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ID

31357

Description

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Mots-clés

  1. 08/07/2018 08/07/2018 -
  2. 21/07/2018 21/07/2018 -
  3. 18/08/2018 18/08/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

    History of Lymphoma

    1. StudyEvent: ODM
      1. History of Lymphoma
    Tumor Stage
    Description

    Tumor Stage

    Alias
    UMLS CUI-1
    C1300072
    Stage at Diagnosis
    Description

    Stage at Diagnosis

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C0011900
    Stage at Enrollment
    Description

    Stage at Enrollment

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C1516879
    Date of Diagnosis
    Description

    Date of Diagnosis

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2316983
    Cell Type
    Description

    Cell Type

    Alias
    UMLS CUI-1
    C0449475
    Small lymphocytic with plasmacytoid differentiation
    Description

    Small lymphocytic with plasmacytoid differentiation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0855095
    UMLS CUI [1,2]
    C1403406
    Small lymphocytic without plasmacytoid differentiation
    Description

    Small lymphocytic without plasmacytoid differentiation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0855095
    UMLS CUI [1,2]
    C1403406
    UMLS CUI [1,3]
    C0332288
    Follicular, small- cleaved cell
    Description

    Follicular, small- cleaved cell

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079765
    Follicular, mixed small- cleaved cell (<50% large cell)
    Description

    Follicular, mixed small- cleaved cell

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0079765
    UMLS CUI [1,2]
    C0205430
    UMLS CUI [2,1]
    C0024299
    UMLS CUI [2,2]
    C1513997
    UMLS CUI [2,3]
    C0439165
    Follicular, large cell
    Description

    Follicular, large cell

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079745
    Diffuse, small cleaved
    Description

    Diffuse, small cleaved

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1398349
    Diffuse, mixed small-cleaved & large cell
    Description

    Diffuse, mixed small-cleaved & large cell

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1398349
    UMLS CUI [1,2]
    C0079744
    UMLS CUI [1,3]
    C0079757
    Diffuse, large cell
    Description

    Diffuse, large cell

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079744
    Large cell, immunoblastic
    Description

    Large cell, immunoblastic

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079746
    Lymphoblastic, convoluted
    Description

    Lymphoblastic, convoluted

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0079748
    UMLS CUI [1,2]
    C0333859
    Lymphoblastic, non-convolutet
    Description

    Lymphoblastic, non-convolutet

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079748
    Monocytoid B- Cell
    Description

    Monocytoid B- Cell

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0855139
    Other cell type
    Description

    Other

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0449475
    UMLS CUI [1,2]
    C0205394
    If other cell type, please specify
    Description

    Other specify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0449475
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Grade
    Description

    Grade

    Alias
    UMLS CUI-1
    C0919553
    Low Grade
    Description

    Low grade (well to moderately differentiated)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1273125
    Intermediate Grade
    Description

    Intermediate grade histologic differentiation

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1320484
    High Grade
    Description

    High grade (poorly differentiated to undifferentiated)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1273126
    Extranodal involvement at Enrollment
    Description

    Extranodal involvement at Enrollment

    Alias
    UMLS CUI-1
    C3899187
    UMLS CUI-2
    C1516879
    Extranodal involvement at Enrollment
    Description

    Extranodal involvement at Enrollment

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3899187
    UMLS CUI [1,2]
    C1516879
    CD20 Reactivity
    Description

    CD20 Reactivity

    Alias
    UMLS CUI-1
    C0054946
    UMLS CUI-2
    C0443286
    CD20 Reactivity
    Description

    CD20 Reactivity

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0054946
    UMLS CUI [1,2]
    C0443286
    Date tissue obtained
    Description

    Date tissue obtained

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0011008
    Date of assay
    Description

    Date of assay

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1510438
    UMLS CUI [1,2]
    C0011008
    Tumor Size
    Description

    Tumor Size

    Alias
    UMLS CUI-1
    C0475440
    Does the patient have evidence of bulky disease (>500gm)?
    Description

    undefined item

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1511341
    UMLS CUI [1,2]
    C0043100
    Record the maximum unidimensional tumor diameter (excluding organs)
    Description

    Neoplasms; Maximum; Diameter (qualifier value); Measurement Unit

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0806909
    UMLS CUI [1,3]
    C1301886
    UMLS CUI [1,4]
    C0242485
    cm

