ID

30148

Description

https://clinicaltrials.gov/show/NCT00989664 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. 5/15/18 5/15/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 15, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    29959_Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

    English

    General Medical History, Physical Examination Baseline

    1 forms  
    Administration
    Description

    Administration

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

    Site Number

    Data type

    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
    Description

    Patient Number

    Data type

    integer

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

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Medical History Date
    Description

    Medical History Date

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0011008 (Date in time)
    SNOMED
    410671006
    Medical History Date
    Description

    Medical History Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Series Page
    Description

    Series Page

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Last page
    Description

    Last page

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [1,2]
    C1704732 (Page (document))
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298 (Demography)
    LOINC
    LP204151-7
    Patient date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnic Origin
    Description

    Ethnic Origin

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Diagnosis/Condition
    Description

    Diagnosis/Condition

    Alias
    UMLS CUI-1
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI-2
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Disease/Condition
    Description

    Disease/Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Date of Onset
    Description

    Date of Onset

    Data type

    date

    Alias
    UMLS CUI [1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    Status
    Description

    Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Physical Examination - Baseline
    Description

    Physical Examination - Baseline

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Does the patient currently have evidence of "B" symptoms?
    Description

    B-Symptoms

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1706867 (B-Symptoms)
    If yes, please check current "B" symptoms
    Description

    If Yes to B-Symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C1706867 (B-Symptoms)
    Date of physical examination
    Description

    Date of physical examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    Height
    Description

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Karnofsky Status
    Description

    Karnofsky Status

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    %
    Respirations (breaths/min)
    Description

    Respirations

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0035203 (Respiration)
    SNOMED
    719983008
    LOINC
    LA25346-0
    Blood Pressure (mmHg)
    Description

    Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Pulse (bpm)
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    bpm
    Temperature (Celcius)
    Description

    Temperature

    Data type

    float

    Measurement units
    • C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    C
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Organ/System
    Description

    Organ/System

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    Result of Physical Examination
    Description

    Result of PE

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    If abnormal Physical Examination, specify
    Description

    If abnormal PE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Back to the top of the page

    Similar models

    General Medical History, Physical Examination 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
    Medical History Date
    C0262926 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Medical History Date
    Item
    Medical History Date
    date
    C0262926 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Series Page
    Item
    Series Page
    integer
    C0237753 (UMLS CUI [1])
    Last page
    Item
    Last page
    boolean
    C0237753 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Patient date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    M (1)
    CL Item
    F (2)
    Item
    Ethnic Origin
    text
    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
    Diagnosis/Condition
    C0011900 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    Disease/Condition
    Item
    Disease/Condition
    text
    C0011900 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Date of Onset
    Item
    Date of Onset
    date
    C0574845 (UMLS CUI [1])
    Item
    Status
    integer
    C0449438 (UMLS CUI [1])
    Status
    Code List
    Status
    CL Item
    Active (1)
    CL Item
    Inactive (2)
    Item Group
    Physical Examination - Baseline
    C0031809 (UMLS CUI-1)
    Item
    Does the patient currently have evidence of "B" symptoms?
    integer
    C1706867 (UMLS CUI [1])
    B-Symptoms
    Code List
    Does the patient currently have evidence of "B" symptoms?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    N/A (0)
    Item
    If yes, please check current "B" symptoms
    text
    C1706867 (UMLS CUI [1])
    If Yes to B-Symptoms
    Code List
    If yes, please check current "B" symptoms
    CL Item
    Night Sweats (1)
    CL Item
    Intermittent Fevers (2)
    CL Item
    Weight Loss (3)
    Date of physical examination
    Item
    Date of physical examination
    date
    C2826643 (UMLS CUI [1])
    Height
    Item
    Height
    float
    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 (breaths/min)
    integer
    C0035203 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood Pressure (mmHg)
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse (bpm)
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature (Celcius)
    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
    General Appearance  (1)
    CL Item
    Skin  (2)
    CL Item
    HEENT  (3)
    CL Item
    Neck  (4)
    CL Item
    Lymph Nodes  (5)
    CL Item
    Lungs  (6)
    CL Item
    Heart  (7)
    CL Item
    Neurological  (8)
    CL Item
    Genitourinary  (9)
    CL Item
    Abdomen  (10)
    CL Item
    Musculoskeletal  (11)
    CL Item
    Other (12)
    Item
    Result of Physical Examination
    integer
    C1274040 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    Result of PE
    Code List
    Result of Physical Examination
    CL Item
    Not Done (1)
    CL Item
    Normal (2)
    CL Item
    Abnormal (3)
    If abnormal PE
    Item
    If abnormal Physical Examination, specify
    text
    C0205161 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
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