ID

31809

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)
  1. 30/09/18 30/09/18 -
  2. 30/09/18 30/09/18 -
  3. 08/10/18 08/10/18 -
  4. 08/10/18 08/10/18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30 settembre 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 Seizure (Clinical Study ID: 105-040)s in Pediatric Patients (Clinical Study ID: 105-040)

Englisch

Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschreibung

Study Site; Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient's initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Study Continuitation Record - Date of assessment
Beschreibung

Study Continuitation Record - Date of assessment

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C2985720
Date of assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Study Continuitation Record - Eligibility Criteria
Beschreibung

Study Continuitation Record - Eligibility Criteria

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1516637
Has this patient become menarcheal since the last clinic visit?
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
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?
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If the answer is No, the patient will be withdrawn from the study.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
Does this patient employ a contraceptive method (whether a drug, device or abstinence) acceptable to the investigator?
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
Has this patient either signed or have had signed by a parent or guardian on their behalf, a statement of intent to avoid pregnancy?
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
Date of Examination (Vital Signs/ Weight, Physical Examination)
Beschreibung

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

Alias
UMLS CUI-1
C2826643
Date of Examination (Vital Signs/ Weight, Physical Examination)
Beschreibung

Physical Examination Date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Vital Signs/ Weight
Beschreibung

Vital Signs/ Weight

Alias
UMLS CUI-1
C0518766
UMLS CUI-3
C0005910
Blood pressure (systolic/ diastolic)
Beschreibung

Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse rate
Beschreibung

Pulse Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschreibung

Height

Alias
UMLS CUI-1
C0005890
Hieght or lenght (if applicable)
Beschreibung

Body Height; Length

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C1444754
cm
Method of collection
Beschreibung

Collection (action); Evaluation Method

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C2911685
Physical Examination - Changes
Beschreibung

Physical Examination - Changes

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0392747
Are there any clinically significant changes from the Baseline Phase (Study Week 8) information? If Yes, list changes below.
Beschreibung

Changing; Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C2826293
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Body region/ system
Beschreibung

body system

Datentyp

integer

Alias
UMLS CUI [1]
C0460002
If other body region/ system, specify
Beschreibung

body system; Other; Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Briefly specify change
Beschreibung

Changing; Specification

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C2348235
Neurological Examination - Date and Finding
Beschreibung

Neurological Examination - Date and Finding

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C0011008
UMLS CUI-3
C0437208
Date of examination
Beschreibung

Neurologic Examination; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
Exam- either normal OR abnormalities present
Beschreibung

Neurological examination normal | On examination - neurological findings

Datentyp

integer

Alias
UMLS CUI [1]
C1112287
UMLS CUI [2]
C0437208
Neurological Examination abnormalities - Mental status
Beschreibung

Neurological Examination abnormalities - Mental status

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0278060
Mental status abnormalities
Beschreibung

Abnormality; Mental state

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
If other abnormal mental status, specify.
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
Check if mental status changed or appeared.
Beschreibung

Abnormality; Mental state

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
Intensity of abnormality (mental status)
Beschreibung

Abnormality; Severities | Mental state (observable entity)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [2]
C0278060
Neurological Examination abnormalities - Speech/ language
Beschreibung

Neurological Examination abnormalities - Speech/ language

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0564649
Speech/ language abnormalities
Beschreibung

Speech Disorders | Languages; Abnormality

Datentyp

integer

Alias
UMLS CUI [1]
C0037822
UMLS CUI [2,1]
C0023008
UMLS CUI [2,2]
C1704258
Check if abnormality changed or appeared.
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
Intensity of abnormality (speech/ language)
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
Neurological Examination abnormalities - Cranial nerves
Beschreibung

Neurological Examination abnormalities - Cranial nerves

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-4
C0010268
Cranial nerves abnormalities
Beschreibung

Cranial Nerves; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Cranial Nerves

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0010268
Intensity of abnormality (cranial nerves)
Beschreibung

Abnormality; Severities; Cranial Nerves

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0010268
If other abnormality of cranial nerves, specify.
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
Neurological Examination abnormalities - Gait
Beschreibung

