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ID

6487

Descrição

AMC-063 Velcade Administration Form (DA2) Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma NCT01016730 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=817724CA-1778-200C-E040-BB89AD434BB8

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=817724CA-1778-200C-E040-BB89AD434BB8

Palavras-chave

Versões (2)
  1. 19/09/2012 19/09/2012 -
  2. 03/01/2015 03/01/2015 - Martin Dugas
Transferido a

3 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Sarcoma NCT01016730 Treatment - AMC-063 Velcade Administration Form (DA2) - 3021247v1.0

    Inglês

    No Instruction available.

    1 Formulários  
    1. StudyEvent: AMC-063 Velcade Administration Form (DA2)
      1. No Instruction available.
    Header Module
    Descrição

    Header Module

    Alias
    UMLS CUI-1
    C1320722
    Visit number
    Descrição

    Visit number

    Tipo de dados

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ObjectClass
    C16696
    NCI Thesaurus Property
    C25385
    UMLS CUI-1
    C1549755
    Comments
    Descrição

    Research Comments

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Dose Escalation
    Descrição

    Dose Escalation

    Alias
    UMLS CUI-1
    C3816728
    Was the participant's dose increased at this cycle from the dose level which was assigned at Baseline
    Descrição

    Dose Increased

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707810
    NCI Thesaurus ObjectClass
    C25488
    NCI Thesaurus Property
    C25572
    Dose administered
    Descrição

    Agent dose administered

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C0678766
    NCI Thesaurus Property
    C25616
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property-2
    C25375
    NCI Thesaurus Property-3
    C25431
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    BSA (m^2)
    Descrição

    Body Surface Area

    Tipo de dados

    float

    Unidades de medida
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Day 1
    Descrição

    Day 1

    Alias
    UMLS CUI-1
    C1442449
    Dose modification
    Descrição

    Dose Modification Status

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose administered
    Descrição

    Agent dose administered

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C0678766
    NCI Thesaurus Property
    C25616
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property-2
    C25375
    NCI Thesaurus Property-3
    C25431
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    Dose administered date (mm/dd/yyyy)
    Descrição

    Dose administered date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1716416
    NCI Thesaurus Property
    C25488
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property-2
    C25382
    Agent Total Dose (mg)
    Descrição

    Agent Total Dose

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Duration Delay (days)
    Descrição

    Delay of drug therapy

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C25477
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C1299700
    NCI Thesaurus Property-2
    C25409
    NCI Thesaurus ValueDomain
    C25330
    Dose Modification Reason (delay)
    Descrição

    Dose Modification Reason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Other, specify
    Descrição

    Dose Modification Reason, other

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Day 8
    Descrição

    Day 8

    Alias
    UMLS CUI-1
    C0439228
    UMLS CUI-2
    C0205454
    Dose modification
    Descrição

    Dose Modification Status

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose administered
    Descrição

    Agent dose administered

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C0678766
    NCI Thesaurus Property
    C25616
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property-2
    C25375
    NCI Thesaurus Property-3
    C25431
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    Dose administered date (mm/dd/yyyy)
    Descrição

    Dose administered date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1716416
    NCI Thesaurus Property
    C25488
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property-2
    C25382
    Agent Total Dose (mg)
    Descrição

    Agent Total Dose

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Duration Delay (days)
    Descrição

    Delay of drug therapy

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C25477
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C1299700
    NCI Thesaurus Property-2
    C25409
    NCI Thesaurus ValueDomain
    C25330
    Dose Modification Reason (delay)
    Descrição

    Dose Modification Reason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Other, specify
    Descrição

    Dose Modification Reason, other

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Day 15
    Descrição

    Day 15

    Alias
    UMLS CUI-1
    C0439228
    UMLS CUI-2
    C3715153
    Dose modification
    Descrição

    Dose Modification Status

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose administered
    Descrição

    Agent dose administered

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C0678766
    NCI Thesaurus Property
    C25616
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property-2
    C25375
    NCI Thesaurus Property-3
    C25431
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    Dose administered date (mm/dd/yyyy)
    Descrição

    Dose administered date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1716416
    NCI Thesaurus Property
    C25488
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property-2
    C25382
    Agent Total Dose (mg)
    Descrição

    Agent Total Dose

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Duration Delay (days)
    Descrição

    Delay of drug therapy

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C25477
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-1
    C1299700
    NCI Thesaurus Property-2
    C25409
    NCI Thesaurus ValueDomain
    C25330
    Dose Modification Reason (delay)
    Descrição

    Dose Modification Reason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Other, specify
    Descrição

