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31180

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

Mots-clés

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  1. 25/07/2018 25/07/2018 -
Détendeur de droits

see clinicaltrials.gov

Téléchargé le

25 juillet 2018

DOI

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

    Anglais

    Post-Treatment Response - Week 7

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site Number
    Description

    Site number

    Type de données

    text

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

    Patient Number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Type de données

    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

    Type de données

    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

    Type de données

    date

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

    Diagnostic Imaging, Head/Neck

    Type de données

    text

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

    Diagnostic Imaging, Head/Neck, Result

    Type de données

    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

    Type de données

    boolean

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

    Diagnostic Imaging, Chest, Date

    Type de données

    date

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

    Diagnostic Imaging, Chest

    Type de données

    text

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

    Diagnostic Imaging, Chest, Results

    Type de données

    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

    Type de données

    boolean

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

    Diagnostic Imaging, Abdomen, Date

    Type de données

    date

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

    Diagnostic Imaging, Abdomen

    Type de données

    text

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

    Diagnostic Imaging, Abdomen, Result

    Type de données

    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

    Type de données

    boolean

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

    Diagnostic Imaging, Pelvis, Date

    Type de données

    date

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

    Diagnostic Imaging, Pelvis

    Type de données

    text

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

    Diagnostic Imaging, Pelvis, Result

    Type de données

    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

    Type de données

    boolean

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

    Diagnostic Imaging, Other, Date

    Type de données

    date

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

    Diagnostic Imaging, Other

    Type de données

    text

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

    Diagnostic Imaging, Other, Result

    Type de données

    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

    Type de données

    date

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

    Bone Marrow Biopsy

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0005954
    Marrow cellularity
    Description

    Bone marrow cellularity finding

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1561532
    Tumor involvement
    Description

    Malignant Neoplasms, Involvement with

    Type de données

    integer

    Unités de mesure
    • %
    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    %
    Tumor involvement
    Description

    Malignant Neoplasms, Involvement with

    Type de données

    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

    Type de données

    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

    Type de données

    text

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

    Measurable Lymphoma Disease, Date

    Type de données

    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

    Type de données

    integer

    Unités de mesure
    • 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

    Type de données

    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

    Type de données

    text

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

    Non-Measurable Disease, Date

    Type de données

    date

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

    Non-Measurable Disease, Status

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1518373
    UMLS CUI [1,3]
    C0449438
    Response
    Description

    Response

    Alias
    UMLS CUI-1
    C0521982
    Response (check one)
    Description

    Response to treatment

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0521982
    Date of Response Evaluation
    Description

    Response to treatment; Date of evaluation

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C2985720
    Comments
    Description

    Response to treatment; Comments

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0947611
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    Similar models

    Post-Treatment Response - Week 7

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    Bone Marrow Biopsy
    text
    C0005954 (UMLS CUI [1])
    Bone Marrow Biopsy
    Code List
    Bone Marrow Biopsy
    CL Item
    Not done (Not done)
    CL Item
    Not indicated (BM not positive at baseline) (Not indicated (BM not positive at baseline))
    CL Item
    Not indicated (patient not in CR) (Not indicated (patient not in CR))
    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)
    Item Group
    Response
    C0521982 (UMLS CUI-1)
    Item
    Response (check one)
    text
    C0521982 (UMLS CUI [1])
    Response to treatment
    Code List
    Response (check one)
    CL Item
    CR (CR)
    CL Item
    CCR (CCR)
    CL Item
    PR (PR)
    CL Item
    SD (SD)
    CL Item
    PD (PD)
    Response to treatment; Date of evaluation
    Item
    Date of Response Evaluation
    date
    C0521982 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Response to treatment; Comments
    Item
    Comments
    text
    C0521982 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
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