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ID

14018

Beschrijving

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Trefwoorden

  1. 22-03-16 22-03-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

22 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    VX-950HPC3006 NCT01571583 Dispensation of Peg-IFN

    VX-950HPC3006 NCT01571583 Dispensation of Peg-IFN

    Dispensation of Peg-IFN
    Beschrijving

    Dispensation of Peg-IFN

    Visit number
    Beschrijving

    Visit number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Date of kit allocation
    Beschrijving

    Date of kit allocation

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1706778 (Allocation)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Kit number assigned by IWRS
    Beschrijving

    Kit number assigned by IWRS

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Kit number from medication tear off label to be dispensed to subject
    Beschrijving

    Kit number from medication tear off label to be dispensed to subject

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Was this kit assigned by IWRS dispensed to the subject?
    Beschrijving

    kit assigned by IWRS dispensed

    Datatype

    integer

    Date of dispensation
    Beschrijving

    Date of dispensation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Number of syringes taken by subject
    Beschrijving

    Number of syringes

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0039142 (Syringes)
    SNOMED
    61968008
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Kit number returned by subject to site
    Beschrijving

    Kit number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Date when kit was returned by subject to site
    Beschrijving

    Date when kit was returned by subject to site

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Number of syringes in kit returned by subject to site
    Beschrijving

    Number of syringes in kit

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0039142 (Syringes)
    SNOMED
    61968008
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Office use only
    Beschrijving

    Office use only

    Datatype

    text

    Similar models

    VX-950HPC3006 NCT01571583 Dispensation of Peg-IFN

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Dispensation of Peg-IFN
    Visit number
    Item
    Visit number
    text
    C1549755 (UMLS CUI [1])
    Date of kit allocation
    Item
    Date of kit allocation
    date
    C1706778 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Kit number assigned by IWRS
    Item
    Kit number assigned by IWRS
    text
    C0237753 (UMLS CUI [1])
    Kit number from medication tear off label to be dispensed to subject
    Item
    Kit number from medication tear off label to be dispensed to subject
    text
    C0237753 (UMLS CUI [1])
    Item
    Was this kit assigned by IWRS dispensed to the subject?
    integer
    Code List
    Was this kit assigned by IWRS dispensed to the subject?
    CL Item
    Yes (1)
    CL Item
    No, misallocated (please contact monitor immediately) (2)
    CL Item
    No, study medication discontinued (after kit was assigned but prior to dispensation) (3)
    CL Item
    No, kit not available at site (please contact IWRS for new kit assignment) (4)
    CL Item
    No, other please specify (5)
    Item
    Date of dispensation
    integer
    C0011008 (UMLS CUI [1])
    Code List
    Date of dispensation
    CL Item
    Same as date of kit allocation by IWRS (1)
    CL Item
    other, specify: (2)
    Number of syringes
    Item
    Number of syringes taken by subject
    text
    C0039142 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item
    Kit number returned by subject to site
    integer
    C0237753 (UMLS CUI [1])
    Code List
    Kit number returned by subject to site
    CL Item
    kit number: (1)
    CL Item
    N/A (kit never returned) (2)
    Date when kit was returned by subject to site
    Item
    Date when kit was returned by subject to site
    date
    C0011008 (UMLS CUI [1])
    Number of syringes in kit
    Item
    Number of syringes in kit returned by subject to site
    text
    C0039142 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Office use only
    Item
    Office use only
    text

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