ID
44920
Descripción
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
Palabras clave
Versiones (4)
- 23/9/18 23/9/18 -
- 27/9/18 27/9/18 -
- 8/10/18 8/10/18 -
- 20/4/22 20/4/22 - Martin Dugas
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de abril de 2022
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12
- StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Descripción
Study Subject Participation Status | Assessment Date
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Descripción
Study Subject Participation Status | Clinical Trial Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Descripción
Menarche; Visit; Last; Since
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Descripción
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Descripción
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Tipo de datos
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
Descripción
Statement; Signature; Pregnancy; avoidance
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Descripción
Physical Examination Date
Alias
- UMLS CUI-1
- C2826643
Descripción
Vital signs | Body Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Descripción
Blood Pressure
Tipo de datos
text
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Descripción
Pulse Rate
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Descripción
Body Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Neurologic Examination; Date in time |On examination - neurological findings
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Descripción
Neurologic Examination; Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Descripción
Neurological examination normal | On examination - neurological findings
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Descripción
Neurologic Examination | Abnormalities | Mental state
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Descripción
Abnormality; Mental state
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Descripción
Abnormality; Mental state; Other; Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Abnormality; Mental state
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Descripción
Abnormality; Severities | Mental state (observable entity)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Descripción
Neurologic Examination; Abnormalities | Speech and language finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Descripción
Speech Disorders | Languages; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Descripción
Abnormality; Speech | Abnormality; Languages
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Descripción
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Tipo de datos
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
Descripción
Neurologic Examination; Abnormalities | Cranial Nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Descripción
Cranial Nerves; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Cranial Nerves
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Descripción
Abnormality; Severities; Cranial Nerves
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Descripción
Abnormality; Cranial Nerves; Other; Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Neurologic Examination; Abnormalities | Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Descripción
Gait; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Gait
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Descripción
Abnormality; Severities; Gait
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Descripción
Neurologic Examination | Abnormality | Physiologic Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Descripción
Physiologic Coordination; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Physiologic Coordination
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Descripción
Abnormality; Severities; Physiologic Coordination
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Descripción
Neurologic Examination | Abnormality | Esthesia
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Descripción
Esthesia; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Esthesia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Descripción
Abnormality; Severities; Esthesia
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Descripción
Neurologic Examination | Abnormality | Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Descripción
Muscle Strength; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Muscle Strength
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Descripción
Abnormality; Severities; Muscle Strength
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Descripción
Neurologic Examination | Abnormality | Muscle Tonus
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Descripción
Muscle Tonus; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Muscle Tonus
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Descripción
Abnormality; Severities; Muscle Tonus
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Descripción
Neurologic Examination | Abnormality | Reflex action
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Descripción
Reflex action; Abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Descripción
Abnormality; Reflex action
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Descripción
Abnormality; Type - attribute; Reflex action
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Descripción
Laboratory; Specimen collection date
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Descripción
Laboratory test finding
Alias
- UMLS CUI-1
- C0587081
Descripción
Laboratory Results; Clinical Significance; Unexpected
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Descripción
Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Descripción
Comment | Laboratory; Parameter Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Descripción
Laboratory examination; Clinical | Chemistry, Clinical
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Descripción
Sodium measurement
Tipo de datos
float
Unidades de medida
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Descripción
Potassium measurement
Tipo de datos
float
Unidades de medida
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Descripción
Bicarbonate measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0202059
Descripción
Creatinine measurement, serum (procedure)
Tipo de datos
float
Unidades de medida
- mg/dl
Alias
- UMLS CUI [1]
- C0201976
Descripción
Bilirubin, total measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0201913
Descripción
Alkaline phosphatase measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0201850
Descripción
Aspartate aminotransferase measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0201899
Descripción
Alanine aminotransferase measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0201836
Descripción
Albumin measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0201838
Descripción
Plasma Glucose Measurement
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0202042
Descripción
Urinalysis; Urine dipstick test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Descripción
Serum pregnancy test (B-HCG)
Alias
- UMLS CUI-1
- C0430060
Descripción
Urine Specimen Collection
Alias
- UMLS CUI-1
- C0200354
Descripción
Urine specimen collection, 24 hours; Start Date and Time of Procedure
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3897500
Descripción
Urine specimen collection, 24 hours; End Date and Time of Procedure
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C3899266
Descripción
Urine specimen collection, 24 hours; Volume Measurement
Tipo de datos
integer
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Descripción
Collection (action); Complete
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0205197
Similar models
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12
- StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
C0237753 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C1516637 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
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])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])
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])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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)
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)
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)
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
C0549193 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C3897500 (UMLS CUI [1,2])
C3899266 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])