ID
38161
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
Mots-clés
Versions (1)
- 23/09/2019 23/09/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 septembre 2019
DOI
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Licence
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
Description
Vital Signs
Description
Systolic blood pressure sitting
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Diastolic blood pressure sitting
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Pulse sitting
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C2029904
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination - Changes
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0392747
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0015392
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0278350
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0007226
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C2709248
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0000726
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0024204
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0015385
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C1123023
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1]
- C0026860
Description
Briefly specify change from previous examination including additional/ new abnormalities found.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Behaviour
Type de données
integer
Alias
- UMLS CUI [1]
- C0004927
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0004927
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0004927
- UMLS CUI [2,2]
- C0184511
Description
Vision
Type de données
integer
Alias
- UMLS CUI [1]
- C0042789
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0042789
- UMLS CUI [2,2]
- C0184511
Description
Hearing
Type de données
integer
Alias
- UMLS CUI [1]
- C0018767
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0018767
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0018767
- UMLS CUI [2,2]
- C0184511
Description
Speech
Type de données
integer
Alias
- UMLS CUI [1]
- C0037817
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0037817
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0037817
- UMLS CUI [2,2]
- C0184511
Description
Non-verbal Communication
Type de données
integer
Alias
- UMLS CUI [1]
- C0558264
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0558264
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0558264
- UMLS CUI [2,2]
- C0184511
Description
Cranial Nerves
Type de données
integer
Alias
- UMLS CUI [1]
- C0010268
Description
Please give brief details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0010268
- UMLS CUI [2,2]
- C0184511
Description
Upper Limb Function
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1140618
- UMLS CUI [1,2]
- C0542341
Description
Please give brief details
Type de données
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
Description
Lower Limb function
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0023216
- UMLS CUI [1,2]
- C0542341
Description
Please give brief details
Type de données
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
Description
Fine Co-ordination
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0205232
Description
Please give brief details
Type de données
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
Description
Gross Co-ordination
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0439806
Description
Please give brief details
Type de données
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
Description
Please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Description
Other neurological examination finding
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0437208
- UMLS CUI [1,2]
- C0205394
Description
Other neurological examination - Deteriorated/ Improved finding
Type de données
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
Description
Haematology
Alias
- UMLS CUI-1
- C0018941
Description
Haematology - Date sample collected
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Description
Haematology - Laboratory number
Type de données
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
Type de données
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
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C0023508
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Clinical Chemistry - Date sample collected
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0008000
Description
Clinical Chemistry - Laboratory number
Type de données
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
Type de données
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
Type de données
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
Type de données
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
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [1,3]
- C0683150
Description
Drug NOT including Study Medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
Description
Time since last dose
Type de données
integer
Unités de mesure
- hrs
Alias
- UMLS CUI [1,1]
- C0946444
- UMLS CUI [1,2]
- C1711239
Description
Medication Concentration Value
Type de données
float
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1522609
Description
Medication Concentration Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1519795
Description
Compliance Record
Alias
- UMLS CUI-1
- C3714738
- UMLS CUI-2
- C0034869
Description
Have the patient's study medication bottles been returned for Weeks 13 and 14?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Description
Have the patient's study medication bottles been returned for Weeks 15 and 16?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Description
If study medication has been returned, how many tablets were returned?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Description
Was the study medication taken as prescribed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
Description
If study medication has not been taken as prescribed, specify the reason
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0566251
Description
Quality of Life
Alias
- UMLS CUI-1
- C0034380
Description
Global Evaluation
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C2348867
Description
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.
Type de données
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
Description
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.
Type de données
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])
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])
C0027853 (UMLS CUI [2,1])
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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C0003299 (UMLS CUI [1,2])
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