ID

38153

Beschreibung

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

Stichworte

Versionen (1)
  1. 23.09.19 23.09.19 -
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GlaxoSmithKline

Hochgeladen am

23. September 2019

DOI

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

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Beschreibung

Patient's initials

Datentyp

text

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

Patient's trial number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Center number
Beschreibung

Center number

Datentyp

text

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

Haematology

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

Haematology - Date sample collected

Datentyp

date

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

Haematology - Laboratory number

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0518015
Quantitative platelet count
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0032181
WBC
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0023508
Clinical Chemistry
Beschreibung

Clinical Chemistry

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

Clinical Chemistry - Date sample collected

Datentyp

date

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

Clinical Chemistry - Laboratory number

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

Plasma Concentrations of AEDs

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

AED plasma concentration - Date of sample

Datentyp

date

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

Drug NOT including Study Medication

Datentyp

text

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

Time since last dose

Datentyp

durationDatetime

Maßeinheiten
  • hrs
Alias
UMLS CUI [1,1]
C0946444
UMLS CUI [1,2]
C1711239
hrs
Medication Concentration Value
Beschreibung

Medication Concentration Value

Datentyp

float

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

Medication Concentration Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1519795
Adverse Experiences and Concomitant Medication
Beschreibung

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?
Beschreibung

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

Datentyp

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?
Beschreibung

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

Datentyp

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?
Beschreibung

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

Datentyp

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?
Beschreibung

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

Datentyp

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
Beschreibung

Admission Criteria

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

Are inclusion and exclusion criteria at Screen still satisfied?

Datentyp

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?
Beschreibung

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

Datentyp

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)?
Beschreibung

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

Datentyp

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
Beschreibung

Randomisation

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

Patient's Randomisation Number

Datentyp

integer

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

Please check one.

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
Compliance Record
Beschreibung

Compliance Record

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

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

Datentyp

integer

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

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

Datentyp

integer

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

Was the study medication taken as prescribed?

Datentyp

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.
Beschreibung

Please check one.

Datentyp

integer

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

Adverse Experiences

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

Have any adverse experiences occured during the trial?

Datentyp

boolean

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

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Adverse Experience
Beschreibung

Adverse Experience

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Experience Occurence
Beschreibung

Adverse Experience Occurence

Datentyp

durationDatetime

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

Adverse Experience ongoing at the end of study

Datentyp

integer

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

Adverse Experience Intensity

Datentyp

integer

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

Adverse Experience Seriousness

Datentyp

integer

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

Attributability to study drug

Datentyp

integer

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

Action taken with study drug

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Other action taken
Beschreibung

Other action taken

Datentyp

boolean

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

Include other action taken

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Concomitant AED Medication
Beschreibung

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?
Beschreibung

If yes, please record below

Datentyp

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
Beschreibung

Concomitant AED Medication

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

use AED Abbreviation

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
mg
Date of change
Beschreibung

Date of change

Datentyp

date

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

Reason for change

Datentyp

text

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

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?
Beschreibung

Was any additional emergency AED therapy given during the study?

Datentyp

boolean

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

Emergency AED Therapy used irregularly as required

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

Emergency AED therapy Dates

Datentyp

durationDatetime

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

Emergency AED therapy - Drug

Datentyp

text

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

Emergency AED Threapy - Total Daily Dose

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Emergency AED Therapy - Route

Datentyp

text

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

Emergency AED Therapy - Reason

Datentyp

text

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

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?
Beschreibung

If Yes, please record below.

Datentyp

boolean

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

Concomitant Medication other than AEDs

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

Date first taken during study

Datentyp

date

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

generic name

Datentyp

text

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

If given for an Adverse Experience, please give AE number

Datentyp

integer

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

Seizure Record

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

Week

Datentyp

integer

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

Date of Day 1

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Day
Beschreibung

Day

Datentyp

integer

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

Number of Drop Attacks - Atonic

Datentyp

integer

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

Number of Drop Attacks - Tonic

Datentyp

integer

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

Number of Drop Attacks - Major Myoclonic

Datentyp

integer

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

Atypical Absence Seizures (1 Hour Count)

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

Date of Atypical Abscence Seizure

Datentyp

date

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

Time of Atypical Abscence Seizure

Datentyp

time

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

Number of atypical abscence seizures in ONE hour

Datentyp

integer

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

Please check one.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0595948
UMLS CUI [1,2]
C0750480
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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