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ID

41781

Description

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

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Versions (1)
  1. 1/19/21 1/19/21 -
Copyright Holder

GlaxoSmithKline

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January 19, 2021

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Creative Commons BY 4.0
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    Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

    English

    End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3828490
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Description

    Date of subject completion or withdrawal

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    Time of withdrawal
    Description

    Time of withdrawal

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0040223
    Was the subject withdrawn from the study?
    Description

    Was the subject withdrawn from the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    If subject was withdrawn from the study, check the primary reason for withdrawal
    Description

    If subject was withdrawn from the study, check the primary reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3146298
    Specify other reason for withdrawal
    Description

    Specify other reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2]
    C2348235
    Investigator Comment Log
    Description

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    CRF page number if applicable
    Description

    CRF page number if applicable

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's Signature
    Description

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's Signature - Date
    Description

    Investigator's Signature - Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's name
    Description

    Investigator's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Did the subject become pregnant during the study?
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (not of childbearing potential or male) (X)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Time of withdrawal
    Item
    Time of withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    If subject was withdrawn from the study, check the primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    If subject was withdrawn from the study, check the primary reason for withdrawal
    Code List
    If subject was withdrawn from the study, check the primary reason for withdrawal
    CL Item
    Adverse events (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated study (5)
    CL Item
    Non-compliance (17)
    CL Item
    Other, specify (Z)
    Specify other reason for withdrawal
    Item
    Specify other reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [2])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF page number if applicable
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's Signature - Date
    Item
    Investigator's Signature - Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
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