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Description

Form 9 - Relapse/ Progressive Disease Report Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06B0201-DAB9-5179-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06B0201-DAB9-5179-E034-080020C9C0E0

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 12/22/14 12/22/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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September 19, 2012

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Creative Commons BY-NC 3.0 Legacy
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    Lung Cancer NCT00049543 Response - Form 9 - Relapse/ Progressive Disease Report - 2034459v3.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
      1. No Instruction available.
    1. Patient Information
    Description

    1. Patient Information

    Pt. Serial #
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Hospital #
    Description

    PatientMedicalRecordNumber

    Data type

    text

    Pt. Initials
    Description

    PatientInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Intergroup Patient Serial #
    Description

    PatientStudyID,ParticipatingGroup

    Data type

    text

    Site #
    Description

    NCIInstitutionNumber

    Data type

    text

    Patient's Social Security # (USA only)
    Description

    PatientSocialSecurityNumber

    Data type

    double

    Institution
    Description

    InstitutionName

    Data type

    text

    Investigator
    Description

    RegisteredInvestigator

    Data type

    text

    2. Radiology
    Description

    2. Radiology

    Chest x-ray
    Description

    ChestX-RayResult

    Data type

    text

    ultrasound/CT scan of abdomen/MRI
    Description

    CT/MRI/USupperabdomen

    Data type

    text

    ultrasound/CT scan of abdomen/MRI (circle one)
    Description

    AssessmentType

    Data type

    text

    bone scan
    Description

    bonescan

    Data type

    text

    CT of brain
    Description

    HeadCTResult

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C17204
    UMLS 2011AA ObjectClass
    C0040405
    NCI Thesaurus ObjectClass
    C12419
    UMLS 2011AA ObjectClass
    C0018670
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    other: (specify)
    Description

    other:(specify)

    Data type

    text

    other: (specify)2
    Description

    AssessmentType,Specify

    Data type

    text

    Date
    Description

    AssessmentDate

    Data type

    date

    6. COMMENTS
    Description

    Comments

    Data type

    text

    3. Disease Status
    Description

    3. Disease Status

    Date of documented relapse or progression
    Description

    ProgressionDate

    Data type

    date

    Ncic Ctg Use Only
    Description

    Ncic Ctg Use Only

    Logged
    Description

    LoggedEntryInitials

    Data type

    text

    Unnamed1
    Description

    LoggedEntryDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Study Coord
    Description

    CoordinatorReviewInitials

    Data type

    text

    Unnamed2
    Description

    CoordinatorReviewDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Phy
    Description

    PhysicianReviewInitials

    Data type

    text

    Data Ent'd
    Description

    DataEntryInitials

    Data type

    text

    Verified
    Description

    DataVerificationInitials

    Data type

    text

    Unnamed1
    Description

    Unnamed1

    Pt. Serial #
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Pt. Initials
    Description

    PatientInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    4. Recurrence Table
    Description

    4. Recurrence Table

    Lung (* Local recurrence in the area of tumour bed or Hilum.)
    Description

    LungSiteInd

    Data type

    text

    Liver
    Description

    LiverSiteInd

    Data type

    text

    Pleura (to be discussed)
    Description

    PleuraSiteInd

    Data type

    text

    CNS (excluding brain)
    Description

    CNSSiteInd

    Data type

    text

    Brain
    Description

    BrainSiteInd

    Data type

    text

    Bone
    Description

    BoneSiteInd

    Data type

    text

    Opposite Lung
    Description

    OppositeLungInd

    Data type

    text

    Regional Lymph nodes (** Mediastinal lymph nodes)
    Description

    RegionalLymphNode(s)Ind

    Data type

    text

    Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
    Description

    DistantLymphNode(s)Ind

    Data type

    text

    Distant Skin or Subcutaneous tissue
    Description

    DistantSkin/SubcutaneousTissueInd

    Data type

    text

    Other
    Description

    OtherSiteInd

    Data type

    text

    Other (please describe)
    Description

    OtherSiteName

    Data type

    text

    Suspected Date
    Description

    ProgressionSuspectedBeginDate

    Data type

    date

    Definite Date
    Description

    ProgressionDefiniteBeginDate

    Data type

    date

    Supporting Evidence (please describe)
    Description

    ProgressionCriteria

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Unnamed2
    Description

    Unnamed2

    Pt. Serial #
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Pt. Initials
    Description

    PatientInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    5. Treatment Plan
    Description

