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ID

10571

Descrição

S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM NCT00020709 S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CA62D43-50BE-361C-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CA62D43-50BE-361C-E034-080020C9C0E0

Palavras-chave

  1. 19/09/2012 19/09/2012 -
  2. 28/05/2015 28/05/2015 -
  3. 03/06/2015 03/06/2015 -
Transferido a

3 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM NCT00020709

    No Instruction available.

    1. StudyEvent: S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM
      1. No Instruction available.
    SWOG clinical trial administrative data
    Descrição

    SWOG clinical trial administrative data

    SWOG Patient ID
    Descrição

    SWOGPatientID

    Tipo de dados

    text

    SWOG Study No.
    Descrição

    SWOGStudyNo.

    Tipo de dados

    text

    Registration Step
    Descrição

    RegistrationStep

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS 2011AA ValueDomain
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus ValueDomain
    C16154 (undefined)
    UMLS 2011AA ValueDomain
    C1704379 (Treatment Step)
    Submission Time
    Descrição

    SubmissionTime:

    Tipo de dados

    text

    Patient Initials (L, F,M)
    Descrição

    PatientInitials

    Tipo de dados

    text

    Institution / Affiliate
    Descrição

    Institution/Affiliate

    Tipo de dados

    text

    Physician
    Descrição

    Physician

    Tipo de dados

    text

    Group Name (Groups other than SWOG )
    Descrição

    GroupName

    Tipo de dados

    text

    Study No. (Groups other than SWOG )
    Descrição

    StudyNo.

    Tipo de dados

    double

    Pt. ID (Groups other than SWOG )
    Descrição

    Pt.ID

    Tipo de dados

    text

    Treatment
    Descrição

    Treatment

    Reporting Begin Date (4 week period)
    Descrição

    ReportingBeginDate:

    Tipo de dados

    text

    Reporting End Date
    Descrição

    ReportingEndDate:

    Tipo de dados

    text

    Were there any dose modifications or additions/deletions to protocol treatment?
    Descrição

    Werethereanydosemodificationsoradditions/deletionstoprotocoltreatment?

    Tipo de dados

    text

    Delay
    Descrição

    Delay:

    Tipo de dados

    text

    Dose reduction
    Descrição

    Dosereduction:

    Tipo de dados

    text

    Total dose for this reporting period (mg ZD1839 1 Tablet = 250 mg)
    Descrição

    Totaldoseforthisreportingperiod:

    Tipo de dados

    text

    Toxicity
    Descrição

    Toxicity

    Were toxicities assessed during this time period?
    Descrição

    Weretoxicitiesassessedduringthistimeperiod?

    Tipo de dados

    text

    Date of most recent toxicity assessment
    Descrição

    Dateofmostrecenttoxicityassessment:

    Tipo de dados

    text

    CTC 2.0 Code
    Descrição

    CTC2.0Code

    Tipo de dados

    text

    Toxicity
    Descrição

    Toxicity

    Tipo de dados

    text

    Grade (1 - 5)
    Descrição

    Grade

    Tipo de dados

    double

    Treatment Relation
    Descrição

    TreatmentRelation

    Tipo de dados

    text

    Other Toxicities (specify:)
    Descrição

    OtherToxicities

    Tipo de dados

    text

    Notes
    Descrição

    Notes

    Notes
    Descrição

    Notes

    Tipo de dados

    text

    Similar models

    No Instruction available.

