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ID

36945

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-06-23 2019-06-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 juni 2019

DOI

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Licens

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

    Engelsk

    Pregnancy Information; Study Conclusion; Investigational Comment Log; Investigator's Signature

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Beskrivning

    Subject identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pregnancy Information
    Beskrivning

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did a female partner ofthe male subject become pregnant during the study?
    Beskrivning

    If Yes, complete Pregnancy Notification form.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0919624
    Study Conclusion
    Beskrivning

    Study Conclusion

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

    Date of subject completion or withdrawal

    Datatyp

    date

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    Was the subject withdrawn from the study?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

    If Yes, check one primary reason for withdrawal:

    Datatyp

    boolean

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

    Primary reason for withdrawal

    Datatyp

    integer

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

    Specify Investigator diecretion

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0022423
    UMLS CUI [1,3]
    C2348235
    Investigator Comment Log
    Beskrivning

    Investigator Comment Log

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

    CRF page number if applicable

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Investigator Comment
    Beskrivning

    Investigator Comment

    Datatyp

    text

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

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    lnvestigator's signature
    Beskrivning

    lnvestigator's signature

    Datatyp

    text

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

    lnvestigator's name (print)

    Datatyp

    text

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

    lnvestigator's signature date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Tillbaka till toppen

    Similar models

    Pregnancy Information; Study Conclusion; Investigational Comment Log; Investigator's Signature

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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