ID

38153

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 2; 3; 4; 5; 6 - Dispensing Record; Adverse Experiences; Concomitant Medication; Seizure Counts

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
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
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

durationDatetime

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
Adverse Experiences and Concomitant Medication
Description

Adverse Experiences and Concomitant Medication

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
Since the last assessment has the patient had any changes in his/ her health?
Description

Since the last assessment has the patient had any changes in his/ her health?

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C0018759
UMLS CUI [2,2]
C0392747
Since the last assessment has the patient had any changes in concomitant AED medication?
Description

Since the last assessment has the patient had any changes in concomitant AED medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0003299
UMLS CUI [2,3]
C0392747
Since the last assessment has the patient had emergency AED therapy?
Description

Since the last assessment has the patient had emergency AED therapy?

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C0013956
UMLS CUI [2,3]
C0087111
Since the last assessment has the patient had any changes in concomitant medication other than AEDs?
Description

Since the last assessment has the patient had any changes in concomitant medication other than AEDs?

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0205394
Admission Criteria
Description

Admission Criteria

Alias
UMLS CUI-1
C0809949
UMLS CUI-2
C0243161
Are inclusion and exclusion criteria at Screen still satisfied?
Description

Are inclusion and exclusion criteria at Screen still satisfied?

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0220908
UMLS CUI [1,4]
C4084799
Are the results of an EEG during sleep and awake states available?
Description

Are the results of an EEG during sleep and awake states available?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0013819
UMLS CUI [2,2]
C0234422
UMLS CUI [2,3]
C0470187
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)?
Description

Does the patient have any clinically significant abnormalities in the laboratory tests taken at screen?

Data type

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C0014431
UMLS CUI [2,2]
C2347852
UMLS CUI [2,3]
C0003299
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Patient's Randomisation Number
Description

Patient's Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Patient's treatment group
Description

Please check one.

Data type

integer

Alias
UMLS CUI [1]
C1522541
Compliance Record
Description

Compliance Record

Alias
UMLS CUI-1
C1321605
Have the patient's Study medication bottles been returned for . . .
Description

Have the patient's Study medication bottles been returned for . . .

Data type

integer

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]
C0304229
UMLS CUI [1,2]
C2699071
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 the study medication has not been taken as prescripted, specify the reasons.
Description

Please check one.

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0392360
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Have any adverse experiences occured during the trial?
Description

Have any adverse experiences occured during the trial?

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Adverse Experience
Description

Adverse Experience

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse Experience Occurence
Description

Adverse Experience Occurence

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
Adverse Experience ongoing at the end of study
Description

Adverse Experience ongoing at the end of study

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
Adverse Experience Intensity
Description

Adverse Experience Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Adverse Experience Seriousness
Description

Adverse Experience Seriousness

Data type

integer

Alias
UMLS CUI [1]
C1710056
Attributability to study drug
Description

Attributability to study drug

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0596130
UMLS CUI [1,3]
C0877248
Action taken with study drug
Description

Action taken with study drug

Data type

integer

Alias
UMLS CUI [1]
C2826626
Other action taken
Description

Other action taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0205394
Comments
Description

Include other action taken

Data type

text

Alias
UMLS CUI [1]
C0947611
Concomitant AED Medication
Description

Concomitant AED Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0003299
Since the Screen assessment, has the patient had any changes in concomitant AED medications?
Description

If yes, please record below

Data type

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0003299
UMLS CUI [1,4]
C0392747
Concomitant AED Medication
Description

Concomitant AED Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0003299
Drug
Description

use AED Abbreviation

Data type

text

Alias
UMLS CUI [1]
C0013227
Total daily dose
Description

Total daily dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
mg
Date of change
Description

Date of change

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
Reason for change
Description

Reason for change

Data type

text

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C0392360
Emergency AED Therapy used irregularly as required
Description

Emergency AED Therapy used irregularly as required

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0013956
UMLS CUI-3
C0205271
Was any additional emergency AED therapy given during the study?
Description

Was any additional emergency AED therapy given during the study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C1524062
Emergency AED Therapy used irregularly as required
Description

Emergency AED Therapy used irregularly as required

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0013956
UMLS CUI-3
C0205271
Emergency AED therapy Dates
Description

Emergency AED therapy Dates

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0011008
Emergency AED therapy - Drug
Description

Emergency AED therapy - Drug

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0013227
Emergency AED Therapy - Total Daily Dose
Description

Emergency AED Threapy - Total Daily Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0439810
mg
Emergency AED Therapy - Route
Description

Emergency AED Therapy - Route

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013153
Emergency AED Therapy - Reason
Description

Emergency AED Therapy - Reason

Data type

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0392360
Concomitant Medication other than AEDs
Description

Concomitant Medication other than AEDs

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0003299
UMLS CUI-3
C0205394
Were any additional medications taken during the study?
Description

If Yes, please record below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
Concomitant Medication other than AEDs
Description

Concomitant Medication other than AEDs

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0003299
UMLS CUI-3
C0205394
Date first taken during study
Description

Date first taken during study

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1883727
Other Concomitant Medication - Drug
Description

generic name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0205394
If given for an Adverse Experience, please give AE number
Description