    Dose Modification Reason, other

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
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    1 Formulários
    1. StudyEvent: AMC-063 Velcade Administration Form (DA2)
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header Module
    C1320722 (UMLS CUI-1)
    Visit number
    Item
    Visit number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C16696 (NCI Thesaurus ObjectClass)
    C25385 (NCI Thesaurus Property)
    C1549755 (UMLS CUI-1)
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Dose Escalation
    C3816728 (UMLS CUI-1)
    Dose Increased
    Item
    Was the participant's dose increased at this cycle from the dose level which was assigned at Baseline
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707810 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Item
    Dose administered
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0678766 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C1521801 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property-2)
    C25431 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    CL.10
    Code List
    Dose administered
    CL Item
    0.75 Mg/m^2 (0.75 mg/m^2)
    CL Item
    1.00 Mg/m^2 (1.00 mg/m^2)
    CL Item
    1.30 Mg/m^2 (1.30 mg/m^2)
    CL Item
    1.60 Mg/m^2 (1.60 mg/m^2)
    Body Surface Area
    Item
    BSA (m^2)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item Group
    Day 1
    C1442449 (UMLS CUI-1)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.9
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Escalated (Dose escalated)
    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 administered
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0678766 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C1521801 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property-2)
    C25431 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    CL.10
    Code List
    Dose administered
    CL Item
    0.75 Mg/m^2 (0.75 mg/m^2)
    CL Item
    1.00 Mg/m^2 (1.00 mg/m^2)
    CL Item
    1.30 Mg/m^2 (1.30 mg/m^2)
    CL Item
    1.60 Mg/m^2 (1.60 mg/m^2)
    Dose administered date
    Item
    Dose administered date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1716416 (UMLS CUI-1)
    C25488 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C25382 (NCI Thesaurus Property-2)
    Agent Total Dose
    Item
    Agent Total Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Delay of drug therapy
    Item
    Duration Delay (days)
    float
    C25477 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C1299700 (UMLS CUI-1)
    C25409 (NCI Thesaurus Property-2)
    C25330 (NCI Thesaurus ValueDomain)
    Item
    Dose Modification Reason (delay)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    CL.11
    Code List
    Dose Modification Reason (delay)
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Forgot (Patient forgot)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Patient Request (Patient request)
    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
    Day 8
    C0439228 (UMLS CUI-1)
    C0205454 (UMLS CUI-2)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.9
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Escalated (Dose escalated)
    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 administered
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0678766 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C1521801 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property-2)
    C25431 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    CL.10
    Code List
    Dose administered
    CL Item
    0.75 Mg/m^2 (0.75 mg/m^2)
    CL Item
    1.00 Mg/m^2 (1.00 mg/m^2)
    CL Item
    1.30 Mg/m^2 (1.30 mg/m^2)
    CL Item
    1.60 Mg/m^2 (1.60 mg/m^2)
    Dose administered date
    Item
    Dose administered date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1716416 (UMLS CUI-1)
    C25488 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C25382 (NCI Thesaurus Property-2)
    Agent Total Dose
    Item
    Agent Total Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Delay of drug therapy
    Item
    Duration Delay (days)
    float
    C25477 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C1299700 (UMLS CUI-1)
    C25409 (NCI Thesaurus Property-2)
    C25330 (NCI Thesaurus ValueDomain)
    Item
    Dose Modification Reason (delay)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    CL.11
    Code List
    Dose Modification Reason (delay)
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Forgot (Patient forgot)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Patient Request (Patient request)
    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
    Day 15
    C0439228 (UMLS CUI-1)
    C3715153 (UMLS CUI-2)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.9
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Escalated (Dose escalated)
    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 administered
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0678766 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C1521801 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property-2)
    C25431 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    CL.10
    Code List
    Dose administered
    CL Item
    0.75 Mg/m^2 (0.75 mg/m^2)
    CL Item
    1.00 Mg/m^2 (1.00 mg/m^2)
    CL Item
    1.30 Mg/m^2 (1.30 mg/m^2)
    CL Item
    1.60 Mg/m^2 (1.60 mg/m^2)
    Dose administered date
    Item
    Dose administered date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1716416 (UMLS CUI-1)
    C25488 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C25382 (NCI Thesaurus Property-2)
    Agent Total Dose
    Item
    Agent Total Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Delay of drug therapy
    Item
    Duration Delay (days)
    float
    C25477 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C1299700 (UMLS CUI-1)
    C25409 (NCI Thesaurus Property-2)
    C25330 (NCI Thesaurus ValueDomain)
    Item
    Dose Modification Reason (delay)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    CL.11
    Code List
    Dose Modification Reason (delay)
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Forgot (Patient forgot)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Patient Request (Patient request)
    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)
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