ID
31938
Beskrivning
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
Nyckelord
Versioner (3)
- 2018-09-22 2018-09-22 -
- 2018-09-27 2018-09-27 -
- 2018-10-08 2018-10-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 oktober 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8
Beskrivning
Date of Examination (Vital Signs/ Weight, Physical Examination)
Alias
- UMLS CUI-1
- C2826643
Beskrivning
Vital Signs/ Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Beskrivning
Blood Pressure
Datatyp
text
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Pulse Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
body system
Datatyp
integer
Alias
- UMLS CUI [1]
- C0460002
Beskrivning
body system; Other; Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Finding
Datatyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beskrivning
Physical Examination Abnormal Finding
Datatyp
text
Alias
- UMLS CUI [1]
- C2826636
Beskrivning
Neurological Examination - Date and Finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Beskrivning
Neurologic Examination; Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Beskrivning
Neurological examination normal | On examination - neurological findings
Datatyp
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Beskrivning
Neurological Examination abnormalities - Mental status
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Beskrivning
Abnormality; Mental state
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beskrivning
Abnormality; Mental state; Other; Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Abnormality; Mental state
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beskrivning
Abnormality; Severities | Mental state (observable entity)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Beskrivning
Neurological Examination abnormalities - Speech/ language
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Beskrivning
Speech Disorders | Languages; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Beskrivning
Abnormality; Speech | Abnormality; Languages
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Beskrivning
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Datatyp
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
Beskrivning
Neurological Examination abnormalities - Cranial nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Beskrivning
Cranial Nerves; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Cranial Nerves
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Beskrivning
Abnormality; Severities; Cranial Nerves
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Beskrivning
Abnormality; Cranial Nerves; Other; Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Neurological Examination abnormalities - Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Beskrivning
Gait; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Gait
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Beskrivning
Abnormality; Severities; Gait
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Beskrivning
Neurological Examination abnormalities - Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Beskrivning
Physiologic Coordination; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Physiologic Coordination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Beskrivning
Abnormality; Severities; Physiologic Coordination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Beskrivning
Neurological Examination abnormalities - Sensation
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Beskrivning
Esthesia; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Esthesia
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Beskrivning
Abnormality; Severities; Esthesia
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Beskrivning
Neurological Examination abnormalities - Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Beskrivning
Muscle Strength; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Muscle Strength
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Beskrivning
Abnormality; Severities; Muscle Strength
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Beskrivning
Neurological Examination abnormalities - Muscle tone
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Beskrivning
Muscle Tonus; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Muscle Tonus
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Beskrivning
Abnormality; Severities; Muscle Tonus
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Beskrivning
Neurological Examination abnormalities - Reflexes
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Beskrivning
Reflex action; Abnormality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abnormality; Reflex action
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Beskrivning
Abnormality; Type - attribute; Reflex action
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Beskrivning
Electroencephalogram
Alias
- UMLS CUI-1
- C0013819
Beskrivning
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Electrocardiogram Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
electrocardiogram: ventricular rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beskrivning
Electrocardiogram: P-R interval
Datatyp
float
Måttenheter
- sec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QT interval - finding
Datatyp
float
Måttenheter
- sec
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
RR interval
Datatyp
float
Måttenheter
- sec
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
QRS complex duration (observable entity)
Datatyp
float
Måttenheter
- sec
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
ECG normal | Electrocardiography; Variant; Normal | Electrocardiogram abnormal
Datatyp
integer
Alias
- UMLS CUI [1]
- C0522054
- UMLS CUI [2,1]
- C1623258
- UMLS CUI [2,2]
- C0205419
- UMLS CUI [2,3]
- C0205307
- UMLS CUI [3]
- C0522055
Beskrivning
Cardiac rhythm type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Cardiac conduction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Ventricular Depolarization [PE] | Repolarization abnormalities
Datatyp
integer
Alias
- UMLS CUI [1]
- C1331539
- UMLS CUI [2]
- C3279217
Beskrivning
Electrocardiogram finding; Other
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0205394
Beskrivning
Electrocardiogram finding; Other; Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Electrocardiography; Comment | Electrocardiography; Conclusion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [2,1]
- C1623258
- UMLS CUI [2,2]
- C1707478
Similar models
Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8
C0237753 (UMLS CUI [1,2])
C0005910 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0011008 (UMLS CUI-2)
C0437208 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0437208 (UMLS CUI [2])
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)
C0278060 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0278060 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)
C0023008 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0037817 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0023008 (UMLS CUI [2,2])
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])
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)
C1704258 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
C0010268 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
C1623258 (UMLS CUI [2,1])
C0205419 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C0522055 (UMLS CUI [3])
C3279217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C1707478 (UMLS CUI [2,2])