0 Ratings
ID

36210

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

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License

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

    English

    Concomitant Medications

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Description

    Concomitant Agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Drug Name
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Description

    Concomitant Agent, Dosage

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Units
    Description

    Concomitant Agent, Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439148 (Unit)
    SNOMED
    767525000
    Frequency
    Description

    Concomitant Agent, Frequencies

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    Route
    Description

    Concomitant Agent, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Reason for Medication
    Description

    Concomitant Agent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3146298 (Indication)
    Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Start Time
    Description

    Concomitant Agent, Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Taken Prior to Study?
    Description

    Concomitant Medication Previous Occurrence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Stop Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    Stop Time
    Description

    Concomitant Agent, End Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Ongoing Medication?
    Description

    Concomitant Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
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    Similar models

    Concomitant Medications

    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
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Agent
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent, Medication name
    Item
    Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Dosage
    Item
    Unit Dose
    integer
    C2347852 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Concomitant Agent, Unit
    Item
    Units
    text
    C2347852 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Concomitant Agent, Frequencies
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent, Indication
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Agent, Start Time
    Item
    Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Concomitant Medication Previous Occurrence
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    Stop Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Agent, End Time
    Item
    Stop Time
    time
    C2347852 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Concomitant Medication Ongoing
    Item
    Ongoing Medication?
    boolean
    C2826666 (UMLS CUI [1])
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