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ID

31034

Description

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Keywords

Versions (1)
  1. 2018-07-12 2018-07-12 -
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see clinicaltrials.gov

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12 juli 2018

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License

Creative Commons BY 4.0
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    Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

    English

    Disease Staging - Baseline

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site Number
    Description

    Site number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Diagnostic Imaging, Head/Neck
    Description

    Diagnostic Imaging, Head/Neck

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0460004
    Not Done
    Description

    Diagnostic Imaging, Head and neck structure, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0460004
    UMLS CUI [1,3]
    C1272696
    Date
    Description

    Diagnostic Imaging, Head and neck structure, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0460004
    UMLS CUI [1,3]
    C0011008
    Imaging
    Description

    Diagnostic Imaging, Head/Neck

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0460004
    Result
    Description

    Diagnostic Imaging, Head/Neck, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0460004
    UMLS CUI [1,3]
    C1274040
    Diagnostic Imaging; Chest
    Description

    Diagnostic Imaging; Chest

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0817096
    Not Done
    Description

    Diagnostic Imaging, Chest, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0817096
    UMLS CUI [1,3]
    C1272696
    Date
    Description

    Diagnostic Imaging, Chest, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0817096
    UMLS CUI [1,3]
    C0011008
    Imaging
    Description

    Diagnostic Imaging, Chest

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0817096
    Result
    Description

    Diagnostic Imaging, Chest, Results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0817096
    UMLS CUI [1,3]
    C1274040
    Diagnostic Imaging, Abdomen
    Description

    Diagnostic Imaging, Abdomen

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0000726
    Not done
    Description

    Diagnostic Imaging, Abdomen, Not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C1272696
    Date
    Description

    Diagnostic Imaging, Abdomen, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C0011008
    Imaging
    Description

    Diagnostic Imaging, Abdomen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0000726
    Result
    Description

    Diagnostic Imaging, Abdomen, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C1274040
    Diagnostic Imaging, Pelvis
    Description

    Diagnostic Imaging, Pelvis

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0030797
    Not Done
    Description

    Diagnostic Imaging, Pelvis, Not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0030797
    UMLS CUI [1,3]
    C1272696
    Date
    Description

    Diagnostic Imaging, Pelvis, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0030797
    UMLS CUI [1,3]
    C0011008
    Imaging
    Description

    Diagnostic Imaging, Pelvis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0030797
    Result
    Description

    Diagnostic Imaging, Pelvis, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0030797
    UMLS CUI [1,3]
    C1274040
    Diagnostic Imaging, Other
    Description

    Diagnostic Imaging, Other

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C0205394
    Not Done
    Description

    Diagnostic Imaging, Other, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1272696
    Date
    Description

    Diagnostic Imaging, Other, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0011008
    Imaging
    Description

    Diagnostic Imaging, Other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0205394
    Result
    Description

    Diagnostic Imaging, Other, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1274040
    Bone Marrow Biopsy
    Description

    Bone Marrow Biopsy

    Alias
    UMLS CUI-1
    C0005954
    Date of biopsy
    Description

    Biopsy, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    Marrow cellularity
    Description

    Bone marrow cellularity finding

    Data type

    text

    Alias
    UMLS CUI [1]
    C1561532
    Tumor involvement
    Description

    Malignant Neoplasms, Involvement with

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    %
    Tumor involvement
    Description

    Malignant Neoplasms, Involvement with

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    Measurable Lymphoma Disease
    Description

    Measurable Lymphoma Disease

    Alias
    UMLS CUI-1
    C0024299
    UMLS CUI-2
    C1513041
    Site
    Description

    Measurable Lymphoma Disease, Site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C1513041
    UMLS CUI [1,3]
    C1515974
    Method of Determination
    Description

    Measurable Lymphoma Disease, Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C1513041
    UMLS CUI [1,3]
    C2911685
    Date
    Description

    Measurable Lymphoma Disease, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C1513041
    UMLS CUI [1,3]
    C0242485
    UMLS CUI [1,4]
    C0011008
    Tumor Measurements
    Description

    Measurable Lymphoma Disease, Tumor Measurements

    Data type

    integer

    Measurement units
    • cm x cm = cm²
    Alias
    UMLS CUI [1,1]
    C0024299
    UMLS CUI [1,2]
    C1513041
    UMLS CUI [1,3]
    C0475440
    cm x cm = cm²
    Non-Measurable Disease
    Description

    Non-Measurable Disease

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C1518373
    Site
    Description

    Non-Measurable Disease, Site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1518373
    UMLS CUI [1,3]
    C1515974
    Method of Determination
    Description

    Non-Measurable Disease, Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1518373
    UMLS CUI [1,3]
    C2911685
    Date
    Description

    Non-Measurable Disease, Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1518373
    UMLS CUI [1,3]
    C0011008
    Check one
    Description

    Non-Measurable Disease, Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1518373
    UMLS CUI [1,3]
    C0449438
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    Similar models

