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ID

16691

Description

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

Keywords

Versions (2)
  1. 27/07/16 27/07/16 -
  2. 01/08/16 01/08/16 -
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1 agosto 2016

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

    English

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

    1 forms  
    Header
    Description

    Header

    Site Number
    Description

    Site number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018704 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Number
    Description

    Patient Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Demographics
    Description

    Demographics

    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnicity
    Description

    Ethnicity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Race
    Description

    Race

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    If other, specify
    Description

    Race

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    Screening Eligibility Criteria
    Description

    Screening Eligibility Criteria

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

    Inclusion Criteria

    Data type

    boolean

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

    Inclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C1512693 (Inclusion)
    Did the patient meet any of the screening exclusion criteria?
    Description

    Exclusion Criteria

    Data type

    boolean

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

    Exclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    lf any screening eligibility criteria were not met, was an exemption granted by OSI?
    Description

    Eligibility Criteria

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516637 (Clinical Trial Eligibility Criteria)
    UMLS CUI [1,2]
    C2348482 (Exemption)
    Date screening consent was signed:
    Description

    Date screening consent was signed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    IVRS Screening Number
    Description

    IVRS Screening Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710477 (Trial Screening)
    Treatment Eligibility Criteria
    Description

    Treatment Eligibility Criteria

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

    Inclusion Criteria

    Data type

    boolean

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

    Inclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C1512693 (Inclusion)
    Did the patient meet any of the treatment exclusion criteria?
    Description

    Exclusion Criteria

    Data type

    boolean

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

    Exclusion Criteria

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
    Description

    Eligibility Criteria

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516637 (Clinical Trial Eligibility Criteria)
    UMLS CUI [1,2]
    C2348482 (Exemption)
    Date main study consent was signed:
    Description

    Date main study consent was signed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    IVRS Randomization
    Description

    IVRS Randomization

    Date randomized through IVRS:
    Description

    Study drug therapy must start within 5 days of randomization.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0034656 (Randomization)
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    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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