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ID

30832

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 This form is to be completed every 6 months once the patient has entered long-term follow-up.

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Versions (1)
  1. 6/25/18 6/25/18 -
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see clinicaltrials.gov

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June 25, 2018

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    Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

    English

    Long-Term Follow-Up for Survival & Disease Status

    1 forms  
    Default Itemgroup
    Description

    Default Itemgroup

    Site number
    Description

    Site number

    Data type

    text

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

    Patient number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient initials
    Description

    Patient initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient status
    Description

    Patient vital status

    Data type

    text

    Alias
    UMLS CUI [1]
    C1148433
    Date of status
    Description

    Date of status

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    How contact was made
    Description

    Contact

    Data type

    text

    Alias
    UMLS CUI [1]
    C2051442
    Does the patient have an ongoing response to Iodine I 131 Tositumomab?
    Description

    Iodine I 131 Tositumomab

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0768182
    Additional therapy for NHL since the last LTFU
    Description

    Additional therapy for NHL since the last LTFU

    Alias
    UMLS CUI-1
    C0024305
    UMLS CUI-2
    C1706712
    Has any additional therapy for NHL been administered?
    Description

    additional therapy for NHL

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C1706712
    Subsequent NHL therapy since last LTFU
    Description

    Lymphoma, Non-Hodgkin Therapeutic procedure Following Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0545082
    Start Date
    Description

    Start Date, Lymphoma, Non-Hodgkin, Therapeutic procedure

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0808070
    Stop Date
    Description

    End date, Lymphoma, Non-Hodgkin, Therapeutic procedure

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0806020
    Total number of cycles
    Description

    chemotherapeutics regimen total number of cycles ordered, Lymphoma, Non-Hodgkin, Therapeutic procedure

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2045831
    UMLS CUI [1,2]
    C0024305
    Myelodysplasia
    Description

    Myelodysplasia

    Alias
    UMLS CUI-1
    C0026985
    Has the patient had a documented diagnosis of myelodysplasia?
    Description

    Myelodysplasia diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026985
    UMLS CUI [1,2]
    C0011900
    If yes, date of diagnosis
    Description

    Myelodysplasia Date of diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0026985
    UMLS CUI [1,2]
    C2316983
    AML
    Description

    AML

    Alias
    UMLS CUI-1
    C0023467
    Has the patient had a documented diagnosis of AML?
    Description

    AML diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0011900
    If yes, date of diagnosis
    Description

    AML date of diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C2316983
    Another malignancy
    Description

    Another malignancy

    Alias
    UMLS CUI-1
    C0006826
    Has the patient had a diagnosis of another malignancy?
    Description

    Malignancy diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0011900
    If yes, date of diagnosis
    Description

    Malignancy Date of diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C2316983
    TSH measurement
    Description

    TSH measurement

    Alias
    UMLS CUI-1
    C0202230
    Date
    Description

    TSH measurement Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0202230
    UMLS CUI [1,2]
    C0011008
    Result
    Description

    TSH measurement Result

    Data type

    float

    Measurement units
    • µIU/mL
    Alias
    UMLS CUI [1,1]
    C0202230
    UMLS CUI [1,2]
    C1254595
    µIU/mL
    Not done
    Description

    TSH measurement Not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0202230
    UMLS CUI [1,2]
    C1272696
    HAMA
    Description

    HAMA

    Alias
    UMLS CUI-1
    C1291910
    Was a HAMA obtained since the last LTFU?
    Description

    HAMA since last encounter

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C3872643
    If yes, enter accession #
    Description

    HAMA accession number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1291910
    UMLS CUI [1,2]
    C1510755
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    Similar models

    Long-Term Follow-Up for Survival & Disease Status

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    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
    Patient status
    text
    C1148433 (UMLS CUI [1])
    Patient status
    Code List
    Patient status
    CL Item
    Alive (1)
    CL Item
    Dead (complete "Notification of Patient Death" Form) (2)
    CL Item
    Lost to follow-up (3)
    Date of status
    Item
    Date of status
    date
    C2985720 (UMLS CUI [1])
    Item
    How contact was made
    text
    C2051442 (UMLS CUI [1])
    contact
    Code List
    How contact was made
    CL Item
    Tumor registry (1)
    CL Item
    Contact with patient (2)
    CL Item
    Contact with MD (3)
    CL Item
    Other (4)
    CL Item
    Other (4)
    Iodine I 131 Tositumomab
    Item
    Does the patient have an ongoing response to Iodine I 131 Tositumomab?
    boolean
    C0768182 (UMLS CUI [1])
    Item Group
    Additional therapy for NHL since the last LTFU
    C0024305 (UMLS CUI-1)
    C1706712 (UMLS CUI-2)
    additional therapy for NHL
    Item
    Has any additional therapy for NHL been administered?
    boolean
    C0024305 (UMLS CUI [1,1])
    C1706712 (UMLS CUI [1,2])
    Lymphoma, Non-Hodgkin Therapeutic procedure Following Visit
    Item
    Subsequent NHL therapy since last LTFU
    text
    C0024305 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0545082 (UMLS CUI [1,4])
    Start Date, Lymphoma, Non-Hodgkin, Therapeutic procedure
    Item
    Start Date
    date
    C0024305 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    End date, Lymphoma, Non-Hodgkin, Therapeutic procedure
    Item
    Stop Date
    date
    C0024305 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    chemotherapeutics regimen total number of cycles ordered, Lymphoma, Non-Hodgkin, Therapeutic procedure
    Item
    Total number of cycles
    text
    C2045831 (UMLS CUI [1,1])
    C0024305 (UMLS CUI [1,2])
    Item Group
    Myelodysplasia
    C0026985 (UMLS CUI-1)
    Myelodysplasia diagnosis
    Item
    Has the patient had a documented diagnosis of myelodysplasia?
    boolean
    C0026985 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Myelodysplasia Date of diagnosis
    Item
    If yes, date of diagnosis
    date
    C0026985 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Item Group
    AML
    C0023467 (UMLS CUI-1)
    AML diagnosis
    Item
    Has the patient had a documented diagnosis of AML?
    boolean
    C0023467 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    AML date of diagnosis
    Item
    If yes, date of diagnosis
    date
    C0023467 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Item Group
    Another malignancy
    C0006826 (UMLS CUI-1)
    Malignancy diagnosis
    Item
    Has the patient had a diagnosis of another malignancy?
    boolean
    C0006826 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Malignancy Date of diagnosis
    Item
    If yes, date of diagnosis
    date
    C0006826 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Item Group
    TSH measurement
    C0202230 (UMLS CUI-1)
    TSH measurement Date
    Item
    Date
    date
    C0202230 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    TSH measurement Result
    Item
    Result
    float
    C0202230 (UMLS CUI [1,1])
    C1254595 (UMLS CUI [1,2])
    TSH measurement Not done
    Item
    Not done
    boolean
    C0202230 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Item Group
    HAMA
    C1291910 (UMLS CUI-1)
    Item
    Was a HAMA obtained since the last LTFU?
    text
    C1291910 (UMLS CUI [1,1])
    C3872643 (UMLS CUI [1,2])
    HAMA since last encounter
    Code List
    Was a HAMA obtained since the last LTFU?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not applicable (Not applicable)
    HAMA accession number
    Item
    If yes, enter accession #
    text
    C1291910 (UMLS CUI [1,1])
    C1510755 (UMLS CUI [1,2])
    Back to the top of the page 

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