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])
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])
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])
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])
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
Behaviour
integer
C0004927 (UMLS CUI [1])
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 - 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 - 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 - 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])
Code List
Non-verbal Communication
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 - 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])
Code List
Upper Limb Function
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])
Code List
Lower Limb function
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])
Code List
Fine Co-ordination
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])
Code List
Gross Co-ordination
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])
Code List
Other neurological examination finding
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])
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])
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])
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])
Code List
Drug NOT including Study Medication
CL Item
Acetazoiamide (ACE)
CL Item
Carbamazepine (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Ethosuximide (ESM)
CL Item
Flunarizine (FNR)
CL Item
Hydrocortisone (HC)
CL Item
Oxcarbazepine (OCZ)
CL Item
Phenobarbitone (PB)
CL Item
Valproate Sodium (VPA)
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])
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])
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)
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
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])
Code List
Investigator's global evaluation of seizure control
CL Item
Marked Deterioration (1)
CL Item
Some Deterioration (2)
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])
Code List
Parent/ Carer's evaluation of general health
CL Item
Marked Deterioration (1)
CL Item
Some Deterioration (2)
CL Item
Some Improvement (4)
CL Item
Marked Improvement (5)