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ID

12241

Description

An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Keywords

Versions (2)
  1. 9/30/15 9/30/15 -
  2. 10/28/15 10/28/15 -
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October 28, 2015

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Creative Commons BY-NC 3.0
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    CLL Adverse Event BO17072 NCT00090051

    English

    Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

    1 forms  
    Adverse event
    Description

    Adverse event

    Name adverse event
    Description

    Name adverse event

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Date of Onset
    Description

    Adverse Event Onset Date

    Data type

    date

    Measurement units
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C2985916 (Adverse Event Onset Date)
    dd/mm/yy
    Serious Adverse Event
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Did this event start during a MabThera® infusion?
    Description

    Adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1314901 (Mabthera)
    Did this event start within 24 hours of finishing a MabThera® infusion?
    Description

    Adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    CTCAE grade
    Description

    Initial intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1517874 (Life Threatening Adverse Event)
    Test drug adjustment
    Description

    Test drug adjustment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0376209 (Individual Adjustment)
    SNOMED
    410616005
    Was treatment given for this event
    Description

    Adverse event treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981656 (Adverse Event Treatment)
    Most extreme intensity CTCAE grade
    Description

    Most extreme intensity CTCAE grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1517874 (Life Threatening Adverse Event)
    Adverse event
    Description

    Relationship to study drugs

    Data type

    integer

    Adverse Event Outcome
    Description

    Adverse Event Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    Resolved Date
    Description

    Resolved Date

    Data type

    date

    Measurement units
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    dd/mm/yy
    Adverse Event Comment
    Description

    Adverse Event Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Adverse event treatments
    Description

    Adverse event treatments

    Name of treatment
    Description

    Name of treatment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826274 (Treatment Name)
    Treatment Start Date
    Description

    Treatment Start Date

    Data type

    date

    Measurement units
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    dd/mm/yy
    Treatment End Date
    Description

    Treatment End Date

    Data type

    date

    Measurement units
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000
    dd/mm/yy
    Treatment Ongoing
    Description

    Treatment Ongoing at final contact

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2091305 (continue current medication)
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    Similar models

    Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse event
    Name adverse event
    Item
    Name adverse event
    integer
    C0877248 (UMLS CUI [1])
    Adverse Event Onset Date
    Item
    Date of Onset
    date
    C2985916 (UMLS CUI [1])
    Serious Adverse Event
    Item
    Serious Adverse Event
    boolean
    C1519255 (UMLS CUI [1])
    Adverse Event
    Item
    Did this event start during a MabThera® infusion?
    boolean
    C1314901 (UMLS CUI [1])
    Adverse event
    Item
    Did this event start within 24 hours of finishing a MabThera® infusion?
    boolean
    C0877248 (UMLS CUI [1])
    Item
    CTCAE grade
    integer
    C1517874 (UMLS CUI [1])
    Initial intensity
    Code List
    CTCAE grade
    CL Item
    CTCAE grade 1 (1)
    C1556202 (UMLS CUI-1)
    CL Item
    CTCAE grade 2 (2)
    C1556203 (UMLS CUI-1)
    CL Item
    CTCAE grade 3 (3)
    C1556204 (UMLS CUI-1)
    CL Item
    CTCAE grade 4 (4)
    C1556205 (UMLS CUI-1)
    Item
    Test drug adjustment
    integer
    C0376209 (UMLS CUI [1])
    Test drug adjustment
    Code List
    Test drug adjustment
    CL Item
    none (1)
    C0549184 (UMLS CUI-1)
    CL Item
    dosage modified/interrupted (2)
    C0392747 (UMLS CUI-1)
    CL Item
    discontinued (3)
    C1444662 (UMLS CUI-1)
    Adverse event treatment
    Item
    Was treatment given for this event
    boolean
    C2981656 (UMLS CUI [1])
    Item
    Most extreme intensity CTCAE grade
    integer
    C1517874 (UMLS CUI [1])
    Initial intensity
    Code List
    Most extreme intensity CTCAE grade
    CL Item
    CTCAE grade 1 (1)
    C1556202 (UMLS CUI-1)
    CL Item
    CTCAE grade 2 (2)
    C1556203 (UMLS CUI-1)
    CL Item
    CTCAE grade 3 (3)
    C1556204 (UMLS CUI-1)
    CL Item
    CTCAE grade 4 (4)
    C1556205 (UMLS CUI-1)
    Item
    Adverse event
    integer
    Adverse event
    Code List
    Adverse event
    CL Item
    unrelated (1)
    C0445356 (UMLS CUI-1)
    CL Item
    remote (2)
    C0205157 (UMLS CUI-1)
    CL Item
    possible (3)
    C0332149 (UMLS CUI-1)
    CL Item
    probable (4)
    C1709683 (UMLS CUI-1)
    Item
    Adverse Event Outcome
    text
    C1705586 (UMLS CUI [1])
    Adverse Event Outcome
    Code List
    Adverse Event Outcome
    CL Item
    resolved, no sequelae (1)
    CL Item
    resolved, with sequelae (2)
    CL Item
    unresoved (3)
    CL Item
    death (4)
    Resolved Date
    Item
    Resolved Date
    date
    C0011008 (UMLS CUI [1])
    Adverse Event Comment
    Item
    Adverse Event Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Adverse event treatments
    Name of treatment
    Item
    Name of treatment
    integer
    C2826274 (UMLS CUI [1])
    Treatment Start Date
    Item
    Treatment Start Date
    date
    C3173309 (UMLS CUI [1])
    Treatment End Date
    Item
    Treatment End Date
    date
    C1531784 (UMLS CUI [1])
    Treatment Ongoing
    Item
    Treatment Ongoing
    boolean
    C2091305 (UMLS CUI [1])
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