ID

44912

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

Pädiatrie

Neurologic Examination

23-09-18 23-09-18 -
27-09-18 27-09-18 -
08-10-18 08-10-18 -
07-04-22 07-04-22 - Martin Dugas

Houder van rechten

GlaxoSmithKline

Geüploaded op

7 april 2022

DOI

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Licentie

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

model
Details

Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments and Clinical Laboratory Examination - Treatment Phase Study Week 10

1 Formulieren

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 and Clinical Laboratory Examination - Treatment Phase Study Week 10

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative documentation

Item Group

Administrative

C1320722 (UMLS CUI-1)

Study Site; Numbers

Item

Site number

text

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

Person Initials

Item

Patient's initials

text

C2986440 (UMLS CUI [1])

Clinical Trial Subject Unique Identifier

Item

Patient's trial number

text

C2348585 (UMLS CUI [1])

Study Subject Participation Status | Assessment Date

Item Group

Study Continuitation Record - Date of assessment

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

Assessment Date

Item

Date of assessment

date

C2985720 (UMLS CUI [1])

Study Subject Participation Status | Clinical Trial Eligibility Criteria

Item Group

Study Continuitation Record - Eligibility Criteria

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

Menarche; Visit; Last; Since

Item

Has this patient become menarcheal since the last clinic visit?

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

If patient become menarcheal since the last clinic visit, is this patient not currently pregnant (the result of a serum pregnancy test conducted at this visit is negative) or breastfeeding?

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

Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?

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

Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?

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

Date of Examination (Vital Signs/ Weight, Physical Examination)

C2826643 (UMLS CUI-1)

Physical Examination Date

Item

Date of Examination (Vital Signs/ Weight, Physical Examination)

date

C2826643 (UMLS CUI [1])

Vital signs | Body Weight

Item Group

Vital Signs/ Weight

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

Blood Pressure

Item

Blood pressure (systolic/ diastolic)

text

C0005823 (UMLS CUI [1])

Pulse Rate

Item

Pulse rate

integer

C0232117 (UMLS CUI [1])

Body Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

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

Item Group

Neurological Examination - Date and Finding

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

Neurologic Examination; Date in time

Item

Date of examination

date

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

Neurological examination normal | On examination - neurological findings

Item

Exam- either normal OR abnormalities present

integer

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

undefined item

Code List

Exam- either normal OR abnormalities present

CL Item

Nromal (1)

CL Item

Abnormalities present (2)

Neurologic Examination | Abnormalities | Mental state

Item Group

Neurological Examination abnormalities - Mental status

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

Abnormality; Mental state

Item

Mental status abnormalities

integer

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

Abnormality

Code List

Mental status abnormalities

CL Item

Decreased attention (e.g. decreased consentration, poor/ short attention span) (1)

CL Item

Psychomotor slowing or retardation (developmental delay) (2)

CL Item

Somnolence (e.g. sedation, drowsiness, lethargy, sleepiness) (3)

CL Item

Depressed affect (4)

CL Item

Inapropriate affect (5)

CL Item

Hyperactivity (6)

CL Item

Behavioral discontrol (7)

CL Item

Other, specify (8)

Abnormality; Mental state; Other; Specification

Item

If other abnormal mental status, specify.

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

Check if abnormal mental status.

integer

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

undefined item

Code List

Check if abnormal mental status.

CL Item

Abnormal (1)

Abnormality; Severities | Mental state (observable entity)

Item

Intensity of abnormality (mental status)

integer

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

undefined item

Code List

Intensity of abnormality (mental status)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination; Abnormalities | Speech and language finding

Item Group

Neurological Examination abnormalities - Speech/ language

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

Speech Disorders | Languages; Abnormality

Item

Speech/ language abnormalities

integer

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

undefined item

Code List

Speech/ language abnormalities

CL Item

Dysarthria (1)

CL Item

Dysphasia or aphasia (2)

Abnormality; Speech | Abnormality; Languages

Item

Check if abnormality changed or appeared.

integer

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

Abnormality;

Code List

Check if abnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

Item

Intensity of abnormality (speech/ language)

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

Intensity of abnormality (speech/ language)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination; Abnormalities | Cranial Nerves

