0 Evaluaciones
ID

36945

Descripción

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

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Versiones (1)
  1. 23.06.19 23.06.19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23. Juni 2019

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identifier
    Descripción

    Subject identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Pregnancy Information
    Descripción

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    Did a female partner ofthe male subject become pregnant during the study?
    Descripción

    If Yes, complete Pregnancy Notification form.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0919624 (Pregnancy of partner)
    Study Conclusion
    Descripción

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Descripción

    Date of subject completion or withdrawal

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,3]
    C1549507 (Report completion date/time)
    Was the subject withdrawn from the study?
    Descripción

    If Yes, check one primary reason for withdrawal:

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Primary reason for withdrawal
    Descripción

    Primary reason for withdrawal

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Specify Investigator diecretion
    Descripción

    Specify Investigator diecretion

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,2]
    C0022423 (Judgment)
    SNOMED
    61254005
    UMLS CUI [1,3]
    C2348235 (Specification)
    Investigator Comment Log
    Descripción

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961 (Clinical Investigators)
    UMLS CUI-2
    C0947611 (Comment)
    LOINC
    LP72293-1
    CRF page number if applicable
    Descripción

    CRF page number if applicable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1704732 (Page (document))
    UMLS CUI [1,2]
    C1516308 (Case Report Form)
    Investigator Comment
    Descripción

    Investigator Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C0008961 (Clinical Investigators)
    Investigator's Signature
    Descripción

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    lnvestigator's signature
    Descripción

    lnvestigator's signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    lnvestigator's name (print)
    Descripción

    lnvestigator's name (print)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    lnvestigator's signature date
    Descripción

    lnvestigator's signature date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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