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ID

43164

Description

On-Study 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=A65D6B91-79C6-4288-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D6B91-79C6-4288-E034-0003BA0B1A09

Keywords

Versions (4)
  1. 19.09.12 19.09.12 -
  2. 28.05.15 28.05.15 -
  3. 03.06.15 03.06.15 -
  4. 20.09.21 20.09.21 -
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20. September 2021

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Creative Commons BY-NC 3.0 Legacy
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    On-Study Form NCT00058149

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: On-Study Form
      1. No Instruction available.
    ECOG clinical trial administrative data
    Description

    ECOG clinical trial administrative data

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Data type

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Data type

    text

    Registration Step
    Description

    RegistrationStep

    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

    Are data amended?
    Description

    AmendedDataInd

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Form No.
    Description

    FormNo.

    Data type

    text

    Patient vital status
    Description

    Patient vital status

    Performance status
    Description

    PerformanceStatus

    Data type

    text

    Weight loss in previous 6 months (choose one)
    Description

    WeightLossPriorSixMonths

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3445
    UMLS 2011AA Property
    C1262477
    Disease Description
    Description

    Disease Description

    Date of initial diagnosis of primary tumor (first positive biopsy date)
    Description

    FirstPositiveBiopsyDate

    Data type

    date

    Date of most recent prior recurrence (if patient has responded to prior treatment)
    Description

    PriorRecentRecurrenceDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25279
    UMLS 2011AA Property
    C0332162
    Primary site (choose one)
    Description

    PrimarySite

    Data type

    text

    Primary Site, other specify
    Description

    PrimarySite,Other

    Data type

    text

    Histologic grade (choose one)
    Description

    HistologicGrade

    Data type

    text

    Histologic Type (choose one)
    Description

    HistologicType

    Data type

    text

    Other specify
    Description

    HistologicType,OtherName

    Data type

    text

    Is there histologic proof of residual or metastatic malignant disease?
    Description

    Istherehistologicproofofresidualormetastaticmalignantdisease?

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain-2
    C25180
    UMLS 2011AA ValueDomain-2
    C1522602
    Site(s) Of Involvement
    Description

    Site(s) Of Involvement

    Pancreas
    Description

    Primarytumor/Pancreas

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain-2
    C25180
    UMLS 2011AA ValueDomain-2
    C1522602
    Regional lymph nodes
    Description

    RegionalLymphNode(s)Ind

    Data type

    boolean

    Distant lymph nodes
    Description

    DistantLymphNode(s)Ind

    Data type

    boolean

    Adjacent viscera/vessels
    Description

    Adjacentviscera/vessels

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain-2
    C25180
    UMLS 2011AA ValueDomain-2
    C1522602
    Liver
    Description

    LiverSiteInd

    Data type

    boolean

    Peritoneum
    Description

    PeritoneumInd

    Data type

    boolean

    Lung
    Description

    LungSiteInd

    Data type

    boolean

    Bone
    Description

    BoneSiteInd

    Data type

    boolean

    Other
    Description

    OtherSiteInd

    Data type

    boolean

    Other specify
    Description

    OtherSiteName

    Data type

    text

    Advanced Disease Status at Registration
    Description

    AdvancedDiseaseRegistrationStatus

    Data type

    text

    CEA (ng/dl)
    Description

    CEA

    Data type

    text

    CEA ULN
    Description

    LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C25159
    UMLS 2011AA Property
    C0007082
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Date CEA obtained (M D Y)
    Description

    CarcinoembryonicAntigenSpecimenCollectionDate

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25159
    UMLS 2011AA ObjectClass
    C0007082
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    CA19-9 (U/ml)
    Description

    CA19-9

    Data type

    text

    Date CA19-9 obtained (M D Y)
    Description

    DateCA19-9obtained

    Data type

    text

    Baseline Hematology/chemistry
    Description

    Baseline Hematology/chemistry

    WBC count (x1000), LLN
    Description

    WBCcount(x1000),LLN

    Data type

    text

    WBC count (x1000), Value
    Description

    Lab,Hematology,WBC

    Data type

    float

    Date Obtained (M D Y)
    Description

    Lab,Hematology,SampleCollectionDate

    Data type

    date

    Granulocyte count (AGC/ANC), Value
    Description

    Lab,Hematology,GranulocyteCount

    Data type

    float

    Platelets 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
    Platelets 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

