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31921

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 (2)
  1. 9/27/18 9/27/18 -
  2. 10/8/18 10/8/18 -
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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 105-040

    English

    Study Continuitation Record, Vital Signs/Weight,Physical Examination, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 26

    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
    Study Continuitation Record - Date of assessment
    Description

    Study Continuitation Record - Date of assessment

    Alias
    UMLS CUI-1
    C2348568
    UMLS CUI-2
    C2985720
    Date of assessment
    Description

    Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Study Continuitation Record - Eligibility Criteria
    Description

    Study Continuitation Record - Eligibility Criteria

    Alias
    UMLS CUI-1
    C2348568
    UMLS CUI-2
    C1516637
    Has this patient become menarcheal since the last clinic visit?
    Description

    Menarche; Visit; Last; Since

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025274
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1517741
    UMLS CUI [1,4]
    C1711239
    If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?
    Description

    If the answer is No, the patient will be withdrawn from the study.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0025274
    UMLS CUI [2]
    C0032961
    UMLS CUI [3]
    C0430061
    UMLS CUI [4]
    C0006147
    Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
    Description

    If the answer is No, the patient will be withdrawn from the study.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [2,1]
    C0700589
    UMLS CUI [2,2]
    C0699733
    UMLS CUI [3,1]
    C0700589
    UMLS CUI [3,2]
    C3843422
    Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
    Description

    In addition, all other appropriate person (e.g. parent or legal guardian, if not already obtained as part of the previous requirement, investigator and witness) must also sign this statement. If the answer is No, the patient will be withdrawn from the study.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1710187
    UMLS CUI [1,2]
    C1519316
    UMLS CUI [1,3]
    C0032961
    UMLS CUI [1,4]
    C0870186
    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
    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
    Laboratory - Date sample collected
    Description

    Laboratory - Date sample collected

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C1302413
    Date sample collected
    Description

    Specimen collection date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory finding
    Description

    Laboratory finding

    Alias
    UMLS CUI-1
    C0587081
    Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
    Description

    If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [1,3]
    C4055646
    Laboratory results that are of potential or actual clinical significance and unexpected
    Description

    Laboratory results that are of potential or actual clinical significance and unexpected

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C2826293
    UMLS CUI-3
    C4055646
    Laboratory parameter
    Description

    Laboratory; Parameter Value

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0549193
    Comment (Laboratory parameter)
    Description

    Comment | Laboratory; Parameter Value

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2,1]
    C0022877
    UMLS CUI [2,2]
    C0549193
    Clinical laboratory examination - Hematology
    Description

    Clinical laboratory examination - Hematology

    Alias
    UMLS CUI-1
    C0260877
    UMLS CUI-2
    C0205210
    UMLS CUI-3
    C0018943
    Hemoglobin
    Description

    Hemoglobin

    Data type

    text

    Alias
    UMLS CUI [1]
    C0019046
    MCV
    Description

    Erythrocyte Mean Corpuscular Volume Measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C1948043
    Quantitative platelet count
    Description

    Platelet Count measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032181
    WBC
    Description

    White Blood Cell Count procedure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023508
    Differential WBC
    Description

    Differential white blood cell count procedure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0162401
    Clinical laboratory examination - Clinical chemistry
    Description

    Clinical laboratory examination - Clinical chemistry

    Alias
    UMLS CUI-1
    C0260877
    UMLS CUI-2
    C0205210
    UMLS CUI-3
    C0008000
    Sodium
    Description

    Sodium measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0337443
    Potassium
    Description

    Potassium measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202194
    Bicarbonate
    Description

    Bicarbonate measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202059
    Creatinine
    Description

    Creatinine measurement, serum (procedure)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201976
    Total Bilirubin
    Description

    Bilirubin, total measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201913
    Alkaline Phosphatase
    Description

    Alkaline phosphatase measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201850
    AST (SGOT)
    Description

    Aspartate aminotransferase measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201899
    ALT (SGTP)
    Description

    Alanine aminotransferase measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201836
    Albumin
    Description

    Albumin measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201838
    Glucose
    Description

    Plasma Glucose Measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202042
    Dipstick Urinalysis
    Description

    Dipstick Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0430370
    Urine Protein
    Description

    Urine total protein measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0428541
    Urine Blood
    Description

    Urine dipstick for blood

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430372
    Serum pregnancy (for females of childbearing potential only)
    Description

    Serum pregnancy (for females of childbearing potential only)

