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ID

16691

Descrição

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Screening Assessments

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

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Versões (2)
  1. 27/07/2016 27/07/2016 -
  2. 01/08/2016 01/08/2016 -
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1 de agosto de 2016

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Licença

Creative Commons BY 4.0
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    Screening Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

    Inglês

    Screening Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1 Formulários  
    Header
    Descrição

    Header

    Site Number
    Descrição

    Site number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440
    Demographics
    Descrição

    Demographics

    Date of birth
    Descrição

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descrição

    Gender

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Descrição

    Ethnicity

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race
    Descrição

    Race

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0034510
    If other, specify
    Descrição

    Race

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0034510
    Screening Eligibility Criteria
    Descrição

    Screening Eligibility Criteria

    Did the patient meet all of the screening inclusion criteria?
    Descrição

    Inclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    lf No, which was/were not met? Inclusion Letter(s):
    Descrição

    Inclusion Criteria

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1512693
    Did the patient meet any of the screening exclusion criteria?
    Descrição

    Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    If Yes, which was/were met? Exclusion Letter(s):
    Descrição

    Exclusion Criteria

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0680251
    lf any screening eligibility criteria were not met, was an exemption granted by OSI?
    Descrição

    Eligibility Criteria

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C2348482
    Date screening consent was signed:
    Descrição

    Date screening consent was signed

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021430
    IVRS Screening Number
    Descrição

    IVRS Screening Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1710477
    Treatment Eligibility Criteria
    Descrição

    Treatment Eligibility Criteria

    Did the patient meet all of the treatment inclusion criteria?
    Descrição

    Inclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    lf No, which was/were not met? Inclusion Number(s):
    Descrição

    Inclusion Criteria

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1512693
    Did the patient meet any of the treatment exclusion criteria?
    Descrição

    Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    If Yes, which was/were met? Exclusion Number(s):
    Descrição

    Exclusion Criteria

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0680251
    lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
    Descrição

    Eligibility Criteria

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C2348482
    Date main study consent was signed:
    Descrição

    Date main study consent was signed

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021430
    IVRS Randomization
    Descrição

    IVRS Randomization

    Date randomized through IVRS:
    Descrição

    Study drug therapy must start within 5 days of randomization.

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0034656
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    Similar models

    Screening Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    Site number
    Item
    Site Number
    integer
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Demographics
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (1)
    CL Item
    Female (2)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    Code List
    Ethnicity
    CL Item
    Hispanic/Latino (1)
    CL Item
    Not Hispanic/Latino (2)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Ethnicity
    Code List
    Race
    CL Item
    American Indian/Alaska Native (1)
    CL Item
    Asian: Far East (2)
    CL Item
    Asian: Southeast Asia (3)
    CL Item
    Asian: Indian Subcontinent (4)
    CL Item
    Black (5)
    CL Item
    Native Hawaiian/Pacific Islander (6)
    CL Item
    White (7)
    CL Item
    Other (8)
    Race
    Item
    If other, specify
    text
    C0034510 (UMLS CUI [1])
    Item Group
    Screening Eligibility Criteria
    Inclusion Criteria
    Item
    Did the patient meet all of the screening inclusion criteria?
    boolean
    C1512693 (UMLS CUI [1])
    Inclusion Criteria
    Item
    lf No, which was/were not met? Inclusion Letter(s):
    text
    C1512693 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Did the patient meet any of the screening exclusion criteria?
    boolean
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Item
    If Yes, which was/were met? Exclusion Letter(s):
    text
    C0680251 (UMLS CUI [1])
    Item
    lf any screening eligibility criteria were not met, was an exemption granted by OSI?
    integer
    C1516637 (UMLS CUI [1,1])
    C2348482 (UMLS CUI [1,2])
    Eligibility Criteria
    Code List
    lf any screening eligibility criteria were not met, was an exemption granted by OSI?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Date screening consent was signed
    Item
    Date screening consent was signed:
    date
    C0011008 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    IVRS Screening Number
    Item
    IVRS Screening Number
    text
    C1710477 (UMLS CUI [1])
    Item Group
    Treatment Eligibility Criteria
    Inclusion Criteria
    Item
    Did the patient meet all of the treatment inclusion criteria?
    boolean
    C1512693 (UMLS CUI [1])
    Inclusion Criteria
    Item
    lf No, which was/were not met? Inclusion Number(s):
    text
    C1512693 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Did the patient meet any of the treatment exclusion criteria?
    boolean
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Item
    If Yes, which was/were met? Exclusion Number(s):
    text
    C0680251 (UMLS CUI [1])
    Item
    lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
    integer
    C1516637 (UMLS CUI [1,1])
    C2348482 (UMLS CUI [1,2])
    Eligibility Criteria
    Code List
    lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Date main study consent was signed
    Item
    Date main study consent was signed:
    date
    C0011008 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Item Group
    IVRS Randomization
    Randomization Date
    Item
    Date randomized through IVRS:
    date
    C0011008 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
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