    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), Value
    Description

    Lab,Chemistry,Albumin

    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

    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

    Bilirubin (mg/dl), ULN
    Description

    Bilirubin(mg/dl),ULN

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Bilirubin (mg/dl), Value
    Description

    Lab,Hepatic,Bilirubin

    Data type

    float

    Prior Therapy
    Description

    Prior Therapy

    Prior radiation therapy? (Choose one:)
    Description

    PriorRTInd

    Data type

    boolean

    Prior RT begin date (M D Y)
    Description

    PriorRTBeginDate

    Data type

    date

    Prior RT end date (M D Y)
    Description

    PriorRTEndDate

    Data type

    date

    RT site:
    Description

    RTSite

    Data type

    text

    Ccrr Module For On-study Form
    Description

    Ccrr Module For On-study Form

    Site(s) of Involvement, Other specify
    Description

    DiseaseInvolvementSite,Other

    Data type

    text

    Specify agents
    Description

    Specifyagents

    Data type

    text

    Prior surgery
    Description

    PriorSurgeryInd

    Data type

    boolean

    Specify prior thrombotic event
    Description

    Specifypriorthromboticevent

    Data type

    text

    Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
    Description

    Doesthepatienthaveapriorhistoryofdeepveinthrombosisorpulmonaryembolus?

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Prior thrombosis?
    Description

    Priorthrombosis?

    Data type

    boolean

    Time frame of thrombosis
    Description

    Timeframeofthrombosis

    Data type

    text

    Prior embolus?
    Description

    Priorembolus?

    Data type

    boolean

    Time frame of embolus
    Description

    Timeframeofembolus

    Data type

    text

    date of prior surgery
    Description

    PriorSurgeryDate

    Data type

    date

    Date of initial diagnosis of unresectable locally advanced disease
    Description