    1. StudyEvent: S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    SWOG clinical trial administrative data
    SWOGPatientID
    Item
    SWOG Patient ID
    text
    SWOGStudyNo.
    Item
    SWOG Study No.
    text
    RegistrationStep
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16154 (NCI Thesaurus ValueDomain)
    C1704379 (UMLS 2011AA ValueDomain)
    Item
    Submission Time
    text
    Code List
    Submission Time
    CL Item
    4 week (First) Submission (4 week (First) Submission)
    CL Item
    8 week (Second) Submission (8 week (Second) Submission)
    CL Item
    Other (Other)
    PatientInitials
    Item
    Patient Initials (L, F,M)
    text
    Institution/Affiliate
    Item
    Institution / Affiliate
    text
    Physician
    Item
    Physician
    text
    GroupName
    Item
    Group Name (Groups other than SWOG )
    text
    StudyNo.
    Item
    Study No. (Groups other than SWOG )
    double
    Pt.ID
    Item
    Pt. ID (Groups other than SWOG )
    text
    Item Group
    Treatment
    ReportingBeginDate:
    Item
    Reporting Begin Date (4 week period)
    text
    ReportingEndDate:
    Item
    Reporting End Date
    text
    Item
    Were there any dose modifications or additions/deletions to protocol treatment?
    text
    Code List
    Were there any dose modifications or additions/deletions to protocol treatment?
    CL Item
    No (No)
    CL Item
    Yes, planned (per protocol guidelines) (Yes, planned (per protocol guidelines))
    CL Item
    Yes, unplanned (not per protocol guidelines) (Yes, unplanned (not per protocol guidelines))
    Item
    Delay
    text
    Code List
    Delay
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Dose reduction
    text
    Code List
    Dose reduction
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Totaldoseforthisreportingperiod:
    Item
    Total dose for this reporting period (mg ZD1839 1 Tablet = 250 mg)
    text
    Item Group
    Toxicity
    Item
    Were toxicities assessed during this time period?
    text
    Code List
    Were toxicities assessed during this time period?
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    Dateofmostrecenttoxicityassessment:
    Item
    Date of most recent toxicity assessment
    text
    Item
    CTC 2.0 Code
    text
    Code List
    CTC 2.0 Code
    CL Item
    SK11 (SK11)
    CL Item
    EY01 (EY01)
    CL Item
    EY02 (EY02)
    CL Item
    EY30 (EY30)
    CL Item
    EY40 (EY40)
    CL Item
    EY99 (EY99)
    CL Item
    FL40 (FL40)
    CL Item
    LI00 (LI00)
    CL Item
    LI12 (LI12)
    CL Item
    GI00 (GI00)
    CL Item
    GI01 (GI01)
    CL Item
    GI10 (GI10)
    CL Item
    GI20 (GI20)
    CL Item
    GU50 (GU50)
    CL Item
    HE00 (HE00)
    CL Item
    HE10 (HE10)
    CL Item
    HE20 (HE20)
    CL Item
    HE30 (HE30)
    CL Item
    IM00 (IM00)
    CL Item
    IN00 (IN00)
    CL Item
    IN05 (IN05)
    CL Item
    IN30 (IN30)
    Item
    Toxicity
    text
    Code List
    Toxicity
    CL Item
    Rash/Desquamation (Rash/Desquamation)
    CL Item
    Conjunctivitis (Conjunctivitis)
    CL Item
    Keratitis (Keratitis)
    CL Item
    Tearing (Tearing)
    CL Item
    Vision, NOS (Vision, NOS)
    CL Item
    Eye, Other (Eye, Other)
    CL Item
    Fatigue (Fatigue)
    CL Item
    Bilirubin increase (Bilirubin increase)
    CL Item
    SGPT increase (SGPT increase)
    CL Item
    Nausea (Nausea)
    CL Item
    Anorexia (Anorexia)
    CL Item
    Vomiting (Vomiting)
    CL Item
    Diarrhea (Diarrhea)
    CL Item
    Creatinine increase (Creatinine increase)
    CL Item
    Leukopenia (Leukopenia)
    CL Item
    Thrombocytopenia (Thrombocytopenia)
    CL Item
    Anemia (Anemia)
    CL Item
    Neutropenia/granulocytopenia (Neutropenia/granulocytopenia)
    CL Item
    Allergy/hypersensitivity (Allergy/hypersensitivity)
    CL Item
    Infection w/o 3-4 neutropenia (Infection w/o 3-4 neutropenia)
    CL Item
    Infection with 3-4 neutropenia (Infection with 3-4 neutropenia)
    CL Item
    Febrile neutropenia (Febrile neutropenia)
    Grade
    Item
    Grade (1 - 5)
    double
    Item
    Treatment Relation
    text
    Code List
    Treatment Relation
    CL Item
    unrelated (unrelated)
    CL Item
    unlikely (unlikely)
    CL Item
    possible (possible)
    CL Item
    probable (probable)
    CL Item
    definite (definite)
    OtherToxicities
    Item
    Other Toxicities (specify:)
    text
    Item Group
    Notes
    Notes
    Item
    Notes
    text

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