ID
31922
Beschreibung
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
Stichworte
Versionen (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
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Oktober 2018
DOI
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Lizenz
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
Beschreibung
Study Continuitation Record - Date of assessment
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Beschreibung
Study Continuitation Record - Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beschreibung
Menarche; Visit; Last; Since
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beschreibung
If the answer is No, the patient will be withdrawn from the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beschreibung
If the answer is No, the patient will be withdrawn from the study.
Datentyp
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
Beschreibung
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 If the answer is No, the patient will be withdrawn from the study.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Beschreibung
Date of Examination (Vital Signs/ Weight, Physical Examination)
Alias
- UMLS CUI-1
- C2826643
Beschreibung
Vital Signs/ Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Beschreibung
Blood Pressure
Datentyp
text
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Pulse Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Neurological Examination - Date and Finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Beschreibung
Neurologic Examination; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Beschreibung
Neurological examination normal | On examination - neurological findings
Datentyp
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Beschreibung
Neurological Examination abnormalities - Mental status
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Beschreibung
Abnormality; Mental state
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschreibung
Abnormality; Mental state; Other; Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschreibung
Abnormality; Mental state
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschreibung
Abnormality; Severities | Mental state (observable entity)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Beschreibung
Neurological Examination abnormalities - Speech/ language
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Beschreibung
Speech Disorders | Languages; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Beschreibung
Abnormality; Speech | Abnormality; Languages
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Beschreibung
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Datentyp
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
Beschreibung
Neurological Examination abnormalities - Cranial nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Beschreibung
Cranial Nerves; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Cranial Nerves
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Beschreibung
Abnormality; Severities; Cranial Nerves
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Beschreibung
Abnormality; Cranial Nerves; Other; Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschreibung
Neurological Examination abnormalities - Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Beschreibung
Gait; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Gait
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Beschreibung
Abnormality; Severities; Gait
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Beschreibung
Neurological Examination abnormalities - Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Beschreibung
Physiologic Coordination; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Physiologic Coordination
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Beschreibung
Abnormality; Severities; Physiologic Coordination
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Beschreibung
Neurological Examination abnormalities - Sensation
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Beschreibung
Esthesia; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Esthesia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Beschreibung
Abnormality; Severities; Esthesia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Beschreibung
Neurological Examination abnormalities - Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Beschreibung
Muscle Strength; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Muscle Strength
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Beschreibung
Abnormality; Severities; Muscle Strength
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Beschreibung
Neurological Examination abnormalities - Muscle tone
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Beschreibung
Muscle Tonus; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Muscle Tonus
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Beschreibung
Abnormality; Severities; Muscle Tonus
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Beschreibung
Neurological Examination abnormalities - Reflexes
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Beschreibung
Reflex action; Abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Beschreibung
Abnormality; Reflex action
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Beschreibung
Abnormality; Type - attribute; Reflex action
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Beschreibung
Laboratory - Date sample collected
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Beschreibung
Laboratory finding
Alias
- UMLS CUI-1
- C0587081
Beschreibung
If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C4055646
Beschreibung
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
Beschreibung
Laboratory; Parameter Value
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschreibung
Comment | Laboratory; Parameter Value
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschreibung
Clinical laboratory examination - Hematology
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Beschreibung
Hemoglobin
Datentyp
text
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Erythrocyte Mean Corpuscular Volume Measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C1948043
Beschreibung
Platelet Count measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0032181
Beschreibung
White Blood Cell Count procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Differential white blood cell count procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0162401
Beschreibung
Clinical laboratory examination - Clinical chemistry
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beschreibung
Sodium measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0337443
Beschreibung
Potassium measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Bicarbonate measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202059
Beschreibung
Creatinine measurement, serum (procedure)
Datentyp
text
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Bilirubin, total measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
Alkaline phosphatase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Aspartate aminotransferase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
Alanine aminotransferase measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Albumin measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201838
Beschreibung
Plasma Glucose Measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Dipstick Urinalysis
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschreibung
Serum pregnancy (for females of childbearing potential only)
Alias
- UMLS CUI-1
- C0430060
Beschreibung
AED plasma concentration
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beschreibung
Plasma Samples
Alias
- UMLS CUI-1
- C0444263
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beschreibung
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.
Datentyp
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
Beschreibung
Experimental drug; Date last dose | Experimental drug; Time last dose
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beschreibung
Experimental drug; Dosage
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
Ähnliche Modelle
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])