    Alias
    UMLS CUI-1
    C0430060
    Serum pregnancy
    Description

    Serum pregnancy test (B-HCG)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430060
    AED plasma concentration
    Description

    AED plasma concentration

    Alias
    UMLS CUI-1
    C0683150
    UMLS CUI-2
    C0003299
    AED plasma concentration (trough)
    Description

    plasma concentration; Antiepileptic Agents; Trough

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0683150
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [1,3]
    C0444506
    Plasma Samples
    Description

    Plasma Samples

    Alias
    UMLS CUI-1
    C0444263
    Antiepileptic drug (trough)
    Description

    Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled AED dose, as close to the dose as is reasonably possible.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C0444506
    Study Medication (trough) - Date and Time sample drawn
    Description

    Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled anticipated study medication dose, as close to the dose as is reasonably possible.

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0444506
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0040223
    UMLS CUI [2,3]
    C0200345
    Last dose of study medication - Date and Time
    Description

    Experimental drug; Date last dose | Experimental drug; Time last dose

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1762893
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0946444
    Last dose of study medication - Amount
    Description

    Experimental drug; Dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    mg
    The Patient's Clinical Status
    Description

    The Patient's Clinical Status

    Alias
    UMLS CUI-1
    C0449440
    Date of assessment
    Description

    Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Clinical Status Finding
    Description

    Clinical Status Finding

    Alias
    UMLS CUI-1
    C0449440
    UMLS CUI-2
    C0243095
    Clinical factors
    Description

    Factor; Clinical

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1521761
    UMLS CUI [1,2]
    C0205210
    Clinical Status
    Description

    Clinical status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449440
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    Similar models

    Study Continuitation Record, Vital Signs/Weight,Physical Examination, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 26

