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ID

12244

Beschrijving

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

Trefwoorden

  1. 01-10-15 01-10-15 -
  2. 28-10-15 28-10-15 -
  3. 28-10-15 28-10-15 -
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28 oktober 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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    CLL Pharmacokinetics BO17072 NCT00090051

    Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

    Blood sampling for pharmacokinetics (Rituximab)
    Beschrijving

    Blood sampling for pharmacokinetics (Rituximab)

    Scheduled sampling time
    Beschrijving

    Scheduled sampling time

    Datatype

    time

    Maateenheden
    • h
    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    h
    Scheduled sampling date
    Beschrijving

    Scheduled sampling date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Sample number
    Beschrijving

    Sample number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    Sample collection date
    Beschrijving

    Sample collection date

    Datatype

    date

    Maateenheden
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1549498 (Collection date/time, equivalent to film or sample collection date/time)
    dd/mm/yy
    Sample collection time
    Beschrijving

    Sample collection time

    Datatype

    time

    Maateenheden
    • hh:mm
    Alias
    UMLS CUI [1]
    C0427352 (Fluid sample collection time)
    SNOMED
    168149003
    hh:mm
    Remarks
    Beschrijving

    Remarks

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.
    Beschrijving

    If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.

    Scheduled sampling time
    Beschrijving

    After the end of infusion

    Datatype

    time

    Maateenheden
    • h
    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    h
    Sampling number
    Beschrijving

    Sampling number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    Sample collection date
    Beschrijving

    Sample collection date

    Datatype

    date

    Maateenheden
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1549498 (Collection date/time, equivalent to film or sample collection date/time)
    dd/mm/yy
    Sample collection time
    Beschrijving

    Sample collection time

    Datatype

    time

    Maateenheden
    • hh:mm
    Alias
    UMLS CUI [1]
    C0427352 (Fluid sample collection time)
    SNOMED
    168149003
    hh:mm
    Remarks
    Beschrijving

    Remarks

    Datatype

    text

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

    Similar models

    Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Blood sampling for pharmacokinetics (Rituximab)
    Scheduled sampling time
    Item
    Scheduled sampling time
    time
    C0040223 (UMLS CUI [1])
    Scheduled sampling date
    Item
    Scheduled sampling date
    date
    C0011008 (UMLS CUI [1])
    Sample number
    Item
    Sample number
    integer
    C1299222 (UMLS CUI [1])
    Sample collection date
    Item
    Sample collection date
    date
    C1549498 (UMLS CUI [1])
    Sample collection time
    Item
    Sample collection time
    time
    C0427352 (UMLS CUI [1])
    Remarks
    Item
    Remarks
    text
    C0947611 (UMLS CUI [1])
    Item Group
    If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.
    Scheduled sampling time
    Item
    Scheduled sampling time
    time
    C0040223 (UMLS CUI [1])
    Sampling number
    Item
    Sampling number
    integer
    C1299222 (UMLS CUI [1])
    Sample collection date
    Item
    Sample collection date
    date
    C1549498 (UMLS CUI [1])
    Sample collection time
    Item
    Sample collection time
    time
    C0427352 (UMLS CUI [1])
    Remarks
    Item
    Remarks
    text
    C0947611 (UMLS CUI [1])

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