    Similar models

    History of Lymphoma

    1. StudyEvent: ODM
      1. History of Lymphoma
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Tumor Stage
    C1300072 (UMLS CUI-1)
    Item
    Stage at Diagnosis
    text
    C1300072 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Code List
    Stage at Diagnosis
    CL Item
    I (1)
    CL Item
    II (2)
    CL Item
    III (3)
    CL Item
    IV (4)
    Item
    Stage at Enrollment
    text
    C1300072 (UMLS CUI [1,1])
    C1516879 (UMLS CUI [1,2])
    Code List
    Stage at Enrollment
    CL Item
    I (1)
    CL Item
    II (2)
    CL Item
    III (3)
    CL Item
    IV (4)
    Date of Diagnosis
    Item
    Date of Diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item Group
    Cell Type
    C0449475 (UMLS CUI-1)
    Item
    Small lymphocytic with plasmacytoid differentiation
    text
    C0855095 (UMLS CUI [1,1])
    C1403406 (UMLS CUI [1,2])
    Code List
    Small lymphocytic with plasmacytoid differentiation
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Small lymphocytic without plasmacytoid differentiation
    text
    C0855095 (UMLS CUI [1,1])
    C1403406 (UMLS CUI [1,2])
    C0332288 (UMLS CUI [1,3])
    Code List
    Small lymphocytic without plasmacytoid differentiation
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Follicular, small- cleaved cell
    text
    C0079765 (UMLS CUI [1])
    Code List
    Follicular, small- cleaved cell
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Follicular, mixed small- cleaved cell (<50% large cell)
    text
    C0079765 (UMLS CUI [1,1])
    C0205430 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [2,1])
    C1513997 (UMLS CUI [2,2])
    C0439165 (UMLS CUI [2,3])
    Code List
    Follicular, mixed small- cleaved cell (<50% large cell)
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Follicular, large cell
    text
    C0079745 (UMLS CUI [1])
    Code List
    Follicular, large cell
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Diffuse, small cleaved
    text
    C1398349 (UMLS CUI [1])
    Code List
    Diffuse, small cleaved
    CL Item
    At Enrollment (1)
    Item
    Diffuse, mixed small-cleaved & large cell
    text
    C1398349 (UMLS CUI [1,1])
    C0079744 (UMLS CUI [1,2])
    C0079757 (UMLS CUI [1,3])
    Code List
    Diffuse, mixed small-cleaved & large cell
    CL Item
    At Enrollment (1)
    Item
    Diffuse, large cell
    text
    C0079744 (UMLS CUI [1])
    Code List
    Diffuse, large cell
    CL Item
    At Enrollment (1)
    Item
    Large cell, immunoblastic
    text
    C0079746 (UMLS CUI [1])
    Code List
    Large cell, immunoblastic
    CL Item
    At Enrollment (1)
    Item
    Lymphoblastic, convoluted
    text
    C0079748 (UMLS CUI [1,1])
    C0333859 (UMLS CUI [1,2])
    Code List
    Lymphoblastic, convoluted
    CL Item
    At Enrollment (1)
    Item
    Lymphoblastic, non-convolutet
    text
    C0079748 (UMLS CUI [1])
    Code List
    Lymphoblastic, non-convolutet
    CL Item
    At Enrollment (1)
    Item
    Monocytoid B- Cell
    text
    C0855139 (UMLS CUI [1])
    Code List
    Monocytoid B- Cell
    CL Item
    At Enrollment (1)
    Item
    Other cell type
    text
    C0449475 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Code List
    Other cell type
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Other specify
    Item
    If other cell type, please specify
    text
    C0449475 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Grade
    C0919553 (UMLS CUI-1)
    Item
    Low Grade
    text
    C1273125 (UMLS CUI [1])
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    Intermediate Grade
    text
    C1320484 (UMLS CUI [1])
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item
    High Grade
    text
    C1273126 (UMLS CUI [1])
    CL Item
    At Diagnosis (1)
    CL Item
    At Enrollment (2)
    Item Group
    Extranodal involvement at Enrollment
    C3899187 (UMLS CUI-1)
    C1516879 (UMLS CUI-2)
    Item
    Extranodal involvement at Enrollment
    text
    C3899187 (UMLS CUI [1,1])
    C1516879 (UMLS CUI [1,2])
    Code List
    Extranodal involvement at Enrollment
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 or more sites (3)
    Item Group
    CD20 Reactivity
    C0054946 (UMLS CUI-1)
    C0443286 (UMLS CUI-2)
    Item
    CD20 Reactivity
    text
    C0054946 (UMLS CUI [1,1])
    C0443286 (UMLS CUI [1,2])
    Code List
    CD20 Reactivity
    CL Item
    Histopathology (1)
    CL Item
    Flow Cytometry (2)
    Date tissue obtained
    Item
    Date tissue obtained
    date
    C0200345 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of assay
    Item
    Date of assay
    date
    C1510438 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Tumor Size
    C0475440 (UMLS CUI-1)
    undefined item
    Item
    Does the patient have evidence of bulky disease (>500gm)?
    boolean
    C1511341 (UMLS CUI [1,1])
    C0043100 (UMLS CUI [1,2])
    Neoplasms; Maximum; Diameter (qualifier value); Measurement Unit
    Item
    Record the maximum unidimensional tumor diameter (excluding organs)
    float
    C0027651 (UMLS CUI [1,1])
    C0806909 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    C0242485 (UMLS CUI [1,4])

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