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ID

29792

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 Concomitant Medications.

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

    Concomitant Medications

    1 forms  
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Description

    If Yes, complete the other Items of this Itemgroup.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Drug Name
    Description

    Record over-the-counter and prescription drugs prescribed. Trade names are preferred for all medications; this is particularly encouraged for all combination medications, e.g., multivitamins and cold medications. The subject should be encouraged to disclose all medications he/she is taking, including non-prescribed medications, herbal remedies, and nutritional supplements. If the subject is female, cross-check with the DEMOGRAPHY FOR FEMALES page that any contraceptive drugs taken by the subject are recorded.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Dose
    Description

    Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C3174092
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826646
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826654
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826730
    Date Started
    Description

    If the concomitant medication start date is prior to the study start date, affirm ‘Was medication started pre-study?’.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Was medication started pre-study?
    Description

    If a concomitant medication was started pre-study, check that the indication is recorded on the CURRENT MEDICAL CONDITIONS page.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2981448
    Date stopped
    Description

    Record the stop date if concomitant medication is stopped prior to the end of the study. If the subject is to continue taking the concomitant medication after the study is over, affirm ‘Was medication continued post-study?’.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Was medication continued post-study?
    Description

    Ongoing Medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Conditions treated / Indication
    Description

    Conditions treated / Indication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Prophylaxis?
    Description

    Prophylaxis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199176
    Was drug administered for an adverse event?
    Description

    If the concomitant medication was taken for an adverse event, check that the event is entered on the appropriate ADVERSE EVENTS page(s) and that the dates are consistent with the event.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2347852
    Was drug administered as a rescue medication?
    Description

    Rescue medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0884980
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    Similar models

    Concomitant Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject during the study?
    text
    C2347852 (UMLS CUI [1])
    Concomitant Medications
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Dose
    Item
    Dose
    float
    C3174092 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C2826646 (UMLS CUI [1])
    Frequency
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C2826730 (UMLS CUI [1])
    Date Started
    Item
    Date Started
    date
    C2826734 (UMLS CUI [1])
    Pre-study start
    Item
    Was medication started pre-study?
    boolean
    C2981448 (UMLS CUI [1])
    Date stopped
    Item
    Date stopped
    date
    C2826744 (UMLS CUI [1])
    Ongoing Medication
    Item
    Was medication continued post-study?
    boolean
    C2826666 (UMLS CUI [1])
    Conditions treated / Indication
    Item
    Conditions treated / Indication
    text
    C2826696 (UMLS CUI [1])
    Item
    Prophylaxis?
    text
    C0199176 (UMLS CUI [1])
    Prophylaxis
    Code List
    Prophylaxis?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Item
    Was drug administered for an adverse event?
    text
    C0877248 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant Medications
    Code List
    Was drug administered for an adverse event?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was drug administered as a rescue medication?
    text
    C0013227 (UMLS CUI [1,1])
    C0884980 (UMLS CUI [1,2])
    Concomitant Medications
    Code List
    Was drug administered as a rescue medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Back to the top of the page 

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