Item Group

Neurological Examination abnormalities - Cranial nerves

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

Cranial Nerves; Abnormality

Item

Cranial nerves abnormalities

integer

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

Cranial Nerves; Abnormality

Code List

Cranial nerves abnormalities

CL Item

Nystagmus on lateral gaze (horizontal) (1)

CL Item

Other, specify (2)

Abnormality; Cranial Nerves

Item

Check if abnormality changed or appeared.

integer

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

undefined item

Code List

Check if abnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Cranial Nerves

Item

Intensity of abnormality (cranial nerves)

integer

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

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

Code List

Intensity of abnormality (cranial nerves)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Abnormality; Cranial Nerves; Other; Specification

Item

If other abnormality of cranial nerves, specify.

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

Neurological Examination abnormalities - Gait

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

Gait; Abnormality

Item

Gait abnormalities

integer

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

Gait; Abnormality

Code List

Gait abnormalities

CL Item

Ataxia gait (1)

CL Item

Hemiplegic gait (2)

CL Item

Spasticity, bilateral (3)

CL Item

Other gait disturbance (4)

Abnormality; Gait

Item

Check ifabnormality changed or appeared.

integer

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

Abnormality; Gait

Code List

Check ifabnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Gait

Item

Intensity of abnormality (gait)

integer

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

undefined item

Code List

Intensity of abnormality (gait)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination | Abnormality | Physiologic Coordination

Item Group

Neurological Examination abnormalities - Coordination

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

Physiologic Coordination; Abnormality

Item

Coordination abnormalities

integer

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

undefined item

Code List

Coordination abnormalities

CL Item

Resting tremor (1)

CL Item

Intention tremor (2)

CL Item

Postural tremor (3)

CL Item

Dysdiadochokinesia (on rapid alt. movements) (4)

CL Item

Dysmetria (5)

Abnormality; Physiologic Coordination

Item

Check if abnormality changed or appeared.

integer

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

undefined item

Code List

Check if abnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Physiologic Coordination

Item

Intensity of abnormality (coordination)

integer

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

Abnormality; Severities; Physiologic Coordination

Code List

Intensity of abnormality (coordination)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination | Abnormality | Esthesia

Item Group

Neurological Examination abnormalities - Sensation

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

Esthesia; Abnormality

Item

Sensation abnormalities

integer

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

Esthesia; Abnormality

Code List

Sensation abnormalities

CL Item

Pain (1)

CL Item

Light touch (2)

CL Item

Position (3)

CL Item

Vibration (4)

CL Item

Romberg positive (5)

Abnormality; Esthesia

Item

Check if abnormality changed or appeared.

integer

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

Abnormality; Esthesia

Code List

Check if abnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Esthesia

Item

Intensity of abnormality (sensation)

integer

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

undefined item

Code List

Intensity of abnormality (sensation)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination | Abnormality | Muscle strength

Item Group

Neurological Examination abnormalities - Muscle strength

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

Muscle Strength; Abnormality

Item

Muscle strength abnormalities

integer

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

Muscle Strength; Abnormality

Code List

Muscle strength abnormalities

CL Item

Decreased muscle strength (1)

Abnormality; Muscle Strength

Item

Check if abnormality changed or appeared.

integer

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

Abnormality; Muscle Strength

Code List

Check if abnormality changed or appeared.

CL Item

abnormality changed or appeared (1)

Abnormality; Severities; Muscle Strength

Item

Intensity of abnormality (muscle strength)

integer

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

Abnormality; Severities; Muscle Strength

Code List

Intensity of abnormality (muscle strength)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination | Abnormality | Muscle Tonus

Item Group

Neurological Examination abnormalities - Muscle tone

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

Muscle Tonus; Abnormality

Item

Muscle tone abnormalities

integer

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

Muscle Tonus; Abnormality

Code List

Muscle tone abnormalities

CL Item

Hypertonia (1)

CL Item

Hypotonia (2)

Abnormality; Muscle Tonus

Item

Check if abnormality changed or appeared.

integer

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

Abnormality; Muscle Tonus

Code List

Check if abnormality changed or appeared.

