ID
44921
Description
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
Keywords
Versions (4)
- 9/27/18 9/27/18 -
- 9/27/18 9/27/18 -
- 10/8/18 10/8/18 -
- 4/20/22 4/20/22 - Martin Dugas
Copyright Holder
GlaxoSmithKline
Uploaded on
April 20, 2022
DOI
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License
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
Description
Study Subject Participation Status | Assessment Date
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Description
Study Subject Participation Status | Clinical Trial Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Description
Menarche; Visit; Last; Since
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Description
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Data type
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Description
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Data type
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
Description
Statement; Signature; Pregnancy; avoidance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Description
Physical Examination Date
Alias
- UMLS CUI-1
- C2826643
Description
Vital signs | Body Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Description
Blood Pressure
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Neurologic Examination; Date in time |On examination - neurological findings
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Description
Neurologic Examination; Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Description
Neurological examination normal | On examination - neurological findings
Data type
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Description
Neurologic Examination | Abnormalities | Mental state
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Description
Abnormality; Mental state
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Description
Abnormality; Mental state; Other; Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Abnormality; Mental state
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Description
Abnormality; Severities | Mental state (observable entity)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Description
Neurologic Examination; Abnormalities | Speech and language finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Description
Speech Disorders | Languages; Abnormality
Data type
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Description
Abnormality; Speech | Abnormality; Languages
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Description
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Data type
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
Description
Neurologic Examination; Abnormalities | Cranial Nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Description
Cranial Nerves; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Cranial Nerves
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Description
Abnormality; Severities; Cranial Nerves
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Description
Abnormality; Cranial Nerves; Other; Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Neurologic Examination; Abnormalities | Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Description
Gait; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Gait
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Description
Abnormality; Severities; Gait
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Description
Neurologic Examination | Abnormality | Physiologic Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Description
Physiologic Coordination; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Physiologic Coordination
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Description
Abnormality; Severities; Physiologic Coordination
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Description
Neurologic Examination | Abnormality | Esthesia
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Description
Esthesia; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Esthesia
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Description
Abnormality; Severities; Esthesia
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Description
Neurologic Examination | Abnormality | Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Description
Muscle Strength; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Muscle Strength
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Description
Abnormality; Severities; Muscle Strength
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Description
Neurologic Examination | Abnormality | Muscle Tonus
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Description
Muscle Tonus; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Muscle Tonus
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Description
Abnormality; Severities; Muscle Tonus
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Description
Neurologic Examination | Abnormality | Reflex action
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Description
Reflex action; Abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Description
Abnormality; Reflex action
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Description
Abnormality; Type - attribute; Reflex action
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Description
Laboratory; Specimen collection date
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Description
Laboratory test finding
Alias
- UMLS CUI-1
- C0587081
Description
Laboratory Results; Clinical Significance; Unexpected
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Description
Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Description
Comment | Laboratory; Parameter Value
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Description
Laboratory examination; Clinical | Hematology (discipline)
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Description
Hemoglobin
Data type
float
Measurement units
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte Mean Corpuscular Volume Measurement
Data type
float
Alias
- UMLS CUI [1]
- C1948043
Description
Platelet Count measurement
Data type
float
Alias
- UMLS CUI [1]
- C0032181
Description
White Blood Cell Count procedure
Data type
float
Alias
- UMLS CUI [1]
- C0023508
Description
Differential white blood cell count procedure
Data type
text
Alias
- UMLS CUI [1]
- C0162401
Description
Laboratory examination; Clinical | Chemistry, Clinical
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Description
Sodium measurement
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium measurement
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Description
Bicarbonate measurement
Data type
float
Alias
- UMLS CUI [1]
- C0202059
Description
Creatinine measurement, serum (procedure)
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0201976
Description
Bilirubin, total measurement
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
Alkaline phosphatase measurement
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
Aspartate aminotransferase measurement
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
Alanine aminotransferase measurement
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Albumin measurement
Data type
float
Alias
- UMLS CUI [1]
- C0201838
Description
Plasma Glucose Measurement
Data type
float
Alias
- UMLS CUI [1]
- C0202042
Description
Urinalysis; Urine dipstick test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Description
Serum pregnancy test (B-HCG)
Alias
- UMLS CUI-1
- C0430060
Description
plasma concentration; Antiepileptic Agents
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Description
Plasma specimen
Alias
- UMLS CUI-1
- C0444263
Description
Plasma specimen | Antiepileptic Agents; Trough
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Description
Experimental drug; Trough | Date in time; Time; Specimen Collection
Data type
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
Description
Experimental drug; Date last dose | Experimental drug; Time last dose
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Description
Experimental drug; Dosage
Data type
float
Measurement units
- 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])