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ID

14115

Description

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

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  1. 3/30/16 3/30/16 -
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CC BY-NC 3.0

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March 30, 2016

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Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB6]

    English

    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB6]

    1 forms  
    Laboratory blood urine pregnancy
    Description

    Laboratory blood urine pregnancy

    Alias
    UMLS CUI-1
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    date of collection
    Description

    date of collection

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516698 (Collection (action))
    LOINC
    LP20988-9
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    if other date, please specify
    Description

    other date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Outcome of urine pregnancy test
    Description

    Outcome of urine pregnancy test

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    UMLS CUI [1,2]
    C0085565 (Outcome Assessment, Health Care)
    remarks regarding sample collection, if any
    Description

    remarks

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    clinically significant abnormalities?
    Description

    overall interpretation of laboratory report(s)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258 (Abnormality)
    UMLS CUI [1,2]
    C2985739 (Clinically Significant Indicator)
    central laboratory reference number
    Description

    sample reference numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826265 (Reference ID)
    UMLS CUI [1,2]
    C1880016 (Central Laboratory)
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    Similar models

    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB6]

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Laboratory blood urine pregnancy
    C0022877 (UMLS CUI-1)
    Item
    date of collection
    integer
    C1516698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    date of collection
    Code List
    date of collection
    CL Item
    same date as visit date (1)
    CL Item
    other date please specify (2)
    other date
    Item
    if other date, please specify
    date
    C0011008 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Outcome of urine pregnancy test
    integer
    C0430056 (UMLS CUI [1,1])
    C0085565 (UMLS CUI [1,2])
    Outcome of urine pregnancy test
    Code List
    Outcome of urine pregnancy test
    CL Item
    positive (1)
    CL Item
    negative (2)
    CL Item
    not applicable (3)
    CL Item
    not done (4)
    remarks
    Item
    remarks regarding sample collection, if any
    text
    C0947611 (UMLS CUI [1])
    abnormality clinically significant
    Item
    clinically significant abnormalities?
    boolean
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    central laboratory reference number
    Item
    central laboratory reference number
    text
    C2826265 (UMLS CUI [1,1])
    C1880016 (UMLS CUI [1,2])
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