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ID

31177

Beschrijving

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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  1. 25-07-18 25-07-18 -
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see clinicaltrials.gov

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25 juli 2018

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    Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

    Engels

    Long-Term Follow-Up for Survival & Disease Status

    1 Formulieren  
    Default Itemgroup
    Beschrijving

    Default Itemgroup

    Site number
    Beschrijving

    Site number

    Datatype

    text

    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

    text

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

    Patient initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Patient status
    Beschrijving

    Patient status

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0449437 (Patient status)
    SNOMED
    246097001
    Date last known alive
    Beschrijving

    Date last known alive

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3274947 (Last Time Seen Alive)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Date of last contact
    Beschrijving

    Date of last contact

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    How contact was made
    Beschrijving

    Contact

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2051442 (patient contacted by)
    Does the patient have an ongoing response to Iodine I 131 Tositumomab?
    Beschrijving

    Iodine I 131 Tositumomab

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0768182 (iodine-131-tositumomab)
    Additional therapy for NHL since the last LTFU
    Beschrijving

    Additional therapy for NHL since the last LTFU

    Alias
    UMLS CUI-1
    C0024305 (Lymphoma, Non-Hodgkin)
    SNOMED
    1929004
    UMLS CUI-2
    C1706712 (Additional Therapy)
    Has any additional therapy for NHL been administered? (If yes, specify therapy and start dates in comment section below)
    Beschrijving

    additional therapy for NHL

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0024305 (Lymphoma, Non-Hodgkin)
    SNOMED
    1929004
    UMLS CUI [1,2]
    C1706712 (Additional Therapy)
    Myelodysplasia
    Beschrijving

    Myelodysplasia

    Alias
    UMLS CUI-1
    C0026985 (Myelodysplasia)
    Has the patient had a documented (bone marrow biopsy) new diagnosis of myelodysplasia?
    Beschrijving

    Myelodysplasia diagnosis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0026985 (Myelodysplasia)
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    If yes, date of diagnosis
    Beschrijving

    Myelodysplasia Date of diagnosis

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0026985 (Myelodysplasia)
    UMLS CUI [1,2]
    C2316983 (Date of diagnosis)
    SNOMED
    432213005
    LOINC
    LP114957-6
    Another malignancy
    Beschrijving

    Another malignancy

    Alias
    UMLS CUI-1
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    Has the patient had a new diagnosis of a secondary malignancy? (If yes, please specify type of malignancy)
    Beschrijving

    Malignancy Diagnosis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    if yes, date of diagnosis
    Beschrijving

    Malignancy, Date of Diagnosis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C2316983 (Date of diagnosis)
    SNOMED
    432213005
    LOINC
    LP114957-6
    Thyroid medication
    Beschrijving

    Thyroid medication

    Alias
    UMLS CUI-1
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    UMLS CUI-2
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Is the patient taking thyroid medication?
    Beschrijving

    Thyroid medication

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    If yes, drug name
    Beschrijving

    Thyroid medication; drug name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Start Date
    Beschrijving

    Thyroid medication; Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C0808070 (Start Date)
    Comments
    Beschrijving

    Comments

    Alias
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    Comments
    Beschrijving

    Comments

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Similar models

    Long-Term Follow-Up for Survival & Disease Status

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    C0449437 (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 last known alive
    Item
    Date last known alive
    date
    C3274947 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (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? (If yes, specify therapy and start dates in comment section below)
    boolean
    C0024305 (UMLS CUI [1,1])
    C1706712 (UMLS CUI [1,2])
    Item Group
    Myelodysplasia
    C0026985 (UMLS CUI-1)
    Myelodysplasia diagnosis
    Item
    Has the patient had a documented (bone marrow biopsy) new 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
    Another malignancy
    C0006826 (UMLS CUI-1)
    Malignancy Diagnosis
    Item
    Has the patient had a new diagnosis of a secondary malignancy? (If yes, please specify type of malignancy)
    boolean
    C0006826 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Malignancy, Date of Diagnosis
    Item
    if yes, date of diagnosis
    boolean
    C0006826 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Item Group
    Thyroid medication
    C0040128 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    Thyroid medication
    Item
    Is the patient taking thyroid medication?
    boolean
    C0040128 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Thyroid medication; drug name
    Item
    If yes, drug name
    text
    C0040128 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Thyroid medication; Start Date
    Item
    Start Date
    date
    C0040128 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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