0 Evaluaciones
ID

29783

Descripción

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 4 - Visit 6.

Link

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

Palabras clave

Versiones (1)
  1. 19/4/18 19/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

    Inglés

    Week 4 - Visit 6

    1 formularios  
    1. StudyEvent: ODM
      1. Week 4 - Visit 6
    Vital Signs
    Descripción

    Vital Signs

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

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

    Tipo de datos

    date

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

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

    Tipo de datos

    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
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Psychiatric Evaluation
    Descripción

    Psychiatric Evaluation

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

    Positive and Negative Syndrome Scale (PANSS)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0451383 (Positive and negative syndrome scale)
    SNOMED
    273703003
    Total score of "Scale for the Assessment of Negative Symptoms"
    Descripción

    5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C4511599 (Negative symptoms co-occurrent and due to primary psychotic disorder)
    SNOMED
    724756001
    UMLS CUI [1,2]
    C0681889 (rating scale)
    UMLS CUI [1,3]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    Score of "Calgary Depression Scale for Schizophrenia"
    Descripción

    Calgary Depression Scale for Schizophrenia (CDSS)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0679604 (depression scale)
    UMLS CUI [1,2]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Descripción

    Clinicians Global Impressions - Severity (CGI-S)

    Tipo de datos

    integer

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

    Clinicians Global Impressions - Improvement (CGI-I)

    Tipo de datos

    integer

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

    Simpson Angus Scale

    Tipo de datos

    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"
    Descripción

    The Barnes Akathisia Scale

    Tipo de datos

    integer

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

    Abnormal Involuntary Movement Scale (AIMS)

    Tipo de datos

    integer

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

    Pharmacokinetic Sampling

    Sampling Date
    Descripción

    Sample No.: BLD003

    Tipo de datos

    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
    Descripción

    Sampling Time

    Tipo de datos

    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?
    Descripción

    Sample No.: BLD003

    Tipo de datos

    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
    Descripción

    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
    Descripción

    Drug Name

    Tipo de datos

    text

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

    Taking

    Tipo de datos

    boolean

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

    Date dose taken

    Tipo de datos

    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
    Descripción

    Time dose taken

    Tipo de datos

    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
    Descripción

    Investigational Product dosing

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

    Planned relative Time: Day before Clinic Visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time dose taken
    Descripción

    Time dose taken

    Tipo de datos

    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
    Volver a la parte superior de la página

    Similar models

    Week 4 - Visit 6

    1 formularios
    1. StudyEvent: ODM
      1. Week 4 - Visit 6
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Scale for the Assessment of Negative Symptoms (SANS)
    Item
    Total score of "Scale for the Assessment of Negative Symptoms"
    integer
    C4511599 (UMLS CUI [1,1])
    C0681889 (UMLS CUI [1,2])
    C0036341 (UMLS CUI [1,3])
    Calgary Depression Scale for Schizophrenia (CDSS)
    Item
    Score of "Calgary Depression Scale for Schizophrenia"
    integer
    C0679604 (UMLS CUI [1,1])
    C0036341 (UMLS CUI [1,2])
    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])
    C0304229 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial