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11027

Beskrivning

E1609 Treatment/Vital Status Form - Arm A NCT01274338 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 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97E81F9F-45B5-261A-E040-BB89AD434355

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97E81F9F-45B5-261A-E040-BB89AD434355

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-06-16 2015-06-16 -
Uppladdad den

16 juni 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    E1609 Treatment/Vital Status Form - Arm A NCT01274338

    No Instruction available.

    1. StudyEvent: E1609 Treatment/Vital Status Form - Arm A
      1. No Instruction available.
    Clinical trial administrative data
    Beskrivning

    Clinical trial administrative data

    Patient Initials (Last, First)
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Beskrivning

    Protocol Number ECOG

    Datatyp

    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
    Participating Group Protocol Number
    Beskrivning

    Study Number Participating Group

    Datatyp

    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
    Beskrivning

    Institution Name

    Datatyp

    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
    ECOG Patient ID
    Beskrivning

    Patient ID ECOG

    Datatyp

    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 Patient ID
    Beskrivning

    Trial subject ID Participating Group

    Datatyp

    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
    DCI Name
    Beskrivning

    Generic drug form

    Datatyp

    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 (1)
    Beskrivning

    Registration Number

    Datatyp

    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
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    Beskrivning

    Data amended

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended (s - mm/dd/yyyy)
    Beskrivning

    Data amended date

    Datatyp

    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 Reporting Period
    Beskrivning

    On Treatment Reporting Period

    On Treatment Reporting Period
    Beskrivning

    Cycle number

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Reporting Period Start Date (mm/dd/yyyy)
    Beskrivning

    Reporting Period Start Date

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25616
    UMLS CUI-1
    C2361257
    NCI Thesaurus Property-2
    C25651
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period End Date (mm/dd/yyyy)
    Beskrivning

    Reporting Period End Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Vital Status
    Beskrivning

    Vital Status

    Patient's Vital Status
    Beskrivning

    Patient Status

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3846084
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25717
    Date of last contact or death (mm/dd/yyyy)
    Beskrivning

    Date last contact

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C0805839
    NCI Thesaurus Property
    C25461
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Primary Cause of Death
    Beskrivning

    Primary Cause of Death

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C28554
    NCI Thesaurus ValueDomain-2
    C25251
    Describe cause of death
    Beskrivning

    Cause of Death, specify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Weight (Day 1 of this reporting period)
    Beskrivning

    Patient Weight

    Datatyp

    float

    Måttenheter
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Patient Characteristics
    Beskrivning

    Patient Characteristics

    Therapy Administered - Section I
    Beskrivning

    Therapy Administered - Section I

    Agent Name
    Beskrivning

    Agent

    Datatyp

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Was the agent administered during this reporting period? (Ipilimumab)
    Beskrivning

    Agent administered during reporting period

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Date Agent Administered (If yes:)
    Beskrivning

    Agent Administered Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0450442
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    UMLS CUI-3
    C0011008
    Agent Dose (mg)
    Beskrivning

    Medication Dose

    Datatyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25488
    UMLS CUI-1
    C3174092
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain-2
    C1708
    NCI Thesaurus Property
    C25382
    Were there any dose modifications or additions/omissions to protocol treatment?
    Beskrivning

    Dose Modification

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    Section E: Non-protocol Therapy
    Beskrivning

    Section E: Non-protocol Therapy

    Was any non-protocol therapy given during protocol treatment (not previously reported)?
    Beskrivning

    Non-protocol therapy

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25590
    UMLS CUI-1
    C1518384
    NCI Thesaurus ObjectClass-2
    C16212
    UMLS CUI-2
    C0087111
    NCI Thesaurus Property
    C25320
    NCI Thesaurus Property-2
    C49236
    NCI Thesaurus Property-3
    C25456
    NCI Thesaurus Property-4
    C25382
    NCI Thesaurus ValueDomain
    C38148
    Comments
    Beskrivning

    Comments

    Investigator Signature
    Beskrivning

    Investigator Signature

    Datatyp

    text

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

    Investigator Signature Date

    Datatyp

    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

    Similar models

    No Instruction available.

    1. StudyEvent: E1609 Treatment/Vital Status Form - Arm A
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Clinical trial administrative data
    Patient Initials
    Item
    Patient Initials (Last, First)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    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)
    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)
    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)
    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)
    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 (1)
    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)
    Data amended
    Item
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    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 - mm/dd/yyyy)
    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 Reporting Period
    Item
    On Treatment Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    Code List
    On Treatment Reporting 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 24 (Week 24)
    CL Item
    Week 36 (Week 36)
    CL Item
    Week 48 (Week 48)
    CL Item
    Week 60 (Week 60)
    Reporting Period Start Date
    Item
    Reporting Period Start Date (mm/dd/yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Reporting Period End Date
    Item
    Reporting Period End Date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Item Group
    Vital Status
    Item
    Patient's Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Date last contact
    Item
    Date of last contact or death (mm/dd/yyyy)
    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
    Primary Cause of Death
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    Code List
    Primary Cause of Death
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Cause of Death, specify
    Item
    Describe cause of death
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1521902 (UMLS CUI-2)
    C28554 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (Day 1 of this reporting period)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item Group
    Patient Characteristics
    Item Group
    Therapy Administered - Section I
    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)
    Agent administered during reporting period
    Item
    Was the agent administered during this reporting period? (Ipilimumab)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Agent Administered Date
    Item
    Date Agent Administered (If yes:)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-3)
    Medication Dose
    Item
    Agent Dose (mg)
    float
    C25488 (NCI Thesaurus ValueDomain)
    C3174092 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain-2)
    C25382 (NCI Thesaurus Property)
    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)
    CL Item
    Yes, Both Planned And Unplanned (Yes, both planned and unplanned)
    Item Group
    Section E: Non-protocol Therapy
    Non-protocol therapy
    Item
    Was any non-protocol therapy given during protocol treatment (not previously reported)?
    boolean
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS CUI-1)
    C16212 (NCI Thesaurus ObjectClass-2)
    C0087111 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C49236 (NCI Thesaurus Property-2)
    C25456 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C38148 (NCI Thesaurus ValueDomain)
    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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