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ID

29790

Beskrivning

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 15 - Visit 13: 7-Day Follow-up.

Länk

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

Nyckelord

Versioner (1)
  1. 2018-04-19 2018-04-19 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 april 2018

DOI

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Licens

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

    Engelsk

    Week 15 - Visit 13: 7-Day Follow-up

    1 Formulär  
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beskrivning

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

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0518766
    Subject Position
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1262869
    UMLS CUI [1,2]
    C0518766
    Systolic Blood Pressure
    Beskrivning

    Systolic Blood Pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Beskrivning

    Diastolic Blood Pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Pregnancy Test
    Beskrivning

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0430056
    Is pregnancy test applicable?
    Beskrivning

    Pregnancy Test applicable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1706839
    If pregnancy test is applicable, was it performed?
    Beskrivning

    Pregnancy test performed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0884358
    If a pregnancy test was performed, pick a result.
    Beskrivning

    If positive, complete PREGNANCY NOTIFICATION FORM.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Pharmacokinetic Sampling
    Beskrivning

    Pharmacokinetic Sampling

    Sampling Date
    Beskrivning

    Sample No.: BLD007

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0201734
    Sampling TIme
    Beskrivning

    Sampling Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0201734
    Blood Sample taken?
    Beskrivning

    Sample No.: BLD007

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0201734
    Atypical Antipsychotic Dosing
    Beskrivning

    Atypical Antipsychotic Dosing

    Alias
    UMLS CUI-1
    C0040615
    UMLS CUI-2
    C0205182
    UMLS CUI-3
    C0178602
    Drug Name
    Beskrivning

    Drug Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C1276996
    Was this atypical antipsychotic medication taken?
    Beskrivning

    Taking

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C1276996
    Date dose taken
    Beskrivning

    Date dose taken

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1276996
    Time dose taken
    Beskrivning

    Time dose taken

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1276996
    Tillbaka till toppen

    Similar models

    Week 15 - Visit 13: 7-Day Follow-up

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Pregnancy Test
    C0430056 (UMLS CUI-1)
    Pregnancy Test applicable
    Item
    Is pregnancy test applicable?
    boolean
    C0032976 (UMLS CUI [1,1])
    C1706839 (UMLS CUI [1,2])
    Pregnancy test performed
    Item
    If pregnancy test is applicable, was it performed?
    boolean
    C0032976 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Item
    If a pregnancy test was performed, pick a result.
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy Test Results
    Code List
    If a pregnancy test was performed, pick a result.
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    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])
    Tillbaka till toppen 

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