ID

31947

Descrição

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

Palavras-chave

Neurologic Examination

Pediatrics

Electroencephalography

Titular dos direitos

GlaxoSmithKline

Transferido a

October 8, 2018

DOI

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Licença

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

model
Detalhes

AED History, current AED Information, Vital Signs/ Physical Examination, Neurological Examination and Electroencephalogram - Screen

1 Formulários

StudyEvent: ODM
1. AED History, current AED Information, Vital Signs/ Physical Examination, Neurological Examination and Electroencephalogram - Screen

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative documentation

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])

Assessment Date

Item

Date of assessment

date

C2985720 (UMLS CUI [1])

Antiepileptic Agents; Medical History

Item Group

Antiepileptic drugs history

C0003299 (UMLS CUI-1)
C0262926 (UMLS CUI-2)

Antiepileptic Agents | C0013230 Investigational New Drugs; C2828389 Exclusion

Item

Antiepileptic drugs - Excluding investigational drugs

text

C0003299 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])

Indication of (contextual qualifier); Discontinuation (procedure)

Item

Reason for discontinuation

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])

undefined item

Code List

Reason for discontinuation

CL Item

Ineffectiveness (1)

CL Item

Adverse reaction (2)

CL Item

Other (3)

Adverse event; Specification

Item

Specify adverse reaction

text

C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Indication of (contextual qualifier); Discontinuation (procedure); Other; Specification

Item

If other reason for discontinuation, specify.

text

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Antiepileptic Agents; Current (present time); Information

Item Group

Current antiepileptic drugs information

C0003299 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
C1533716 (UMLS CUI-3)

Antiepileptic Agents

Item

Antiepileptic drug

text

C0003299 (UMLS CUI [1])

Length; Antiepileptic Agents; Duration (temporal concept)

Item

Length of time on drug

float

C1444754 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])

Vital signs | Body Weight

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])

Body Height

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])

Collection (action); Evaluation Method

Item

Method of collection

integer

C1516698 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])

undefined item

Code List

Method of collection

CL Item

Height (1)

CL Item

Length (2)

Physical Examination

Item Group

Physical examination

C0031809 (UMLS CUI-1)

body system

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])

Finding

Item

Finding

integer

C0243095 (UMLS CUI [1])

Finding

Code List

Finding

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not examinated (3)

Physical Examination Abnormal Finding

Item

Abnormal physical finding

text

C2826636 (UMLS CUI [1])

On examination - neurological findings

Item Group

Neurological Examination Finding

C0437208 (UMLS CUI-1)

Neurological examination normal | On examination - neurological findings

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)

Neurologic Examination | Abnormalities | Mental state

Item Group

Neurological Examination abnormalities - Mental status

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)

Abnormality; Mental state

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])

Abnormality; Mental state

Item

Check if abnormal mental status.

integer

C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])

undefined item

Code List

Check if abnormal mental status.

CL Item

Abnormal (1)

Abnormality; Severities | Mental state (observable entity)

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)

Neurologic Examination; Abnormalities | Speech and language finding

Item Group

Neurological Examination abnormalities - Speech/ language

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)

Speech Disorders | Languages; Abnormality

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)

Abnormality; Speech | Abnormality; Languages

Item

Check if abnormal Speech/ language.

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 abnormal Speech/ language.

CL Item

Abnormal (1)

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

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)

Neurologic Examination; Abnormalities | Cranial Nerves

Item Group

Neurological Examination abnormalities - Cranial nerves

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)

Cranial Nerves; Abnormality

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)

Abnormality; Cranial Nerves

Item

Check if abnormal cranial nerves.

integer

C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])

undefined item

Code List

Check if abnormal cranial nerves.

CL Item

Abnormal (1)

Abnormality; Severities; Cranial Nerves

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)

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])

Neurologic Examination; Abnormalities | Gait

Item Group

Neurological Examination abnormalities - Gait

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)

Gait; Abnormality

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)

Abnormality; Gait

Item

Check if abnormal gait.

integer

C1704258 (UMLS CUI [1,1])
C0016928 (UMLS CUI [1,2])

Abnormality; Gait

Code List

Check if abnormal gait.

CL Item

Abnormal (1)

Abnormality; Severities; Gait

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)

Neurologic Examination | Abnormality | Physiologic Coordination

Item Group

Neurological Examination abnormalities - Coordination

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)

Physiologic Coordination; Abnormality

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)

Abnormality; Physiologic Coordination

Item

Check if abnormal coordination.

integer

C1704258 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])

undefined item

Code List

Check if abnormal coordination.

CL Item

Abnormal (1)

Abnormality; Severities; Physiologic Coordination

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)

Neurologic Examination | Abnormality | Esthesia

Item Group

Neurological Examination abnormalities - Sensation

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)

Esthesia; Abnormality

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)

Abnormality; Esthesia

Item

Check if abnormal sensation.

integer

C1704258 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])

Abnormality; Esthesia

Code List

Check if abnormal sensation.

CL Item

Abnormal (1)

Abnormality; Severities; Esthesia

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)

Neurologic Examination | Abnormality | Muscle strength

Item Group

Neurological Examination abnormalities - Muscle strength

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)

Muscle Strength; Abnormality

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)

Abnormality; Muscle Strength

Item

Check if abnormal muscle strength.

integer

C1704258 (UMLS CUI [1,1])
C0517349 (UMLS CUI [1,2])

Abnormality; Muscle Strength

Code List

Check if abnormal muscle strength.

CL Item

Abnormal (1)

Abnormality; Severities; Muscle Strength

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)

Neurologic Examination | Abnormality | Muscle Tonus

Item Group

Neurological Examination abnormalities - Muscle tone

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)

Muscle Tonus; Abnormality

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)

Abnormality; Muscle Tonus

Item

Check if abnormal muscle tone.

integer

C1704258 (UMLS CUI [1,1])
C0026841 (UMLS CUI [1,2])

Abnormality; Muscle Tonus

Code List

Check if abnormal muscle tone.

CL Item

Abnormal (1)

Abnormality; Severities; Muscle Tonus

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)

Neurologic Examination | Abnormality | Reflex action

Item Group

Neurological Examination abnormalities - Reflexes

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)

Reflex action; Abnormality

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)

Abnormality; Reflex action

Item

Check if abnormal reflexes.

integer

C1704258 (UMLS CUI [1,1])
C0034929 (UMLS CUI [1,2])

Abnormality; Reflex action

Code List

Check if abnormal reflexes.

CL Item

Abnormal (1)

Abnormality; Type - attribute; Reflex action

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)

Electroencephalography

Item Group

Electroencephalogram

C0013819 (UMLS CUI-1)

Assessment Date

Item

Date of assessment

date

C2985720 (UMLS CUI [1])

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ID

Descrição

Palavras-chave

Versões (5)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

AED History, current AED Information, Vital Signs/ Physical Examination, Neurological Examination and Electroencephalogram - Screen

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Unidades de medida

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Unidades de medida

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