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ID

36945

Description

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Keywords

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 23, 2019

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License

Creative Commons BY-NC 3.0
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    The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503

    English

    Pregnancy Information; Study Conclusion; Investigational 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 a female partner ofthe male subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0919624
    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 [1,1]
    C0011008
    UMLS CUI [1,2]
    C0422727
    UMLS CUI [1,3]
    C1549507
    Was the subject withdrawn from the study?
    Description

    If Yes, check one primary reason for withdrawal:

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Primary reason for withdrawal
    Description

    Primary reason for withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Specify Investigator diecretion
    Description

    Specify Investigator diecretion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0022423
    UMLS CUI [1,3]
    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
    Investigator Comment
    Description

    Investigator Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0008961
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    lnvestigator's signature
    Description

    lnvestigator's signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    lnvestigator's name (print)
    Description

    lnvestigator's name (print)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    lnvestigator's signature date
    Description

    lnvestigator's signature date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Pregnancy Information; Study Conclusion; Investigational 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 a female partner ofthe male subject become pregnant during the study?
    text
    C0919624 (UMLS CUI [1])
    Did a female partner ofthe male subject become pregnant during the study?
    Code List
    Did a female partner ofthe male subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (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
    C0011008 (UMLS CUI [1,1])
    C0422727 (UMLS CUI [1,2])
    C1549507 (UMLS CUI [1,3])
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse event --> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
    CL Item
    Protocol deviation (2)
    CL Item
    Subject reached protocol defined stopping criteria (3)
    CL Item
    Study closed/terminated (4)
    CL Item
    Lost to follow-up (5)
    CL Item
    Investigator discretion (Only check if none of the other primary reasons are appropriate), specify (6)
    CL Item
    Withdrew consent (Only check if none of the other primary reasons are appropriate) (7)
    Specify Investigator diecretion
    Item
    Specify Investigator diecretion
    text
    C0008961 (UMLS CUI [1,1])
    C0022423 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    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])
    Investigator Comment
    Item
    Investigator Comment
    text
    C0947611 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    lnvestigator's signature
    Item
    lnvestigator's signature
    text
    C2346576 (UMLS CUI [1])
    lnvestigator's name (print)
    Item
    lnvestigator's name (print)
    text
    C2826892 (UMLS CUI [1])
    lnvestigator's signature date
    Item
    lnvestigator's signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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