ID

44921

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

Pädiatrie

Neurologische Untersuchung

Laboratorien

Körpergewicht

Klinische Studie [Dokumenttyp]

Vitalzeichen

Epilepsien, partielle

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

20. April 2022

DOI

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Lizenz

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

Modell
Details

Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

1 Formulare

StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
1. Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Administrative documentation

Item Group

C1320722 (UMLS CUI-1)

Study Site; Numbers

Item

text

C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Person Initials

Item

text

C2986440 (UMLS CUI [1])

Clinical Trial Subject Unique Identifier

Item

text

C2348585 (UMLS CUI [1])

Study Subject Participation Status | Assessment Date

Item Group

C2348568 (UMLS CUI-1)
C2985720 (UMLS CUI-2)

Assessment Date

Item

date

C2985720 (UMLS CUI [1])

Study Subject Participation Status | Clinical Trial Eligibility Criteria

Item Group

C2348568 (UMLS CUI-1)
C1516637 (UMLS CUI-2)

Menarche; Visit; Last; Since

Item

boolean

C0025274 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])

Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding

Item

boolean

C0025274 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])

Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence

Item

boolean

C0700589 (UMLS CUI [1,1])
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])

Statement; Signature; Pregnancy; avoidance

Item

boolean

C1710187 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])

Physical Examination Date

Item Group

C2826643 (UMLS CUI-1)

Physical Examination Date

Item

date

C2826643 (UMLS CUI [1])

Vital signs | Body Weight

Item Group

C0518766 (UMLS CUI-1)
C0005910 (UMLS CUI-3)

Blood Pressure

Item

text

C0005823 (UMLS CUI [1])

Pulse Rate

Item

integer

C0232117 (UMLS CUI [1])

Body Weight

Item

float

C0005910 (UMLS CUI [1])

Neurologic Examination; Date in time |On examination - neurological findings

Item Group

C0027853 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0437208 (UMLS CUI-3)

Neurologic Examination; Date in time

Item

date

C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Neurological examination normal | On examination - neurological findings

Item

integer

C1112287 (UMLS CUI [1])
C0437208 (UMLS CUI [2])

undefined item

Code List

Neurological examination normal | On examination - neurological findings

CL Item

(1)

CL Item

(2)

Neurologic Examination | Abnormalities | Mental state

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)

Abnormality; Mental state

Item

integer

C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])

Abnormality

Code List

Abnormality; Mental state

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

CL Item

(5)

CL Item

(6)

CL Item

(7)

CL Item

(8)

Abnormality; Mental state; Other; Specification

Item

text

C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Abnormality; Mental state

Item

integer

C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])

undefined item

Code List

Abnormality; Mental state

CL Item

(1)

Abnormality; Severities | Mental state (observable entity)

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])

undefined item

Code List

Abnormality; Severities | Mental state (observable entity)

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination; Abnormalities | Speech and language finding

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)

Speech Disorders | Languages; Abnormality

Item

integer

C0037822 (UMLS CUI [1])
C0023008 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])

undefined item

Code List

Speech Disorders | Languages; Abnormality

CL Item

(1)

CL Item

(2)

Abnormality; Speech | Abnormality; Languages

Item

integer

C1704258 (UMLS CUI [1,1])
C0037817 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0023008 (UMLS CUI [2,2])

Abnormality;

Code List

Abnormality; Speech | Abnormality; Languages

CL Item

(1)

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

Item

integer

C1704258 (UMLS CUI [1,1])
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])

Abnormality; Severities |

Code List

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination; Abnormalities | Cranial Nerves

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)

Cranial Nerves; Abnormality

Item

integer

C0010268 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Cranial Nerves; Abnormality

Code List

Cranial Nerves; Abnormality

CL Item

(1)

CL Item

(2)

Abnormality; Cranial Nerves

Item

integer

C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])

undefined item

Code List

Abnormality; Cranial Nerves

CL Item

(1)

Abnormality; Severities; Cranial Nerves

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

Code List

Abnormality; Severities; Cranial Nerves

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Abnormality; Cranial Nerves; Other; Specification

Item

text

C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Neurologic Examination; Abnormalities | Gait

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)

Gait; Abnormality

Item

integer

C0016928 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Gait; Abnormality

Code List

Gait; Abnormality

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Abnormality; Gait

Item

integer

C1704258 (UMLS CUI [1,1])
C0016928 (UMLS CUI [1,2])

Abnormality; Gait

Code List

Abnormality; Gait

CL Item

(1)

Abnormality; Severities; Gait

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])

undefined item

Code List

Abnormality; Severities; Gait

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination | Abnormality | Physiologic Coordination

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)

Physiologic Coordination; Abnormality

Item

integer

C0242414 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

undefined item

Code List

Physiologic Coordination; Abnormality

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

CL Item

(5)

Abnormality; Physiologic Coordination

Item

integer

C1704258 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])

undefined item

Code List

Abnormality; Physiologic Coordination

CL Item

(1)

Abnormality; Severities; Physiologic Coordination

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])

Abnormality; Severities; Physiologic Coordination

Code List

Abnormality; Severities; Physiologic Coordination

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination | Abnormality | Esthesia

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)

Esthesia; Abnormality

Item

integer

C0036658 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Esthesia; Abnormality

Code List

Esthesia; Abnormality

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

CL Item

(5)

Abnormality; Esthesia

Item

integer

C1704258 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])

Abnormality; Esthesia

Code List

Abnormality; Esthesia

CL Item

(1)

Abnormality; Severities; Esthesia

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])

undefined item

Code List

Abnormality; Severities; Esthesia

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination | Abnormality | Muscle strength

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)

Muscle Strength; Abnormality

Item

integer

C0517349 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Muscle Strength; Abnormality

