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)
- 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)
Visit 2; 3; 4; 5; 6 - Dispensing Record; Adverse Experiences; Concomitant Medication; Seizure Counts
Description
Haematology
Alias
- UMLS CUI-1
- C0018941
Description
Haematology - Date sample collected
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Description
Haematology - Laboratory number
Data type
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0018941
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
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
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
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Clinical Chemistry - Date sample collected
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0008000
Description
Clinical Chemistry - Laboratory number
Data type
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0008000
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
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
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
Description
Plasma Concentrations of AEDs
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
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
Description
Drug NOT including Study Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
Description
Time since last dose
Data type
durationDatetime
Measurement units
- hrs
Alias
- UMLS CUI [1,1]
- C0946444
- UMLS CUI [1,2]
- C1711239
Description
Medication Concentration Value
Data type
float
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1522609
Description
Medication Concentration Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1519795
Description
Adverse Experiences and Concomitant Medication
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
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
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
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
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
Description
Admission Criteria
Alias
- UMLS CUI-1
- C0809949
- UMLS CUI-2
- C0243161
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
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
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
Description
Randomisation
Alias
- UMLS CUI-1
- C0034656
Description
Compliance Record
Alias
- UMLS CUI-1
- C1321605
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
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
Description
Was the study medication taken as prescribed?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
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
Description
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Experience
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Experience Occurence
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2745955
Description
Adverse Experience ongoing at the end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0549178
Description
Adverse Experience Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
Adverse Experience Seriousness
Data type
integer
Alias
- UMLS CUI [1]
- C1710056
Description
Attributability to study drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0596130
- UMLS CUI [1,3]
- C0877248
Description
Action taken with study drug
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Other action taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1547656
- UMLS CUI [1,2]
- C0205394
Description
Include other action taken
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Concomitant AED Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
Description
Concomitant AED Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
Description
use AED Abbreviation
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Total daily dose
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Description
Date of change
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Description
Reason for change
Data type
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0392360
Description
Emergency AED Therapy used irregularly as required
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0013956
- UMLS CUI-3
- C0205271
Description
Emergency AED Therapy used irregularly as required
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0013956
- UMLS CUI-3
- C0205271
Description
Emergency AED therapy Dates
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0011008
Description
Emergency AED therapy - Drug
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0013227
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
Description
Emergency AED Therapy - Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013153
Description
Emergency AED Therapy - Reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0392360
Description
Concomitant Medication other than AEDs
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
- UMLS CUI-3
- C0205394
Description
Concomitant Medication other than AEDs
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
- UMLS CUI-3
- C0205394
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
Description
generic name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0205394
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
Description
Seizure Record
Alias
- UMLS CUI-1
- C0036572
- UMLS CUI-2
- C0034869
Description
Week
Data type
integer
Alias
- UMLS CUI [1]
- C0439230
Description
Date of Day 1
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Day
Data type
integer
Alias
- UMLS CUI [1]
- C0439228
Description
Number of Drop Attacks - Atonic
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086236
- UMLS CUI [1,2]
- C0237753
Description
Number of Drop Attacks - Tonic
Data type
integer
Alias
- UMLS CUI [1,1]
- C0270844
- UMLS CUI [1,2]
- C0237753
Description
Number of Drop Attacks - Major Myoclonic
Data type
integer
Alias
- UMLS CUI [1,1]
- C0014550
- UMLS CUI [1,2]
- C0237753
Description
Atypical Absence Seizures (1 Hour Count)
Alias
- UMLS CUI-1
- C0595948
- UMLS CUI-2
- C0439227
Description
Date of Atypical Abscence Seizure
Data type
date
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0011008
Description
Time of Atypical Abscence Seizure
Data type
time
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0040223
Description
Number of atypical abscence seizures in ONE hour
Data type
integer
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0237753
Description
Please check one.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0750480
Similar models
Visit 2; 3; 4; 5; 6 - Dispensing Record; Adverse Experiences; Concomitant Medication; Seizure Counts
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C1517741 (UMLS CUI [1,2])
C0018759 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1517741 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0003299 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C1517741 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1517741 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0680251 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C4084799 (UMLS CUI [1,4])
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])
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])
C0237753 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,2])
C0033080 (UMLS CUI [1,2])
C0033080 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0596130 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0003299 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0003299 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,4])
C0003299 (UMLS CUI-2)
C0439810 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0013956 (UMLS CUI-2)
C0205271 (UMLS CUI-3)
C0013956 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0013956 (UMLS CUI-2)
C0205271 (UMLS CUI-3)
C0013956 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0013956 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013956 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
C0013153 (UMLS CUI [1,2])
C0013956 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0003299 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1524062 (UMLS CUI [1,2])
C0003299 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0013227 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0439227 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])