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31919

Description

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Keywords

Versions (4)
  1. 9/30/18 9/30/18 -
  2. 9/30/18 9/30/18 -
  3. 10/8/18 10/8/18 -
  4. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

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October 8, 2018

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Creative Commons BY-NC 3.0
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    Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Clinical Study ID: 105-040

    English

    Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site number
    Description

    Study Site; Numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Patient's initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient's trial number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Examination (Vital Signs/ Weight, Physical Examination)
    Description

    Date of Examination (Vital Signs/ Weight, Physical Examination)

    Alias
    UMLS CUI-1
    C2826643
    Date of Examination (Vital Signs/ Weight, Physical Examination)
    Description

    Physical Examination Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Vital Signs/ Weight
    Description

    Vital Signs/ Weight

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-3
    C0005910
    Blood pressure (systolic/ diastolic)
    Description

    Blood Pressure

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse rate
    Description

    Pulse Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Weight
    Description

    Body Weight

    Data type

    float

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

    Height

    Alias
    UMLS CUI-1
    C0005890
    Hieght or lenght (if applicable)
    Description

    Body Height; Length

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    UMLS CUI [2]
    C1444754
    cm
    Method of collection
    Description

    Collection (action); Evaluation Method

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516698
    UMLS CUI [1,2]
    C2911685
    Physical Examination - Changes
    Description

    Physical Examination - Changes

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0392747
    Are there any clinically significant changes from the Baseline Phase (Study Week 8) information? If Yes, list changes below.
    Description

    Changing; Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392747
    UMLS CUI [1,2]
    C2826293
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Body region/ system
    Description

    body system

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0460002
    If other body region/ system, specify
    Description

    body system; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0460002
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Briefly specify change
    Description

    Changing; Specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392747
    UMLS CUI [1,2]
    C2348235
    Neurological Examination - Date and Finding
    Description

    Neurological Examination - Date and Finding

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C0011008
    UMLS CUI-3
    C0437208
    Date of examination
    Description

    Neurologic Examination; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027853
    UMLS CUI [1,2]
    C0011008
    Exam- either normal OR abnormalities present
    Description

    Neurological examination normal | On examination - neurological findings

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1112287
    UMLS CUI [2]
    C0437208
    Neurological Examination abnormalities - Mental status
    Description

    Neurological Examination abnormalities - Mental status

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0278060
    Mental status abnormalities
    Description

    Abnormality; Mental state

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0278060
    If other abnormal mental status, specify.
    Description

    Abnormality; Mental state; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0278060
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Check if mental status changed or appeared.
    Description

    Abnormality; Mental state

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0278060
    Intensity of abnormality (mental status)
    Description

    Abnormality; Severities | Mental state (observable entity)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [2]
    C0278060
    Neurological Examination abnormalities - Speech/ language
    Description

    Neurological Examination abnormalities - Speech/ language

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0564649
    Speech/ language abnormalities
    Description

    Speech Disorders | Languages; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0037822
    UMLS CUI [2,1]
    C0023008
    UMLS CUI [2,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Speech | Abnormality; Languages

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0037817
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C0023008
    Intensity of abnormality (speech/ language)
    Description

    Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0037817
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C0439793
    UMLS CUI [2,3]
    C0023008
    Neurological Examination abnormalities - Cranial nerves
    Description

    Neurological Examination abnormalities - Cranial nerves

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-4
    C0010268
    Cranial nerves abnormalities
    Description

    Cranial Nerves; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0010268
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Cranial Nerves

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0010268
    Intensity of abnormality (cranial nerves)
    Description

    Abnormality; Severities; Cranial Nerves

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0010268
    If other abnormality of cranial nerves, specify.
    Description

    Abnormality; Cranial Nerves; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0010268
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Neurological Examination abnormalities - Gait
    Description

    Neurological Examination abnormalities - Gait

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0016928
    Gait abnormalities
    Description

    Gait; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0016928
    UMLS CUI [1,2]
    C1704258
    Check ifabnormality changed or appeared.
    Description

    Abnormality; Gait

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0016928
    Intensity of abnormality (gait)
    Description