    InitialDiagnosisDate,LocallyAdvanced

    Data type

    date

    Date of initial diagnosis of metastatic disease
    Description

    InitialDiagnosisDate,Metastatic

    Data type

    date

    Is measurable disease present?
    Description

    DiseaseAssessment,MeasurableInd

    Data type

    boolean

    Is non-measurable disease present?
    Description

    DiseaseAssessment,Non-measurableInd

    Data type

    boolean

    Prior adjuvant chemotherapy end date
    Description

    PriorAdjuvantChemotherapyEndDate

    Data type

    date

    Prior adjuvant chemotherapy begin date
    Description

    PriorAdjuvantChemotherapyBeginDate

    Data type

    date

    Footer module
    Description

    Footer module

    Comments
    Description

    Comments

    Data type

    text

    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

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    1 forms
    1. StudyEvent: On-Study Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    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?
    boolean
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    FormNo.
    Item
    Form No.
    text
    Item Group
    Patient vital status
    Item
    Performance status
    text
    CL.2
    Code List
    Performance status
    CL Item
    0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
    C0919414 (NCI Metathesaurus)
    CL Item
    1 (Restricted in physically strenuous activity but ambulatory (K 70-80))
    CL Item
    2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
    C66833 (NCI Thesaurus)
    C0205448 (UMLS 2011AA)
    CL Item
    3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
    CL Item
    4 (completely disabled (K 10-20))
    Item
    Weight loss in previous 6 months (choose one)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3445 (NCI Thesaurus Property)
    C1262477 (UMLS 2011AA Property)
    CL.3
    Code List
    Weight loss in previous 6 months (choose one)
    CL Item
    <5% Of Body Weight (less than 5% of body weight)
    CL Item
    5 To <10% Of Body Weight (5 - <10% of body weight)
    CL Item
    10 To <20% Of Body Weight (10 - <20% of body weight)
    CL Item
    > Or = 20% Of Body Weight (greater than or equal to 20% of body weight)
    Item Group
    Disease Description
    FirstPositiveBiopsyDate
    Item
    Date of initial diagnosis of primary tumor (first positive biopsy date)
    date
    PriorRecentRecurrenceDate
    Item
    Date of most recent prior recurrence (if patient has responded to prior treatment)
    date
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25279 (NCI Thesaurus Property)
    C0332162 (UMLS 2011AA Property)
    Item
    Primary site (choose one)
    text
    CL.4
    Code List
    Primary site (choose one)
    CL Item
    Head Of Pancreas (Head of pancreas)
    C0227579 (NCI Metathesaurus)
    CL Item
    Body Of Pancreas (Body of pancreas)
    C0227582 (NCI Metathesaurus)
    CL Item
    Tail Of Pancreas (Tail of pancreas)
    C0227590 (NCI Metathesaurus)
    CL Item
    Uncinate Process (Uncinate process)
    CL Item
    Diffuse (Diffuse)
    C14175 (NCI Thesaurus)
    C0205219 (UMLS 2011AA)
    CL Item
    Other, Specify (Other)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PrimarySite,Other
    Item
    Primary Site, other specify
    text
    Item
    Histologic grade (choose one)
    text
    CL.5
    Code List
    Histologic grade (choose one)
    CL Item
    Tumor Is Well Differentiated According To Who Grading System (Well differentiated)
    CL Item
    Tumor Is Moderately Differentiated According To Who Grading System (Moderately differentiated)
    CL Item
    Tumor Is Poorly Differentiated According To Who Grading System (Poorly differentiated)
    CL Item
    Tumor Is Undifferentiated According To Who Grading System (Undifferentiated)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Histologic Type (choose one)
    text
    CL.6
    Code List
    Histologic Type (choose one)
    CL Item
    Ductal Adenocarcinoma (Ductal adenocarcinoma)
    CL Item
    Neuroendocrine Carcinoma (Neuroendocrine carcinoma)
    C3773 (NCI Thesaurus)
    C0206695 (UMLS 2011AA)
    CL Item
    Mixed-type (ductal-endocrine Or Acinar-endocrine) (Mixed ductal - endocrine carcinoma)
    CL Item
    Undifferentiated (anaplastic) Carcinoma (Undifferentiated (anaplastic) carcinoma)
    CL Item
    Other, Specify (Other)
    HistologicType,OtherName
    Item
    Other specify
    text
    Item
    Is there histologic proof of residual or metastatic malignant disease?
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25180 (NCI Thesaurus ValueDomain-2)
    C1522602 (UMLS 2011AA ValueDomain-2)
    CL.7
    Code List
    Is there histologic proof of residual or metastatic malignant disease?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Site(s) Of Involvement
    Primarytumor/Pancreas
    Item
    Pancreas
    boolean
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25180 (NCI Thesaurus ValueDomain-2)
    C1522602 (UMLS 2011AA ValueDomain-2)
    RegionalLymphNode(s)Ind
    Item
    Regional lymph nodes
    boolean
