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ID

44258

Description

A Study of Advanced or Metastatic Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00988858

Link

https://clinicaltrials.gov/show/NCT00988858

Keywords

Versions (2)
  1. 7/15/18 7/15/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

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September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Non Small Cell Lung Cancer NCT00988858

    English

    Eligibility Non Small Cell Lung Cancer NCT00988858

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    must agree to have a tumor biopsy at screening
    Description

    Agreement Tumor Biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680240
    UMLS CUI [1,2]
    C0027651
    UMLS CUI [1,3]
    C0005558
    must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
    Description

    Non-Squamous Non-Small Cell Lung Carcinoma Advanced | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Disease Progression Post Prior Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4324656
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [2]
    C4288755
    UMLS CUI [3,1]
    C0242656
    UMLS CUI [3,2]
    C0687676
    UMLS CUI [3,3]
    C1514463
    must be available for the duration of the study and willing to follow the study procedures
    Description

    Patient Available Study duration | Protocol Compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0470187
    UMLS CUI [1,3]
    C0489652
    UMLS CUI [2]
    C0525058
    if participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
    Description

    Childbearing Potential Pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    must have discontinued radiation therapy at least 4 weeks before entering this study
    Description

    Therapeutic radiology procedure Discontinued

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C1444662
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
    Description

    Drugs, Non-Prescription

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013231
    must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child.
    Description

    Pregnancy | Breast Feeding | Pregnancy considering | Reproduction considering | Females & males of reproductive potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C0750591
    UMLS CUI [4,1]
    C0035150
    UMLS CUI [4,2]
    C0750591
    UMLS CUI [5,1]
    C4034483
    UMLS CUI [5,2]
    C0700589
    must not have known positive test in human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab).
    Description

    HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody test positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0149709
    UMLS CUI [3]
    C1277805
    must not have previously participated in a study involving ly2603618
    Description

    Study Subject Participation Status | Involvement with LY2603618

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C1314939
    UMLS CUI [2,2]
    C2825835
    must not have previously taken pemetrexed for cancer
    Description

    Pemetrexed Relationship Cancer treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0210657
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0920425
    must not have a known allergy to ly2603618 or pemetrexed
    Description

    Hypersensitivity LY2603618 | Hypersensitivity Pemetrexed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C2825835
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0210657
    must not currently have an infection that may affect patient's ability to tolerate the therapy
    Description

    Communicable Disease Affecting Therapeutic aspects

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0039798
    must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
    Description

    Medical condition Serious Study Subject Participation Status At risk | Disease Serious Study Subject Participation Status At risk | Diabetic - poor control | Chest Pain Due to Heart Disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C1444641
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C2348568
    UMLS CUI [2,4]
    C1444641
    UMLS CUI [3]
    C0421258
    UMLS CUI [4,1]
    C0008031
    UMLS CUI [4,2]
    C0678226
    UMLS CUI [4,3]
    C0018799
    if taking certain medications called non-steroidal anti-inflammatory drugs (nsaids), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
    Description

    Non-Steroidal Anti-Inflammatory Agents Discontinue Able | Ibuprofen Discontinue Able

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003211
    UMLS CUI [1,2]
    C1444662
    UMLS CUI [1,3]
    C0085732
    UMLS CUI [2,1]
    C0020740
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [2,3]
    C0085732
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    Similar models

    Eligibility Non Small Cell Lung Cancer NCT00988858

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Agreement Tumor Biopsy
    Item
    must agree to have a tumor biopsy at screening
    boolean
    C0680240 (UMLS CUI [1,1])
    C0027651 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [1,3])
    Non-Squamous Non-Small Cell Lung Carcinoma Advanced | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Disease Progression Post Prior Therapy
    Item
    must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
    boolean
    C4324656 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C4288755 (UMLS CUI [2])
    C0242656 (UMLS CUI [3,1])
    C0687676 (UMLS CUI [3,2])
    C1514463 (UMLS CUI [3,3])
    Patient Available Study duration | Protocol Compliance
    Item
    must be available for the duration of the study and willing to follow the study procedures
    boolean
    C0030705 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    C0489652 (UMLS CUI [1,3])
    C0525058 (UMLS CUI [2])
    Childbearing Potential Pregnancy test negative
    Item
    if participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    Therapeutic radiology procedure Discontinued
    Item
    must have discontinued radiation therapy at least 4 weeks before entering this study
    boolean
    C1522449 (UMLS CUI [1,1])
    C1444662 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Drugs, Non-Prescription
    Item
    must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
    boolean
    C0013231 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy considering | Reproduction considering | Females & males of reproductive potential Contraceptive methods
    Item
    must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032961 (UMLS CUI [3,1])
    C0750591 (UMLS CUI [3,2])
    C0035150 (UMLS CUI [4,1])
    C0750591 (UMLS CUI [4,2])
    C4034483 (UMLS CUI [5,1])
    C0700589 (UMLS CUI [5,2])
    HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody test positive
    Item
    must not have known positive test in human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab).
    boolean
    C0019699 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    C1277805 (UMLS CUI [3])
    Study Subject Participation Status | Involvement with LY2603618
    Item
    must not have previously participated in a study involving ly2603618
    boolean
    C2348568 (UMLS CUI [1])
    C1314939 (UMLS CUI [2,1])
    C2825835 (UMLS CUI [2,2])
    Pemetrexed Relationship Cancer treatment
    Item
    must not have previously taken pemetrexed for cancer
    boolean
    C0210657 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0920425 (UMLS CUI [1,3])
    Hypersensitivity LY2603618 | Hypersensitivity Pemetrexed
    Item
    must not have a known allergy to ly2603618 or pemetrexed
    boolean
    C0020517 (UMLS CUI [1,1])
    C2825835 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0210657 (UMLS CUI [2,2])
    Communicable Disease Affecting Therapeutic aspects
    Item
    must not currently have an infection that may affect patient's ability to tolerate the therapy
    boolean
    C0009450 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0039798 (UMLS CUI [1,3])
    Medical condition Serious Study Subject Participation Status At risk | Disease Serious Study Subject Participation Status At risk | Diabetic - poor control | Chest Pain Due to Heart Disease
    Item
    must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C1444641 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C2348568 (UMLS CUI [2,3])
    C1444641 (UMLS CUI [2,4])
    C0421258 (UMLS CUI [3])
    C0008031 (UMLS CUI [4,1])
    C0678226 (UMLS CUI [4,2])
    C0018799 (UMLS CUI [4,3])
    Non-Steroidal Anti-Inflammatory Agents Discontinue Able | Ibuprofen Discontinue Able
    Item
    if taking certain medications called non-steroidal anti-inflammatory drugs (nsaids), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
    boolean
    C0003211 (UMLS CUI [1,1])
    C1444662 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [1,3])
    C0020740 (UMLS CUI [2,1])
    C1444662 (UMLS CUI [2,2])
    C0085732 (UMLS CUI [2,3])
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