ID

30223

Description

General Medical History and Physical Examination 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

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Versions (1)
  1. 5/22/18 5/22/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

    English

    General Medical History and Physical Examination

    1 forms  
    Medical history
    Description

    Medical history

    Alias
    UMLS CUI-1
    C0262926
    Medical history date
    Description

    Medical history date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0011008
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Ethnic Origin
    Description

    Ethnic Origin

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Diagnoses/Condition
    Description

    Diagnoses/Condition

    Alias
    UMLS CUI-1
    C0011900
    Diagnoses/Condition
    Description

    Diagnoses/Condition

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Day of Onset
    Description

    Month/Year

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C0574845
    Status
    Description

    Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C0012634
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Does the patient currently have evidence of "B" symptoms?
    Description

    "B" symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706867
    Date of physical examination
    Description

    Date of physical examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    If yes, please check current "B" symptoms:
    Description

    Current "B" symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1706867
    UMLS CUI [1,2]
    C0521116
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Karnofsky Status
    Description

    Karnofsky Status

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0206065
    %
    Respirations
    Description

    Respirations

    Data type

    integer

    Measurement units
    • breaths/minute
    Alias
    UMLS CUI [1]
    C0035203
    breaths/minute
    Blood Pressure
    Description

    Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Organ/System
    Description

    Organ/System

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0678852
    Examination finding
    Description

    Examination finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0243095
    If abnormal, specify:
    Description

    Abnormal finding Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826279
    UMLS CUI [1,2]
    C2348235
    If abnormal, specify:
    Description

    Abnormal finding Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826279
    UMLS CUI [1,2]
    C2348235
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    Similar models

    General Medical History and Physical Examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Medical history
    C0262926 (UMLS CUI-1)
    Medical history date
    Item
    Medical history date
    date
    C0262926 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (1)
    CL Item
    Female (2)
    Item
    Ethnic Origin
    integer
    C0015031 (UMLS CUI [1])
    Ethnic Origin
    Code List
    Ethnic Origin
    CL Item
    White (1)
    CL Item
    Hispanic (2)
    CL Item
    Asian (3)
    CL Item
    Black (4)
    CL Item
    Native American (5)
    CL Item
    Other (6)
    Item Group
    Diagnoses/Condition
    C0011900 (UMLS CUI-1)
    Diagnoses/Condition
    Item
    Diagnoses/Condition
    text
    C0011900 (UMLS CUI [1])
    Day of Onset
    Item
    Day of Onset
    partialDate
    C0574845 (UMLS CUI [1])
    Item
    Status
    integer
    C0449438 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Status
    Code List
    Status
    CL Item
    Active (1)
    CL Item
    Inactive (2)
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    "B" symptoms
    Item
    Does the patient currently have evidence of "B" symptoms?
    boolean
    C1706867 (UMLS CUI [1])
    Date of physical examination
    Item
    Date of physical examination
    date
    C2826643 (UMLS CUI [1])
    Item
    If yes, please check current "B" symptoms:
    integer
    C1706867 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Current "B" symptoms
    Code List
    If yes, please check current "B" symptoms:
    CL Item
    Night sweats (1)
    CL Item
    lntermittent fevers (2)
    CL Item
    Weight loss (3)
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Karnofsky Status
    Item
    Karnofsky Status
    integer
    C0206065 (UMLS CUI [1])
    Respirations
    Item
    Respirations
    integer
    C0035203 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood Pressure
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    Item
    Organ/System
    integer
    C0678852 (UMLS CUI [1])
    Organ/System
    Code List
    Organ/System
    CL Item
    1. General Appearance (1)
    CL Item
    2. Skin (2)
    CL Item
    3. HEENT (3)
    CL Item
    4. Neck (4)
    CL Item
    5. Lymph Nodes (5)
    CL Item
    6. Lungs (6)
    CL Item
    7. Heart (7)
    CL Item
    8. Neurological (8)
    CL Item
    9. Genitourinary (9)
    CL Item
    10. Abdomen (10)
    CL Item
    11. Musculoskeletal (11)
    CL Item
    12. Other (12)
    Item
    Examination finding
    integer
    C0031809 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Examination finding
    Code List
    Examination finding
    CL Item
    Not Done (1)
    CL Item
    Normal (2)
    CL Item
    Abnormal (3)
    Abnormal finding Specification
    Item
    If abnormal, specify:
    text
    C2826279 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Abnormal finding Specification
    Item
    If abnormal, specify:
    text
    C2826279 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Back to the top of the page 

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