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ID

44324

Description

https://clinicaltrials.gov/show/NCT00989664 Central Pathology Assessment Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

  1. 5/25/18 5/25/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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    Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

    Central Pathology Assessment

    Central Pathology Assessment
    Description

    Central Pathology Assessment

    Alias
    UMLS CUI-1
    C0030664
    Biopsy Number
    Description

    Biopsy Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0237753
    Biopsy date:
    Description

    Biopsy date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    Site:
    Description

    Biopsy site

    Data type

    text

    Alias
    UMLS CUI [1]
    C1301128
    Accession #:
    Description

    Accession #

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1510755
    UMLS CUI [1,2]
    C0005558
    Number of slides:
    Description

    Number of slides

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705201
    UMLS CUI [1,2]
    C0449788
    Name/location of original path site:
    Description

    Name/location of original path site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1527021
    UMLS CUI [1,2]
    C0205145
    UMLS CUI [1,3]
    C0027365
    Working Formulation Classification: Histology
    Description

    Histology Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0237753
    Histology - Cell types
    Description

    Histology - Cell types

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449574
    Specify: Other cell type
    Description

    Other Cell type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0449475
    UMLS CUI [1,2]
    C2348235
    Central Pathologist Assessment
    Description

    Central Pathologist Assessment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0334866
    UMLS CUI [1,2]
    C1516048
    Transformed Low-Grade NHL
    Description

    Transformed Low-Grade NHL

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C1282907
    UMLS CUI [1,3]
    C0457344
    Basis of Assessment
    Description

    Basis of Assessment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C1874451
    Pathology Assessment Description
    Description

    Pathology Assessment Description

    Alias
    UMLS CUI-1
    C0030664
    UMLS CUI-2
    C0678257
    Description:
    Description

    Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0030664
    Central Pathology Diagnosis:
    Description

    Central Pathology Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030664
    UMLS CUI [1,2]
    C0011900
    Concordance with Original Pathology Report:
    Description

    Concordance with Original Pathology Report

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C2347585
    UMLS CUI [1,3]
    C0680240
    Concordance with Study Site Pathology Report:
    Description

    Concordance with Study Site Pathology Report

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C2347585
    UMLS CUI [1,3]
    C0680240
    Administration
    Description

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Signature
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008

    Similar models

    Central Pathology Assessment

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Central Pathology Assessment
    C0030664 (UMLS CUI-1)
    Item
    Biopsy Number
    integer
    C0005558 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Code List
    Biopsy Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    Biopsy date
    Item
    Biopsy date:
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Biopsy site
    Item
    Site:
    text
    C1301128 (UMLS CUI [1])
    Accession #
    Item
    Accession #:
    integer
    C1510755 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    Number of slides
    Item
    Number of slides:
    integer
    C1705201 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Name/location of original path site
    Item
    Name/location of original path site:
    text
    C1527021 (UMLS CUI [1,1])
    C0205145 (UMLS CUI [1,2])
    C0027365 (UMLS CUI [1,3])
    Item
    Working Formulation Classification: Histology
    integer
    C0019638 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Code List
    Working Formulation Classification: Histology
    CL Item
    1 (1)
    CL Item
    2 (2)
    Item
    Histology - Cell types
    integer
    C0449574 (UMLS CUI [1])
    Code List
    Histology - Cell types
    CL Item
    Small lymphocytic with plasmacytoid differentiation (1)
    CL Item
    Small lymphocytic without plasmacytoid differentiation (2)
    CL Item
    Follicular small-cleaved cell (3)
    CL Item
    Follicular mixed ( <50% large cell) (4)
    CL Item
    Follicular large cell (5)
    CL Item
    Diffuse small-cleaved cell (6)
    CL Item
    Diffuse mixed small-cell and large cell (7)
    CL Item
    Diffuse large cell (8)
    CL Item
    Large cell, immunoblastic (9)
    CL Item
    Lymphoblastic, convoluted (10)
    CL Item
    Lymphoblastic, non-convoluted (11)
    CL Item
    Other, specify (12)
    Other Cell type
    Item
    Specify: Other cell type
    text
    C0449475 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Central Pathologist Assessment
    integer
    C0334866 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Code List
    Central Pathologist Assessment
    CL Item
    Low-Grade NHL (1)
    CL Item
    Transformed Low-Grade NHL (2)
    CL Item
    Non-diagnostic (3)
    Item
    Transformed Low-Grade NHL
    integer
    C0024305 (UMLS CUI [1,1])
    C1282907 (UMLS CUI [1,2])
    C0457344 (UMLS CUI [1,3])
    Code List
    Transformed Low-Grade NHL
    CL Item
    subsequent to low-grade diagnosis (1)
    CL Item
    composite (single biopsy site) (2)
    CL Item
    concurrent with low-grade diagnosis (multiple biopsy sites) (3)
    Item
    Basis of Assessment
    integer
    C0220825 (UMLS CUI [1,1])
    C1874451 (UMLS CUI [1,2])
    Code List
    Basis of Assessment
    CL Item
    Pathology Specimen(s) (1)
    CL Item
    Pathology Report(s) (2)
    Item Group
    Pathology Assessment Description
    C0030664 (UMLS CUI-1)
    C0678257 (UMLS CUI-2)
    Description
    Item
    Description:
    text
    C0678257 (UMLS CUI [1,1])
    C0030664 (UMLS CUI [1,2])
    Central Pathology Diagnosis
    Item
    Central Pathology Diagnosis:
    text
    C0030664 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item
    Concordance with Original Pathology Report:
    integer
    C0449438 (UMLS CUI [1,1])
    C2347585 (UMLS CUI [1,2])
    C0680240 (UMLS CUI [1,3])
    Code List
    Concordance with Original Pathology Report:
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Report unavailable (3)
    Item
    Concordance with Study Site Pathology Report:
    integer
    C0449438 (UMLS CUI [1,1])
    C2347585 (UMLS CUI [1,2])
    C0680240 (UMLS CUI [1,3])
    Code List
    Concordance with Study Site Pathology Report:
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Report unavailable (3)
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Signature
    Item
    Signature
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])

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