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ID

11923

Description

Southwest Oncology Group S0518 Treatment Form NCT00569127 Octreotide and Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F23B84D-2C40-70EC-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F23B84D-2C40-70EC-E044-0003BA3F9857

Mots-clés

  1. 19/09/2012 19/09/2012 -
  2. 30/12/2014 30/12/2014 - Martin Dugas
  3. 22/08/2015 22/08/2015 - Martin Dugas
Téléchargé le

22 août 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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    Treatment Neuroendocrine Carcinoma SWOG S0518 NCT00569127

    No Instruction available.

    1. StudyEvent: Southwest Oncology Group S0518 Treatment Form
      1. No Instruction available.
    Administrative documentation
    Description

    Administrative documentation

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    SWOG Patient ID
    Description

    Trial subject ID SWOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    SWOG Study No.
    Description

    Protocol ID SWOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C1519429 (SWOG)
    LOINC
    LA4458-1
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25699 (undefined)
    Registration Step
    Description

    Registration Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C1514821 (Registration)
    NCI Thesaurus ObjectClass
    C25646 (undefined)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus Property
    C16154 (undefined)
    NCI Thesaurus ValueDomain-2
    C16154 (undefined)
    Current Cycle Number
    Description

    Cycle Number Chemotherapeutics

    Type de données

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2045829 (chemotherapeutics regimen status cycle number)
    NCI Thesaurus Property
    C25471 (undefined)
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property-2
    C25379 (undefined)
    Patient Initials (L, F M)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Institution/Affiliate
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454 (undefined)
    UMLS CUI-1
    C1301943 (Institution name)
    SNOMED
    398321007
    NCI Thesaurus ObjectClass-2
    C21541 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    NCI Thesaurus ValueDomain-2
    C21541 (undefined)
    Physician
    Description

    Investigator Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2826892 (Investigator Name)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    NCI Thesaurus ObjectClass-2
    C25644 (undefined)
    Participating Group Name
    Description

    Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus ObjectClass
    C25608 (undefined)
    NCI Thesaurus ObjectClass-2
    C17005 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Participating Study No.
    Description

    Study Number Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Participating Patient ID
    Description

    Trial subject ID Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    Status
    Description

    Status

    Alias
    UMLS CUI-1
    C0589120 (Follow-up status)
    SNOMED
    308273005
    LOINC
    LA9177-2
    Date of Last Contact or Death
    Description

    Date last contact

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-1
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    NCI Thesaurus Property
    C25461 (undefined)
    NCI Thesaurus Property-2
    C25551 (undefined)
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    NCI Thesaurus ValueDomain-2
    C25367 (undefined)
    Vital Status
    Description

    Patient Status

    Type de données

    integer

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus ValueDomain
    C18003 (undefined)
    NCI Thesaurus ValueDomain-2
    C25688 (undefined)
    NCI Thesaurus Property
    C25717 (undefined)
    UMLS CUI-1
    C3846084 (undefined)
    Has the patient progressed?
    Description

    Has the patient progressed per the definition in Section 10.0 of the protocol?

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25320 (undefined)
    NCI Thesaurus Property-2
    C19987 (undefined)
    UMLS CUI-1
    C0178874 (Tumor Progression)
    SNOMED
    419835002
    Treatment for This Cycle
    Description

    Treatment for This Cycle

    Alias
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    UMLS CUI-2
    C0521116 (Current (present time))
    SNOMED
    15240007
    Assigned Treatment Arm
    Description

    Protocol Treatment Arm

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ObjectClass-2
    C42651 (undefined)
    UMLS CUI-1
    C1522541 (Protocol Treatment Arm)
    NCI Thesaurus Property
    C32141 (undefined)
    NCI Thesaurus Property-2
    C25426 (undefined)
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    Cycle Start Date
    Description

    Chemotherapy Cycle Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ValueDomain-2
    C25431 (undefined)
    UMLS CUI-2
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    NCI Thesaurus Property
    C25379 (undefined)
    Date of last treatment for this cycle
    Description

    Chemotherapy Cycle End Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property
    C25379 (undefined)
    UMLS CUI-2
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Body weight
    Description

    Weight (first day this cycle - kg)

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    NCI Thesaurus ValueDomain
    C25209 (undefined)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25208 (undefined)
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Body surface area
    Description

    BSA (first day this cycle - m2)

    Type de données

    float

    Unités de mesure
    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    NCI Thesaurus ValueDomain
    C25712 (undefined)
    NCI Thesaurus Property
    C25157 (undefined)
    UMLS CUI [1]
    C0005902 (Body Surface Area)
    SNOMED
    301898006
    Were there any dose modifications or additions/omissions to protocol treatment?
    Description

    Dose Modification

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS CUI-1
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25256 (undefined)
    NCI Thesaurus Property
    C25572 (undefined)
    NCI Thesaurus ValueDomain-2
    C25572 (undefined)
    Agent Name
    Description

    Agent

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS CUI-1
    C1521826 (Protocol Agent)
    NCI Thesaurus ObjectClass
    C1708 (undefined)
    NCI Thesaurus ValueDomain
    C1708 (undefined)
    NCI Thesaurus ValueDomain-2
    C42614 (undefined)
    Total Dose (this cycle)
    Description

    Cumulative Dose Agent

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C1708 (undefined)
    UMLS CUI-1
    C2986497 (Cumulative Dose)
    NCI Thesaurus ObjectClass-2
    C25470 (undefined)
    UMLS CUI-2
    C1521826 (Protocol Agent)
    NCI Thesaurus Property
    C25304 (undefined)
    NCI Thesaurus Property-2
    C25256 (undefined)
    NCI Thesaurus ValueDomain
    C25304 (undefined)
    NCI Thesaurus ValueDomain-2
    C25488 (undefined)
    Units
    Description

