0 Beoordelingen
ID

30171

Beschrijving

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

Trefwoorden

Versies (1)
  1. 16-05-18 16-05-18 - Halim Ugurlu
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

16 mei 2018

DOI

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Licentie

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

    Engels

    Disease Staging Baseline

    1 Formulieren  
    Administration
    Beschrijving

    Administration

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site Number:
    Beschrijving

    Site Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0018704 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Patient Initials
    Beschrijving

    Patient Initials

    Datatype

    text

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

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

    Alias
    UMLS CUI-1
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    UMLS CUI-2
    C1274040 (Result)
    SNOMED
    394617004
    Imaging Site
    Beschrijving

    Imaging Site

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1515974 (Anatomic Site)
    UMLS CUI [1,2]
    C1704254 (Medical Image)
    Not done
    Beschrijving

    Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696 (Not Done)
    SNOMED
    385660001
    UMLS CUI [1,2]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    Imaging Type
    Beschrijving

    Imaging Type

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Result
    Beschrijving

    Result

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,2]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    Bone Marrow Biopsy (within 42 days of entry)
    Beschrijving

    Bone Marrow Biopsy (within 42 days of entry)

    Alias
    UMLS CUI-1
    C0005954 (Bone marrow biopsy)
    SNOMED
    234326005
    Bone Marrow Biopsy (Done or not done)
    Beschrijving

    Bone Marrow Biopsy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005954 (Bone marrow biopsy)
    SNOMED
    234326005
    Date of biopsy
    Beschrijving

    Date of biopsy

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0005954 (Bone marrow biopsy)
    SNOMED
    234326005
    Marrow Cellularity
    Beschrijving

    Marrow Cellularity

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1561532 (Bone marrow cellularity finding)
    Tumor Involvement %
    Beschrijving

    Tumor Involvement

    Datatype

    float

    Alias
    UMLS CUI [1,1]
    C1517677 (Bone Marrow Involvement)
    UMLS CUI [1,2]
    C0368761 (Blast Cell)
    SNOMED
    312256009
    LOINC
    LP15100-8
    Tumor Involvement
    Beschrijving

    Tumor Involvement

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1517677 (Bone Marrow Involvement)
    Measurable Lymphoma Disease
    Beschrijving

    Measurable Lymphoma Disease

    Alias
    UMLS CUI-1
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    UMLS CUI-2
    C1513041 (Measurable Disease)
    Site
    Beschrijving

    Site

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1515974 (Anatomic Site)
    Method of Determination
    Beschrijving

    Method of Determination

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2911685 (Evaluation Method)
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Tumor Measurement-1
    Beschrijving

    Tumor Measurement-1

    Datatype

    float

    Maateenheden
    • cm
    Alias
    UMLS CUI [1,1]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI [1,2]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    cm
    Tumor Measurement-2
    Beschrijving

    Tumor Measurement-2

    Datatype

    float

    Maateenheden
    • cm
    Alias
    UMLS CUI [1,1]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI [1,2]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    cm
    Tumor Measurement in cm2
    Beschrijving

    Tumor Measurement in cm2

    Datatype

    float

    Maateenheden
    • cm2
    Alias
    UMLS CUI [1,1]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI [1,2]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    cm2
    Non-Measurable Disease
    Beschrijving

    Non-Measurable Disease

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

    Non-Measurable Disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1334988 (Non-Measurable Lesion)
    Site
    Beschrijving

    Site

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1515974 (Anatomic Site)
    Method of Determination
    Beschrijving

    Method of Determination

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2911685 (Evaluation Method)
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Check one
    Beschrijving

    Check one

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    UMLS CUI [1,2]
    C1334988 (Non-Measurable Lesion)
    Administration
    Beschrijving

    Administration

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Signature of Investigator
    Beschrijving

    Signature of Investigator

    Datatype

    text

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

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2346576 (Investigator Signature)
    Terug naar het begin van de pagina

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    Disease Staging Baseline

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
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    C0011923 (UMLS CUI-1)
    C1274040 (UMLS CUI-2)
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    Imaging Site
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    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
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    C1272696 (UMLS CUI [1,1])
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    C0011923 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
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    MRI (12)
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    X-Ray (1)
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    Normal (1)
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    C0011923 (UMLS CUI [1,2])
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    Bone Marrow Biopsy (within 42 days of entry)
    C0005954 (UMLS CUI-1)
    Bone Marrow Biopsy
    Item
    Bone Marrow Biopsy (Done or not done)
    boolean
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    Date of biopsy
    Item
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    date
    C0011008 (UMLS CUI [1,1])
    C0005954 (UMLS CUI [1,2])
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    Marrow Cellularity
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    C1561532 (UMLS CUI [1])
    Marrow Cellularity
    Code List
    Marrow Cellularity
    CL Item
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    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
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    C0242485 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
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    Item
    Tumor Measurement in cm2
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    C0242485 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
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    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
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    New (1)
    CL Item
    Increased (2)
    CL Item
    Stable (3)
    CL Item
    Decreased (4)
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    Item
    Signature of Investigator
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    Item
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