0 Ratings
ID

29793

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Pharmacogenetic Research.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

Versions (1)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

    English

    Pharmacogenetic Research

    1 forms  
    Consent for Pharmacogenetic Research
    Description

    Consent for Pharmacogenetic Research

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

    Informed consent for Pharmacogenetic Research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If consent for pharmacogenetic research was obtained, give the date.
    Description

    Date of informed consent for pharmacogenetic research

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347501
    If no consent for pharmacogenetic research was obtained, specify the reason:
    Description

    Reason for no consent for pharmacogenetic research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    Blood sample collection
    Description

    Blood sample collection

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0031325
    Has a blood sample been collected for Pharmacogenetic Research?
    Description

    Blood sample for Pharmacogenetic Research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031325
    If a blood sample has been taken for pharmacogenetic research, give a date:
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0031325
    Withdrawal of consent
    Description

    Withdrawal of consent

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C0031325
    Has this subject withdrawn consent for Pharmacogenetic Research?
    Description

    Withdrawal of consent

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    Blood Sample Destruction
    Description

    Blood Sample Destruction

    Alias
    UMLS CUI-1
    C1948029
    UMLS CUI-2
    C0178913
    UMLS CUI-3
    C0031325
    Has a request been made for sample destruction?
    Description

    Request for Blood Sample Destruction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0031325
    If a request has been made, what was the reason for blood sample destruction?
    Description

    Reason for Blood sample Destruction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0031325
    UMLS CUI [1,4]
    C0392360
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    Similar models

    Pharmacogenetic Research

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Consent for Pharmacogenetic Research
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has informed consent been obtained for Pharmacogenetic Research?
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Informed consent for Pharmacogenetic Research
    Code List
    Has informed consent been obtained for Pharmacogenetic Research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Date of informed consent for pharmacogenetic research
    Item
    If consent for pharmacogenetic research was obtained, give the date.
    date
    C0011008 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347501 (UMLS CUI [1,3])
    Item
    If no consent for pharmacogenetic research was obtained, specify the reason:
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for no consent for pharmacogenetic research
    Code List
    If no consent for pharmacogenetic research was obtained, specify the reason:
    CL Item
    Subject declined (SD)
    CL Item
    Subject not asked by investigator (SI)
    CL Item
    other (X)
    Item Group
    Blood sample collection
    C0005834 (UMLS CUI-1)
    C0031325 (UMLS CUI-2)
    Item
    Has a blood sample been collected for Pharmacogenetic Research?
    text
    C0005834 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Informed consent for Pharmacogenetic Research
    Code List
    Has a blood sample been collected for Pharmacogenetic Research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Date sample taken
    Item
    If a blood sample has been taken for pharmacogenetic research, give a date:
    date
    C1302413 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Item Group
    Withdrawal of consent
    C1707492 (UMLS CUI-1)
    C0031325 (UMLS CUI-2)
    Item
    Has this subject withdrawn consent for Pharmacogenetic Research?
    text
    C1707492 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Informed consent for Pharmacogenetic Research
    Code List
    Has this subject withdrawn consent for Pharmacogenetic Research?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item Group
    Blood Sample Destruction
    C1948029 (UMLS CUI-1)
    C0178913 (UMLS CUI-2)
    C0031325 (UMLS CUI-3)
    Item
    Has a request been made for sample destruction?
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0031325 (UMLS CUI [1,4])
    Informed consent for Pharmacogenetic Research
    Code List
    Has a request been made for sample destruction?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item
    If a request has been made, what was the reason for blood sample destruction?
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0031325 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    Reason for Blood sample Destruction
    Code List
    If a request has been made, what was the reason for blood sample destruction?
    CL Item
    Subject's request (R)
    CL Item
    Screen failure (F)
    CL Item
    other (X)
    Back to the top of the page 

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