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ID

36217

Descrizione

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

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versioni (1)
  1. 22/04/19 22/04/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

22 aprile 2019

DOI

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Licenza

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

    Inglese

    Study Conclusion

    1 moduli  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Descrizione

    Administrative Data

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

    Clinical Trial Subject Unique Identifier

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Descrizione

    Study Conclusion

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

    Report completion date; Patient withdrawn from trial, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1549507 (Report completion date/time)
    UMLS CUI [2,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [2,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of withdrawal
    Descrizione

    Withdraw, Time

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Was the subject withdrawn from the study?
    Descrizione

    Subject withdrawn from trial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    If Yes, tick he primary reason for withdrawal:
    Descrizione

    Subject withdrawn from trial, Indication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3146298 (Indication)
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    Similar models

    Study Conclusion

    1 moduli
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Report completion date; Patient withdrawn from trial, Date in time
    Item
    Date of subject completion or withdrawal
    date
    C1549507 (UMLS CUI [1])
    C0422727 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Withdraw, Time
    Item
    Time of withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Subject withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    If Yes, tick he primary reason for withdrawal:
    text
    C0422727 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Subject withdrawn from trial, Indication
    Code List
    If Yes, tick he primary reason for withdrawal:
    CL Item
    Adverse event  (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated study (5)
    CL Item
    Other (6)
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