ID

34941

Description

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Serum pregnancy test form. It has to be filled in for screening and for follow-up. It also contains the child-bearing potential form. It only has to be filled in for screening.

Keywords

Versions (1)
  1. 2/4/19 2/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 4, 2019

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License

Creative Commons BY-NC 3.0
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    Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

    English

    Serum pregnancy test, child-bearing potential

    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
    Visit Type
    Description

    Visit Type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0545082
    Serum pregnancy test
    Description

    Serum pregnancy test

    Alias
    UMLS CUI-1
    C0430060
    Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0430060
    Test result
    Description

    Test result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C1274040
    Child-bearing potential (Complete for Female Subjects Only}
    Description

    Child-bearing potential (Complete for Female Subjects Only}

    Alias
    UMLS CUI-1
    C3831118
    Child-bearing potential
    Description

    Tick one. Post-menopausal = Women who have completed menopause at least one year ago. Sterile = Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) Note: If the subject is sterile and is not of child-bearing age, then 'post-menopausal' will be the best choice and should be ticked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and 'sterile' should be ticked.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118
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    Similar models

    Serum pregnancy test, child-bearing potential

    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
    Visit Type
    integer
    C0332307 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Visit Type
    Code List
    Visit Type
    CL Item
    Screening (1)
    CL Item
    Follow-up (2)
    Item Group
    Serum pregnancy test
    C0430060 (UMLS CUI-1)
    Date of test
    Item
    Date of test
    date
    C0011008 (UMLS CUI [1,1])
    C0430060 (UMLS CUI [1,2])
    Item
    Test result
    integer
    C0430060 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Test result
    Code List
    Test result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Child-bearing potential (Complete for Female Subjects Only}
    C3831118 (UMLS CUI-1)
    Item
    Child-bearing potential
    integer
    C3831118 (UMLS CUI [1])
    Child-bearing potential
    Code List
    Child-bearing potential
    CL Item
    Post-menopausal (1)
    CL Item
    Sterile (of child-bearing age) (2)
    CL Item
    Potentially able to bear children (3)
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