CL Item

Abnormality changed or appeared (1)

Abnormality; Severities; Muscle Tonus

Item

Intensity of abnormality (muscle tone)

integer

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

Abnormality; Severities; Muscle Tonus

Code List

Intensity of abnormality (muscle tone)

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

NA, abnormality has resolved (4)

Neurologic Examination | Abnormality | Reflex action

Item Group

Neurological Examination abnormalities - Reflexes

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

Reflex action; Abnormality

Item

Reflexes abnormalities

integer

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

Reflex action; Abnormality

Code List

Reflexes abnormalities

CL Item

Biceps left (1)

CL Item

Biceps right (2)

CL Item

Brachioradialis left (3)

CL Item

Brachioradialis right (4)

CL Item

Knee left (5)

CL Item

Knee right (6)

CL Item

Ankle left (7)

CL Item

Ankle right (8)

CL Item

Plantar response left (9)

CL Item

Plantar response right (10)

Abnormality; Reflex action

Item

Check if abnormality changed or appeared.

integer

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

Abnormality; Reflex action

Code List

Check if abnormality changed or appeared.

CL Item

Abnormality changed or appeared (1)

Abnormality; Type - attribute; Reflex action

Item

Type of abnormality (reflexes)

integer

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

Abnormality; Type - attribute; Reflex action

Code List

Type of abnormality (reflexes)

CL Item

Absent (1)

CL Item

Decreased (2)

CL Item

Increased (3)

CL Item

Clonus (4)

CL Item

NA, abnormality has resolved (5)

Laboratory; Specimen collection date

Item Group

Laboratory - Date sample collected

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

Specimen collection date

Item

Date sample collected

date

C1302413 (UMLS CUI [1])

Laboratory test finding

Item Group

Laboratory finding

C0587081 (UMLS CUI-1)

Laboratory Results; Clinical Significance; Unexpected

Item

Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?

boolean

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

Laboratory Results; Clinical Significance; Unexpected

Item Group

Laboratory results that are of potential or actual clinical significance and unexpected

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

Laboratory; Parameter Value

Item

Laboratory parameter

text

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

Comment | Laboratory; Parameter Value

Item

Comment (Laboratory parameter)

text

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

Laboratory examination; Clinical | Chemistry, Clinical

Item Group

Clinical laboratory examination - Clinical chemistry

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

Sodium measurement

Item

Sodium

float

C0337443 (UMLS CUI [1])

Potassium measurement

Item

Potassium

float

C0202194 (UMLS CUI [1])

Bicarbonate measurement

Item

Bicarbonate

float

C0202059 (UMLS CUI [1])

Creatinine measurement, serum (procedure)

Item

Creatinine

float

C0201976 (UMLS CUI [1])

Bilirubin, total measurement

Item

Total Bilirubin

float

C0201913 (UMLS CUI [1])

Alkaline phosphatase measurement

Item

Alkaline Phosphatase

float

C0201850 (UMLS CUI [1])

Aspartate aminotransferase measurement

Item

AST (SGOT)

float

C0201899 (UMLS CUI [1])

Alanine aminotransferase measurement

Item

ALT (SGTP)

float

C0201836 (UMLS CUI [1])

Albumin measurement

Item

Albumin

float

C0201838 (UMLS CUI [1])

Plasma Glucose Measurement

Item

Glucose

float

C0202042 (UMLS CUI [1])

Urinalysis; Urine dipstick test

Item Group

Dipstick Urinalysis

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

Urine total protein measurement

Item

Urine Protein

text

C0428541 (UMLS CUI [1])

Urine dipstick for blood

Item

Urine Blood

text

C0430372 (UMLS CUI [1])

Serum pregnancy test (B-HCG)

Item Group

Serum pregnancy (for females of childbearing potential only)

C0430060 (UMLS CUI-1)

Serum pregnancy test (B-HCG)

Item

Serum pregnancy

text

C0430060 (UMLS CUI [1])

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ID

Beschrijving

Trefwoorden

Versies (4)

Houder van rechten

Geüploaded op

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Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

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 and Clinical Laboratory Examination - Treatment Phase Study Week 10

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