    DistantLymphNode(s)Ind
    Item
    Distant lymph nodes
    boolean
    Adjacentviscera/vessels
    Item
    Adjacent viscera/vessels
    boolean
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25180 (NCI Thesaurus ValueDomain-2)
    C1522602 (UMLS 2011AA ValueDomain-2)
    LiverSiteInd
    Item
    Liver
    boolean
    PeritoneumInd
    Item
    Peritoneum
    boolean
    LungSiteInd
    Item
    Lung
    boolean
    BoneSiteInd
    Item
    Bone
    boolean
    OtherSiteInd
    Item
    Other
    boolean
    OtherSiteName
    Item
    Other specify
    text
    Item
    Advanced Disease Status at Registration
    text
    CL.17
    Code List
    Advanced Disease Status at Registration
    CL Item
    Initial Diagnosis (Initial diagnosis)
    CL Item
    Recurrence (Recurrence)
    CEA
    Item
    CEA (ng/dl)
    text
    LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue
    Item
    CEA ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25159 (NCI Thesaurus Property)
    C0007082 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    CarcinoembryonicAntigenSpecimenCollectionDate
    Item
    Date CEA obtained (M D Y)
    text
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25159 (NCI Thesaurus ObjectClass)
    C0007082 (UMLS 2011AA ObjectClass)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    CA19-9
    Item
    CA19-9 (U/ml)
    text
    DateCA19-9obtained
    Item
    Date CA19-9 obtained (M D Y)
    text
    Item Group
    Baseline Hematology/chemistry
    WBCcount(x1000),LLN
    Item
    WBC count (x1000), LLN
    text
    Lab,Hematology,WBC
    Item
    WBC count (x1000), Value
    float
    Lab,Hematology,SampleCollectionDate
    Item
    Date Obtained (M D Y)
    date
    Lab,Hematology,GranulocyteCount
    Item
    Granulocyte count (AGC/ANC), Value
    float
    Plateletscount(x1000),LLN
    Item
    Platelets 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
    Platelets count (x1000), Value
    float
    Hemoglobin(g/dl),LLN
    Item
    Hemoglobin (g/dl), LLN
    text
    Lab,Hematology,Hemoglobin
    Item
    Hemoglobin (g/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), Value
    float
    Creatinine(mg/dl),ULN
    Item
    Creatinine (mg/dl), ULN
    text
    Lab,Renal,Creatinine
    Item
    Creatinine (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
    Bilirubin(mg/dl),ULN
    Item
    Bilirubin (mg/dl), ULN
    float
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    Lab,Hepatic,Bilirubin
    Item
    Bilirubin (mg/dl), Value
    float
    Item Group
    Prior Therapy
    PriorRTInd
    Item
    Prior radiation therapy? (Choose one:)
    boolean
    PriorRTBeginDate
    Item
    Prior RT begin date (M D Y)
    date
    PriorRTEndDate
    Item
    Prior RT end date (M D Y)
    date
    RTSite
    Item
    RT site:
    text
    Item Group
    Ccrr Module For On-study Form
    DiseaseInvolvementSite,Other
    Item
    Site(s) of Involvement, Other specify
    text
    Specifyagents
    Item
    Specify agents
    text
    PriorSurgeryInd
    Item
    Prior surgery
    boolean
    Item
    Specify prior thrombotic event
    text
    CL.20
    Code List
    Specify prior thrombotic event
    CL Item
    Thrombosis (thrombosis)
    C26891 (NCI Thesaurus)
    C0040053 (UMLS 2011AA)
    CL Item
    Both Thrombosis And Embolus (both thrombosis and embolus)
    CL Item
    Embolus (embolus)
    C0013932 (NCI Metathesaurus)
    Doesthepatienthaveapriorhistoryofdeepveinthrombosisorpulmonaryembolus?
    Item
    Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Priorthrombosis?
    Item
    Prior thrombosis?
    boolean
    Item
    Time frame of thrombosis
    text
    CL.23
    Code List
    Time frame of thrombosis
    CL Item
    > 1 Year Prior To Diagnosis Of Primary Cancer (> 1 year prior to diagnosis of primary cancer)
    CL Item
    Within 1 Year Of Diagnosis Of Primary Cancer (within 1 year of diagnosis of primary cancer)
    Priorembolus?
    Item
    Prior embolus?
    boolean
    Item
    Time frame of embolus
    text
    CL.25
    Code List
    Time frame of embolus
    CL Item
    > 1 Year Prior To Diagnosis Of Primary Cancer (> 1 year prior to diagnosis of primary cancer)
    CL Item
    Within 1 Year Of Diagnosis Of Primary Cancer (within 1 year of diagnosis of primary cancer)
    PriorSurgeryDate
    Item
    date of prior surgery
    date
    InitialDiagnosisDate,LocallyAdvanced
    Item
    Date of initial diagnosis of unresectable locally advanced disease
    date
    InitialDiagnosisDate,Metastatic
    Item
    Date of initial diagnosis of metastatic disease
    date
    DiseaseAssessment,MeasurableInd
    Item
    Is measurable disease present?
    boolean
    DiseaseAssessment,Non-measurableInd
    Item
    Is non-measurable disease present?
    boolean
    PriorAdjuvantChemotherapyEndDate
    Item
    Prior adjuvant chemotherapy end date
    date
    PriorAdjuvantChemotherapyBeginDate
    Item
    Prior adjuvant chemotherapy begin date
    date
    Item Group
    Footer module
    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
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