0 Ratings
ID

33285

Description

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

Versions (2)
  1. 11/30/18 11/30/18 -
  2. 12/4/18 12/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

    English

    Tobacco use, HIV screen

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    HISTORY OF TOBACCO USE
    Description

    HISTORY OF TOBACCO USE

    Alias
    UMLS CUI-1
    C0543414
    What is the subject's history of smoking use (includes all tobacco products)?
    Description

    If current smoker, Exclude subject from study. DEFINITIONS: Never smoked: Never smoked Current smoker: Currently smoking or has smoked within 6 months of screening visit Former smoker: Previously smoked and has not smoked for at least 6 months prior to screening visit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1519384
    If former smoker, when did the subject last smoke?
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0425310
    UMLS CUI [1,2]
    C0011008
    SEROLOGY - HIV SCREEN
    Description

    SEROLOGY - HIV SCREEN

    Alias
    UMLS CUI-1
    C0459958
    UMLS CUI-2
    C0036743
    Date sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Serology for viral infections
    Description

    Tick appropriate box(es)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0521026
    UMLS CUI [1,3]
    C3714514
    Serology for viral infections, result
    Description

    If any screen are positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0521026
    UMLS CUI [1,3]
    C3714514
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    Similar models

    Tobacco use, HIV screen

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    HISTORY OF TOBACCO USE
    C0543414 (UMLS CUI-1)
    Item
    What is the subject's history of smoking use (includes all tobacco products)?
    integer
    C1519384 (UMLS CUI [1])
    History of smoking use
    Code List
    What is the subject's history of smoking use (includes all tobacco products)?
    CL Item
    Never smoked (1)
    CL Item
    Current smoker (2)
    CL Item
    Former smoker (3)
    Date stopped smoking
    Item
    If former smoker, when did the subject last smoke?
    date
    C0425310 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    SEROLOGY - HIV SCREEN
    C0459958 (UMLS CUI-1)
    C0036743 (UMLS CUI-2)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Serology for viral infections
    integer
    C0036743 (UMLS CUI [1,1])
    C0521026 (UMLS CUI [1,2])
    C3714514 (UMLS CUI [1,3])
    HIV screen
    Code List
    Serology for viral infections
    CL Item
    HIV antibody (1)
    CL Item
    Hepatitis B surface antigen (2)
    CL Item
    Hepatitis C antibody (3)
    Item
    Serology for viral infections, result
    text
    C0036743 (UMLS CUI [1,1])
    C0521026 (UMLS CUI [1,2])
    C3714514 (UMLS CUI [1,3])
    HIV screen, result
    Code List
    Serology for viral infections, result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
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