ID

44910

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. 9/27/18 9/27/18 -
  2. 10/8/18 10/8/18 -
  3. 4/7/22 4/7/22 - Martin Dugas
Copyright Holder

GlaxoSmithKline

Uploaded on

April 7, 2022

DOI

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License

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

English

Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

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
Study Continuitation Record - Date of assessment
Description

Study Continuitation Record - Date of assessment

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

Assessment Date

Data type

date

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

Study Continuitation Record - Eligibility Criteria

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1516637
Has this patient become menarcheal since the last clinic visit?
Description

Menarche; Visit; Last; Since

Data type

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?
Description

If the answer is No, the patient will be withdrawn from the study.

Data type

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?
Description

If the answer is No, the patient will be withdrawn from the study.

Data type

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?
Description

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.

Data type

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)
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
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 abnormality changed or appeared.
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 abnormality changed or appeared.
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 ifabnormality changed or appeared.
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 abnormality changed or appeared.
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 abnormality changed or appeared.
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 abnormality changed or appeared.
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 abnormality changed or appeared.
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 abnormality changed or appeared.
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
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

text

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
Laboratory - Date sample collected
Description

Laboratory - Date sample collected

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1302413
Date sample collected
Description

Specimen collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Laboratory finding
Description

Laboratory finding

Alias
UMLS CUI-1
C0587081
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?
Description

If yes, comment on all significant laboratory parameter(s). Identify the parameter(s).

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C4055646
Laboratory results that are of potential or actual clinical significance and unexpected
Description

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

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C2826293
UMLS CUI-3
C4055646
Laboratory parameter
Description

Laboratory; Parameter Value

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0549193
Comment (Laboratory parameter)
Description

Comment | Laboratory; Parameter Value

Data type

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0549193
Clinical laboratory examination - Hematology
Description

Clinical laboratory examination - Hematology

Alias
UMLS CUI-1
C0260877
UMLS CUI-2
C0205210
UMLS CUI-3
C0018943
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
MCV
Description

Erythrocyte Mean Corpuscular Volume Measurement

Data type

float

Alias
UMLS CUI [1]
C1948043
Quantitative platelet count
Description

Platelet Count measurement

Data type

float

Alias
UMLS CUI [1]
C0032181
WBC
Description

White Blood Cell Count procedure

Data type

float

Alias
UMLS CUI [1]
C0023508
Differential WBC
Description

Differential white blood cell count procedure

Data type

float

Alias
UMLS CUI [1]
C0162401
Clinical laboratory examination - Clinical chemistry
Description

Clinical laboratory examination - Clinical chemistry

Alias
UMLS CUI-1
C0260877
UMLS CUI-2
C0205210
UMLS CUI-3
C0008000
Sodium
Description

Sodium measurement

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Potassium
Description

Potassium measurement

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Bicarbonate
Description

Bicarbonate measurement

Data type

float

Alias
UMLS CUI [1]
C0202059
Creatinine
Description

Creatinine measurement, serum (procedure)

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0201976
mg/dl
Total Bilirubin
Description

Bilirubin, total measurement

Data type

float

Alias
UMLS CUI [1]
C0201913
Alkaline Phosphatase
Description

Alkaline phosphatase measurement

Data type

float

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Description

Aspartate aminotransferase measurement

Data type

float

Alias
UMLS CUI [1]
C0201899
ALT (SGTP)
Description

Alanine aminotransferase measurement

Data type

float

Alias
UMLS CUI [1]
C0201836
Albumin
Description

Albumin measurement

Data type

float

Alias
UMLS CUI [1]
C0201838
Glucose
Description

Plasma Glucose Measurement

Data type

float

Alias
UMLS CUI [1]
C0202042
Dipstick Urinalysis
Description

Dipstick Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urine Protein
Description

Urine total protein measurement

Data type

float

Alias
UMLS CUI [1]
C0428541
Urine Blood
Description

Urine dipstick for blood

Data type

text

Alias
UMLS CUI [1]
C0430372
Serum pregnancy (for females of childbearing potential only)
Description

Serum pregnancy (for females of childbearing potential only)

Alias
UMLS CUI-1
C0430060
Serum pregnancy
Description

Serum pregnancy test (B-HCG)

Data type

text

Alias
UMLS CUI [1]
C0430060
AED plasma concentration
Description

AED plasma concentration

Alias
UMLS CUI-1
C0683150
UMLS CUI-2
C0003299
AED plasma concentration (trough)
Description

plasma concentration; Antiepileptic Agents; Trough

Data type

text

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0444506
Urine Creatinine
Description

Urine Creatinine

Alias
UMLS CUI-1
C1318439
Urine Creatinine
Description

Urine creatinine measurement

Data type

float

Alias
UMLS CUI [1]
C1318439
Plasma Samples
Description

Plasma Samples

Alias
UMLS CUI-1
C0444263
Antiepileptic drug (trough)
Description

Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled AED dose, as close to the dose as is reasonably possible.

