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ID

10512

Description

Nontarget Lesions Supplemental Form NCT00058149 A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D5AC6-6244-4284-E034-0003BA0B1A09

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D5AC6-6244-4284-E034-0003BA0B1A09

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 01/06/2015 01/06/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

3 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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    Nontarget Lesions Supplemental Form NCT00058149

    Anglais

    No Instruction available.

    1 Formulaires  
    1. StudyEvent: Nontarget Lesions Supplemental Form
      1. No Instruction available.
    ECOG clinical trial administrative data
    Description

    ECOG clinical trial administrative data

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Type de données

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Type de données

    text

    Registration Step
    Description

    RegistrationStep

    Type de données

    text

    Cycle Number (Use 00 for baseline; leave blank if off-treatment or N/A)
    Description

    CycleNumber

    Type de données

    text

    Patient?s Name
    Description

    Patient'sName

    Type de données

    text

    Participating Group Protocol No.
    Description

    ParticipatingGroupProtocolNo.

    Type de données

    text

    Participating Group Patient ID
    Description

    ParticipatingGroupPatientID

    Type de données

    text

    Institution/Affiliate
    Description

    MainMemberInstitution/Affiliate

    Type de données

    text

    Are data amended? (If yes, please circle amended items in red)
    Description

    AmendedDataInd

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Nontarget Lesions:
    Description

    Nontarget Lesions:

    Lesion Number
    Description

    Lesion,ReferenceNumber

    Type de données

    float

    Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site, but must be reported in same manner as at baseline.)
    Description

    Lesion,AnatomicSite

    Type de données

    text

    Site Code
    Description

    LesionMeasurableEvaluationAnatomicSite

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property-2
    C37894
    UMLS 2011AA Property-2
    C1513040
    Method of Evaluation
    Description

    AssessmentType

    Type de données

    text

    Date of Evaluation (M D Y)
    Description

    AssessmentDate

    Type de données

    date

    Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
    Description

    Follow-UpStatusofLesions

    Type de données

    text

    Cytology Result (For Site Code 04 effusion/ascites ONLY)
    Description

    CytologyResult

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16491
    UMLS 2011AA ObjectClass
    C0010819
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    Unequivocal progressive disease in nontarget lesions is based on: (please decribe)
    Description

    Unequivocalprogressivediseaseinnontargetlesionsisbasedon:(pleasedecribe)

    Type de données

    text

    Comments
    Description

    Comments

    Comments
    Description

    Comments

    Type de données

    text

    Investigator Signature
    Description

    InvestigatorSignature

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Date
    Description

    InvestigatorSignatureDate

    Type de données

    date

    Ccrr Module For Nontarget Lesions Supplemental Form
    Description

    Ccrr Module For Nontarget Lesions Supplemental Form

    Retour au début de la page

    Similar models

    No Instruction available.

    1 Formulaires
    1. StudyEvent: Nontarget Lesions Supplemental Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    ECOG clinical trial administrative data
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    RegistrationStep
    Item
    Registration Step
    text
    CycleNumber
    Item
    Cycle Number (Use 00 for baseline; leave blank if off-treatment or N/A)
    text
    Patient'sName
    Item
    Patient?s Name
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    ParticipatingGroupPatientID
    Item
    Participating Group Patient ID
    text
    MainMemberInstitution/Affiliate
    Item
    Institution/Affiliate
    text
    AmendedDataInd
    Item
    Are data amended? (If yes, please circle amended items in red)
    boolean
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Item Group
    Nontarget Lesions:
    Lesion,ReferenceNumber
    Item
    Lesion Number
    float
    Lesion,AnatomicSite
    Item
    Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site, but must be reported in same manner as at baseline.)
    text
    Item
    Site Code
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C37894 (NCI Thesaurus Property-2)
    C1513040 (UMLS 2011AA Property-2)
    CL.2
    Code List
    Site Code
    CL Item
    Bone (Bone)
    C12366 (NCI Thesaurus)
    C0262950 (UMLS 2011AA)
    CL Item
    Brain (Brain)
    C12439 (NCI Thesaurus)
    C0006104 (UMLS 2011AA)
    CL Item
    Breast (Breast)
    C12971 (NCI Thesaurus)
    C0006141 (UMLS 2011AA)
    CL Item
    Effusion/ascites (Effusion/Ascites)
    CL Item
    Gi (GI)
    CL Item
    Gu (GU)
    CL Item
    Head & Neck (Head & Neck)
    CL Item
    Liver (Liver)
    C12392 (NCI Thesaurus)
    C0023884 (UMLS 2011AA)
    CL Item
    Lung (Lung)
    C12468 (NCI Thesaurus)
    C0024109 (UMLS 2011AA)
    CL Item
    Nodes (Nodes)
    CL Item
    Skin (Skin)
    C12470 (NCI Thesaurus)
    C1123023 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item
    Method of Evaluation
    text
    CL.3
    Code List
    Method of Evaluation
    CL Item
    Clinical Examination (Clinical Exam)
    CL Item
    Chest X-ray (Chest X-Ray)
    CL Item
    Ct Scan (CT Scan (non-spiral))
    CL Item
    Spiral Ct Scan (Spiral CT)
    CL Item
    Mri (MRI)
    CL Item
    Ultrasound (Ultrasound)
    C64384 (NCI Thesaurus)
    C1456803 (UMLS 2011AA)
    CL Item
    Bone Scan (Bone scan)
    C17646 (NCI Thesaurus)
    C0203668 (UMLS 2011AA)
    CL Item
    Not Evaluated (Not evaluated)
    CL Item
    Other (Other (specify in Comments))
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    AssessmentDate
    Item
    Date of Evaluation (M D Y)
    date
    Item
    Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
    text
    CL.4
    Code List
    Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
    CL Item
    Cr (CR)
    CL Item
    Incompl. Resp./sd (Incompl. resp./SD)
    CL Item
    Pd (PD)
    Item
    Cytology Result (For Site Code 04 effusion/ascites ONLY)
    text
    C16491 (NCI Thesaurus ObjectClass)
    C0010819 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.5
    Code List
    Cytology Result (For Site Code 04 effusion/ascites ONLY)
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Not Done (Not done)
    CL281691 (NCI Metathesaurus)
    Unequivocalprogressivediseaseinnontargetlesionsisbasedon:(pleasedecribe)
    Item
    Unequivocal progressive disease in nontarget lesions is based on: (please decribe)
    text
    Item Group
    Comments
    Comments
    Item
    Comments
    text
    InvestigatorSignature
    Item
    Investigator Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Date
    date
    Item Group
    Ccrr Module For Nontarget Lesions Supplemental Form
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