If given for an Adverse Experience, please give AE number

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Seizure Record
Description

Seizure Record

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0034869
Week
Description

Week

Data type

integer

Alias
UMLS CUI [1]
C0439230
Date of Day 1
Description

Date of Day 1

Data type

date

Alias
UMLS CUI [1]
C0011008
Day
Description

Day

Data type

integer

Alias
UMLS CUI [1]
C0439228
Number of Drop Attacks - Atonic
Description

Number of Drop Attacks - Atonic

Data type

integer

Alias
UMLS CUI [1,1]
C0086236
UMLS CUI [1,2]
C0237753
Number of Drop Attacks - Tonic
Description

Number of Drop Attacks - Tonic

Data type

integer

Alias
UMLS CUI [1,1]
C0270844
UMLS CUI [1,2]
C0237753
Number of Drop Attacks - Major Myoclonic
Description

Number of Drop Attacks - Major Myoclonic

Data type

integer

Alias
UMLS CUI [1,1]
C0014550
UMLS CUI [1,2]
C0237753
Atypical Absence Seizures (1 Hour Count)
Description

Atypical Absence Seizures (1 Hour Count)

Alias
UMLS CUI-1
C0595948
UMLS CUI-2
C0439227
Date of Atypical Abscence Seizure
Description

Date of Atypical Abscence Seizure

Data type

date

Alias
UMLS CUI [1,1]
C0595948
UMLS CUI [1,2]
C0011008
Time of Atypical Abscence Seizure
Description

Time of Atypical Abscence Seizure

Data type

time

Alias
UMLS CUI [1,1]
C0595948
UMLS CUI [1,2]
C0040223
Number of atypical abscence seizures in ONE hour
Description

Number of atypical abscence seizures in ONE hour

Data type

integer

Alias
UMLS CUI [1,1]
C0595948
UMLS CUI [1,2]
C0237753
Atypical abscence seizures counted by
Description

Please check one.

Data type

integer

Alias
UMLS CUI [1,1]
C0595948
UMLS CUI [1,2]
C0750480
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Similar models

Visit 2; 3; 4; 5; 6 - Dispensing Record; Adverse Experiences; Concomitant Medication; Seizure Counts

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])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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
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])
Item Group
Adverse Experiences and Concomitant Medication
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
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])
Item Group
Admission Criteria
C0809949 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
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])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
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])
Patient's treatment group
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 Group
Compliance Record
C1321605 (UMLS CUI-1)
Item
Have the patient's Study medication bottles been returned for . . .
integer
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Have the patient's Study medication bottles been returned for . . .
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])
If the study medication has not been taken as prescripted, specify the reasons.
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)
CL Item
other (4)
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
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])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
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])
Adverse Experience ongoing at the end of study
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])
Intensity
Code List
Adverse Experience Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Adverse Experience Seriousness
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Adverse Experience Seriousness
CL Item
Not serious (1)
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])
Attributability to study drug
Code List
Attributability to study drug
CL Item
Not reasonably (1)
CL Item
Possibly (2)
CL Item
Reasonably (3)
Item
Action taken with study drug
integer
C2826626 (UMLS CUI [1])
Action taken with study drug
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])
Item Group
Concomitant AED Medication
C2347852 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
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 Group
Concomitant AED Medication
C2347852 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
Item
Drug
text
C0013227 (UMLS CUI [1])
Drug
Code List
Drug
CL Item
Acetazolamide (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
Lamotrigine  (LTG)
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
ValproateSudium (VPA)
CL Item
Vigabatrin (VGB)
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])
Item Group
Emergency AED Therapy used irregularly as required
C0003299 (UMLS CUI-1)
C0013956 (UMLS CUI-2)
C0205271 (UMLS CUI-3)
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])
Item Group
Emergency AED Therapy used irregularly as required
C0003299 (UMLS CUI-1)
C0013956 (UMLS CUI-2)
C0205271 (UMLS CUI-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])
Emergency AED therapy - Drug
Code List
Emergency AED therapy - Drug
CL Item
Acetazolamide (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
Lamotrigine  (LTG)
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
ValproateSudium (VPA)
CL Item
Vigabatrin (VGB)
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])
Emergency AED Therapy - Route
Code List
Emergency AED Therapy - Route
CL Item
By mouth  (PO)
CL Item
By rectum (PR)
CL Item
Intravenous (IV)
CL Item
Intramuscular (IM)
CL Item
Infusion (INF)
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])
Item Group
Concomitant Medication other than AEDs
C2347852 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
C0205394 (UMLS CUI-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])
Item Group
Concomitant Medication other than AEDs
C2347852 (UMLS CUI-1)
C0003299 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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 Group
Seizure Record
C0036572 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
Item
Week
integer
C0439230 (UMLS CUI [1])
Week
Code List
Week
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of Day 1
Item
Date of Day 1
date
C0011008 (UMLS CUI [1])
Item
Day
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Day 7 (7)
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])
Item Group
Atypical Absence Seizures (1 Hour Count)
C0595948 (UMLS CUI-1)
C0439227 (UMLS CUI-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])
Atypical abscence seizures counted by
Code List
Atypical abscence seizures counted by
CL Item
parent/ carer (1)
CL Item
clinic/ hospital staff member (2)
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