ID

36209

Description

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Keywords

Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

    English

    PGx-Pharmacogenetic Research

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Consent for PGx-Pharmacogenetic Research
    Description

    Consent for PGx-Pharmacogenetic Research

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    Pharmacogenetic Test, Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Description

    Pharmacogenetic Test, Informed Consent, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0011008
    IfNo, tick one reason
    Description

    Pharmacogenetic Test, Informed Consent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    Blood Sample Collection (DNA)
    Description

    Blood Sample Collection (DNA)

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0012854
    Has a blood sample been collected for PGx-pharmacogenetic research?
    Description

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    If Yes, record the date sample taken
    Description

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    Withdrawal of Consent
    Description

    Withdrawal of Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C2349954
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Description

    Pharmacogenetic Test, Informed Consent, Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Blood Sample Destruction
    Description

    Blood Sample Destruction

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0178913
    UMLS CUI-3
    C1948029
    Has a request been made for sample destruction?
    Description

    Pharmacogenetic Test, Blood specimen, Destruction, Request

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    If Yes, tick one reason
    Description

    Pharmacogenetic Test, Blood specimen, Destruction, Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C3146298
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    Similar models

    PGx-Pharmacogenetic Research

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Consent for PGx-Pharmacogenetic Research
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    Pharmacogenetic Test, Informed Consent
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Pharmacogenetic Test, Informed Consent, Date in time
    Item
    If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    IfNo, tick one reason
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Pharmacogenetic Test, Informed Consent, Indication
    Code List
    IfNo, tick one reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other (3)
    Item Group
    Blood Sample Collection (DNA)
    C2347500 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0012854 (UMLS CUI-3)
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been collected for PGx-pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
    Item
    If Yes, record the date sample taken
    date
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Withdrawal of Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C2349954 (UMLS CUI-3)
    Pharmacogenetic Test, Informed Consent, Withdraw
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Item Group
    Blood Sample Destruction
    C2347500 (UMLS CUI-1)
    C0178913 (UMLS CUI-2)
    C1948029 (UMLS CUI-3)
    Pharmacogenetic Test, Blood specimen, Destruction, Request
    Item
    Has a request been made for sample destruction?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    Item
    If Yes, tick one reason
    text
    C2347500 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C3146298 (UMLS CUI [1,4])
    Pharmacogenetic Test, Blood specimen, Destruction, Reason
    Code List
    If Yes, tick one reason
    CL Item
    Subject requested  (1)
    CL Item
    Screen failure (2)
    CL Item
    Other (3)
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