    Abnormality; Severities; Gait

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0016928
    Neurological Examination abnormalities - Coordination
    Description

    Neurological Examination abnormalities - Coordination

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0242414
    Coordination abnormalities
    Description

    Physiologic Coordination; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0242414
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Physiologic Coordination

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0242414
    Intensity of abnormality (coordination)
    Description

    Abnormality; Severities; Physiologic Coordination

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0242414
    Neurological Examination abnormalities - Sensation
    Description

    Neurological Examination abnormalities - Sensation

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0036658
    Sensation abnormalities
    Description

    Esthesia; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036658
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Esthesia

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0036658
    Intensity of abnormality (sensation)
    Description

    Abnormality; Severities; Esthesia

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0036658
    Neurological Examination abnormalities - Muscle strength
    Description

    Neurological Examination abnormalities - Muscle strength

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0517349
    Muscle strength abnormalities
    Description

    Muscle Strength; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0517349
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Muscle Strength

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0517349
    Intensity of abnormality (muscle strength)
    Description

    Abnormality; Severities; Muscle Strength

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0517349
    Neurological Examination abnormalities - Muscle tone
    Description

    Neurological Examination abnormalities - Muscle tone

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0026841
    Muscle tone abnormalities
    Description

    Muscle Tonus; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0026841
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Muscle Tonus

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0026841
    Intensity of abnormality (muscle tone)
    Description

    Abnormality; Severities; Muscle Tonus

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0439793
    UMLS CUI [1,3]
    C0026841
    Neurological Examination abnormalities - Reflexes
    Description

    Neurological Examination abnormalities - Reflexes

    Alias
    UMLS CUI-1
    C0027853
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0034929
    Reflexes abnormalities
    Description

    Reflex action; Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034929
    UMLS CUI [1,2]
    C1704258
    Check if abnormality changed or appeared.
    Description

    Abnormality; Reflex action

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0034929
    Type of abnormality (reflexes)
    Description

