0 Beoordelingen
ID

29786

Beschrijving

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 Week 8 - Visit 9.

Link

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

Trefwoorden

Versies (1)
  1. 19-04-18 19-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 april 2018

DOI

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Licentie

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

    Engels

    Week 8 - Visit 9

    1 Formulieren  
    1. StudyEvent: ODM
      1. Week 8 - Visit 9
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Date
    Beschrijving

    If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Subject Position
    Beschrijving

    Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1262869 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Systolic Blood Pressure
    Beschrijving

    Systolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Beschrijving

    Diastolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Psychiatric Evaluation
    Beschrijving

    Psychiatric Evaluation

    Alias
    UMLS CUI-1
    C0846574 (Psychiatric evaluation)
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    Beschrijving

    Positive and Negative Syndrome Scale (PANSS)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0451383 (Positive and negative syndrome scale)
    SNOMED
    273703003
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Beschrijving

    Clinicians Global Impressions - Severity (CGI-S)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3639887 (CGI - Severity of Illness)
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    Beschrijving

    Clinicians Global Impressions - Improvement (CGI-I)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3639888 (CGI - Global Improvement)
    Score of "Simpson Angus Scale"
    Beschrijving

    Simpson Angus Scale

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0681889 (rating scale)
    UMLS CUI [1,2]
    C0041755 (Adverse reaction to drug)
    SNOMED
    62014003
    LOINC
    LA7429-9
    UMLS CUI [1,3]
    C0015371 (Extrapyramidal Disorders)
    SNOMED
    76349003
    Score of "Barnes Akathisia Scale"
    Beschrijving

    The Barnes Akathisia Scale

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3541345 (Barnes Akathisia Rating Scale Questionnaire)
    Score of "Abnormal Involuntary Movement Scale"
    Beschrijving

    Abnormal Involuntary Movement Scale (AIMS)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0450978 (Abnormal Involuntary Movement Scale)
    SNOMED
    273256000
    Pharmacokinetic Sampling
    Beschrijving

    Pharmacokinetic Sampling

    Sampling Date
    Beschrijving

    Sample No.: BLD004

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Sampling TIme
    Beschrijving

    Sampling Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Blood Sample taken?
    Beschrijving

    Sample No.: BLD004

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Atypical Antipsychotic Dosing
    Beschrijving

    Atypical Antipsychotic Dosing

    Alias
    UMLS CUI-1
    C0040615 (Antipsychotic Agents)
    SNOMED
    10784006
    LOINC
    LP18073-4
    UMLS CUI-2
    C0205182 (Atypical)
    SNOMED
    112231000
    LOINC
    LA13702-8
    UMLS CUI-3
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Drug Name
    Beschrijving

    Drug Name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,2]
    C1276996 (Atypical antipsychotic)
    Was this atypical antipsychotic medication taken?
    Beschrijving

    Taking

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    UMLS CUI [1,2]
    C1276996 (Atypical antipsychotic)
    Date dose taken
    Beschrijving

    Date dose taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1276996 (Atypical antipsychotic)
    Time dose taken
    Beschrijving

    Time dose taken

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1276996 (Atypical antipsychotic)
    Investigational Product Dosing
    Beschrijving

    Investigational Product Dosing

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0678766 (Drug dose)
    SNOMED
    398232005
    Date dose taken
    Beschrijving

    Planned relative Time: Day before Clinic Visit

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Time dose taken
    Beschrijving

    Time dose taken

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Terug naar het begin van de pagina

    Similar models

    Week 8 - Visit 9

    1 Formulieren
    1. StudyEvent: ODM
      1. Week 8 - Visit 9
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Item
    Subject Position
    integer
    C1262869 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Subject Position
    Code List
    Subject Position
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Psychiatric Evaluation
    C0846574 (UMLS CUI-1)
    Positive and Negative Syndrome Scale (PANSS)
    Item
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    integer
    C0451383 (UMLS CUI [1])
    Clinicians Global Impressions - Severity (CGI-S)
    Item
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    integer
    C3639887 (UMLS CUI [1])
    Clinicians Global Impressions - Improvement (CGI-I)
    Item
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    integer
    C3639888 (UMLS CUI [1])
    Simpson Angus Scale
    Item
    Score of "Simpson Angus Scale"
    integer
    C0681889 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    C0015371 (UMLS CUI [1,3])
    The Barnes Akathisia Scale
    Item
    Score of "Barnes Akathisia Scale"
    integer
    C3541345 (UMLS CUI [1])
    Abnormal Involuntary Movement Scale (AIMS)
    Item
    Score of "Abnormal Involuntary Movement Scale"
    integer
    C0450978 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Sampling
    Sampling Date
    Item
    Sampling Date
    date
    C0178913 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    Sampling Time
    Item
    Sampling TIme
    time
    C0040223 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    Blood Sample
    Item
    Blood Sample taken?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
    Item Group
    Atypical Antipsychotic Dosing
    C0040615 (UMLS CUI-1)
    C0205182 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C1276996 (UMLS CUI [1,2])
    Drug Name
    Code List
    Drug Name
    CL Item
    Abilify (aripiprazole) (Abilify (aripiprazole))
    CL Item
    Clozaril (clozapine) (Clozaril (clozapine))
    CL Item
    Geodon (ziprasidone) (Geodon (ziprasidone))
    CL Item
    Risperdal (risperidone) (Risperdal (risperidone))
    CL Item
    Seroquel (quetiapine fumarate) (Seroquel (quetiapine fumarate))
    CL Item
    Zyprexa/Zydis (olanzapine) (Zyprexa/Zydis (olanzapine))
    Taking
    Item
    Was this atypical antipsychotic medication taken?
    boolean
    C1290952 (UMLS CUI [1,1])
    C1276996 (UMLS CUI [1,2])
    Date dose taken
    Item
    Date dose taken
    date
    C0011008 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1276996 (UMLS CUI [1,3])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1276996 (UMLS CUI [1,3])
    Item Group
    Investigational Product Dosing
    C0304229 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    Date dose taken
    Item
    Date dose taken
    date
    C0011008 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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