ID
38161
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
Para solicitar uno, por favor iniciar sesión.
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 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation
Descripción
Vital Signs
Descripción
Systolic blood pressure sitting
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Descripción
Diastolic blood pressure sitting
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Descripción
Pulse sitting
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C2029904
Descripción
Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Physical Examination - Changes
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0392747
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0015392
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0278350
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007226
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2709248
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0000726
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0024204
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0015385
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1123023
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0026860
Descripción
Briefly specify change from previous examination including additional/ new abnormalities found.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Descripción
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Descripción
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Descripción
Behaviour
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0004927
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004927
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0004927
- UMLS CUI [2,2]
- C0184511
Descripción
Vision
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042789
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0042789
- UMLS CUI [2,2]
- C0184511
Descripción
Hearing
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0018767
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018767
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0018767
- UMLS CUI [2,2]
- C0184511
Descripción
Speech
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0037817
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0037817
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0037817
- UMLS CUI [2,2]
- C0184511
Descripción
Non-verbal Communication
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0558264
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0558264
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0558264
- UMLS CUI [2,2]
- C0184511
Descripción
Cranial Nerves
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0010268
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0010268
- UMLS CUI [2,2]
- C0184511
Descripción
Upper Limb Function
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1140618
- UMLS CUI [1,2]
- C0542341
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1140618
- UMLS CUI [1,2]
- C0542341
- UMLS CUI [1,3]
- C1457868
- UMLS CUI [2,1]
- C1140618
- UMLS CUI [2,2]
- C0542341
- UMLS CUI [2,3]
- C0184511
Descripción
Lower Limb function
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0023216
- UMLS CUI [1,2]
- C0542341
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023216
- UMLS CUI [1,2]
- C0542341
- UMLS CUI [1,3]
- C1457868
- UMLS CUI [2,1]
- C0023216
- UMLS CUI [2,2]
- C0542341
- UMLS CUI [2,3]
- C0184511
Descripción
Fine Co-ordination
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0205232
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0205232
- UMLS CUI [1,3]
- C1457868
- UMLS CUI [2,1]
- C0242414
- UMLS CUI [2,2]
- C0205232
- UMLS CUI [2,3]
- C0184511
Descripción
Gross Co-ordination
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0439806
Descripción
Please give brief details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0439806
- UMLS CUI [1,3]
- C1457868
- UMLS CUI [2,1]
- C0242414
- UMLS CUI [2,2]
- C0439806
- UMLS CUI [2,3]
- C0184511
Descripción
Please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Descripción
Other neurological examination finding
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0437208
- UMLS CUI [1,2]
- C0205394
Descripción
Other neurological examination - Deteriorated/ Improved finding
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1457868
- UMLS CUI [2,1]
- C0027853
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0184511
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
integer
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
Compliance Record
Alias
- UMLS CUI-1
- C3714738
- UMLS CUI-2
- C0034869
Descripción
Have the patient's study medication bottles been returned for Weeks 13 and 14?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Descripción
Have the patient's study medication bottles been returned for Weeks 15 and 16?
Tipo de datos
boolean
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]
- C2699071
- UMLS CUI [1,2]
- C0304229
Descripción
Was the study medication taken as prescribed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
Descripción
If study medication has not been taken as prescribed, specify the reason
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0566251
Descripción
Quality of Life
Alias
- UMLS CUI-1
- C0034380
Descripción
Global Evaluation
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C2348867
Descripción
Based on your knowledge of this patient and according to relevant factors (e.g. seizure intensity, duration, frequency), compare his/her status during this treatment to prior to entry into the study. Check one.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2348867
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [2,1]
- C0036572
- UMLS CUI [2,2]
- C0243148
Descripción
Ask for the parent's/ carer's opinion of the patient, comparing his/ her status during this treatment to prior to entry into the study. Check one.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0030551
- UMLS CUI [1,2]
- C0424575
- UMLS CUI [1,3]
- C0220825
- UMLS CUI [2,1]
- C0085537
- UMLS CUI [2,2]
- C0424575
- UMLS CUI [2,3]
- C0220825
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Visit 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation
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C0205232 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0242414 (UMLS CUI [2,1])
C0205232 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
C0439806 (UMLS CUI [1,2])
C0439806 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0242414 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
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C0205394 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
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