ID
31796
Beschrijving
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
Trefwoorden
Versies (4)
- 27-09-18 27-09-18 -
- 27-09-18 27-09-18 -
- 08-10-18 08-10-18 -
- 20-04-22 20-04-22 - Martin Dugas
Houder van rechten
GlaxoSmithKline
Geüploaded op
27 september 2018
DOI
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Licentie
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
Beschrijving
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Beschrijving
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beschrijving
Menarche; Visit; Last; Since
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beschrijving
If the answer is No, the patient will be withdrawn from the study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beschrijving
If the answer is No, the patient will be withdrawn from the study.
Datatype
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
Beschrijving
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 If the answer is No, the patient will be withdrawn from the study.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Beschrijving
Date of Examination (Vital Signs/ Weight, Physical Examination)
Alias
- UMLS CUI-1
- C2826643
Beschrijving
Vital Signs/ Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Beschrijving
Blood Pressure
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Neurological Examination - Date and Finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Beschrijving
Neurologic Examination; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Beschrijving
Neurological examination normal | On examination - neurological findings
Datatype
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Beschrijving
Neurological Examination abnormalities - Mental status
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Beschrijving
Abnormality; Mental state
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschrijving
Abnormality; Mental state; Other; Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Abnormality; Mental state
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschrijving
Abnormality; Severities | Mental state (observable entity)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Beschrijving
Neurological Examination abnormalities - Speech/ language
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Beschrijving
Speech Disorders | Languages; Abnormality
Datatype
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Beschrijving
Abnormality; Speech | Abnormality; Languages
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Beschrijving
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Datatype
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
Beschrijving
Neurological Examination abnormalities - Cranial nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Beschrijving
Cranial Nerves; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Cranial Nerves
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Beschrijving
Abnormality; Severities; Cranial Nerves
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Beschrijving
Abnormality; Cranial Nerves; Other; Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Neurological Examination abnormalities - Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Beschrijving
Gait; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Gait
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Beschrijving
Abnormality; Severities; Gait
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Beschrijving
Neurological Examination abnormalities - Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Beschrijving
Physiologic Coordination; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Physiologic Coordination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Beschrijving
Abnormality; Severities; Physiologic Coordination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Beschrijving
Neurological Examination abnormalities - Sensation
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Beschrijving
Esthesia; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Esthesia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Beschrijving
Abnormality; Severities; Esthesia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Beschrijving
Neurological Examination abnormalities - Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Beschrijving
Muscle Strength; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Muscle Strength
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Beschrijving
Abnormality; Severities; Muscle Strength
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Beschrijving
Neurological Examination abnormalities - Muscle tone
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Beschrijving
Muscle Tonus; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Muscle Tonus
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Beschrijving
Abnormality; Severities; Muscle Tonus
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Beschrijving
Neurological Examination abnormalities - Reflexes
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Beschrijving
Reflex action; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Reflex action
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Beschrijving
Abnormality; Type - attribute; Reflex action
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Beschrijving
Laboratory - Date sample collected
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Beschrijving
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beschrijving
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschrijving
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
Beschrijving
Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschrijving
Comment | Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschrijving
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Beschrijving
Hemoglobin
Datatype
text
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Erythrocyte Mean Corpuscular Volume Measurement
Datatype
text
Alias
- UMLS CUI [1]
- C1948043
Beschrijving
Platelet Count measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
White Blood Cell Count procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Differential white blood cell count procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0162401
Beschrijving
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beschrijving
Sodium measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Bicarbonate measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202059
Beschrijving
Creatinine measurement, serum (procedure)
Datatype
text
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Bilirubin, total measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Alkaline phosphatase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Aspartate aminotransferase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Albumin measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Plasma Glucose Measurement
Datatype
text
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschrijving
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beschrijving
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beschrijving
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beschrijving
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.
Datatype
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
Beschrijving
Experimental drug; Date last dose | Experimental drug; Time last dose
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beschrijving
Experimental drug; Dosage
Datatype
float
Maateenheden
- 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])