ID

38161

Description

Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

English

Visit 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Description

Patient's initials

Data type

text

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

Patient's trial number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Centre number
Description

Centre number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Vital Signs
Description

Vital Signs

Systolic blood pressure sitting
Description

Systolic blood pressure sitting

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mm[Hg]
Diastolic blood pressure sitting
Description

Diastolic blood pressure sitting

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mm[Hg]
Pulse sitting
Description

Pulse sitting

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029904
beats/min
Weight
Description

Weight

Data type

float

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

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Are there any clinically significant changes from the screen examination?
Description

If yes, please list changes below

Data type

boolean

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0220908
Physical Examination - Changes
Description

Physical Examination - Changes

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0392747
Eyes
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0015392
Ears, Nose, Throat
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0278350
Cardiovascular
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0007226
Pulmonary
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C2709248
Abdomen
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0000726
Lymph Nodes
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0024204
Extremities
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0015385
Skin
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C1123023
Muskuloskeletal
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1]
C0026860
Other physical examination
Description

Briefly specify change from previous examination including additional/ new abnormalities found.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
Are there any clinically significant changes from the screen examination?
Description

If Yes, please list changes below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0027853
UMLS CUI [1,4]
C0220908
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
Behaviour
Description

Behaviour

Data type

integer

Alias
UMLS CUI [1]
C0004927
Behaviour - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0004927
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0004927
UMLS CUI [2,2]
C0184511
Vision
Description

Vision

Data type

integer

Alias
UMLS CUI [1]
C0042789
Vision - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0042789
UMLS CUI [2,2]
C0184511
Hearing
Description

Hearing

Data type

integer

Alias
UMLS CUI [1]
C0018767
Hearing - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0018767
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0018767
UMLS CUI [2,2]
C0184511
Speech
Description

Speech

Data type

integer

Alias
UMLS CUI [1]
C0037817
Speech - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0037817
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0037817
UMLS CUI [2,2]
C0184511
Non-verbal Communication
Description

Non-verbal Communication

Data type

integer

Alias
UMLS CUI [1]
C0558264
Non-verbal Communication - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0558264
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0558264
UMLS CUI [2,2]
C0184511
Cranial Nerves
Description

Cranial Nerves

Data type

integer

Alias
UMLS CUI [1]
C0010268
Cranial Nerves - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C1457868
UMLS CUI [2,1]
C0010268
UMLS CUI [2,2]
C0184511
Upper Limb Function
Description

Upper Limb Function

Data type

integer

Alias
UMLS CUI [1,1]
C1140618
UMLS CUI [1,2]
C0542341
Upper Limb function - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C1140618
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C1457868
UMLS CUI [2,1]
C1140618
UMLS CUI [2,2]
C0542341
UMLS CUI [2,3]
C0184511
Lower Limb function
Description

Lower Limb function

Data type

integer

Alias
UMLS CUI [1,1]
C0023216
UMLS CUI [1,2]
C0542341
Lower Limb function - Deterioration/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0023216
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C1457868
UMLS CUI [2,1]
C0023216
UMLS CUI [2,2]
C0542341
UMLS CUI [2,3]
C0184511
Fine Co-ordination
Description

Fine Co-ordination

Data type

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0205232
Fine Co-ordination - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0205232
UMLS CUI [1,3]
C1457868
UMLS CUI [2,1]
C0242414
UMLS CUI [2,2]
C0205232
UMLS CUI [2,3]
C0184511
Gross Co-ordination
Description

Gross Co-ordination

Data type

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0439806
Fine Co-ordination - Deteriorated/ Improved finding
Description

Please give brief details

Data type

text

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C1457868
UMLS CUI [2,1]
C0242414
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0184511
Other neurological examination
Description

Please specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0205394
Other neurological examination finding
Description

Other neurological examination finding

Data type

integer

Alias
UMLS CUI [1,1]
C0437208
UMLS CUI [1,2]
C0205394
Other neurological examination - Deteriorated/ Improved finding
Description

Other neurological examination - Deteriorated/ Improved finding

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457868
UMLS CUI [2,1]
C0027853
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0184511
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0018941
Haematology - Date sample collected
Description