    5. Treatment Plan

    5. TREATMENT PLAN (please describe)
    Description

    TreatmentAssignmentCode

    Data type

    text

    6. Comments
    Description

    6. Comments

    6. COMMENTS
    Description

    Comments

    Data type

    text

    7. Have You Attached Copies Of
    Description

    7. Have You Attached Copies Of

    7. HAVE YOU ATTACHED COPIES OF (please _)
    Description

    HAVEYOUATTACHEDCOPIESOF

    Data type

    text

    Other: specify
    Description

    VisitReportMonthSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C29846
    UMLS 2011AA Property
    C0439231
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Thesaurus ObjectClass
    C25716
    UMLS 2011AA ObjectClass
    C0545082
    8. Investigator Signature
    Description

    8. Investigator Signature

    Signature of Responsible Investigator
    Description

    InvestigatorSignature

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Name of Clinical Research Associate
    Description

    PersonCompletingForm,LastName

    Data type

    text

    Date
    Description

    FormCompletionDate,Original

    Data type

    date

    Ccrr Module For Form 9 - Relapse/ Progressive Disease Report
    Description

    Ccrr Module For Form 9 - Relapse/ Progressive Disease Report

    Person Completing Form, First Name
    Description

    PersonCompletingForm,FirstName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Ascites
    Description

    AscitesInd

    Data type

    text

    Pleural Effusion
    Description

    PleuralEffusionInd

    Data type

    text

    Local Lung Site Ind
    Description

    LocalLungSiteIndicator

    Data type

    text

    Distant Lung Site Ind
    Description

    DistantLungSiteInd

    Data type

    text

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    No Instruction available.

