ID

14136

Descripción

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

Palabras clave

  1. 31/3/16 31/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

31 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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    VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

    VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

    final rash/cutaneous event evaluation
    Descripción

    final rash/cutaneous event evaluation

    date of visit
    Descripción

    date of visit

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    should this visit be marked as deleted?
    Descripción

    deleted visit

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C1880274 (Deletion (action))
    rash or cutaneous event number for this subject
    Descripción

    rash or cutaneous event number for this subject

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    final investigator's diagnosis
    Descripción

    please enter corresponding AE number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0332144 (Final diagnosis (discharge))
    SNOMED
    89100005
    UMLS CUI [1,2]
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    local dermatologist's diagnosis
    Descripción

    local dermatologist's diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0259831 (Dermatologist)
    SNOMED
    18803008
    date of dermatologist's diagnosis (=date of visit local dermatologist)
    Descripción

    date of dermatologist's diagnosis (=date of visit local dermatologist)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0259831 (Dermatologist)
    SNOMED
    18803008
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    office use only
    Descripción

    office use only

    Tipo de datos

    text

    Similar models

    VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    final rash/cutaneous event evaluation
    date of visit
    Item
    date of visit
    datetime
    C1320303 (UMLS CUI [1])
    Item
    should this visit be marked as deleted?
    integer
    C0545082 (UMLS CUI [1,1])
    C1880274 (UMLS CUI [1,2])
    Code List
    should this visit be marked as deleted?
    CL Item
    deleted (1)
    rash or cutaneous event number for this subject
    Item
    rash or cutaneous event number for this subject
    text
    C0015230 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    final investigator's diagnosis
    Item
    final investigator's diagnosis
    text
    C0332144 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    local dermatologist's diagnosis
    Item
    local dermatologist's diagnosis
    text
    C0011900 (UMLS CUI [1,1])
    C0259831 (UMLS CUI [1,2])
    date of dermatologist's diagnosis (=date of visit local dermatologist)
    Item
    date of dermatologist's diagnosis (=date of visit local dermatologist)
    date
    C0011900 (UMLS CUI [1,1])
    C0259831 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    office use only
    Item
    office use only
    text

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