Haematology - Date sample collected

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology - Laboratory number
Description

Haematology - Laboratory number

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0018941
Haemoglobin
Description

If any of the values are outside the Normal Ranges, please detail as follows NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0518015
Quantitative platelet count
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0032181
WBC
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0023508
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Clinical Chemistry - Date sample collected
Description

Clinical Chemistry - Date sample collected

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Clinical Chemistry - Laboratory number
Description

Clinical Chemistry - Laboratory number

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0008000
Creatinine
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201976
ALT (SGPT)
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201836
AST (SGOT)
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201899
Plasma Concentrations of AEDs
Description

Plasma Concentrations of AEDs

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0683150
AED plasma concentration - Date of sample
Description

AED plasma concentration - Date of sample

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0683150
Drug NOT including Study Medication
Description

Drug NOT including Study Medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
Time since last dose
Description

Time since last dose

Data type

integer

Measurement units
  • hrs
Alias
UMLS CUI [1,1]
C0946444
UMLS CUI [1,2]
C1711239
hrs
Medication Concentration Value
Description

Medication Concentration Value

Data type

float

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1522609
Medication Concentration Units
Description

Medication Concentration Units

Data type

text

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1519795
Compliance Record
Description

Compliance Record

Alias
UMLS CUI-1
C3714738
UMLS CUI-2
C0034869
Have the patient's study medication bottles been returned for Weeks 13 and 14?
Description

Have the patient's study medication bottles been returned for Weeks 13 and 14?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
Have the patient's study medication bottles been returned for Weeks 15 and 16?
Description

Have the patient's study medication bottles been returned for Weeks 15 and 16?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
If study medication has been returned, how many tablets were returned?
Description

If study medication has been returned, how many tablets were returned?

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Was the study medication taken as prescribed?
Description

Was the study medication taken as prescribed?

Data type

boolean

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0033080
If study medication has not been taken as prescribed, specify the reason
Description

If study medication has not been taken as prescribed, specify the reason

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0566251
Quality of Life
Description

Quality of Life

Alias
UMLS CUI-1
C0034380
Is the same person to complete the Quality of Life questionnaire as on Day0/ Visit2?
Description

Is the same person to complete the Quality of Life questionnaire as on Day0/ Visit2?

Data type

boolean

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1550483
Global Evaluation
Description

Global Evaluation

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C2348867
Investigator's global evaluation of seizure control
Description

Based on your knowledge of this patient and according to relevant factors (e.g. seizure intensity, duration, frequency), compare his/her status during this treatment to prior to entry into the study. Check one.

Data type

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2348867
UMLS CUI [1,3]
C0008961
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0243148
Parent/ Carer's evaluation of general health
Description

Ask for the parent's/ carer's opinion of the patient, comparing his/ her status during this treatment to prior to entry into the study. Check one.

Data type

integer

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0424575
UMLS CUI [1,3]
C0220825
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C0424575
UMLS CUI [2,3]
C0220825
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Similar models

