ID

31938

Description

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

Keywords

Versions (3)
  1. 9/22/18 9/22/18 -
  2. 9/27/18 9/27/18 -
  3. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 2018

DOI

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License

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

English

Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site; Numbers

Data type

text

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

Person Initials

Data type

text

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

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Examination (Vital Signs/ Weight, Physical Examination)
Description

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

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

Physical Examination Date

Data type

date

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

Vital Signs/ Weight

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

Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse rate
Description

Pulse Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Body region/ system
Description

body system

Data type

integer

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

body system; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Finding
Description

Finding

Data type

integer

Alias
UMLS CUI [1]
C0243095
Abnormal physical finding
Description

Physical Examination Abnormal Finding

Data type

text

Alias
UMLS CUI [1]
C2826636
Neurological Examination - Date and Finding
Description

Neurological Examination - Date and Finding

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

Neurologic Examination; Date in time

Data type

date

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

Neurological examination normal | On examination - neurological findings

Data type

integer

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

Neurological Examination abnormalities - Mental status

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

Abnormality; Mental state

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
If other abnormal mental status, specify.
Description

Abnormality; Mental state; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Check if abnormal mental status.
Description

Abnormality; Mental state

Data type

integer

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

Abnormality; Severities | Mental state (observable entity)

Data type

integer

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

Neurological Examination abnormalities - Speech/ language

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

Speech Disorders | Languages; Abnormality

Data type

integer

Alias
UMLS CUI [1]
C0037822
UMLS CUI [2,1]
C0023008
UMLS CUI [2,2]
C1704258
Check if abnormal Speech/ language.
Description

Abnormality; Speech | Abnormality; Languages

Data type

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)
Description

Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages

Data type

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
Description

Neurological Examination abnormalities - Cranial nerves

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

Cranial Nerves; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C1704258
Check if abnormal cranial nerves.
Description

Abnormality; Cranial Nerves

Data type

integer

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

Abnormality; Severities; Cranial Nerves

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0010268
If other abnormality of cranial nerves, specify.
Description

Abnormality; Cranial Nerves; Other; Specification

Data type

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
Description

Neurological Examination abnormalities - Gait

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

Gait; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C1704258
Check if abnormal gait.
Description

Abnormality; Gait

Data type

integer

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

Abnormality; Severities; Gait

Data type

integer

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

Neurological Examination abnormalities - Coordination

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

Physiologic Coordination; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C1704258
Check if abnormal coordination.
Description

Abnormality; Physiologic Coordination

Data type

integer

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

Abnormality; Severities; Physiologic Coordination

Data type

integer

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

Neurological Examination abnormalities - Sensation

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

Esthesia; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0036658
UMLS CUI [1,2]
C1704258
Check if abnormal sensation.
Description

Abnormality; Esthesia

Data type

integer

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

Abnormality; Severities; Esthesia

Data type

integer

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

Neurological Examination abnormalities - Muscle strength

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

Muscle Strength; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C1704258
Check if abnormal muscle strength.
Description

Abnormality; Muscle Strength

Data type

integer

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

Abnormality; Severities; Muscle Strength

Data type

integer

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

Neurological Examination abnormalities - Muscle tone

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

Muscle Tonus; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0026841
UMLS CUI [1,2]
C1704258
Check if abnormal muscle tone.
Description

Abnormality; Muscle Tonus

Data type

integer

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

Abnormality; Severities; Muscle Tonus

Data type

integer

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

Neurological Examination abnormalities - Reflexes

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

Reflex action; Abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0034929
UMLS CUI [1,2]
C1704258
Check if abnormal reflexes.
Description

Abnormality; Reflex action

Data type

integer

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

Abnormality; Type - attribute; Reflex action

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0034929
Electroencephalogram
Description

Electroencephalogram

Alias
UMLS CUI-1
C0013819
Date of assessment
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Date of ECG
Description

Electrocardiogram Date

Data type

date

Alias
UMLS CUI [1]
C2826640
Ventricular rate
Description

electrocardiogram: ventricular rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR interval
Description

Electrocardiogram: P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QT
Description

QT interval - finding

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C1287082
sec
RR
Description

RR interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0489636
sec
QRS duration
Description

QRS complex duration (observable entity)

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429025
sec
ECG EITHER normal OR normal variants present/ Abnormalities present
Description

ECG normal | Electrocardiography; Variant; Normal | Electrocardiogram abnormal

Data type

integer

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C0205419
UMLS CUI [2,3]
C0205307
UMLS CUI [3]
C0522055
A. Rhythm
Description

Cardiac rhythm type

Data type

integer

Alias
UMLS CUI [1]
C0232187
B. Conduction
Description

Cardiac conduction

Data type

integer

Alias
UMLS CUI [1]
C0232217
C. Depolarization/ Repolarization (QRS-T)
Description