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0444506
Study Medication (trough) - Date and Time sample drawn
Description

Draw blood samples at a time that is constant for the patient throughout the study (+/- 30 minutes) and prior to the next scheduled anticipated study medication dose, as close to the dose as is reasonably possible.

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0444506
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0200345
Last dose of study medication - Date and Time
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0946444
Last dose of study medication - Amount
Description

Experimental drug; Dosage

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
mg
The Patient's Clinical Status
Description

The Patient's Clinical Status

Alias
UMLS CUI-1
C0449440
Date of assessment
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Clinical Status Finding
Description

Clinical Status Finding

Alias
UMLS CUI-1
C0449440
UMLS CUI-2
C0243095
Clinical factors
Description

undefined item

Data type

integer

Clinical Status
Description

Clinical status

Data type

integer

Alias
UMLS CUI [1]
C0449440
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Similar models

Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

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
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
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)
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)
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])
ECG normal | Electrocardiography; Variant; Normal | Electrocardiogram abnormal
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])
Ventricular Depolarization [PE] | Repolarization abnormalities
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)
Electrocardiogram finding; Other
Item
Other ECG findings
text
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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])
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])
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])
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])
Item Group
Clinical laboratory examination - Hematology
C0260877 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0018943 (UMLS CUI-3)
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Erythrocyte Mean Corpuscular Volume Measurement
Item
MCV
float
C1948043 (UMLS CUI [1])
Platelet Count measurement
Item
Quantitative platelet count
float
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
WBC
float
C0023508 (UMLS CUI [1])
Differential white blood cell count procedure
Item
Differential WBC
float
C0162401 (UMLS CUI [1])
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])
Item Group
Dipstick Urinalysis
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Urine total protein measurement
Item
Urine Protein
float
C0428541 (UMLS CUI [1])
Urine dipstick for blood
Item
Urine Blood
text
C0430372 (UMLS CUI [1])
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])
Item Group
AED plasma concentration
C0683150 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
plasma concentration; Antiepileptic Agents; Trough
Item
AED plasma concentration (trough)
text
C0683150 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
Item Group
Urine Creatinine
C1318439 (UMLS CUI-1)
Urine creatinine measurement
Item
Urine Creatinine
float
C1318439 (UMLS CUI [1])
Item Group
Plasma Samples
C0444263 (UMLS CUI-1)
Plasma specimen | Antiepileptic Agents; Trough
Item
Antiepileptic drug (trough)
text
C0003299 (UMLS CUI [1,1])
C0444506 (UMLS CUI [1,2])
Experimental drug; Trough | Date in time; Time; Specimen Collection
Item
Study Medication (trough) - Date and Time sample drawn
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
Last dose of study medication - Date and Time
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
Last dose of study medication - Amount
float
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
The Patient's Clinical Status
C0449440 (UMLS CUI-1)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Clinical Status Finding
C0449440 (UMLS CUI-1)
C0243095 (UMLS CUI-2)
Item
Clinical factors
integer
undefined item
Code List
Clinical factors
CL Item
Seizure frequency (1)
(Comment:en)
CL Item
Seizure duration (2)
(Comment:en)
CL Item
Seizure intensity (3)
(Comment:en)
CL Item
Adverse Experiences (4)
(Comment:en)
CL Item
Patient's perception of his/ her well- being (5)
(Comment:en)
CL Item
Social functioning (6)
(Comment:en)
CL Item
Intellectual functioning (7)
(Comment:en)
CL Item
Motor functioning (8)
(Comment:en)
CL Item
Overall Status (9)
(Comment:en)
Item
Clinical Status
integer
C0449440 (UMLS CUI [1])
Clinical status
Code List
Clinical Status
CL Item
Marked deterioration (1)
CL Item
Moderate deterioration (2)
CL Item
Mild deterioration (3)
CL Item
No change (4)
CL Item
Mild improvement (5)
CL Item
Moderate improvement (6)
CL Item
Marked improvement (7)
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