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41496

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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Versions (1)
  1. 10/28/20 10/28/20 -
Copyright Holder

GlaxoSmithKline

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October 28, 2020

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Creative Commons BY 4.0
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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Screening - Laboratory Tests (Annex Report 2 Final)

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Laboratory Tests
    Description

    Laboratory Tests

    Alias
    UMLS CUI-1
    C0022885
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Lab Code
    Description

    (For GSK use only)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0805701
    Laboratory Assay
    Description

    Laboratory Assay

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C1510438
    Has a blood sample been taken?
    Description

    Has a blood sample been taken?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date blood sample taken
    Description

    Date blood sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Haematology
    Description

    Haematology

    Alias
    UMLS CUI-1
    C0018941
    Haematology Test
    Description

    Haematology Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology Result
    Description

    Haematology Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0474523
    Biochemistry
    Description

    Biochemistry

    Alias
    UMLS CUI-1
    C0005477
    Biochemistry Test
    Description

    Biochemistry Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1655775
    Biochemistry Result
    Description

    Biochemistry Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C1274040
    Hepatic Function
    Description

    Hepatic Function

    Alias
    UMLS CUI-1
    C0232741
    Hepatic Function Test
    Description

    Hepatic Function Test

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0022885
    Hepatic Function Result
    Description

    Hepatic Function Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C1274040
    Renal Function
    Description

    Renal Function

    Alias
    UMLS CUI-1
    C0232804
    Renal Function Test
    Description

    Renal Function Test

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0022885
    Renal Function Result
    Description

    Renal Function Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C1274040
    HCG Urine or Blood Pregnancy Test
    Description

    HCG Urine or Blood Pregnancy Test

    Alias
    UMLS CUI-1
    C0430056
    UMLS CUI-2
    C0430060
    Has a urine or blood sample been taken for pregnancy test?
    Description

    Has a urine or blood sample been taken for pregnancy test?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0032976
    Date of pregnancy test
    Description

    Date of pregnancy test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Description

    Pregnancy test result

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0427777
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    Similar models

    Screening - Laboratory Tests (Annex Report 2 Final)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Laboratory Tests
    C0022885 (UMLS CUI-1)
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Lab Code
    Item
    Lab Code
    text
    C0022885 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Item Group
    Laboratory Assay
    C0022877 (UMLS CUI-1)
    C1510438 (UMLS CUI-2)
    Has a blood sample been taken?
    Item
    Has a blood sample been taken?
    boolean
    C0005834 (UMLS CUI [1])
    Date blood sample taken
    Item
    Date blood sample taken
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Haematology
    C0018941 (UMLS CUI-1)
    Item
    Haematology Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology Test
    Code List
    Haematology Test
    CL Item
    Hemoglobin (1)
    CL Item
    Platelets (2)
    CL Item
    White Blood Cells (3)
    CL Item
    Neutrophils (4)
    CL Item
    Lymphocytes (5)
    Haematology Result
    Item
    Haematology Result
    text
    C0474523 (UMLS CUI [1])
    Item Group
    Biochemistry
    C0005477 (UMLS CUI-1)
    Item
    Biochemistry Test
    integer
    C1655775 (UMLS CUI [1])
    Biochemistry Test
    Code List
    Biochemistry Test
    CL Item
    LDH (1)
    Biochemistry Result
    Item
    Biochemistry Result
    text
    C0005477 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Hepatic Function
    C0232741 (UMLS CUI-1)
    Item
    Hepatic Function Test
    integer
    C0232741 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Hepatic Function Test
    Code List
    Hepatic Function Test
    CL Item
    Total bilirubin (1)
    CL Item
    Aspartate transaminase (ASAT) (2)
    CL Item
    Alanine transaminase (ALAT) (3)
    CL Item
    Alkaline phosphatase (4)
    Hepatic Function Result
    Item
    Hepatic Function Result
    text
    C0232741 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Renal Function
    C0232804 (UMLS CUI-1)
    Item
    Renal Function Test
    integer
    C0232804 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Renal Function Test
    Code List
    Renal Function Test
    CL Item
    Creatinine (1)
    Renal Function Result
    Item
    Renal Function Result
    text
    C0232804 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    HCG Urine or Blood Pregnancy Test
    C0430056 (UMLS CUI-1)
    C0430060 (UMLS CUI-2)
    Item
    Has a urine or blood sample been taken for pregnancy test?
    integer
    C0005834 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Has a urine or blood sample been taken for pregnancy test?
    Code List
    Has a urine or blood sample been taken for pregnancy test?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (Not of childbearing potential or male) (3)
    Date of pregnancy test
    Item
    Date of pregnancy test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    integer
    C0427777 (UMLS CUI [1])
    Pregnancy test result
    Code List
    Pregnancy test result
    CL Item
    Negative (1)
    CL Item
    Positive (please complete screening conclusion) (2)
    Back to the top of the page 

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