    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
    Study Continuitation Record - Date of assessment
    C2348568 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Assessment Date
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Study Continuitation Record - Eligibility Criteria
    C2348568 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    Menarche; Visit; Last; Since
    Item
    Has this patient become menarcheal since the last clinic visit?
    boolean
    C0025274 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    C1711239 (UMLS CUI [1,4])
    Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
    Item
    If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?
    boolean
    C0025274 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    C0430061 (UMLS CUI [3])
    C0006147 (UMLS CUI [4])
    Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
    Item
    Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
    boolean
    C0700589 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [2,1])
    C0699733 (UMLS CUI [2,2])
    C0700589 (UMLS CUI [3,1])
    C3843422 (UMLS CUI [3,2])
    Statement; Signature; Pregnancy; avoidance
    Item
    Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
    boolean
    C1710187 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    C0032961 (UMLS CUI [1,3])
    C0870186 (UMLS CUI [1,4])
    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
    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)
    Item Group
    Laboratory - Date sample collected
    C0022877 (UMLS CUI-1)
    C1302413 (UMLS CUI-2)
    Specimen collection date
    Item
    Date sample collected
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Laboratory finding
    C0587081 (UMLS CUI-1)
    Laboratory Results; Clinical Significance; Unexpected
    Item
    Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
    boolean
    C1254595 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C4055646 (UMLS CUI [1,3])
    Item Group
    Laboratory results that are of potential or actual clinical significance and unexpected
    C1254595 (UMLS CUI-1)
    C2826293 (UMLS CUI-2)
    C4055646 (UMLS CUI-3)
    Laboratory; Parameter Value
    Item
    Laboratory parameter
    text
    C0022877 (UMLS CUI [1,1])
    C0549193 (UMLS CUI [1,2])
    Comment | Laboratory; Parameter Value
    Item
    Comment (Laboratory parameter)
    text
    C0947611 (UMLS CUI [1])
    C0022877 (UMLS CUI [2,1])
    C0549193 (UMLS CUI [2,2])
    Item Group
    Clinical laboratory examination - Hematology
    C0260877 (UMLS CUI-1)
    C0205210 (UMLS CUI-2)
    C0018943 (UMLS CUI-3)
    Hemoglobin
    Item
    Hemoglobin
    text
    C0019046 (UMLS CUI [1])
    Erythrocyte Mean Corpuscular Volume Measurement
    Item
    MCV
    text
    C1948043 (UMLS CUI [1])
    Platelet Count measurement
    Item
    Quantitative platelet count
    text
    C0032181 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    WBC
    text
    C0023508 (UMLS CUI [1])
    Differential white blood cell count procedure
    Item
    Differential WBC
    text
    C0162401 (UMLS CUI [1])
    Item Group
    Clinical laboratory examination - Clinical chemistry
    C0260877 (UMLS CUI-1)
    C0205210 (UMLS CUI-2)
    C0008000 (UMLS CUI-3)
    Sodium measurement
    Item
    Sodium
    text
    C0337443 (UMLS CUI [1])
    Potassium measurement
    Item
    Potassium
    text
    C0202194 (UMLS CUI [1])
    Bicarbonate measurement
    Item
    Bicarbonate
    text
    C0202059 (UMLS CUI [1])
    Creatinine measurement, serum (procedure)
    Item
    Creatinine
    text
    C0201976 (UMLS CUI [1])
    Bilirubin, total measurement
    Item
    Total Bilirubin
    text
    C0201913 (UMLS CUI [1])
    Alkaline phosphatase measurement
    Item
    Alkaline Phosphatase
    text
    C0201850 (UMLS CUI [1])
    Aspartate aminotransferase measurement
    Item
    AST (SGOT)
    text
    C0201899 (UMLS CUI [1])
    Alanine aminotransferase measurement
    Item
    ALT (SGTP)
    text
    C0201836 (UMLS CUI [1])
    Albumin measurement
    Item
    Albumin
    text
    C0201838 (UMLS CUI [1])
    Plasma Glucose Measurement
    Item
    Glucose
    text
    C0202042 (UMLS CUI [1])
    Item Group
    Dipstick Urinalysis
    C0042014 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Urine total protein measurement
    Item
    Urine Protein
    text
    C0428541 (UMLS CUI [1])
    Urine dipstick for blood
    Item
    Urine Blood
    text
    C0430372 (UMLS CUI [1])
    Item Group
    Serum pregnancy (for females of childbearing potential only)
    C0430060 (UMLS CUI-1)
    Serum pregnancy test (B-HCG)
    Item
    Serum pregnancy
    text
    C0430060 (UMLS CUI [1])
    Item Group
    AED plasma concentration
    C0683150 (UMLS CUI-1)
    C0003299 (UMLS CUI-2)
    plasma concentration; Antiepileptic Agents; Trough
    Item
    AED plasma concentration (trough)
    text
    C0683150 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0444506 (UMLS CUI [1,3])
    Item Group
    Plasma Samples
    C0444263 (UMLS CUI-1)
    Plasma specimen | Antiepileptic Agents; Trough
    Item
    Antiepileptic drug (trough)
    text
    C0003299 (UMLS CUI [1,1])
    C0444506 (UMLS CUI [1,2])
    Experimental drug; Trough | Date in time; Time; Specimen Collection
    Item
    Study Medication (trough) - Date and Time sample drawn
    datetime
    C0304229 (UMLS CUI [1,1])
    C0444506 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0040223 (UMLS CUI [2,2])
    C0200345 (UMLS CUI [2,3])
    Experimental drug; Date last dose | Experimental drug; Time last dose
    Item
    Last dose of study medication - Date and Time
    datetime
    C0304229 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [2,1])
    C0946444 (UMLS CUI [2,2])
    Experimental drug; Dosage
    Item
    Last dose of study medication - Amount
    float
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Item Group
    The Patient's Clinical Status
    C0449440 (UMLS CUI-1)
    Assessment Date
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Clinical Status Finding
    C0449440 (UMLS CUI-1)
    C0243095 (UMLS CUI-2)
    Item
    Clinical factors
    integer
    C1521761 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    undefined item
    Code List
    Clinical factors
    CL Item
    Seizure frequency (1)
    (Comment:en)
    CL Item
    Seizure duration (2)
    (Comment:en)
    CL Item
    Seizure intensity (3)
    (Comment:en)
    CL Item
    Adverse Experiences (4)
    (Comment:en)
    CL Item
    Patient's perception of his/ her well- being (5)
    (Comment:en)
    CL Item
    Social functioning (6)
    (Comment:en)
    CL Item
    Intellectual functioning (7)
    (Comment:en)
    CL Item
    Motor functioning (8)
    (Comment:en)
    CL Item
    Overall Status (9)
    (Comment:en)
    Item
    Clinical Status
    integer
    C0449440 (UMLS CUI [1])
    Clinical status
    Code List
    Clinical Status
    CL Item
    Marked deterioration (1)
    CL Item
    Moderate deterioration (2)
    CL Item
    Mild deterioration (3)
    CL Item
    No change (4)
    CL Item
    Mild improvement (5)
    CL Item
    Moderate improvement (6)
    CL Item
    Marked improvement (7)
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