ID
31922
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
October 8, 2018
DOI
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License
Creative Commons BY-NC 3.0
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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
Description
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Description
Study Continuitation Record - 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
If the answer is No, the patient will be withdrawn from the study.
Data type
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Description
If the answer is No, the patient will be withdrawn from the study.
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
In addition, all other appropriate person (e.g. parent or legal guardian, if not already obtained as part of the previous requirement, investigator and witness) must also sign this statement. If the answer is No, the patient will be withdrawn from the study.
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
Date of Examination (Vital Signs/ Weight, Physical Examination)
Alias
- UMLS CUI-1
- C2826643
Description
Vital Signs/ 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
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Neurological Examination - Date and Finding
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
Neurological Examination abnormalities - Mental status
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
Neurological Examination abnormalities - Speech/ language
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
Neurological 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
Neurological 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
Neurological Examination abnormalities - 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
Neurological Examination abnormalities - Sensation
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
Neurological Examination abnormalities - 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
Neurological Examination abnormalities - Muscle tone
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
Neurological Examination abnormalities - Reflexes
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 - Date sample collected
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Description
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Description
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Description
Laboratory results that are of potential or actual clinical significance and 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
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Description
Hemoglobin
Data type
text
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte Mean Corpuscular Volume Measurement
Data type
text
Alias
- UMLS CUI [1]
- C1948043
Description
Platelet Count measurement
Data type
text
Alias
- UMLS CUI [1]
- C0032181
Description
White Blood Cell Count procedure
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
Differential white blood cell count procedure
Data type
text
Alias
- UMLS CUI [1]
- C0162401
Description
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Description
Sodium measurement
Data type
text
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202194
Description
Bicarbonate measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202059
Description
Creatinine measurement, serum (procedure)
Data type
text
Alias
- UMLS CUI [1]
- C0201976
Description
Bilirubin, total measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201913
Description
Alkaline phosphatase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201850
Description
Aspartate aminotransferase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201899
Description
Alanine aminotransferase measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201836
Description
Albumin measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201838
Description
Plasma Glucose Measurement
Data type
text
Alias
- UMLS CUI [1]
- C0202042
Description
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Description
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Description
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Description
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Description
Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled AED dose, as close to the dose as is reasonably possible.
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Description
Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled anticipated study medication dose, as close to the dose as is reasonably possible.
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
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])
C0005910 (UMLS CUI-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])
C1302413 (UMLS CUI-2)
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)
C0430370 (UMLS CUI-2)
C0003299 (UMLS CUI-2)
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])