    Abnormality; Type - attribute; Reflex action

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C0034929
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    Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Site; Numbers
    Item
    Site number
    text
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Person Initials
    Item
    Patient's initials
    text
    C2986440 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Patient's trial number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Date of Examination (Vital Signs/ Weight, Physical Examination)
    C2826643 (UMLS CUI-1)
    Physical Examination Date
    Item
    Date of Examination (Vital Signs/ Weight, Physical Examination)
    date
    C2826643 (UMLS CUI [1])
    Item Group
    Vital Signs/ Weight
    C0518766 (UMLS CUI-1)
    C0005910 (UMLS CUI-3)
    Blood Pressure
    Item
    Blood pressure (systolic/ diastolic)
    text
    C0005823 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse rate
    integer
    C0232117 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Height
    C0005890 (UMLS CUI-1)
    Body Height; Length
    Item
    Hieght or lenght (if applicable)
    float
    C0005890 (UMLS CUI [1])
    C1444754 (UMLS CUI [2])
    Item
    Method of collection
    integer
    C1516698 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Collection (action); Evaluation Method
    Code List
    Method of collection
    CL Item
    Height (1)
    CL Item
    Length (2)
    Item Group
    Physical Examination - Changes
    C0031809 (UMLS CUI-1)
    C0392747 (UMLS CUI-2)
    Changing; Clinical Significance
    Item
    Are there any clinically significant changes from the Baseline Phase (Study Week 8) information? If Yes, list changes below.
    boolean
    C0392747 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    Item
    Body region/ system
    integer
    C0460002 (UMLS CUI [1])
    body system
    Code List
    Body region/ system
    CL Item
    Eyes (1)
    CL Item
    Ears, nose, throat (2)
    CL Item
    Cardiovascular (3)
    CL Item
    Pulmonary (4)
    CL Item
    Abdomen (5)
    CL Item
    Lymph nodes (6)
    CL Item
    Extremities (7)
    CL Item
    Skin (8)
    CL Item
    Musculoskeletal (9)
    CL Item
    Other, specify (10)
    body system; Other; Specification
    Item
    If other body region/ system, specify
    text
    C0460002 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Briefly specify change
    integer
    C0392747 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Finding
    Code List
    Briefly specify change
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examinated (3)
    Item Group
    Neurological Examination - Date and Finding
    C0027853 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    C0437208 (UMLS CUI-3)
    Neurologic Examination; Date in time
    Item
    Date of examination
    date
    C0027853 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Exam- either normal OR abnormalities present
    integer
    C1112287 (UMLS CUI [1])
    C0437208 (UMLS CUI [2])
    undefined item
    Code List
    Exam- either normal OR abnormalities present
    CL Item
    Nromal (1)
    CL Item
    Abnormalities present (2)
    Item Group
    Neurological Examination abnormalities - Mental status
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0278060 (UMLS CUI-3)
    Item
    Mental status abnormalities
    integer
    C1704258 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Abnormality
    Code List
    Mental status abnormalities
    CL Item
    Decreased attention (e.g. decreased consentration, poor/ short attention span) (1)
    CL Item
    Psychomotor slowing or retardation (developmental delay) (2)
    CL Item
    Somnolence (e.g. sedation, drowsiness, lethargy, sleepiness) (3)
    CL Item
    Depressed affect (4)
    CL Item
    Inapropriate affect (5)
    CL Item
    Hyperactivity (6)
    CL Item
    Behavioral discontrol (7)
    CL Item
    Other, specify (8)
    Abnormality; Mental state; Other; Specification
    Item
    If other abnormal mental status, specify.
    text
    C1704258 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Check if mental status changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    undefined item
    Code List
    Check if mental status changed or appeared.
    CL Item
    Abnormal (1)
    Item
    Intensity of abnormality (mental status)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0278060 (UMLS CUI [2])
    undefined item
    Code List
    Intensity of abnormality (mental status)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Speech/ language
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0564649 (UMLS CUI-3)
    Item
    Speech/ language abnormalities
    integer
    C0037822 (UMLS CUI [1])
    C0023008 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    undefined item
    Code List
    Speech/ language abnormalities
    CL Item
    Dysarthria (1)
    CL Item
    Dysphasia or aphasia (2)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0037817 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [2,1])
    C0023008 (UMLS CUI [2,2])
    Abnormality;
    Code List
    Check if abnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (speech/ language)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0037817 (UMLS CUI [1,3])
    C1704258 (UMLS CUI [2,1])
    C0439793 (UMLS CUI [2,2])
    C0023008 (UMLS CUI [2,3])
    Abnormality; Severities |
    Code List
    Intensity of abnormality (speech/ language)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Cranial nerves
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0010268 (UMLS CUI-4)
    Item
    Cranial nerves abnormalities
    integer
    C0010268 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Cranial Nerves; Abnormality
    Code List
    Cranial nerves abnormalities
    CL Item
    Nystagmus on lateral gaze (horizontal) (1)
    CL Item
    Other, specify (2)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0010268 (UMLS CUI [1,2])
    undefined item
    Code List
    Check if abnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (cranial nerves)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0010268 (UMLS CUI [1,3])
    Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
    Code List
    Intensity of abnormality (cranial nerves)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Abnormality; Cranial Nerves; Other; Specification
    Item
    If other abnormality of cranial nerves, specify.
    text
    C1704258 (UMLS CUI [1,1])
    C0010268 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Neurological Examination abnormalities - Gait
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0016928 (UMLS CUI-3)
    Item
    Gait abnormalities
    integer
    C0016928 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Gait; Abnormality
    Code List
    Gait abnormalities
    CL Item
    Ataxia gait (1)
    CL Item
    Hemiplegic gait (2)
    CL Item
    Spasticity, bilateral (3)
    CL Item
    Other gait disturbance (4)
    Item
    Check ifabnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0016928 (UMLS CUI [1,2])
    Abnormality; Gait
    Code List
    Check ifabnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (gait)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0016928 (UMLS CUI [1,3])
    undefined item
    Code List
    Intensity of abnormality (gait)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Coordination
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0242414 (UMLS CUI-3)
    Item
    Coordination abnormalities
    integer
    C0242414 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    undefined item
    Code List
    Coordination abnormalities
    CL Item
    Resting tremor (1)
    CL Item
    Intention tremor (2)
    CL Item
    Postural tremor (3)
    CL Item
    Dysdiadochokinesia (on rapid alt. movements) (4)
    CL Item
    Dysmetria (5)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0242414 (UMLS CUI [1,2])
    undefined item
    Code List
    Check if abnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (coordination)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0242414 (UMLS CUI [1,3])
    Abnormality; Severities; Physiologic Coordination
    Code List
    Intensity of abnormality (coordination)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Sensation
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0036658 (UMLS CUI-3)
    Item
    Sensation abnormalities
    integer
    C0036658 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Esthesia; Abnormality
    Code List
    Sensation abnormalities
    CL Item
    Pain (1)
    CL Item
    Light touch (2)
    CL Item
    Position (3)
    CL Item
    Vibration (4)
    CL Item
    Romberg positive (5)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0036658 (UMLS CUI [1,2])
    Abnormality; Esthesia
    Code List
    Check if abnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (sensation)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0036658 (UMLS CUI [1,3])
    undefined item
    Code List
    Intensity of abnormality (sensation)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Muscle strength
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0517349 (UMLS CUI-3)
    Item
    Muscle strength abnormalities
    integer
    C0517349 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Muscle Strength; Abnormality
    Code List
    Muscle strength abnormalities
    CL Item
    Decreased muscle strength (1)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0517349 (UMLS CUI [1,2])
    Abnormality; Muscle Strength
    Code List
    Check if abnormality changed or appeared.
    CL Item
    abnormality changed or appeared (1)
    Item
    Intensity of abnormality (muscle strength)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0517349 (UMLS CUI [1,3])
    Abnormality; Severities; Muscle Strength
    Code List
    Intensity of abnormality (muscle strength)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Muscle tone
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0026841 (UMLS CUI-3)
    Item
    Muscle tone abnormalities
    integer
    C0026841 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Muscle Tonus; Abnormality
    Code List
    Muscle tone abnormalities
    CL Item
    Hypertonia (1)
    CL Item
    Hypotonia (2)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0026841 (UMLS CUI [1,2])
    Abnormality; Muscle Tonus
    Code List
    Check if abnormality changed or appeared.
    CL Item
    Abnormality changed or appeared (1)
    Item
    Intensity of abnormality (muscle tone)
    integer
    C1704258 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    C0026841 (UMLS CUI [1,3])
    Abnormality; Severities; Muscle Tonus
    Code List
    Intensity of abnormality (muscle tone)
    CL Item
    Mild  (1)
    CL Item
    Moderate  (2)
    CL Item
    Severe (3)
    CL Item
    NA, abnormality has resolved (4)
    Item Group
    Neurological Examination abnormalities - Reflexes
    C0027853 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0034929 (UMLS CUI-3)
    Item
    Reflexes abnormalities
    integer
    C0034929 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Reflex action; Abnormality
    Code List
    Reflexes abnormalities
    CL Item
    Biceps left (1)
    CL Item
    Biceps right (2)
    CL Item
    Brachioradialis left (3)
    CL Item
    Brachioradialis right (4)
    CL Item
    Knee left (5)
    CL Item
    Knee right (6)
    CL Item
    Ankle left (7)
    CL Item
    Ankle right (8)
    CL Item
    Plantar response left (9)
    CL Item
    Plantar response right (10)
    Item
    Check if abnormality changed or appeared.
    integer
    C1704258 (UMLS CUI [1,1])
    C0034929 (UMLS CUI [1,2])
    Abnormality; Reflex action
    Code List
    Check if abnormality changed or appeared.
    CL Item
    Abnormality changed or appeared (1)
    Item
    Type of abnormality (reflexes)
    integer
    C1704258 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C0034929 (UMLS CUI [1,3])
    Abnormality; Type - attribute; Reflex action
    Code List
    Type of abnormality (reflexes)
    CL Item
    Absent (1)
    CL Item
    Decreased (2)
    CL Item
    Increased (3)
    CL Item
    Clonus (4)
    CL Item
    NA, abnormality has resolved (5)
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