Code List

Muscle Strength; Abnormality

CL Item

(1)

Abnormality; Muscle Strength

Item

integer

C1704258 (UMLS CUI [1,1])
C0517349 (UMLS CUI [1,2])

Abnormality; Muscle Strength

Code List

Abnormality; Muscle Strength

CL Item

(1)

Abnormality; Severities; Muscle Strength

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])

Abnormality; Severities; Muscle Strength

Code List

Abnormality; Severities; Muscle Strength

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination | Abnormality | Muscle Tonus

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)

Muscle Tonus; Abnormality

Item

integer

C0026841 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Muscle Tonus; Abnormality

Code List

Muscle Tonus; Abnormality

CL Item

(1)

CL Item

(2)

Abnormality; Muscle Tonus

Item

integer

C1704258 (UMLS CUI [1,1])
C0026841 (UMLS CUI [1,2])

Abnormality; Muscle Tonus

Code List

Abnormality; Muscle Tonus

CL Item

(1)

Abnormality; Severities; Muscle Tonus

Item

integer

C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])

Abnormality; Severities; Muscle Tonus

Code List

Abnormality; Severities; Muscle Tonus

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

Neurologic Examination | Abnormality | Reflex action

Item Group

C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)

Reflex action; Abnormality

Item

integer

C0034929 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Reflex action; Abnormality

Code List

Reflex action; Abnormality

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

CL Item

(5)

CL Item

(6)

CL Item

(7)

CL Item

(8)

CL Item

(9)

CL Item

(10)

Abnormality; Reflex action

Item

integer

C1704258 (UMLS CUI [1,1])
C0034929 (UMLS CUI [1,2])

Abnormality; Reflex action

Code List

Abnormality; Reflex action

CL Item

(1)

Abnormality; Type - attribute; Reflex action

Item

integer

C1704258 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])

Abnormality; Type - attribute; Reflex action

Code List

Abnormality; Type - attribute; Reflex action

CL Item

(1)

CL Item

(2)

CL Item

(3)

CL Item

(4)

CL Item

(5)

Laboratory; Specimen collection date

Item Group

C0022877 (UMLS CUI-1)
C1302413 (UMLS CUI-2)

Specimen collection date

Item

date

C1302413 (UMLS CUI [1])

Laboratory test finding

Item Group

C0587081 (UMLS CUI-1)

Laboratory Results; Clinical Significance; Unexpected

Item

boolean

C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])

Laboratory Results; Clinical Significance; Unexpected

Item Group

C1254595 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)

Laboratory; Parameter Value

Item

text

C0022877 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])

Comment | Laboratory; Parameter Value

Item

text

C0947611 (UMLS CUI [1])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])

Laboratory examination; Clinical | Hematology (discipline)

Item Group

C0260877 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0018943 (UMLS CUI-3)

Hemoglobin

Item

float

C0019046 (UMLS CUI [1])

Erythrocyte Mean Corpuscular Volume Measurement

Item

float

C1948043 (UMLS CUI [1])

Platelet Count measurement

Item

float

C0032181 (UMLS CUI [1])

White Blood Cell Count procedure

Item

float

C0023508 (UMLS CUI [1])

Differential white blood cell count procedure

Item

text

C0162401 (UMLS CUI [1])

Laboratory examination; Clinical | Chemistry, Clinical

Item Group

C0260877 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)

Sodium measurement

Item

float

C0337443 (UMLS CUI [1])

Potassium measurement

Item

float

C0202194 (UMLS CUI [1])

Bicarbonate measurement

Item

float

C0202059 (UMLS CUI [1])

Creatinine measurement, serum (procedure)

Item

float

C0201976 (UMLS CUI [1])

Bilirubin, total measurement

Item

float

C0201913 (UMLS CUI [1])

Alkaline phosphatase measurement

Item

float

C0201850 (UMLS CUI [1])

Aspartate aminotransferase measurement

Item

float

C0201899 (UMLS CUI [1])

Alanine aminotransferase measurement

Item

float

C0201836 (UMLS CUI [1])

Albumin measurement

Item

float

C0201838 (UMLS CUI [1])

Plasma Glucose Measurement

Item

float

C0202042 (UMLS CUI [1])

Urinalysis; Urine dipstick test

Item Group

C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)

Urine total protein measurement

Item

text

C0428541 (UMLS CUI [1])

Urine dipstick for blood

Item

text

C0430372 (UMLS CUI [1])

Serum pregnancy test (B-HCG)

Item Group

C0430060 (UMLS CUI-1)

Serum pregnancy test (B-HCG)

Item

text

C0430060 (UMLS CUI [1])

plasma concentration; Antiepileptic Agents

Item Group

C0683150 (UMLS CUI-1)
C0003299 (UMLS CUI-2)

plasma concentration; Antiepileptic Agents; Trough

Item

text

C0683150 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])

Plasma specimen

Item Group

C0444263 (UMLS CUI-1)

Plasma specimen | Antiepileptic Agents; Trough

Item

text

C0003299 (UMLS CUI [1,1])
C0444506 (UMLS CUI [1,2])

Experimental drug; Trough | Date in time; Time; Specimen Collection

Item

datetime

C0304229 (UMLS CUI [1,1])
C0444506 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])

Experimental drug; Date last dose | Experimental drug; Time last dose

Item

datetime

C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])

Experimental drug; Dosage

Item

float

C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

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ID

Beschreibung

Stichworte

Versionen (4)

Rechteinhaber

Hochgeladen am

DOI

Lizenz

Modell Kommentare :

Itemgroup Kommentare für :

Item Kommentare für :

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

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Alias

Beschreibung

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Maßeinheiten

Alias

Beschreibung

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Maßeinheiten

Alias

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