    Disease Staging - Baseline

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Site number
    Item
    Site Number
    text
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Diagnostic Imaging, Head/Neck
    C0011923 (UMLS CUI-1)
    C0460004 (UMLS CUI-2)
    Diagnostic Imaging, Head and neck structure, Not Done
    Item
    Not Done
    boolean
    C0011923 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Diagnostic Imaging, Head and neck structure, Date
    Item
    Date
    date
    C0011923 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Imaging
    text
    C0011923 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    Diagnostic Imaging, Head/Neck
    Code List
    Imaging
    CL Item
    CT (CT)
    CL Item
    MRI (MRI)
    CL Item
    X-ray (X-ray)
    CL Item
    Other (Other)
    Item
    Result
    text
    C0011923 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Diagnostic Imaging, Head/Neck
    Code List
    Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (specify) (Abnormal (specify))
    Item Group
    Diagnostic Imaging; Chest
    C0011923 (UMLS CUI-1)
    C0817096 (UMLS CUI-2)
    Diagnostic Imaging, Chest, Not Done
    Item
    Not Done
    boolean
    C0011923 (UMLS CUI [1,1])
    C0817096 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Diagnostic Imaging, Chest, Date
    Item
    Date
    date
    C0011923 (UMLS CUI [1,1])
    C0817096 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Imaging
    text
    C0011923 (UMLS CUI [1,1])
    C0817096 (UMLS CUI [1,2])
    Diagnostic Imaging, Chest
    Code List
    Imaging
    CL Item
    CT (CT)
    CL Item
    MRI (MRI)
    CL Item
    X-ray (X-ray)
    CL Item
    Other (Other)
    Item
    Result
    text
    C0011923 (UMLS CUI [1,1])
    C0817096 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Diagnostic Imaging, Chest
    Code List
    Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (specify) (Abnormal (specify))
    Item Group
    Diagnostic Imaging, Abdomen
    C0011923 (UMLS CUI-1)
    C0000726 (UMLS CUI-2)
    Diagnostic Imaging, Abdomen, Not done
    Item
    Not done
    boolean
    C0011923 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Diagnostic Imaging, Abdomen, Date
    Item
    Date
    date
    C0011923 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Imaging
    text
    C0011923 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Diagnostic Imaging, Abdomen
    Code List
    Imaging
    CL Item
    CT (CT)
    CL Item
    MRI (MRI)
    CL Item
    X-ray (X-ray)
    CL Item
    Other (Other)
    Item
    Result
    text
    C0011923 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Diagnostic Imaging, Abdomen
    Code List
    Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (specify) (Abnormal (specify))
    Item Group
    Diagnostic Imaging, Pelvis
    C0011923 (UMLS CUI-1)
    C0030797 (UMLS CUI-2)
    Diagnostic Imaging, Pelvis, Not done
    Item
    Not Done
    boolean
    C0011923 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Diagnostic Imaging, Pelvis, Date
    Item
    Date
    date
    C0011923 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Imaging
    text
    C0011923 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    Diagnostic Imaging, Pelvis
    Code List
    Imaging
    CL Item
    CT (CT)
    CL Item
    MRI (MRI)
    CL Item
    X-ray (X-ray)
    CL Item
    Other (Other)
    Item
    Result
    text
    C0011923 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Diagnostic Imaging, Pelvis
    Code List
    Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (specify) (Abnormal (specify))
    Item Group
    Diagnostic Imaging, Other
    C0011923 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Diagnostic Imaging, Other, Not Done
    Item
    Not Done
    boolean
    C0011923 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Diagnostic Imaging, Other, Date
    Item
    Date
    date
    C0011923 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Imaging
    text
    C0011923 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Diagnostic Imaging, Other
    Code List
    Imaging
    CL Item
    CT (CT)
    CL Item
    MRI (MRI)
    CL Item
    X-ray (X-ray)
    CL Item
    Other (Other)
    Item
    Result
    text
    C0011923 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Diagnostic Imaging, Other
    Code List
    Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (specify) (Abnormal (specify))
    Item Group
    Bone Marrow Biopsy
    C0005954 (UMLS CUI-1)
    Biopsy, Date in time
    Item
    Date of biopsy
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Marrow cellularity
    text
    C1561532 (UMLS CUI [1])
    Marrow cellularity
    Code List
    Marrow cellularity
    CL Item
    Normal (1)
    CL Item
    Hypocellular (2)
    CL Item
    Hypercellular (3)
    Malignant Neoplasms, Involvement with
    Item
    Tumor involvement
    integer
    C0006826 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    Item
    Tumor involvement
    text
    C0006826 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    Malignant Neoplasms, Involvement with
    Code List
    Tumor involvement
    CL Item
    Unilateral (1)
    CL Item
    Bilateral (2)
    Item Group
    Measurable Lymphoma Disease
    C0024299 (UMLS CUI-1)
    C1513041 (UMLS CUI-2)
    Measurable Lymphoma Disease, Site
    Item
    Site
    text
    C0024299 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [1,3])
    Measurable Lymphoma Disease, Method of Determination
    Item
    Method of Determination
    text
    C0024299 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    C2911685 (UMLS CUI [1,3])
    Measurable Lymphoma Disease, Date
    Item
    Date
    date
    C0024299 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    C0242485 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Measurable Lymphoma Disease, Tumor Measurements
    Item
    Tumor Measurements
    integer
    C0024299 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    C0475440 (UMLS CUI [1,3])
    Item Group
    Non-Measurable Disease
    C0012634 (UMLS CUI-1)
    C1518373 (UMLS CUI-2)
    Non-Measurable Disease, Site
    Item
    Site
    text
    C0012634 (UMLS CUI [1,1])
    C1518373 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [1,3])
    Non-Measurable Disease, Method of Determination
    Item
    Method of Determination
    text
    C0012634 (UMLS CUI [1,1])
    C1518373 (UMLS CUI [1,2])
    C2911685 (UMLS CUI [1,3])
    Non-Measurable Disease, Date
    Item
    Date
    date
    C0012634 (UMLS CUI [1,1])
    C1518373 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Check one
    text
    C0012634 (UMLS CUI [1,1])
    C1518373 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Non-Measurable Disease, Status
    Code List
    Check one
    CL Item
    New (New)
    CL Item
    Increased (Increased)
    CL Item
    Stable (Stable)
    CL Item
    Decreased (Decreased)
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