0 Evaluaciones
ID

44324

Descripción

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

Palabras clave

Versiones (2)
  1. 25/5/18 25/5/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

    Inglés

    Central Pathology Assessment

    1 formularios  
    Central Pathology Assessment
    Descripción

    Central Pathology Assessment

    Alias
    UMLS CUI-1
    C0030664 (Pathology)
    SNOMED
    394595002
    Biopsy Number
    Descripción

    Biopsy Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Biopsy date:
    Descripción

    Biopsy date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Site:
    Descripción

    Biopsy site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1301128 (Biopsy site)
    SNOMED
    396991001
    LOINC
    MTHU064249
    Accession #:
    Descripción

    Accession #

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1510755 (Accession Number (identifier))
    UMLS CUI [1,2]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    Number of slides:
    Descripción

    Number of slides

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1705201 (Slide Device)
    SNOMED
    433466003
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Name/location of original path site:
    Descripción

    Name/location of original path site

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1527021 (Text)
    LOINC
    LP6885-0
    UMLS CUI [1,2]
    C0205145 (Site)
    SNOMED
    10546003
    LOINC
    MTHU014632
    UMLS CUI [1,3]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Working Formulation Classification: Histology
    Descripción

    Histology Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0019638 (Histology)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Histology - Cell types
    Descripción

    Histology - Cell types

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0449574 (Histologic type)
    SNOMED
    263541007
    LOINC
    LP72692-4
    Specify: Other cell type
    Descripción

    Other Cell type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0449475 (cell type)
    SNOMED
    246238003
    UMLS CUI [1,2]
    C2348235 (Specification)
    Central Pathologist Assessment
    Descripción

    Central Pathologist Assessment

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0334866 (Medical pathologist)
    SNOMED
    61207006
    UMLS CUI [1,2]
    C1516048 (Assessed)
    Transformed Low-Grade NHL
    Descripción

    Transformed Low-Grade NHL

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0024305 (Lymphoma, Non-Hodgkin)
    SNOMED
    1929004
    UMLS CUI [1,2]
    C1282907 (Low Grade)
    UMLS CUI [1,3]
    C0457344 (Transformed phase)
    SNOMED
    278178002
    Basis of Assessment
    Descripción

    Basis of Assessment

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,2]
    C1874451 (Basis)
    Pathology Assessment Description
    Descripción

    Pathology Assessment Description

    Alias
    UMLS CUI-1
    C0030664 (Pathology)
    SNOMED
    394595002
    UMLS CUI-2
    C0678257 (Description)
    LOINC
    LP6800-9
    Description:
    Descripción

    Description

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0678257 (Description)
    LOINC
    LP6800-9
    UMLS CUI [1,2]
    C0030664 (Pathology)
    SNOMED
    394595002
    Central Pathology Diagnosis:
    Descripción

    Central Pathology Diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0030664 (Pathology)
    SNOMED
    394595002
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Concordance with Original Pathology Report:
    Descripción

    Concordance with Original Pathology Report

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    UMLS CUI [1,2]
    C2347585 (Central Pathology Review)
    UMLS CUI [1,3]
    C0680240 (Agreement)
    Concordance with Study Site Pathology Report:
    Descripción

    Concordance with Study Site Pathology Report

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    UMLS CUI [1,2]
    C2347585 (Central Pathology Review)
    UMLS CUI [1,3]
    C0680240 (Agreement)
    Administration
    Descripción

    Administration

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Signature
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Volver a la parte superior de la página

    Similar models

    Central Pathology Assessment

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Central Pathology Assessment
    C0030664 (UMLS CUI-1)
    Item
    Biopsy Number
    integer
    C0005558 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Biopsy Number
    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])
    Histology Number
    Code List
    Working Formulation Classification: Histology
    CL Item
    1 (1)
    CL Item
    2 (2)
    Item
    Histology - Cell types
    integer
    C0449574 (UMLS CUI [1])
    Histology - Cell types
    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])
    Central Pathologist Assessment
    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])
    Transformed Low-Grade NHL
    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])
    Basis of Assessment
    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])
    Concordance with Original Pathology Report
    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])
    Concordance with Study Site Pathology Report
    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])
    Volver a la parte superior de la página 

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