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31307

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 Please record all presumed and confirmed invasive infections through the Week 13 visit. Record only one infection per form.

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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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    Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

    English

    Infection Summary

    1 forms  
    1. StudyEvent: ODM
      1. Infection Summary
    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
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Infections
    Description

    Infections

    Alias
    UMLS CUI-1
    C0009450
    Has the patient had a presumed or confirmed invasive infection (e.g. sepsis, pneumonia) during study participation?
    Description

    invasive infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    Type on infection
    Description

    Type on infection

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0332307
    Method of confirmation
    Description

    Infection; Method of confirmation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430022
    Was a culture obtained?
    Description

    Infection; culture obtained

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430400
    Infection; Laboratory culture
    Description

    Infection; Laboratory culture

    Alias
    UMLS CUI-1
    C0009450
    UMLS CUI-2
    C0430400
    Source Code
    Description

    Infection; Laboratory Culture; Source Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C1710131
    Date
    Description

    Infection; Laboratory Culture; Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C0011008
    Result
    Description

    Infection; Laboratory Culture; Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C1274040
    If positive, indicate organism code
    Description

    Infection; Laboratory culture; Positive; Organism Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C1446409
    UMLS CUI [1,4]
    C0029235
    UMLS CUI [1,5]
    C1708523
    Anti-infectives
    Description

    Anti-infectives

    Alias
    UMLS CUI-1
    C0003204
    Was an anti-infective administered?
    Description

    Infection; Anti-infective agent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    Anti-Infective
    Description

    Infection; Anti-infective agent

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    Empiric or Therapeutic?
    Description

    Infection; Anti-infective agent; type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    UMLS CUI [1,3]
    C0332307
    Start Date
    Description

    Infection; Anti-infective agent; start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    UMLS CUI [1,3]
    C0808070
    Stop Date
    Description

    Infection; Anti-infective agent; end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    UMLS CUI [1,3]
    C0806020
    Ongoing
    Description

    Infection; Anti-infective agent; Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0003204
    UMLS CUI [1,3]
    C0549178
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    Similar models

    Infection Summary

    1 forms
    1. StudyEvent: ODM
      1. Infection Summary
    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])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Infections
    C0009450 (UMLS CUI-1)
    invasive infection
    Item
    Has the patient had a presumed or confirmed invasive infection (e.g. sepsis, pneumonia) during study participation?
    boolean
    C0009450 (UMLS CUI [1])
    Item
    Type on infection
    text
    C0009450 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type on infection
    Code List
    Type on infection
    CL Item
    Meningitis (Meningitis)
    CL Item
    Pyelonephritis (Pyelonephritis)
    CL Item
    Sepsis (Sepsis)
    CL Item
    Pneumonia (Pneumonia)
    CL Item
    Endocarditis/Pericarditis (Endocarditis/Pericarditis)
    CL Item
    Peritonitis (Peritonitis)
    CL Item
    Other (Other)
    Item
    Method of confirmation
    text
    C0009450 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    Type on infection
    Code List
    Method of confirmation
    CL Item
    Other (Other)
    CL Item
    PE (PE)
    CL Item
    CT Scan (CT Scan)
    CL Item
    X-ray (X-ray)
    Infection; culture obtained
    Item
    Was a culture obtained?
    boolean
    C0009450 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    Item Group
    Infection; Laboratory culture
    C0009450 (UMLS CUI-1)
    C0430400 (UMLS CUI-2)
    Infection; Laboratory Culture; Source Code
    Item
    Source Code
    text
    C0009450 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C1710131 (UMLS CUI [1,3])
    Infection; Laboratory Culture; Date
    Item
    Date
    date
    C0009450 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Result
    text
    C0009450 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Infection; Laboratory Culture; Result
    Code List
    Result
    CL Item
    Pos (Pos)
    CL Item
    Neg (Neg)
    Infection; Laboratory culture; Positive; Organism Code
    Item
    If positive, indicate organism code
    text
    C0009450 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C1446409 (UMLS CUI [1,3])
    C0029235 (UMLS CUI [1,4])
    C1708523 (UMLS CUI [1,5])
    Item Group
    Anti-infectives
    C0003204 (UMLS CUI-1)
    Infection; Anti-infective agent
    Item
    Was an anti-infective administered?
    boolean
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    Infection; Anti-infective agent
    Item
    Anti-Infective
    text
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    Item
    Empiric or Therapeutic?
    text
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Infection; Anti-infective agent
    Code List
    Empiric or Therapeutic?
    CL Item
    Empiric (Empiric)
    CL Item
    Therapeutic (Therapeutic)
    Infection; Anti-infective agent; start date
    Item
    Start Date
    date
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Infection; Anti-infective agent; end date
    Item
    Stop Date
    date
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Infection; Anti-infective agent; Continuous
    Item
    Ongoing
    boolean
    C0009450 (UMLS CUI [1,1])
    C0003204 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
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