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11015

Description

E1609 Off-Treatment Form 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=97EE3297-340E-F402-E040-BB89AD436AF2

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97EE3297-340E-F402-E040-BB89AD436AF2

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 16/06/2015 16/06/2015 -
Téléchargé le

16 juin 2015

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Creative Commons BY-NC 3.0 Legacy
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    E1609 Off-Treatment Form NCT01274338

    Anglais

    INSTRUCTIONS : Complete one Off-Treatment Form. After patient has completed protocol treatment, complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files

    1 Formulaires  
    Header
    Description

    Header

    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Type de données

    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
    Description

    Patient ID ECOG

    Type de données

    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
    Description

    Generic drug form

    Type de données

    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
    Description

    Registration Number

    Type de données

    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
    Reporting Period
    Description

    Clinical Trial Period

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    Description

    Data amended

    Type de données

    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)
    Description

    Data amended date

    Type de données

    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
    Patient demographics
    Description

    Patient demographics

    Patient Initials (Last, First)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Type de données

    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
    Description

    Institution Name

    Type de données

    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
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Type de données

    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
    Did patient receive protocol therapy
    Description

    ProtocolTreatmentAdministeredInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Vital Status
    Description

    Vital Status

    Patient's Vital Status
    Description

    Patient Status

    Type de données

    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 (m d y)
    Description

    Date last contact

    Type de données

    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 (if applicable)
    Description

    Primary Cause of Death

    Type de données

    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
    Description

    Cause of Death, specify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Section I
    Description

    Section I

    Reason Treatment Ended
    Description

    Off Treatment Reason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    Other Complicating Disease specify (specify)
    Description

    Off Treatment Reason, specify

    Type de données

    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

    Type de données

    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
    Last date protocol therapy was given (m d y)
    Description

    Protocol Therapy End Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1531784
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    NCI Thesaurus Property
    C25382
    Section II
    Description

    Section II

    Reason treatment never started
    Description

    Reason treatment never started

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25594
    UMLS CUI-1
    C3539764
    NCI Thesaurus Property-2
    C25431
    NCI Thesaurus Property-3
    C25365
    NCI Thesaurus ValueDomain
    C25638
    Comments
    Description

    Comments

    Investigator Signature
    Description

    Investigator Signature

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date (MM DD YYYY)
    Description

    Investigator Signature Date

    Type de données

    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
    Comments
    Description

    Comments

    Type de données

    text

    Alias
    UMLS CUI-1
    C0947611
    Retour au début de la page

    Similar models

    INSTRUCTIONS : Complete one Off-Treatment Form. After patient has completed protocol treatment, complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header
    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
    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)
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    CL.1
    Code List
    Reporting Period
    CL Item
    End Of Treatment (End of treatment)
    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 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)
    Item Group
    Patient demographics
    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)
    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)
    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)
    ProtocolTreatmentAdministeredInd-3
    Item
    Did patient receive protocol therapy
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C0442711 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    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)
    CL.2
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Date last contact
    Item
    Date of Last Contact or Death (m d y)
    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 (if applicable)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    CL.3
    Code List
    Primary Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    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)
    Item Group
    Section I
    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.5
    Code List
    Reason Treatment Ended
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Death On Study (Death on study)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Off Treatment Reason, specify
    Item
    Other Complicating Disease specify (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)
    Protocol Therapy End Date
    Item
    Last date protocol therapy was given (m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1531784 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Item Group
    Section II
    Item
    Reason treatment never started
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25594 (NCI Thesaurus Property)
    C3539764 (UMLS CUI-1)
    C25431 (NCI Thesaurus Property-2)
    C25365 (NCI Thesaurus Property-3)
    C25638 (NCI Thesaurus ValueDomain)
    CL.6
    Code List
    Reason treatment never started
    CL Item
    No Treatment, Per Protocol Criteria (No treatment assigned per protocol)
    CL Item
    Patient_ineligible (Patient ineligible)
    CL Item
    Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse before protocol treatment)
    CL Item
    Adverse Event/side Effects/complications (Adverse events/side effects/complications)
    CL Item
    Death Before Beginning Protocol Therapy (Death before beginning protocol therapy)
    CL Item
    Patient Withdrawal/refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal before beginning protocol therapy)
    CL Item
    Medical Decision (Medical decision)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    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 (MM DD YYYY)
    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)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI-1)
    Retour au début de la page 

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