Neurological Examination abnormalities - Gait

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0016928
Gait abnormalities
Beschreibung

Gait; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C1704258
Check ifabnormality changed or appeared.
Beschreibung

Abnormality; Gait

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0016928
Intensity of abnormality (gait)
Beschreibung

Abnormality; Severities; Gait

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0016928
Neurological Examination abnormalities - Coordination
Beschreibung

Neurological Examination abnormalities - Coordination

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0242414
Coordination abnormalities
Beschreibung

Physiologic Coordination; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Physiologic Coordination

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0242414
Intensity of abnormality (coordination)
Beschreibung

Abnormality; Severities; Physiologic Coordination

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0242414
Neurological Examination abnormalities - Sensation
Beschreibung

Neurological Examination abnormalities - Sensation

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0036658
Sensation abnormalities
Beschreibung

Esthesia; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0036658
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Esthesia

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0036658
Intensity of abnormality (sensation)
Beschreibung

Abnormality; Severities; Esthesia

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0036658
Neurological Examination abnormalities - Muscle strength
Beschreibung

Neurological Examination abnormalities - Muscle strength

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0517349
Muscle strength abnormalities
Beschreibung

Muscle Strength; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Muscle Strength

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0517349
Intensity of abnormality (muscle strength)
Beschreibung

Abnormality; Severities; Muscle Strength

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0517349
Neurological Examination abnormalities - Muscle tone
Beschreibung

Neurological Examination abnormalities - Muscle tone

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0026841
Muscle tone abnormalities
Beschreibung

Muscle Tonus; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0026841
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Muscle Tonus

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0026841
Intensity of abnormality (muscle tone)
Beschreibung

Abnormality; Severities; Muscle Tonus

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0026841
Neurological Examination abnormalities - Reflexes
Beschreibung

Neurological Examination abnormalities - Reflexes

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1704258
UMLS CUI-3
C0034929
Reflexes abnormalities
Beschreibung

Reflex action; Abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034929
UMLS CUI [1,2]
C1704258
Check if abnormality changed or appeared.
Beschreibung

Abnormality; Reflex action

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0034929
Type of abnormality (reflexes)
Beschreibung

Abnormality; Type - attribute; Reflex action

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0034929
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Ähnliche Modelle

Vital Signs/Weight/ Height, Physical Examination, Neurological Examination - Follow-Up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
Item Group
Height
C0005890 (UMLS CUI-1)
Body Height; Length
Item
Hieght or lenght (if applicable)
float
C0005890 (UMLS CUI [1])
C1444754 (UMLS CUI [2])
Item
Method of collection
integer
C1516698 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Collection (action); Evaluation Method
Code List
Method of collection
CL Item
Height (1)
CL Item
Length (2)
Item Group
Physical Examination - Changes
C0031809 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
Changing; Clinical Significance
Item
Are there any clinically significant changes from the Baseline Phase (Study Week 8) information? If Yes, list changes below.
boolean
C0392747 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body region/ system
integer
C0460002 (UMLS CUI [1])
body system
Code List
Body region/ system
CL Item
Eyes (1)
CL Item
Ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Pulmonary (4)
CL Item
Abdomen (5)
CL Item
Lymph nodes (6)
CL Item
Extremities (7)
CL Item
Skin (8)
CL Item
Musculoskeletal (9)
CL Item
Other, specify (10)
body system; Other; Specification
Item
If other body region/ system, specify
text
C0460002 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Briefly specify change
integer
C0392747 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Finding
Code List
Briefly specify change
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examinated (3)
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])
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)
Item Group
Neurological Examination abnormalities - Mental status
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)
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])
Item
Check if mental status changed or appeared.
integer
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
undefined item
Code List
Check if mental status changed or appeared.
CL Item
Abnormal (1)
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)
Item Group
Neurological Examination abnormalities - Speech/ language
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Cranial nerves
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)
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)
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)
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])
Item Group
Neurological Examination abnormalities - Gait
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Coordination
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Sensation
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Muscle strength
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Muscle tone
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
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)
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)
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)
Item Group
Neurological Examination abnormalities - Reflexes
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
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)
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)
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)
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