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ID

9749

Description

Hematology/Chemistry Form 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=A65D4877-9B57-427A-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D4877-9B57-427A-E034-0003BA0B1A09

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/21/15 1/21/15 - Martin Dugas
  3. 1/21/15 1/21/15 - Martin Dugas
Uploaded on

January 21, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Pancreatic Cancer NCT00058149 Follow-Up - Hematology/Chemistry Form - 2048132v3.0

    No Instruction available.

    1. StudyEvent: Hematology/Chemistry Form
      1. No Instruction available.
    Header
    Description

    Header

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Data type

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Data type

    text

    Registration Step
    Description

    RegistrationStep

    Data type

    text

    Cycle Number
    Description

    CycleNumber

    Data type

    text

    Patient?s Name
    Description

    Patient'sName

    Data type

    text

    Participating Group Protocol No.
    Description

    ParticipatingGroupProtocolNo.

    Data type

    text

    Participating Group Patient ID
    Description

    ParticipatingGroupPatientID

    Data type

    text

    Institution/Affiliate
    Description

    MainMemberInstitution/Affiliate

    Data type

    text

    Alias
    UMLS CUI-1
    C12341234123412341234123412
    Comments
    Description

    Comments

    Data type

    text

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

    AmendedDataInd

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Investigator Signature
    Description

    InvestigatorSignature

    Data type

    text

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

    InvestigatorSignatureDate

    Data type

    date

    Laboratory Name:
    Description

    SpecimenLabIdentifierName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C37984
    UMLS 2011AA ObjectClass
    C0022877
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    Date obtained (M D Y)
    Description

    Lab,Hematology,SampleCollectionDate

    Data type

    date

    WBC count (x1000), LLN
    Description

    WBCcount(x1000),LLN

    Data type

    text

    WBC count (x1000), Value
    Description

    Lab,Hematology,WBC

    Data type

    float

    Granulocyte count (AGC/ANC), Value (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
    Description

    Lab,Hematology,GranulocyteCount

    Data type

    float

    Platelet count (x1000), LLN
    Description

    Plateletscount(x1000),LLN

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Platelet count (x1000), Value
    Description

    Lab,Hematology,Platelets

    Data type

    float

    Hemoglobin (g/dl), LLN
    Description

    Hemoglobin(g/dl),LLN

    Data type

    text

    Hemoglobin (g/dl), Value
    Description

    Lab,Hematology,Hemoglobin

    Data type

    float

    Total bilirubin (mg/dl), ULN
    Description

    Totalbilirubin(mg/dl),ULN

    Data type

    text

    Total bilirubin (mg/dl), Value
    Description

    Lab,Hepatic,Bilirubin

    Data type

    float

    SGOT (AST) (U/L), ULN
    Description

    SGOT(AST)ULN

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    SGOT (AST) (U/L), Value
    Description

    Lab,Hepatic,SGOT

    Data type

    float

    Creatinine (mg/dl), ULN
    Description

    Creatinine(mg/dl),ULN

    Data type

    text

    Creatinine (mg/dl), Value
    Description

    Lab,Renal,Creatinine

    Data type

    float

    Albumin (g/dl), LLN
    Description

    Albumin(g/dl),LLN

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Albumin (g/dl)
    Description

    Lab,Chemistry,Albumin

    Data type

    float

    CTC Adverse Event Attribution Code
    Description

    CTCAdverseEventAttributionCode

    Data type

    text

    Bilirubin ULN
    Description

    HepaticBilirubinLabUpperLimitNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C305
    UMLS 2011AA Property-2
    C0005437
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815

    Similar models

    No Instruction available.

    1. StudyEvent: Hematology/Chemistry Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    RegistrationStep
    Item
    Registration Step
    text
    CycleNumber
    Item
    Cycle Number
    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
    C12341234123412341234123412 (UMLS CUI-1)
    Comments
    Item
    Comments
    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)
    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
    SpecimenLabIdentifierName
    Item
    Laboratory Name:
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus ObjectClass)
    C0022877 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    Lab,Hematology,SampleCollectionDate
    Item
    Date obtained (M D Y)
    date
    WBCcount(x1000),LLN
    Item
    WBC count (x1000), LLN
    text
    Lab,Hematology,WBC
    Item
    WBC count (x1000), Value
    float
    Lab,Hematology,GranulocyteCount
    Item
    Granulocyte count (AGC/ANC), Value (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
    float
    Plateletscount(x1000),LLN
    Item
    Platelet count (x1000), LLN
    float
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    Lab,Hematology,Platelets
    Item
    Platelet count (x1000), Value
    float
    Hemoglobin(g/dl),LLN
    Item
    Hemoglobin (g/dl), LLN
    text
    Lab,Hematology,Hemoglobin
    Item
    Hemoglobin (g/dl), Value
    float
    Totalbilirubin(mg/dl),ULN
    Item
    Total bilirubin (mg/dl), ULN
    text
    Lab,Hepatic,Bilirubin
    Item
    Total bilirubin (mg/dl), Value
    float
    SGOT(AST)ULN
    Item
    SGOT (AST) (U/L), ULN
    float
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    Lab,Hepatic,SGOT
    Item
    SGOT (AST) (U/L), Value
    float
    Creatinine(mg/dl),ULN
    Item
    Creatinine (mg/dl), ULN
    text
    Lab,Renal,Creatinine
    Item
    Creatinine (mg/dl), Value
    float
    Albumin(g/dl),LLN
    Item
    Albumin (g/dl), LLN
    float
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    Lab,Chemistry,Albumin
    Item
    Albumin (g/dl)
    float
    Item
    CTC Adverse Event Attribution Code
    text
    Code List
    CTC Adverse Event Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possibly (possible)
    CL Item
    Probably (probable)
    CL Item
    Definitely (definite)
    HepaticBilirubinLabUpperLimitNormalValue
    Item
    Bilirubin ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)

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