    Units

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS CUI-1
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    NCI Thesaurus ValueDomain-2
    C44278 (undefined)
    NCI Thesaurus ObjectClass
    C1708 (undefined)
    NCI Thesaurus Property
    C25256 (undefined)
    Dose modification
    Description

    Dose Modification Status

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488 (undefined)
    UMLS CUI-1
    C1707811 (Dose Modification)
    NCI Thesaurus ValueDomain
    C25688 (undefined)
    NCI Thesaurus Property
    C25572 (undefined)
    Dose Modification Reason
    Description

    Dose Modification Reason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638 (undefined)
    UMLS CUI-1
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25488 (undefined)
    UMLS CUI-2
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    NCI Thesaurus Property
    C25572 (undefined)
    Other, specify
    Description

    Dose Modification Reason, other

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS CUI-1
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25488 (undefined)
    UMLS CUI-2
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    NCI Thesaurus Property
    C25572 (undefined)
    Modification due to Adverse Event
    Description

    Adverse Event causing Dose Modification

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638 (undefined)
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Thesaurus Property
    C41331 (undefined)
    UMLS CUI-2
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25488 (undefined)
    UMLS CUI-3
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    NCI Thesaurus Property-2
    C25572 (undefined)
    Other, specify
    Description

    Adverse Event causing Dose Modification, other

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Thesaurus Property
    C41331 (undefined)
    UMLS CUI-2
    C1707811 (Dose Modification)
    NCI Thesaurus ObjectClass
    C25488 (undefined)
    UMLS CUI-3
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    NCI Thesaurus Property-2
    C25572 (undefined)
    Cycle 1 Only, All Patients
    Description

    Cycle 1 Only, All Patients

    Alias
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    UMLS CUI-2
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    Comments
    Description

    Research Comments

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    NCI Thesaurus ObjectClass
    C15319 (undefined)
    NCI Thesaurus Property
    C25393 (undefined)

    Similar models

    No Instruction available.

    1. StudyEvent: Southwest Oncology Group S0518 Treatment Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative documentation
    C1320722 (UMLS CUI-1)
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Protocol ID SWOG
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-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)
    Cycle Number Chemotherapeutics
    Item
    Current Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    Patient Initials
    Item
    Patient Initials (L, F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    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)
    Investigator Name
    Item
    Physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    C2348585 (UMLS CUI-1)
    C2347449 (UMLS CUI-2)
    Item Group
    Status
    C0589120 (UMLS CUI-1)
    Date last contact
    Item
    Date of Last Contact or Death
    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
    Vital Status
    integer
    C16960 (NCI Thesaurus ObjectClass)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    C3846084 (UMLS CUI-1)
    Code List
    Vital Status
    CL Item
    Alive (1)
    CL Item
    Dead (0)
    Tumor Progression
    Item
    Has the patient progressed?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25320 (NCI Thesaurus Property)
    C19987 (NCI Thesaurus Property-2)
    C0178874 (UMLS CUI-1)
    Item Group
    Treatment for This Cycle
    C1302181 (UMLS CUI-1)
    C0521116 (UMLS CUI-2)
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C25426 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    Code List
    Assigned Treatment Arm
    CL Item
    Arm 1: Octreotide + Bevacizumab (Arm 1: Octreotide + Bevacizumab)
    CL Item
    Arm 1: Octreotide + Interferon Alpha 2b (Arm 1: Octreotide + Interferon alpha 2b)
    Chemotherapy Cycle Start Date
    Item
    Cycle Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C3173309 (UMLS CUI-2)
    C25379 (NCI Thesaurus Property)
    Chemotherapy Cycle End Date
    Item
    Date of last treatment for this cycle
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0806020 (UMLS CUI-2)
    Weight
    Item
    Body weight
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0005910 (UMLS CUI [1])
    BSA
    Item
    Body surface area
    float
    C25190 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    C0005902 (UMLS CUI [1])
    Item
    Were there any dose modifications or additions/omissions to protocol treatment?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment?
    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)
    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)
    Cumulative Dose Agent
    Item
    Total Dose (this cycle)
    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)
    Units
    Item
    Units
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1519795 (UMLS CUI-1)
    C44278 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25256 (NCI Thesaurus Property)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Dose Delayed And Reduced (Dose delayed and reduced)
    CL Item
    Drug Discontinued (Drug discontinued)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Disease Progression (Disease progression)
    C17747 (NCI Thesaurus)
    C0242656 (UMLS 2011AA)
    CL Item
    Death (Death)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    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
    Modification due to Adverse Event
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0877248 (UMLS CUI-1)
    C41331 (NCI Thesaurus Property)
    C1707811 (UMLS CUI-2)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    Code List
    Modification due to Adverse Event
    CL Item
    Gi Toxicity (GI toxicity)
    CL Item
    Renal Toxicity (Renal toxicity)
    CL Item
    Hepatic Toxicity (Hepatic Toxicity)
    CL Item
    Arterial Thrombotic Event (Arterial Thrombotic Event)
    CL Item
    Venous Thrombosis/embolism (Venous Thrombosis/Embolism)
    CL Item
    Hematologic Toxicity (Hematologic toxicity)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Adverse Event causing Dose Modification, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0877248 (UMLS CUI-1)
    C41331 (NCI Thesaurus Property)
    C1707811 (UMLS CUI-2)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    Item Group
    Cycle 1 Only, All Patients
    C1302181 (UMLS CUI-1)
    C0205435 (UMLS CUI-2)
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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