ID
44921
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 (4)
- 2018-09-27 2018-09-27 -
- 2018-09-27 2018-09-27 -
- 2018-10-08 2018-10-08 -
- 2022-04-20 2022-04-20 - Martin Dugas
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 april 2022
DOI
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Licens
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 Plasma Samples- Treatment Phase Study Week 22
- StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Beskrivning
Study Subject Participation Status | Assessment Date
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Beskrivning
Study Subject Participation Status | Clinical Trial Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beskrivning
Menarche; Visit; Last; Since
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beskrivning
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beskrivning
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Datatyp
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
Beskrivning
Statement; Signature; Pregnancy; avoidance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Beskrivning
Physical Examination Date
Alias
- UMLS CUI-1
- C2826643
Beskrivning
Vital signs | Body Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Beskrivning
Neurologic Examination; Date in time |On examination - neurological findings
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
Neurologic Examination | Abnormalities | Mental state
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
Neurologic Examination; Abnormalities | Speech and language finding
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
Neurologic 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
Neurologic 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
Neurologic Examination | Abnormality | Physiologic 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
Neurologic Examination | Abnormality | Esthesia
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
Neurologic Examination | Abnormality | 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
Neurologic Examination | Abnormality | Muscle Tonus
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
Neurologic Examination | Abnormality | Reflex action
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
Laboratory; Specimen collection date
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Beskrivning
Laboratory test finding
Alias
- UMLS CUI-1
- C0587081
Beskrivning
Laboratory Results; Clinical Significance; Unexpected
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Beskrivning
Laboratory; Parameter Value
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beskrivning
Comment | Laboratory; Parameter Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beskrivning
Laboratory examination; Clinical | Hematology (discipline)
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Beskrivning
Hemoglobin
Datatyp
float
Måttenheter
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beskrivning
Erythrocyte Mean Corpuscular Volume Measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C1948043
Beskrivning
Platelet Count measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0032181
Beskrivning
White Blood Cell Count procedure
Datatyp
float
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Differential white blood cell count procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0162401
Beskrivning
Laboratory examination; Clinical | Chemistry, Clinical
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beskrivning
Sodium measurement
Datatyp
float
Måttenheter
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
Potassium measurement
Datatyp
float
Måttenheter
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
Bicarbonate measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0202059
Beskrivning
Creatinine measurement, serum (procedure)
Datatyp
float
Måttenheter
- mg/dl
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
Bilirubin, total measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
Alkaline phosphatase measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
Aspartate aminotransferase measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
Alanine aminotransferase measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
Albumin measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0201838
Beskrivning
Plasma Glucose Measurement
Datatyp
float
Alias
- UMLS CUI [1]
- C0202042
Beskrivning
Urinalysis; Urine dipstick test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beskrivning
Serum pregnancy test (B-HCG)
Alias
- UMLS CUI-1
- C0430060
Beskrivning
plasma concentration; Antiepileptic Agents
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beskrivning
Plasma specimen
Alias
- UMLS CUI-1
- C0444263
Beskrivning
Plasma specimen | Antiepileptic Agents; Trough
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beskrivning
Experimental drug; Trough | Date in time; Time; Specimen Collection
Datatyp
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
Beskrivning
Experimental drug; Date last dose | Experimental drug; Time last dose
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beskrivning
Experimental drug; Dosage
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
Similar models
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22
- 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)
C0018943 (UMLS CUI-3)
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
C0444506 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])