Visit 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient's initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Vital Signs
Systolic blood pressure sitting
Item
Systolic blood pressure sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure sitting
Item
Diastolic blood pressure sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse sitting
Item
Pulse sitting
integer
C2029904 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Are there any clinically significant changes from the screen examination?
Item
Are there any clinically significant changes from the screen examination?
boolean
C2826293 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Item Group
Physical Examination - Changes
C0031809 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
Eyes
Item
Eyes
text
C0015392 (UMLS CUI [1])
Ears, Nose, Throat
Item
Ears, Nose, Throat
text
C0278350 (UMLS CUI [1])
Cardiovascular
Item
Cardiovascular
text
C0007226 (UMLS CUI [1])
Pulmonary
Item
Pulmonary
text
C2709248 (UMLS CUI [1])
Abdomen
Item
Abdomen
text
C0000726 (UMLS CUI [1])
Lymph Nodes
Item
Lymph Nodes
text
C0024204 (UMLS CUI [1])
Extremities
Item
Extremities
text
C0015385 (UMLS CUI [1])
Skin
Item
Skin
text
C1123023 (UMLS CUI [1])
Muskuloskeletal
Item
Muskuloskeletal
text
C0026860 (UMLS CUI [1])
Other physical examination
Item
Other physical examination
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Are there any clinically significant changes from the screen examination?
Item
Are there any clinically significant changes from the screen examination?
boolean
C0392747 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027853 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Item
Behaviour
integer
C0004927 (UMLS CUI [1])
Behaviour
Code List
Behaviour
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Behaviour - Deteriorated/ Improved finding
Item
Behaviour - Deteriorated/ Improved finding
text
C0004927 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0004927 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Vision
integer
C0042789 (UMLS CUI [1])
Vision
Code List
Vision
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Vision - Deteriorated/ Improved finding
Item
Vision - Deteriorated/ Improved finding
text
C0042789 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0042789 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Hearing
integer
C0018767 (UMLS CUI [1])
Hearing
Code List
Hearing
CL Item
Unchanged  (1)
CL Item
Deteriorated  (2)
CL Item
Improved (3)
Hearing - Deteriorated/ Improved finding
Item
Hearing - Deteriorated/ Improved finding
text
C0018767 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0018767 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Speech
integer
C0037817 (UMLS CUI [1])
Speech
Code List
Speech
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Speech - Deteriorated/ Improved finding
Item
Speech - Deteriorated/ Improved finding
text
C0037817 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0037817 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Non-verbal Communication
integer
C0558264 (UMLS CUI [1])
Non-verbal Communication
Code List
Non-verbal Communication
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Non-verbal Communication - Deteriorated/ Improved finding
Item
Non-verbal Communication - Deteriorated/ Improved finding
text
C0558264 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0558264 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Cranial Nerves
integer
C0010268 (UMLS CUI [1])
Cranial Nerves
Code List
Cranial Nerves
CL Item
Unchanged  (1)
CL Item
Deteriorated  (2)
CL Item
Improved (3)
Cranial Nerves - Deteriorated/ Improved finding
Item
Cranial Nerves - Deteriorated/ Improved finding
text
C0010268 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0010268 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
Item
Upper Limb Function
integer
C1140618 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
Upper Limb Function
Code List
Upper Limb Function
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Upper Limb function - Deteriorated/ Improved finding
Item
Upper Limb function - Deteriorated/ Improved finding
text
C1140618 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C1140618 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Item
Lower Limb function
integer
C0023216 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
Lower Limb function
Code List
Lower Limb function
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Lower Limb function - Deterioration/ Improved finding
Item
Lower Limb function - Deterioration/ Improved finding
text
C0023216 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0023216 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Item
Fine Co-ordination
integer
C0242414 (UMLS CUI [1,1])
C0205232 (UMLS CUI [1,2])
Fine Co-ordination
Code List
Fine Co-ordination
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Fine Co-ordination - Deteriorated/ Improved finding
Item
Fine Co-ordination - Deteriorated/ Improved finding
text
C0242414 (UMLS CUI [1,1])
C0205232 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0242414 (UMLS CUI [2,1])
C0205232 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Item
Gross Co-ordination
integer
C0242414 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Gross Co-ordination
Code List
Gross Co-ordination
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
CL Item
Improved (3)
Fine Co-ordination - Deteriorated/ Improved finding
Item
Fine Co-ordination - Deteriorated/ Improved finding
text
C0242414 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0242414 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Other neurological examination
