0 Bedömningar

ID

12246

Beskrivning

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

Nyckelord

  1. 10/1/15 10/1/15 -
  2. 10/28/15 10/28/15 -
  3. 10/28/15 10/28/15 -
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October 28, 2015

DOI

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Licens

Creative Commons BY-NC 3.0

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    CLL Pharmacokinetics BO17072 NCT00090051

    Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

    Blood sampling for pharmacokinetics (Rituximab)
    Beskrivning

    Blood sampling for pharmacokinetics (Rituximab)

    Scheduled sampling time
    Beskrivning

    Scheduled sampling time

    Datatyp

    time

    Måttenheter
    • h
    Alias
    UMLS CUI [1]
    C0040223
    h
    Scheduled sampling date
    Beskrivning

    Scheduled sampling date

    Datatyp

    date

    Måttenheter
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0011008
    dd/mm/yy
    Sample number
    Beskrivning

    Sample number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Sample collection date
    Beskrivning

    Sample collection date

    Datatyp

    date

    Måttenheter
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1549498
    dd/mm/yy
    Sample collection time
    Beskrivning

    Sample collection time

    Datatyp

    time

    Måttenheter
    • hh:mm
    Alias
    UMLS CUI [1]
    C0427352
    hh:mm
    Remarks
    Beskrivning

    Remarks

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.
    Beskrivning

    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
    Beskrivning

    After the end of infusion

    Datatyp

    time

    Måttenheter
    • h
    Alias
    UMLS CUI [1]
    C0040223
    h
    Sampling number
    Beskrivning

    Sampling number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Sample collection date
    Beskrivning

    Sample collection date

    Datatyp

    date

    Måttenheter
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1549498
    dd/mm/yy
    Sample collection time
    Beskrivning

    Sample collection time

    Datatyp

    time

    Måttenheter
    • hh:mm
    Alias
    UMLS CUI [1]
    C0427352
    hh:mm
    Remarks
    Beskrivning

    Remarks

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611

    Similar models

    Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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