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ID

44094

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 Week 14 - Visit 12: End of Down Titration.

Link

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

Keywords

Versions (2)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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

    Week 14 - Visit 12: End of Down Titration

    1 forms  
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

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

    Data type

    date

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

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

    Data type

    integer

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

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Hair and skin
    Description

    Hair and skin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018494
    UMLS CUI [1,2]
    C0558035
    Hair and Skin: If Abnormal, please specify
    Description

    Hair and Skin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018494
    UMLS CUI [1,2]
    C0558035
    UMLS CUI [1,3]
    C1704258
    Lymph nodes
    Description

    Lymph nodes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024204
    Lymph nodes: If Abnormal, please specify
    Description

    Lymph nodes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024204
    UMLS CUI [1,3]
    C1704258
    Eyes
    Description

    Eyes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0200149
    Eyes: If Abnormal, please specify
    Description

    Eyes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0200149
    UMLS CUI [1,3]
    C1704258
    Ears, Nose and Throat
    Description

    Ears, Nose and Throat

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278350
    Ears, Nose and Throat: If Abnormal, please specify
    Description

    Ears, Nose and Throat

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278350
    UMLS CUI [1,3]
    C1704258
    Breasts
    Description

    Breasts

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199850
    Breasts: If Abnormal, please specify
    Description

    Breasts

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199850
    UMLS CUI [1,3]
    C1704258
    Respiratory
    Description

    Respiratory

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0436121
    Respiratory: If Abnormal, please specify
    Description

    Respiratory

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0436121
    UMLS CUI [1,3]
    C1704258
    Cardiovascular
    Description

    Cardiovascular

    Data type

    text

    Alias
    UMLS CUI [1]
    C3854344
    Cardiovascular: If Abnormal, please specify
    Description

    Cardiovascular

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3854344
    UMLS CUI [1,2]
    C1704258
    Abdomen
    Description

    Abdomen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Abdomen: If Abnormal, please specify
    Description

    Abdomen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C1704258
    Urogenital
    Description

    Urogenital

    Data type

    text

    Alias
    UMLS CUI [1]
    C1828035
    Urogenital: If abnormal, please specify
    Description

    Urogenital

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1828035
    UMLS CUI [1,2]
    C1704258
    Pelvic
    Description

    Pelvic

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200045
    Pelvic: If Abnormal, please specify
    Description

    Pelvic

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200045
    UMLS CUI [1,2]
    C1704258
    Rectal
    Description

    Rectal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199900
    Rectal: If abnormal, please specify
    Description

    Rectal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0199900
    UMLS CUI [1,2]
    C1704258
    Musculoskeletal
    Description

    Musculoskeletal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0475091
    Musculoskeletal: If Abnormal, please specify
    Description

    Musculoskeletal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0475091
    UMLS CUI [1,2]
    C1704258
    Neurological
    Description

    Neurological

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027853
    Neurological: If Abnormal, please specify
    Description

    Neurological

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027853
    UMLS CUI [1,2]
    C1704258
    Mental status
    Description

    Mental status

    Data type

    text

    Alias
    UMLS CUI [1]
    C3260990
    Mental Status: If Abnormal, please specify
    Description

    Mental Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3260990
    UMLS CUI [1,2]
    C1704258
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    Similar models

    Week 14 - Visit 12: End of Down Titration

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Hair and skin
    text
    C0018494 (UMLS CUI [1,1])
    C0558035 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Hair and skin
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Hair and Skin
    Item
    Hair and Skin: If Abnormal, please specify
    text
    C0018494 (UMLS CUI [1,1])
    C0558035 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Lymph nodes
    text
    C0031809 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Lymph nodes
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Lymph nodes
    Item
    Lymph nodes: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Eyes
    text
    C0031809 (UMLS CUI [1,1])
    C0200149 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Eyes
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Eyes
    Item
    Eyes: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0200149 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Ears, Nose and Throat
    text
    C0031809 (UMLS CUI [1,1])
    C0278350 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Ears, Nose and Throat
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Ears, Nose and Throat
    Item
    Ears, Nose and Throat: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0278350 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Breasts
    text
    C0031809 (UMLS CUI [1,1])
    C0199850 (UMLS CUI [1,2])
    Breasts
    Code List
    Breasts
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Breasts
    Item
    Breasts: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0199850 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Respiratory
    text
    C0031809 (UMLS CUI [1,1])
    C0436121 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Respiratory
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Respiratory
    Item
    Respiratory: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0436121 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Cardiovascular
    text
    C3854344 (UMLS CUI [1])
    Hair and skin
    Code List
    Cardiovascular
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Cardiovascular
    Item
    Cardiovascular: If Abnormal, please specify
    text
    C3854344 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Hair and skin
    Code List
    Abdomen
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Abdomen
    Item
    Abdomen: If Abnormal, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item
    Urogenital
    text
    C1828035 (UMLS CUI [1])
    Urogenital
    Code List
    Urogenital
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Urogenital
    Item
    Urogenital: If abnormal, please specify
    text
    C1828035 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Pelvic
    text
    C0200045 (UMLS CUI [1])
    Breasts
    Code List
    Pelvic
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Pelvic
    Item
    Pelvic: If Abnormal, please specify
    text
    C0200045 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Rectal
    text
    C0199900 (UMLS CUI [1])
    Breasts
    Code List
    Rectal
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Rectal
    Item
    Rectal: If abnormal, please specify
    text
    C0199900 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Musculoskeletal
    text
    C0475091 (UMLS CUI [1])
    Lymph nodes
    Code List
    Musculoskeletal
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Musculoskeletal
    Item
    Musculoskeletal: If Abnormal, please specify
    text
    C0475091 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Neurological
    text
    C0027853 (UMLS CUI [1])
    Hair and skin
    Code List
    Neurological
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Neurological
    Item
    Neurological: If Abnormal, please specify
    text
    C0027853 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item
    Mental status
    text
    C3260990 (UMLS CUI [1])
    Hair and skin
    Code List
    Mental status
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Mental Status
    Item
    Mental Status: If Abnormal, please specify
    text
    C3260990 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
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