Ventricular Depolarization [PE] | Repolarization abnormalities

Data type

integer

Alias
UMLS CUI [1]
C1331539
UMLS CUI [2]
C3279217
Other ECG findings
Description

Electrocardiogram finding; Other

Data type

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0205394
If other ECG finding, specify.
Description

Electrocardiogram finding; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Comments/ Conclusion (ECG)
Description

Electrocardiography; Comment | Electrocardiography; Conclusion

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C1707478
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Similar models

Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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
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
Finding
integer
C0243095 (UMLS CUI [1])
Finding
Code List
Finding
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examinated (3)
Physical Examination Abnormal Finding
Item
Abnormal physical finding
text
C2826636 (UMLS CUI [1])
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 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)
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)
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 abnormal Speech/ language.
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 abnormal Speech/ language.
CL Item
Abnormal (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)
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 abnormal cranial nerves.
integer
C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])
undefined item
Code List
Check if abnormal cranial nerves.
CL Item
Abnormal (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)
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 if abnormal gait.
integer
C1704258 (UMLS CUI [1,1])
C0016928 (UMLS CUI [1,2])
Abnormality; Gait
Code List
Check if abnormal gait.
CL Item
Abnormal (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)
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 abnormal coordination.
integer
C1704258 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
undefined item
Code List
Check if abnormal coordination.
CL Item
Abnormal (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)
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 abnormal sensation.
integer
C1704258 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Abnormality; Esthesia
Code List
Check if abnormal sensation.
CL Item
Abnormal (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)
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 abnormal muscle strength.
integer
C1704258 (UMLS CUI [1,1])
C0517349 (UMLS CUI [1,2])
Abnormality; Muscle Strength
Code List
Check if abnormal muscle strength.
CL Item
Abnormal (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)
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 abnormal muscle tone.
integer
C1704258 (UMLS CUI [1,1])
C0026841 (UMLS CUI [1,2])
Abnormality; Muscle Tonus
Code List
Check if abnormal muscle tone.
CL Item
Abnormal (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)
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 abnormal reflexes.
integer
C1704258 (UMLS CUI [1,1])
C0034929 (UMLS CUI [1,2])
Abnormality; Reflex action
Code List
Check if abnormal reflexes.
CL Item
Abnormal (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)
Item Group
Electroencephalogram
C0013819 (UMLS CUI-1)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Electrocardiogram
C1623258 (UMLS CUI-1)
Electrocardiogram Date
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
electrocardiogram: ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR interval
float
C0429087 (UMLS CUI [1])
QT interval - finding
Item
QT
float
C1287082 (UMLS CUI [1])
RR interval
Item
RR
float
C0489636 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS duration
float
C0429025 (UMLS CUI [1])
Item
ECG EITHER normal OR normal variants present/ Abnormalities present
integer
C0522054 (UMLS CUI [1])
C1623258 (UMLS CUI [2,1])
C0205419 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C0522055 (UMLS CUI [3])
undefined item
Code List
ECG EITHER normal OR normal variants present/ Abnormalities present
CL Item
Normal (1)
CL Item
Normal variants present (comment below) (2)
CL Item
Abnormalities present (check abnormalities below) (3)
Item
A. Rhythm
integer
C0232187 (UMLS CUI [1])
Cardiac rhythm type
Code List
A. Rhythm
CL Item
Sinus brachycarida (1)
CL Item
Sinus tachycardia (2)
CL Item
Sinus pause (3)
CL Item
Ectopic supraventricular beats (4)
CL Item
Junctional rhythm (5)
CL Item
Supraventricular tachycardia (6)
CL Item
Atrial flutter (7)
CL Item
Atrial fibrillation (8)
CL Item
Ectopic ventricular beats (9)
CL Item
Ventricular escape rhythm (10)
CL Item
Ventricular tachycardia (11)
Item
B. Conduction
integer
C0232217 (UMLS CUI [1])
Cardiac conduction
Code List
B. Conduction
CL Item
First degree AV block (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
Third degree AV block (4)
CL Item
Left axis deviation  (5)
CL Item
Right axis deviation (6)
CL Item
Right bundle branch block (7)
CL Item
Left bundle branch block (8)
CL Item
Nonspecific intraventricular conduction delay (9)
CL Item
Accessory pathway (Wolff- Parkinson- White) (10)
CL Item
QTc prolongation (11)
Item
C. Depolarization/ Repolarization (QRS-T)
integer
C1331539 (UMLS CUI [1])
C3279217 (UMLS CUI [2])
undefined item
Code List
C. Depolarization/ Repolarization (QRS-T)
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, other- comment (2)
CL Item
Non- specific ST-T changes (3)
CL Item
Low QRS voltage (4)
Item
Other ECG findings
integer
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
undefined item
Code List
Other ECG findings
CL Item
Other (1)
Electrocardiogram finding; Other; Specification
Item
If other ECG finding, specify.
text
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiography; Comment | Electrocardiography; Conclusion
Item
Comments/ Conclusion (ECG)
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C1707478 (UMLS CUI [2,2])
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