    1 forms
    1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    1. Patient Information
    PatientStudyID,CoordinatingGroup
    Item
    Pt. Serial #
    text
    PatientMedicalRecordNumber
    Item
    Hospital #
    text
    PatientInitialsName
    Item
    Pt. Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    PatientStudyID,ParticipatingGroup
    Item
    Intergroup Patient Serial #
    text
    NCIInstitutionNumber
    Item
    Site #
    text
    PatientSocialSecurityNumber
    Item
    Patient's Social Security # (USA only)
    double
    InstitutionName
    Item
    Institution
    text
    RegisteredInvestigator
    Item
    Investigator
    text
    Item Group
    2. Radiology
    Item
    Chest x-ray
    text
    CL.1
    Code List
    Chest x-ray
    CL Item
    Not Done (Not Done)
    CL Item
    Negative (Normal)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Abnormal Not Malignant (Abnormal Not Malignant)
    CL Item
    Positive (Abnormal Malignant)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    Item
    ultrasound/CT scan of abdomen/MRI
    text
    CL.2
    Code List
    ultrasound/CT scan of abdomen/MRI
    CL Item
    Not Done (Not Done)
    CL281691 (NCI Metathesaurus)
    CL Item
    Normal (Normal)
    CL Item
    Abnormal Not Malignant (Abnormal Not Malignant)
    CL Item
    Abnormal Malignant (Abnormal Malignant)
    Item
    ultrasound/CT scan of abdomen/MRI (circle one)
    text
    CL.3
    Code List
    ultrasound/CT scan of abdomen/MRI (circle one)
    CL Item
    Ultrasound (Ultrasound)
    C64384 (NCI Thesaurus)
    C1456803 (UMLS 2011AA)
    CL Item
    Ct Scan (CT scan of abdomen)
    CL Item
    Mri (MRI)
    Item
    bone scan
    text
    CL.4
    Code List
    bone scan
    CL Item
    Not Done (Not Done)
    CL281691 (NCI Metathesaurus)
    CL Item
    Normal (Normal)
    CL Item
    Abnormal Not Malignant (Abnormal Not Malignant)
    CL Item
    Abnormal Malignant (Abnormal Malignant)
    Item
    CT of brain
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C17204 (NCI Thesaurus ObjectClass)
    C0040405 (UMLS 2011AA ObjectClass)
    C12419 (NCI Thesaurus ObjectClass)
    C0018670 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.5
    Code List
    CT of brain
    CL Item
    Head Ct Was Not Done (Not Done)
    CL Item
    Head Ct Was Done, And Results Were Negative (Normal)
    CL Item
    Abnormal Not Malignant (Abnormal Not Malignant)
    CL Item
    Head Ct Was Done, And Results Were Positive (Abnormal Malignant)
    Item
    other: (specify)
    text
    CL.6
    Code List
    other: (specify)
    CL Item
    Not Done (Not Done)
    CL281691 (NCI Metathesaurus)
    CL Item
    Normal (Normal)
    CL Item
    Abnormal Not Malignant (Abnormal Not Malignant)
    CL Item
    Abnormal Malignant (Abnormal Malignant)
    AssessmentType,Specify
    Item
    other: (specify)2
    text
    AssessmentDate
    Item
    Date
    date
    Comments
    Item
    6. COMMENTS
    text
    Item Group
    3. Disease Status
    ProgressionDate
    Item
    Date of documented relapse or progression
    date
    Item Group
    Ncic Ctg Use Only
    LoggedEntryInitials
    Item
    Logged
    text
    LoggedEntryDate
    Item
    Unnamed1
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    CoordinatorReviewInitials
    Item
    Study Coord
    text
    CoordinatorReviewDate
    Item
    Unnamed2
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    PhysicianReviewInitials
    Item
    Phy
    text
    DataEntryInitials
    Item
    Data Ent'd
    text
    DataVerificationInitials
    Item
    Verified
    text
    Item Group
    Unnamed1
    PatientStudyID,CoordinatingGroup
    Item
    Pt. Serial #
    text
    PatientInitialsName
    Item
    Pt. Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    Item Group
    4. Recurrence Table
    Item
    Lung (* Local recurrence in the area of tumour bed or Hilum.)
    text
    CL.7
    Code List
    Lung (* Local recurrence in the area of tumour bed or Hilum.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Liver
    text
    CL.8
    Code List
    Liver
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Pleura (to be discussed)
    text
    CL.9
    Code List
    Pleura (to be discussed)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    CNS (excluding brain)
    text
    CL.10
    Code List
    CNS (excluding brain)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Brain
    text
    CL.11
    Code List
    Brain
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Bone
    text
    CL.12
    Code List
    Bone
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Opposite Lung
    text
    CL.13
    Code List
    Opposite Lung
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Regional Lymph nodes (** Mediastinal lymph nodes)
    text
    CL.14
    Code List
    Regional Lymph nodes (** Mediastinal lymph nodes)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
    text
    CL.15
    Code List
    Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Distant Skin or Subcutaneous tissue
    text
    CL.16
    Code List
    Distant Skin or Subcutaneous tissue
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Other
    text
    CL.17
    Code List
    Other
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    OtherSiteName
    Item
    Other (please describe)
    text
    ProgressionSuspectedBeginDate
    Item
    Suspected Date
    date
    ProgressionDefiniteBeginDate
    Item
    Definite Date
    date
    ProgressionCriteria
    Item
    Supporting Evidence (please describe)
    text
    C25331 (NCI Thesaurus ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    Item Group
    Unnamed2
    PatientStudyID,CoordinatingGroup
    Item
    Pt. Serial #
    text
    PatientInitialsName
    Item
    Pt. Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    Item Group
    5. Treatment Plan
    TreatmentAssignmentCode
    Item
    5. TREATMENT PLAN (please describe)
    text
    Item Group
    6. Comments
    Comments
    Item
    6. COMMENTS
    text
    Item Group
    7. Have You Attached Copies Of
    Item
    7. HAVE YOU ATTACHED COPIES OF (please _)
    text
    CL.18
    Code List
    7. HAVE YOU ATTACHED COPIES OF (please _)
    CL Item
    chest x-ray (chest x-ray)
    CL Item
    CT of abdomen/pelvis (CT of abdomen/pelvis)
    CL Item
    pathology/cytology report(s) (pathology/cytology report(s))
    CL Item
    other radiology (other radiology)
    CL Item
    MRI (MRI)
    CL Item
    Other: specify (Other: specify)
    VisitReportMonthSpecify
    Item
    Other: specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C29846 (NCI Thesaurus Property)
    C0439231 (UMLS 2011AA Property)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C25716 (NCI Thesaurus ObjectClass)
    C0545082 (UMLS 2011AA ObjectClass)
    Item Group
    8. Investigator Signature
    InvestigatorSignature
    Item
    Signature of Responsible Investigator
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    PersonCompletingForm,LastName
    Item
    Name of Clinical Research Associate
    text
    FormCompletionDate,Original
    Item
    Date
    date
    Item Group
    Ccrr Module For Form 9 - Relapse/ Progressive Disease Report
    PersonCompletingForm,FirstName
    Item
    Person Completing Form, First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item
    Ascites
    text
    CL.20
    Code List
    Ascites
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Pleural Effusion
    text
    CL.21
    Code List
    Pleural Effusion
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Local Lung Site Ind
    text
    CL.22
    Code List
    Local Lung Site Ind
    CL Item
    NO (NO)
    CL Item
    YES (YES)
    Item
    Distant Lung Site Ind
    text
    CL.19
    Code List
    Distant Lung Site Ind
    CL Item
    No (NO)
    CL Item
    Yes (YES)
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