Item
Other neurological examination
text
C0027853 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other neurological examination finding
integer
C0437208 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other neurological examination finding
Code List
Other neurological examination finding
CL Item
Unchanged (1)
CL Item
Deteriorated (2)
Other neurological examination - Deteriorated/ Improved finding
Item
Other neurological examination - Deteriorated/ Improved finding
text
C0027853 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0027853 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Item Group
Haematology
C0018941 (UMLS CUI-1)
Haematology - Date sample collected
Item
Haematology - Date sample collected
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory number
Item
Haematology - Laboratory number
text
C2986056 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haemoglobin
Item
Haemoglobin
text
C0518015 (UMLS CUI [1])
Quantitative platelet count
Item
Quantitative platelet count
text
C0032181 (UMLS CUI [1])
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry - Date sample collected
Item
Clinical Chemistry - Date sample collected
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Clinical Chemistry - Laboratory number
Item
Clinical Chemistry - Laboratory number
text
C2986056 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
text
C0201976 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
text
C0201836 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
text
C0201899 (UMLS CUI [1])
Item Group
Plasma Concentrations of AEDs
C0003299 (UMLS CUI-1)
C0683150 (UMLS CUI-2)
AED plasma concentration - Date of sample
Item
AED plasma concentration - Date of sample
date
C1302413 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0683150 (UMLS CUI [1,3])
Item
Drug NOT including Study Medication
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Drug NOT including Study Medication
Code List
Drug NOT including Study Medication
CL Item
Acetazoiamide  (ACE)
CL Item
Carbamazepine  (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Clobazam  (CLB)
CL Item
Clonazepam  (CZP)
CL Item
Diazepam  (DZP)
CL Item
Ethosuximide  (ESM)
CL Item
Flunarizine  (FNR)
CL Item
Hydrocortisone  (HC)
CL Item
Lorazepam  (LZP)
CL Item
Nitrazepam  (NZP)
CL Item
Oxcarbazepine  (OCZ)
CL Item
Phenobarbitone  (PB)
CL Item
Phenytoin  (PHT)
CL Item
Primidone  (PRM)
CL Item
Sulthiame  (SUL)
CL Item
Valproate Sodium  (VPA)
CL Item
Vigabatrin (VGB)
Time since last dose
Item
Time since last dose
integer
C0946444 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
Medication Concentration Value
Item
Medication Concentration Value
float
C0683150 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Medication Concentration Units
Item
Medication Concentration Units
text
C0683150 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Item Group
Compliance Record
C3714738 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
Have the patient's study medication bottles been returned for Weeks 13 and 14?
Item
Have the patient's study medication bottles been returned for Weeks 13 and 14?
boolean
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Have the patient's study medication bottles been returned for Weeks 15 and 16?
Item
Have the patient's study medication bottles been returned for Weeks 15 and 16?
boolean
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
If study medication has been returned, how many tablets were returned?
Item
If study medication has been returned, how many tablets were returned?
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Was the study medication taken as prescribed?
Item
Was the study medication taken as prescribed?
boolean
C3854006 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
Item
If study medication has not been taken as prescribed, specify the reason
integer
C3854006 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
If study medication has not been taken as prescribed, specify the reason
Code List
If study medication has not been taken as prescribed, specify the reason
CL Item
Disliked taste/ unable to chew or drink study medication (1)
CL Item
Lost study medication (2)
CL Item
Forgot to take study medication (3)
CL Item
Other (4)
Item Group
Quality of Life
C0034380 (UMLS CUI-1)
Is the same person to complete the Quality of Life questionnaire as on Day0/ Visit2?
Item
Is the same person to complete the Quality of Life questionnaire as on Day0/ Visit2?
boolean
C0034380 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,3])
Item Group
Global Evaluation
C0220825 (UMLS CUI-1)
C2348867 (UMLS CUI-2)
Item
Investigator's global evaluation of seizure control
integer
C0220825 (UMLS CUI [1,1])
C2348867 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0036572 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
Investigator's global evaluation of seizure control
Code List
Investigator's global evaluation of seizure control
CL Item
Marked Deterioration (1)
CL Item
Some Deterioration (2)
CL Item
No Change (3)
CL Item
Some Improvement (4)
CL Item
Marked Improvement (5)
Item
Parent/ Carer's evaluation of general health
integer
C0030551 (UMLS CUI [1,1])
C0424575 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0424575 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Parent/ Carer's evaluation of general health
Code List
Parent/ Carer's evaluation of general health
CL Item
Marked Deterioration (1)
CL Item
Some Deterioration (2)
CL Item
No Change (3)
CL Item
Some Improvement (4)
CL Item
Marked Improvement (5)
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