify
    Description

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Protocol Specific Adverse Event Evaluation
    Description

    Protocol Specific Adverse Event Evaluation

    Any adverse events
    Description

    Adverse Event

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25648
    UMLS CUI-1
    C0877248
    NCI Thesaurus ObjectClass-2
    C41331
    NCI Thesaurus ObjectClass-3
    C15368
    NCI Metathesaurus Property
    C0684224
    NCI Thesaurus ValueDomain
    C38148
    MedDRA disease code
    Description

    MedDRACode

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC AE Term
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE Grade
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE Begin Date (MM DD YYYY)
    Description

    Adverse Event Start Date

    Data type

    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 Attribution Code
    Description

    CTC Adverse Event Attribution Category

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    SAE report submitted
    Description

    SAE report

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    Unnamed Module 4
    Description

    Unnamed Module 4

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    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
    Date
    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
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    INSTRUCTIONS: Form is submitted 1 week after completion of final Gemcitiabine +/- Erlotinib after step 2 registration. All 4 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified.

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Module 1
    Protocol ID RTOG
    Item
    RTOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
    Item
    Case #
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass-2)
    C1514695 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49152 (NCI Thesaurus Property-2)
    C1706256 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Trial subject ID RTOG
    Item
    RTOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Data amended
    Item
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Header
    Item
    Assigned Treatment Arm First Randomization
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C0442711 (UMLS 2011AA ObjectClass)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C32141 (NCI Thesaurus Property-2)
    C1140618 (UMLS 2011AA Property-2)
    C25509 (NCI Thesaurus Property-3)
    C1279901 (UMLS 2011AA Property-3)
    C25426 (NCI Thesaurus Property-4)
    C1516050 (UMLS 2011AA Property-4)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Assigned Treatment Arm First Randomization
    CL Item
    Arm 1 (Arm 1)
    CL Item
    Arm 2 (Arm 2)
    Item Group
    Assessment
    Patient Height
    Item
    Height (CM)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (CM)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    BSA
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item Group
    Unnamed 3
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Medication Start Date
    Item
    Date Agent Started (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1521826 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0808070 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Medication End Date
    Item
    Date Agent Ended (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25275 (NCI Thesaurus Property)
    Cumulative Dose Agent
    Item
    Total Dose
    float
    C1708 (NCI Thesaurus ObjectClass)
    C2986497 (UMLS CUI-1)
    C25470 (NCI Thesaurus ObjectClass-2)
    C1521826 (UMLS CUI-2)
    C25304 (NCI Thesaurus Property)
    C25256 (NCI Thesaurus Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C25488 (NCI Thesaurus ValueDomain-2)
    Item
    Dose Modification (Change)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    CL.3
    Code List
    Dose Modification (Change)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
    Item
    Reason Treatment Ended
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    CL.4
    Code List
    Reason Treatment Ended
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Death On Study (Death on study)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    Alternative therapy, specify
    Item
    Alternative therapy, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0949216 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25415 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Off Treatment Reason, specify
    Item
    Other Complicating Disease specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)
    C25455 (NCI Thesaurus Property-2)
    Off Treatment Reason, specify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)
    TherapyModificationText
    Item
    Details of any treatment modification
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.5
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Held (Dose held)
    CL Item
    Permanent Reduction (Permanent Reduction)
    CL Item
    Non-permanent Reduction (Non-Permanent Reduction)
    CL Item
    Dose Re-escalated (Re-escalated)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item Group
    Protocol Specific Adverse Event Evaluation
    Item
    Any adverse events
    text
    C25648 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass-2)
    C15368 (NCI Thesaurus ObjectClass-3)
    C0684224 (NCI Metathesaurus Property)
    C38148 (NCI Thesaurus ValueDomain)
    CL.6
    Code List
    Any adverse events
    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)
    MedDRACode
    Item
    MedDRA disease code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CTC Adverse Event Term
    Item
    CTC AE Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Start Date
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTC Adverse Event Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.8
    Code List
    CTC Adverse Event Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    CL.9
    Code List
    SAE report submitted
    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
    Unnamed Module 4
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    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
    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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