Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Antiepileptic drugs history
C0003299 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Antiepileptic Agents | C0013230 Investigational New Drugs; C2828389 Exclusion
Item
Antiepileptic drugs - Excluding investigational drugs
text
C0003299 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Item
Reason for discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
Reason for discontinuation
CL Item
Ineffectiveness (1)
CL Item
Adverse reaction (2)
Adverse event; Specification
Item
Specify adverse reaction
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Indication of (contextual qualifier); Discontinuation (procedure); Other; Specification
Item
If other reason for discontinuation, specify.
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Current antiepileptic drugs information
C0003299 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Antiepileptic Agents
Item
Antiepileptic drug
text
C0003299 (UMLS CUI [1])
Length; Antiepileptic Agents; Duration (temporal concept)
Item
Length of time on drug
float
C1444754 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
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])
Code List
Method of collection
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body region/ system
integer
C0460002 (UMLS CUI [1])
Code List
Body region/ system
CL Item
Ears, nose, throat (2)
CL Item
Cardiovascular (3)
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])
CL Item
Not examinated (3)
Physical Examination Abnormal Finding
Item
Abnormal physical finding
text
C2826636 (UMLS CUI [1])
Item Group
Neurological Examination Finding
C0437208 (UMLS CUI-1)
Item
Exam- either normal OR abnormalities present
integer
C1112287 (UMLS CUI [1])
C0437208 (UMLS CUI [2])
Code List
Exam- either normal OR abnormalities present
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])
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])
Code List
Check if abnormal mental status.
Item
Intensity of abnormality (mental status)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])
Code List
Intensity of abnormality (mental status)
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])
Code List
Speech/ language abnormalities
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])
Code List
Check if abnormal Speech/ language.
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])
Code List
Intensity of abnormality (speech/ language)
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])
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])
Code List
Check if abnormal cranial nerves.
Item
Intensity of abnormality (cranial nerves)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
Code List
Intensity of abnormality (cranial nerves)
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])
Code List
Gait abnormalities
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])
Code List
Check if abnormal gait.
Item
Intensity of abnormality (gait)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
Code List
Intensity of abnormality (gait)
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])
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)
Item
Check if abnormal coordination.
integer
C1704258 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Code List
Check if abnormal coordination.
Item
Intensity of abnormality (coordination)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
Code List
Intensity of abnormality (coordination)
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])
Code List
Sensation abnormalities
CL Item
Romberg positive (5)
Item
Check if abnormal sensation.
integer
C1704258 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Code List
Check if abnormal sensation.
Item
Intensity of abnormality (sensation)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
Code List
Intensity of abnormality (sensation)
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])
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])
Code List
Check if abnormal muscle strength.
Item
Intensity of abnormality (muscle strength)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
Code List
Intensity of abnormality (muscle strength)
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])
Code List
Muscle tone abnormalities
Item
Check if abnormal muscle tone.
integer
C1704258 (UMLS CUI [1,1])
C0026841 (UMLS CUI [1,2])
Code List
Check if abnormal muscle tone.
Item
Intensity of abnormality (muscle tone)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
Code List
Intensity of abnormality (muscle tone)
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])
Code List
Reflexes abnormalities
CL Item
Brachioradialis left (3)
CL Item
Brachioradialis right (4)
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])
Code List
Check if abnormal reflexes.
Item
Type of abnormality (reflexes)
integer
C1704258 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
Code List
Type of abnormality (reflexes)
Item Group
Electroencephalogram
C0013819 (UMLS CUI-1)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])