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])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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
durationDatetime
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])
Since the last assessment has the patient had any changes in his/ her health?
Item
Since the last assessment has the patient had any changes in his/ her health?
boolean
C1516048 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0018759 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
Since the last assessment has the patient had any changes in concomitant AED medication?
Item
Since the last assessment has the patient had any changes in concomitant AED medication?
boolean
C1516048 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0003299 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
Since the last assessment has the patient had emergency AED therapy?
Item
Since the last assessment has the patient had emergency AED therapy?
boolean
C1516048 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Since the last assessment has the patient had any changes in concomitant medication other than AEDs?
Item
Since the last assessment has the patient had any changes in concomitant medication other than AEDs?
boolean
C1516048 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Are inclusion and exclusion criteria at Screen still satisfied?
Item
Are inclusion and exclusion criteria at Screen still satisfied?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C4084799 (UMLS CUI [1,4])
Are the results of an EEG during sleep and awake states available?
Item
Are the results of an EEG during sleep and awake states available?
boolean
C0013819 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0013819 (UMLS CUI [2,1])
C0234422 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Does the patient have any clinically significant abnormalities in the laboratory tests taken at screen?
Item
Does the patient have any clinically significant abnormalities in the laboratory tests taken at screen (those attributable to enzyme induction by concomitant AEDs are acceptable)?
boolean
C0438215 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0014431 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0003299 (UMLS CUI [2,3])
Patient's Randomisation Number
Item
Patient's Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Patient's treatment group
integer
C1522541 (UMLS CUI [1])
Code List
Patient's treatment group
CL Item
Group 1 (patients taking sodium valporate and body weight between 15 kg and 25 kg inclusive) (1)
CL Item
Group 2 (patients taking sodium valporate and body weight >25 kg) (2)
CL Item
Group 3 (patients not taking sodium valporate and body weight <= 25 kg) (3)
CL Item
Group 4 (patients not taking sodium valporate and body weight > 25 kg) (4)
Item
Have the patient's Study medication bottles been returned for . . .
integer
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Code List
Have the patient's Study medication bottles been returned for . . .
CL Item
WEEKS -4 and -3 (1)
CL Item
WEEKS -2 and -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
C0304229 (UMLS CUI [1,1])
C2699071 (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 the study medication has not been taken as prescripted, specify the reasons.
integer
C3854006 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Code List
If the study medication has not been taken as prescripted, specify the reasons.
CL Item
disliked taste/unable to chew or drink study medication (1)
CL Item
Iost study medication (2)
CL Item
forgot to take study medication (3)
Have any adverse experiences occured during the trial?
Item
Have any adverse experiences occured during the trial?
boolean
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Occurence
Item
Adverse Experience Occurence
durationDatetime
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item
Adverse Experience ongoing at the end of study
integer
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Adverse Experience ongoing at the end of study
CL Item
ongoing at end of study (1)
Item
Adverse Experience Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Adverse Experience Intensity
Item
Adverse Experience Seriousness
integer
C1710056 (UMLS CUI [1])
Code List
Adverse Experience Seriousness
CL Item
Serious - Life-threatening (2)
CL Item
Serious - Fatal (3)
CL Item
Serious - Other (4)
Item
Attributability to study drug
integer
C0304229 (UMLS CUI [1,1])
C0596130 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Attributability to study drug
CL Item
Not reasonably (1)
Item
Action taken with study drug
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with study drug
CL Item
dosage unchanged (1)
CL Item
dosage adjusted (2)
CL Item
stopped permanently (3)
Other action taken
Item
Other action taken
boolean
C1547656 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Since the Screen assessment, has the patient had any changes in concomitant AED medications?
Item
Since the Screen assessment, has the patient had any changes in concomitant AED medications?
boolean
C0220908 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0003299 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,4])
Item
Drug
text
C0013227 (UMLS CUI [1])
CL Item
Acetazolamide (ACE)
CL Item
Carbamazepine (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Ethosuximide (ESM)
CL Item
Flunarizine (FNR)
CL Item
Hydrocortisone (HC)
CL Item
Lamotrigine (LTG)
CL Item
Oxcarbazepine (OCZ)
CL Item
Phenobarbitone (PB)
CL Item
ValproateSudium (VPA)
Total daily dose
Item
Total daily dose
float
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Date of change
Item
Date of change
date
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Reason for change
Item
Reason for change
text
C0443172 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Was any additional emergency AED therapy given during the study?
Item
Was any additional emergency AED therapy given during the study?
boolean
C0003299 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Emergency AED therapy Dates
Item
Emergency AED therapy Dates
durationDatetime
C0003299 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Emergency AED therapy - Drug
text
C0003299 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Emergency AED therapy - Drug
CL Item
Acetazolamide (ACE)
CL Item
Carbamazepine (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Ethosuximide (ESM)
CL Item
Flunarizine (FNR)
CL Item
Hydrocortisone (HC)
CL Item
Lamotrigine (LTG)
CL Item
Oxcarbazepine (OCZ)
CL Item
Phenobarbitone (PB)
CL Item
ValproateSudium (VPA)
Emergency AED Threapy - Total Daily Dose
Item
Emergency AED Therapy - Total Daily Dose
float
C0003299 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
Item
Emergency AED Therapy - Route
text
C0003299 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Code List
Emergency AED Therapy - Route
CL Item
Intramuscular (IM)
Emergency AED Therapy - Reason
Item
Emergency AED Therapy - Reason
text
C0003299 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Were any additional medications taken during the study?
Item
Were any additional medications taken during the study?
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Date first taken during study
Item
Date first taken during study
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Other Concomitant Medication - Drug
Item
Other Concomitant Medication - Drug
text
C2347852 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If given for an Adverse Experience, please give AE number
Item
If given for an Adverse Experience, please give AE number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Week
integer
C0439230 (UMLS CUI [1])
Date of Day 1
Item
Date of Day 1
date
C0011008 (UMLS CUI [1])
Item
Day
integer
C0439228 (UMLS CUI [1])
Number of Drop Attacks - Atonic
Item
Number of Drop Attacks - Atonic
integer
C0086236 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of Drop Attacks - Tonic
Item
Number of Drop Attacks - Tonic
integer
C0270844 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of Drop Attacks - Major Myoclonic
Item
Number of Drop Attacks - Major Myoclonic
integer
C0014550 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Atypical Abscence Seizure
Item
Date of Atypical Abscence Seizure
date
C0595948 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Atypical Abscence Seizure
Item
Time of Atypical Abscence Seizure
time
C0595948 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Number of atypical abscence seizures in ONE hour
Item
Number of atypical abscence seizures in ONE hour
integer
C0595948 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Atypical abscence seizures counted by
integer
C0595948 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Code List
Atypical abscence seizures counted by
CL Item
parent/ carer (1)
CL Item
clinic/ hospital staff member (2)