0 Evaluaciones
ID

30148

Descripción

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

Palabras clave

Versiones (1)
  1. 15/5/18 15/5/18 - Halim Ugurlu
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

15 de mayo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

    Inglés

    General Medical History, Physical Examination Baseline

    1 formularios  
    Administration
    Descripción

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Site Number:
    Descripción

    Site Number

    Tipo de datos

    integer

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

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Medical History Date
    Descripción

    Medical History Date

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0011008
    Medical History Date
    Descripción

    Medical History Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0011008
    Series Page
    Descripción

    Series Page

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Last page
    Descripción

    Last page

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C1704732
    Demographics
    Descripción

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Patient date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descripción

    Gender

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Ethnic Origin
    Descripción

    Ethnic Origin

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0015031
    Diagnosis/Condition
    Descripción

    Diagnosis/Condition

    Alias
    UMLS CUI-1
    C0011900
    UMLS CUI-2
    C0012634
    Disease/Condition
    Descripción

    Disease/Condition

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0012634
    Date of Onset
    Descripción

    Date of Onset

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0574845
    Status
    Descripción

    Status

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0449438
    Physical Examination - Baseline
    Descripción

    Physical Examination - Baseline

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

    B-Symptoms

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1706867
    If yes, please check current "B" symptoms
    Descripción

    If Yes to B-Symptoms

    Tipo de datos

    text

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

    Date of physical examination

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826643
    Height
    Descripción

    Height

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Karnofsky Status
    Descripción

    Karnofsky Status

    Tipo de datos

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1]
    C0206065
    %
    Respirations (breaths/min)
    Descripción

    Respirations

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0035203
    Blood Pressure (mmHg)
    Descripción

    Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse (bpm)
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Temperature (Celcius)
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • C
    Alias
    UMLS CUI [1]
    C0005903
    C
    Physical Examination
    Descripción

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Organ/System
    Descripción

    Organ/System

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0678852
    Result of Physical Examination
    Descripción

    Result of PE

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0031809
    If abnormal Physical Examination, specify
    Descripción

    If abnormal PE

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205161
    UMLS CUI [1,2]
    C0031809
    Volver a la parte superior de la página

    Similar models

    General Medical History, Physical Examination Baseline

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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