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ID

31306

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 Any adverse experience is defined as a new or worsening pre-existing medical condition or complication occurring while on study, regardless of its perceived relationship to the drug. Please record all adverse experiences from the time of study entry through the Week 13 visit.

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Versions (1)
  1. 8/12/18 8/12/18 -
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see clinicaltrials.gov

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August 12, 2018

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License

Creative Commons BY 4.0
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    Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

    English

    Adverse Experiences

    1 forms  
    1. StudyEvent: ODM
      1. Adverse Experiences
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    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
    Adverse Experiences
    Description

    Adverse Experiences

    Alias
    UMLS CUI-1
    C0877248
    AE #
    Description

    Adverse Event; Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    Adverse Experience (one experience per line)
    Description

    Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Grade per CTC (per Appx F)
    Description

    Adverse Event; CTC grade

    Data type

    text

    Alias
    UMLS CUI [1]
    C2985911
    Serious
    Description

    Adverse event, serious

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Onset Date
    Description

    Adverse event; start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Stop Date
    Description

    Adverse event; end date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    Frequency
    Description

    Adverse event; frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439603
    Therapeutic Measures: Drugs
    Description

    Adverse event; Therapeutic Measures; Drugs

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0013227
    Therapeutic Measures: Other
    Description

    Adverse event; Therapeutic Measures; Other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205394
    Therapeutic Measures: If Other, specify here
    Description

    Adverse event; Therapeutic Measures; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Outcome
    Description

    Adverse event; Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Relationship: Drug
    Description

    Adverse event; Relationship; Drug

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0013227
    Relationship: Disease
    Description

    Adverse event; Relationship; Disease

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0012634
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    Similar models

    Adverse Experiences

    1 forms
    1. StudyEvent: ODM
      1. Adverse Experiences
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    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 Group
    Adverse Experiences
    C0877248 (UMLS CUI-1)
    Adverse Event; Number
    Item
    AE #
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Adverse Event
    Item
    Adverse Experience (one experience per line)
    text
    C0877248 (UMLS CUI [1])
    Adverse Event; CTC grade
    Item
    Grade per CTC (per Appx F)
    text
    C2985911 (UMLS CUI [1])
    Adverse event, serious
    Item
    Serious
    boolean
    C1519255 (UMLS CUI [1])
    Adverse event; start date
    Item
    Onset Date
    date
    C2697888 (UMLS CUI [1])
    Adverse event; end date
    Item
    Stop Date
    date
    C2697886 (UMLS CUI [1])
    Adverse event; frequency
    Item
    Frequency
    text
    C0877248 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Adverse event; Therapeutic Measures; Drugs
    Item
    Therapeutic Measures: Drugs
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Adverse event; Therapeutic Measures; Other
    Item
    Therapeutic Measures: Other
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Adverse event; Therapeutic Measures; Other; Specification
    Item
    Therapeutic Measures: If Other, specify here
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Adverse event; Outcome
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    Adverse event; Relationship; Drug
    Item
    Relationship: Drug
    text
    C0877248 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Adverse event; Relationship; Disease
    Item
    Relationship: Disease
    text
    C0877248 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
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