ID

30171

Description

https://clinicaltrials.gov/show/NCT00989664 Eligibility check 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

Versions (1)
  1. 5/16/18 5/16/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 16, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    30170_29981_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

    English

    Disease Staging Baseline

    1 forms  
    Administration
    Description

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Site Number:
    Description

    Site Number

    Data type

    integer

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

    Patient Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    CT or other Radiological Imaging Results (within 28 days of entry)
    Description

    CT or other Radiological Imaging Results (within 28 days of entry)

    Alias
    UMLS CUI-1
    C0011923
    UMLS CUI-2
    C1274040
    Imaging Site
    Description

    Imaging Site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C1704254
    Not done
    Description

    Not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696
    UMLS CUI [1,2]
    C0011923
    Imaging Type
    Description

    Imaging Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0332307
    Result
    Description

    Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0011923
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0011923
    Bone Marrow Biopsy (within 42 days of entry)
    Description

    Bone Marrow Biopsy (within 42 days of entry)

    Alias
    UMLS CUI-1
    C0005954
    Bone Marrow Biopsy (Done or not done)
    Description

    Bone Marrow Biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005954
    Date of biopsy
    Description

    Date of biopsy

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005954
    Marrow Cellularity
    Description

    Marrow Cellularity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1561532
    Tumor Involvement %
    Description

    Tumor Involvement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1517677
    UMLS CUI [1,2]
    C0368761
    Tumor Involvement
    Description

    Tumor Involvement

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1517677
    Measurable Lymphoma Disease
    Description

    Measurable Lymphoma Disease

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

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C1515974
    Method of Determination
    Description

    Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Tumor Measurement-1
    Description

    Tumor Measurement-1

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0242485
    UMLS CUI [1,2]
    C0024299
    cm
    Tumor Measurement-2
    Description

    Tumor Measurement-2

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0242485
    UMLS CUI [1,2]
    C0024299
    cm
    Tumor Measurement in cm2
    Description

    Tumor Measurement in cm2

    Data type

    float

    Measurement units
    • cm2
    Alias
    UMLS CUI [1,1]
    C0242485
    UMLS CUI [1,2]
    C0024299
    cm2
    Non-Measurable Disease
    Description

    Non-Measurable Disease

    Alias
    UMLS CUI-1
    C1334988
    Non-Measurable Disease (Done/not done)
    Description

    Non-Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1334988
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C1515974
    Method of Determination
    Description

    Method of Determination

    Data type

    text

    Alias
    UMLS CUI [1]
    C2911685
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Check one
    Description

    Check one

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C1334988
    Administration
    Description

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Signature of Investigator
    Description

    Signature of Investigator

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Date

    Data type

    date

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

    Disease Staging Baseline

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Site Number
    Item
    Site Number:
    integer
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    CT or other Radiological Imaging Results (within 28 days of entry)
    C0011923 (UMLS CUI-1)
    C1274040 (UMLS CUI-2)
    Item
    Imaging Site
    text
    C1515974 (UMLS CUI [1,1])
    C1704254 (UMLS CUI [1,2])
    Imaging Site
    Code List
    Imaging Site
    CL Item
    Head and Neck (2)
    CL Item
    Chest (3)
    CL Item
    Abdomen (4)
    CL Item
    Pelvis (5)
    CL Item
    Other (99)
    Not done
    Item
    Not done
    boolean
    C1272696 (UMLS CUI [1,1])
    C0011923 (UMLS CUI [1,2])
    Item
    Imaging Type
    text
    C0011923 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Imaging Type
    Code List
    Imaging Type
    CL Item
    CT (10)
    CL Item
    MRI (12)
    CL Item
    X-Ray (1)
    CL Item
    Other (99)
    Item
    Result
    text
    C1274040 (UMLS CUI [1,1])
    C0011923 (UMLS CUI [1,2])
    Result
    Code List
    Result
    CL Item
    Not Done (0)
    CL Item
    Normal (1)
    CL Item
    Abnormal, specify.......... (2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0011923 (UMLS CUI [1,2])
    Item Group
    Bone Marrow Biopsy (within 42 days of entry)
    C0005954 (UMLS CUI-1)
    Bone Marrow Biopsy
    Item
    Bone Marrow Biopsy (Done or not done)
    boolean
    C0005954 (UMLS CUI [1])
    Date of biopsy
    Item
    Date of biopsy
    date
    C0011008 (UMLS CUI [1,1])
    C0005954 (UMLS CUI [1,2])
    Item
    Marrow Cellularity
    integer
    C1561532 (UMLS CUI [1])
    Marrow Cellularity
    Code List
    Marrow Cellularity
    CL Item
    Normal (1)
    CL Item
    Hypocellular (2)
    CL Item
    Hypercellular (3)
    CL Item
    NA (0)
    Tumor Involvement
    Item
    Tumor Involvement %
    float
    C1517677 (UMLS CUI [1,1])
    C0368761 (UMLS CUI [1,2])
    Item
    Tumor Involvement
    integer
    C1517677 (UMLS CUI [1])
    Tumor Involvement
    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)
    Site
    Item
    Site
    text
    C1515974 (UMLS CUI [1])
    Method of Determination
    Item
    Method of Determination
    text
    C2911685 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Tumor Measurement-1
    Item
    Tumor Measurement-1
    float
    C0242485 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Tumor Measurement-2
    Item
    Tumor Measurement-2
    float
    C0242485 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Tumor Measurement in cm2
    Item
    Tumor Measurement in cm2
    float
    C0242485 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Item Group
    Non-Measurable Disease
    C1334988 (UMLS CUI-1)
    Non-Measurable Disease
    Item
    Non-Measurable Disease (Done/not done)
    boolean
    C1334988 (UMLS CUI [1])
    Site
    Item
    Site
    text
    C1515974 (UMLS CUI [1])
    Method of Determination
    Item
    Method of Determination
    text
    C2911685 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Check one
    integer
    C0332307 (UMLS CUI [1,1])
    C1334988 (UMLS CUI [1,2])
    Check one
    Code List
    Check one
    CL Item
    New (1)
    CL Item
    Increased (2)
    CL Item
    Stable (3)
    CL Item
    Decreased (4)
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Signature of Investigator
    Item
    Signature of Investigator
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C2346576 (UMLS CUI [1,2])
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