ID
38161
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-09-23 2019-09-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 september 2019
DOI
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Licens
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
Beskrivning
Vital Signs
Beskrivning
Systolic blood pressure sitting
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beskrivning
Diastolic blood pressure sitting
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beskrivning
Pulse sitting
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C2029904
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Physical Examination - Changes
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0392747
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0015392
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0278350
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0007226
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C2709248
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0000726
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0024204
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0015385
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C1123023
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1]
- C0026860
Beskrivning
Briefly specify change from previous examination including additional/ new abnormalities found.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beskrivning
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Behaviour
Datatyp
integer
Alias
- UMLS CUI [1]
- C0004927
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004927
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0004927
- UMLS CUI [2,2]
- C0184511
Beskrivning
Vision
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042789
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0042789
- UMLS CUI [2,2]
- C0184511
Beskrivning
Hearing
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018767
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018767
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0018767
- UMLS CUI [2,2]
- C0184511
Beskrivning
Speech
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037817
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037817
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0037817
- UMLS CUI [2,2]
- C0184511
Beskrivning
Non-verbal Communication
Datatyp
integer
Alias
- UMLS CUI [1]
- C0558264
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0558264
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0558264
- UMLS CUI [2,2]
- C0184511
Beskrivning
Cranial Nerves
Datatyp
integer
Alias
- UMLS CUI [1]
- C0010268
Beskrivning
Please give brief details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [2,1]
- C0010268
- UMLS CUI [2,2]
- C0184511
Beskrivning
Upper Limb Function
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140618
- UMLS CUI [1,2]
- C0542341
Beskrivning
Please give brief details
Datatyp
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
Beskrivning
Lower Limb function
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023216
- UMLS CUI [1,2]
- C0542341
Beskrivning
Please give brief details
Datatyp
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
Beskrivning
Fine Co-ordination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0205232
Beskrivning
Please give brief details
Datatyp
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
Beskrivning
Gross Co-ordination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C0439806
Beskrivning
Please give brief details
Datatyp
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
Beskrivning
Please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other neurological examination finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0437208
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other neurological examination - Deteriorated/ Improved finding
Datatyp
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
Beskrivning
Haematology
Alias
- UMLS CUI-1
- C0018941
Beskrivning
Haematology - Date sample collected
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Beskrivning
Haematology - Laboratory number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0018941
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0518015
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0032181
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beskrivning
Clinical Chemistry - Date sample collected
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0008000
Beskrivning
Clinical Chemistry - Laboratory number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986056
- UMLS CUI [1,2]
- C0008000
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
Plasma Concentrations of AEDs
Alias
- UMLS CUI-1
- C0003299
- UMLS CUI-2
- C0683150
Beskrivning
AED plasma concentration - Date of sample
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [1,3]
- C0683150
Beskrivning
Drug NOT including Study Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
Beskrivning
Time since last dose
Datatyp
integer
Måttenheter
- hrs
Alias
- UMLS CUI [1,1]
- C0946444
- UMLS CUI [1,2]
- C1711239
Beskrivning
Medication Concentration Value
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1522609
Beskrivning
Medication Concentration Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0683150
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1519795
Beskrivning
Compliance Record
Alias
- UMLS CUI-1
- C3714738
- UMLS CUI-2
- C0034869
Beskrivning
Have the patient's study medication bottles been returned for Weeks 13 and 14?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Beskrivning
Have the patient's study medication bottles been returned for Weeks 15 and 16?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332156
Beskrivning
If study medication has been returned, how many tablets were returned?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beskrivning
Was the study medication taken as prescribed?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
Beskrivning
If study medication has not been taken as prescribed, specify the reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0566251
Beskrivning
Quality of Life
Alias
- UMLS CUI-1
- C0034380
Beskrivning
Global Evaluation
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C2348867
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Similar models
Visit 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation
C0019994 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0392747 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0027853 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C1457868 (UMLS CUI [1,2])
C0004927 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C1457868 (UMLS CUI [1,2])
C0042789 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C1457868 (UMLS CUI [1,2])
C0018767 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C1457868 (UMLS CUI [1,2])
C0037817 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C1457868 (UMLS CUI [1,2])
C0558264 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C1457868 (UMLS CUI [1,2])
C0010268 (UMLS CUI [2,1])
C0184511 (UMLS CUI [2,2])
C0542341 (UMLS CUI [1,2])
C0542341 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C1140618 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
C0542341 (UMLS CUI [1,2])
C0542341 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0023216 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
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])
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])
C0332156 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0033080 (UMLS CUI [1,2])
C0033080 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,3])
C2348867 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0036572 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0424575 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0424575 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])