ID
38153
Descripción
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
Palabras clave
Versiones (1)
- 23/9/19 23/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de septiembre de 2019
DOI
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Licencia
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
Descripción
Haematology
Alias
- UMLS CUI-1
- C0018941
Descripción
Haematology - Date sample collected
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Descripción
Haematology - Laboratory number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0018941
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0518015
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032181
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023508
Descripción
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Descripción
Clinical Chemistry - Date sample collected
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0008000
Descripción
Clinical Chemistry - Laboratory number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0008000
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201976
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201836
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201899
Descripción
Plasma Concentrations of AEDs
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Descripción
AED plasma concentration - Date of sample
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [1,3]
- C0683150
Descripción
Drug NOT including Study Medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
Descripción
Time since last dose
Tipo de datos
durationDatetime
Unidades de medida
- hrs
Alias
- UMLS CUI [1,1]
- C0946444
- UMLS CUI [1,2]
- C1711239
Descripción
Medication Concentration Value
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1522609
Descripción
Medication Concentration Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1519795
Descripción
Adverse Experiences and Concomitant Medication
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Descripción
Since the last assessment has the patient had any changes in his/ her health?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1516048
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [2,1]
- C0018759
- UMLS CUI [2,2]
- C0392747
Descripción
Since the last assessment has the patient had any changes in concomitant AED medication?
Tipo de datos
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
Descripción
Since the last assessment has the patient had emergency AED therapy?
Tipo de datos
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
Descripción
Since the last assessment has the patient had any changes in concomitant medication other than AEDs?
Tipo de datos
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
Descripción
Admission Criteria
Alias
- UMLS CUI-1
- C0809949
- UMLS CUI-2
- C0243161
Descripción
Are inclusion and exclusion criteria at Screen still satisfied?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C0680251
- UMLS CUI [1,3]
- C0220908
- UMLS CUI [1,4]
- C4084799
Descripción
Are the results of an EEG during sleep and awake states available?
Tipo de datos
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
Descripción
Does the patient have any clinically significant abnormalities in the laboratory tests taken at screen?
Tipo de datos
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
Descripción
Randomisation
Alias
- UMLS CUI-1
- C0034656
Descripción
Compliance Record
Alias
- UMLS CUI-1
- C1321605
Descripción
Have the patient's Study medication bottles been returned for . . .
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Descripción
If study medication has been returned, how many tablets were returned?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2699071
Descripción
Was the study medication taken as prescribed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
Descripción
Please check one.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0392360
Descripción
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Experience
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Adverse Experience Occurence
Tipo de datos
durationDatetime
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2745955
Descripción
Adverse Experience ongoing at the end of study
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0549178
Descripción
Adverse Experience Intensity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Descripción
Adverse Experience Seriousness
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1710056
Descripción
Attributability to study drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0596130
- UMLS CUI [1,3]
- C0877248
Descripción
Action taken with study drug
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826626
Descripción
Other action taken
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1547656
- UMLS CUI [1,2]
- C0205394
Descripción
Include other action taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Descripción
Concomitant AED Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
Descripción
Concomitant AED Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
Descripción
use AED Abbreviation
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013227
Descripción
Total daily dose
Tipo de datos
float
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Descripción
Date of change
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0443172
Descripción
Reason for change
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0392360
Descripción
Emergency AED Therapy used irregularly as required
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0013956
- UMLS CUI-3
- C0205271
Descripción
Emergency AED Therapy used irregularly as required
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0013956
- UMLS CUI-3
- C0205271
Descripción
Emergency AED therapy Dates
Tipo de datos
durationDatetime
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0011008
Descripción
Emergency AED therapy - Drug
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0013227
Descripción
Emergency AED Threapy - Total Daily Dose
Tipo de datos
float
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C2348070
- UMLS CUI [1,4]
- C0439810
Descripción
Emergency AED Therapy - Route
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013153
Descripción
Emergency AED Therapy - Reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0013956
- UMLS CUI [1,3]
- C0392360
Descripción
Concomitant Medication other than AEDs
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
- UMLS CUI-3
- C0205394
Descripción
Concomitant Medication other than AEDs
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0003299
- UMLS CUI-3
- C0205394
Descripción
Date first taken during study
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1883727
Descripción
generic name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0205394
Descripción
If given for an Adverse Experience, please give AE number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
Descripción
Seizure Record
Alias
- UMLS CUI-1
- C0036572
- UMLS CUI-2
- C0034869
Descripción
Week
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0439230
Descripción
Date of Day 1
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Day
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0439228
Descripción
Number of Drop Attacks - Atonic
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0086236
- UMLS CUI [1,2]
- C0237753
Descripción
Number of Drop Attacks - Tonic
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0270844
- UMLS CUI [1,2]
- C0237753
Descripción
Number of Drop Attacks - Major Myoclonic
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0014550
- UMLS CUI [1,2]
- C0237753
Descripción
Atypical Absence Seizures (1 Hour Count)
Alias
- UMLS CUI-1
- C0595948
- UMLS CUI-2
- C0439227
Descripción
Date of Atypical Abscence Seizure
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0011008
Descripción
Time of Atypical Abscence Seizure
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0040223
Descripción
Number of atypical abscence seizures in ONE hour
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0595948
- UMLS CUI [1,2]
- C0237753
Descripción
Please check one.
Tipo de datos
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
C0600091 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0683150 (UMLS CUI-2)
C0003299 (UMLS CUI [1,2])
C0683150 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI-2)
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])