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ID

14122

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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Versions (1)
  1. 30/03/2016 30/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

30 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

    Anglais

    VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

    1 Formulaires  
    Vital signs and anthropometric measurements
    Description

    Vital signs and anthropometric measurements

    rash or cutaneous event number
    Description

    rash or cutaneous event number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0237753
    Date performed
    Description

    Date performed

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0011008
    if other date, please specify
    Description

    other date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0205394
    Weight
    Description

    Weight

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0005910
    Pulse supine
    Description

    after 5 minutes in supine position at rest

    Type de données

    text

    Unités de mesure
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0232117
    UMLS CUI [1,2]
    C0038846
    beats/min
    Blood pressure supine
    Description

    after 5 minutes in supine position at rest

    Type de données

    text

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0038846
    mmHg
    Clinically significant abnormalities
    Description

    Clinically significant abnormalities

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    Retour au début de la page

    Similar models

    VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Vital signs and anthropometric measurements
    rash or cutaneous event number
    Item
    rash or cutaneous event number
    text
    C0015230 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item
    Date performed
    integer
    C0011008 (UMLS CUI [1])
    Date performed
    Code List
    Date performed
    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])
    Weight
    Item
    Weight
    text
    C0005910 (UMLS CUI [1])
    Pulse supine
    Item
    Pulse supine
    text
    C0232117 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Blood pressure supine
    Item
    Blood pressure supine
    text
    C0005823 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Clinically significant abnormalities
    Item
    Clinically significant abnormalities
    boolean
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Retour au début de la page 

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