ID
31796
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
27 september 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizure (Clinical Study ID: 105-040)s in Pediatric Patients (Clinical Study ID: 105-040)
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22
Beskrivning
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Beskrivning
Study Continuitation Record - 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
If the answer is No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beskrivning
If the answer is No, the patient will be withdrawn from the study.
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
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 If the answer is No, the patient will be withdrawn from the study.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
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
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
Laboratory - Date sample collected
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Beskrivning
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beskrivning
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beskrivning
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
Beskrivning
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Beskrivning
Hemoglobin
Datatyp
text
Alias
- UMLS CUI [1]
- C0019046
Beskrivning
Erythrocyte Mean Corpuscular Volume Measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C1948043
Beskrivning
Platelet Count measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0032181
Beskrivning
White Blood Cell Count procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Differential white blood cell count procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0162401
Beskrivning
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beskrivning
Sodium measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
Potassium measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
Bicarbonate measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202059
Beskrivning
Creatinine measurement, serum (procedure)
Datatyp
text
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
Bilirubin, total measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
Alkaline phosphatase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
Aspartate aminotransferase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
Alanine aminotransferase measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
Albumin measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0201838
Beskrivning
Plasma Glucose Measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C0202042
Beskrivning
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beskrivning
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beskrivning
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beskrivning
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beskrivning
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.
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
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])