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Falhas:
ID
31919
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
Versões (4)
- 30/09/2018 30/09/2018 -
- 30/09/2018 30/09/2018 -
- 08/10/2018 08/10/2018 -
- 08/10/2018 08/10/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
8 de outubro de 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 Clinical Study ID: 105-040
Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up
Similar models
Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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)
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; Length
Item
Hieght or lenght (if applicable)
float
C0005890 (UMLS CUI [1])
C1444754 (UMLS CUI [2])
C1444754 (UMLS CUI [2])
Item
Method of collection
integer
C1516698 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Height (1)
CL Item
Length (2)
Item Group
Physical Examination - Changes
C0031809 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
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])
C2826293 (UMLS CUI [1,2])
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])
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])
C2348235 (UMLS CUI [1,2])
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)
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])
C0011008 (UMLS CUI [1,2])
Item
Exam- either normal OR abnormalities present
integer
C1112287 (UMLS CUI [1])
C0437208 (UMLS CUI [2])
C0437208 (UMLS CUI [2])
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)
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)
Item
Mental status abnormalities
integer
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,2])
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])
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])
C0278060 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])
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)
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])
C0023008 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
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])
C0037817 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0023008 (UMLS CUI [2,2])
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])
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])
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)
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)
Item
Cranial nerves abnormalities
integer
C0010268 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0010268 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
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])
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)
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)
Item
Gait abnormalities
integer
C0016928 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0016928 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
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)
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)
Item
Coordination abnormalities
integer
C0242414 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0242414 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
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)
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)
Item
Sensation abnormalities
integer
C0036658 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0036658 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
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)
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
Item
Muscle strength abnormalities
integer
C0517349 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
Decreased muscle strength (1)
Item
Check if abnormality changed or appeared.
integer
C1704258 (UMLS CUI [1,1])
C0517349 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
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)
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
Item
Muscle tone abnormalities
integer
C0026841 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0026841 (UMLS CUI [1,2])
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])
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
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)
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
Item
Reflexes abnormalities
integer
C0034929 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
C0034929 (UMLS CUI [1,2])
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])
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
CL Item
Absent (1)
CL Item
Decreased (2)
CL Item
Increased (3)
CL Item
Clonus (4)
CL Item
NA, abnormality has resolved (5)