ID

38052

Beschreibung

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

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  1. 12.09.19 12.09.19 -
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GlaxoSmithKline

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12. September 2019

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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

Englisch

Visit 1 / Screen - Neurological Examination; EEG

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Beschreibung

Patient's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's trial number
Beschreibung

Patient's trial number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Neurological Examination
Beschreibung

Neurological Examination

Alias
UMLS CUI-1
C0027853
Behaviour
Beschreibung

Behaviour

Datentyp

integer

Alias
UMLS CUI [1]
C0004927
Behaviour - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0004927
Vision
Beschreibung

Vision

Datentyp

integer

Alias
UMLS CUI [1]
C0042789
Vision - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0042789
Hearing
Beschreibung

Hearing

Datentyp

integer

Alias
UMLS CUI [1]
C0018767
Hearing - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0018767
Speech
Beschreibung

Speech

Datentyp

integer

Alias
UMLS CUI [1]
C0037817
Speech - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0037817
Non-verbal Communication
Beschreibung

Non-verbal Communication

Datentyp

integer

Alias
UMLS CUI [1]
C0558264
Non-verbal communication - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0558264
Cranial Nerves
Beschreibung

Cranial Nerves

Datentyp

integer

Alias
UMLS CUI [1]
C0010268
Cranial nerves - Abnromal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0010268
Upper limb motor function
Beschreibung

Upper limb motor function

Datentyp

integer

Alias
UMLS CUI [1,1]
C0234130
UMLS CUI [1,2]
C1140618
Upper limb motor function - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0234130
UMLS CUI [1,4]
C1140618
Lower limb motor function
Beschreibung

Lower limb motor function

Datentyp

integer

Alias
UMLS CUI [1,1]
C0234130
UMLS CUI [1,2]
C0023216
Lower limb motor function - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0234130
UMLS CUI [1,4]
C0023216
Gross Co-ordination
Beschreibung

Gross Co-ordination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0439806
Gross Co-ordination - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0242414
UMLS CUI [1,4]
C0439806
Fine Co-ordination
Beschreibung

Fine Co-ordination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0242414
UMLS CUI [1,2]
C0205232
Fine Co-ordination - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0242414
UMLS CUI [1,4]
C0205232
Other neurological examination
Beschreibung

Please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0205394
Other neurological examination
Beschreibung

Other neurological examination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0205394
Other neurological examination - Abnormal neurological finding
Beschreibung

Please give brief details.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C0205394
Electroencephalography
Beschreibung

Electroencephalography

Alias
UMLS CUI-1
C0013819
EEG Recording Date
Beschreibung

EEG Recording Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013819
Number of recording channels
Beschreibung

Number of recording channels

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439799
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0013819
Duration of EEG
Beschreibung

If continuous ambulatory.

Datentyp

durationDatetime

Maßeinheiten
  • hrs
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0013819
hrs
General background activity
Beschreibung

Please check one.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1706907
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0205246
Sleep - Are approximately 10Hz poly spike and wave discharges present?
Beschreibung

Sleep - Are approximately 10Hz poly spike and wave discharges present?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037313
UMLS CUI [1,2]
C3806403
Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.
Beschreibung

Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037313
UMLS CUI [1,2]
C3806403
UMLS CUI [2]
C0243095
Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?
Beschreibung

Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?

Datentyp

boolean

Alias
UMLS CUI [1]
C0234422
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C2206302
UMLS CUI [2,3]
C0205246
UMLS CUI [2,4]
C0205271
Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.
Beschreibung

Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.

Datentyp

text

Alias
UMLS CUI [1]
C0234422
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C2206302
UMLS CUI [2,3]
C0205246
UMLS CUI [2,4]
C0205271
UMLS CUI [3]
C0243095
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Ähnliche Modelle

Visit 1 / Screen - Neurological Examination; EEG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient's initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Item
Behaviour
integer
C0004927 (UMLS CUI [1])
Behaviour
Code List
Behaviour
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Behaviour - Abnormal neurological finding
Item
Behaviour - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
Item
Vision
integer
C0042789 (UMLS CUI [1])
Vision
Code List
Vision
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Vision - Abnormal neurological finding
Item
Vision - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0042789 (UMLS CUI [1,3])
Item
Hearing
integer
C0018767 (UMLS CUI [1])
Hearing
Code List
Hearing
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Hearing - Abnormal neurological finding
Item
Hearing - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0018767 (UMLS CUI [1,3])
Item
Speech
integer
C0037817 (UMLS CUI [1])
Speech
Code List
Speech
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Speech - Abnormal neurological finding
Item
Speech - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0037817 (UMLS CUI [1,3])
Item
Non-verbal Communication
integer
C0558264 (UMLS CUI [1])
Non-verbal Communication
Code List
Non-verbal Communication
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Non-verbal communication - Abnormal neurological finding
Item
Non-verbal communication - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0558264 (UMLS CUI [1,3])
Item
Cranial Nerves
integer
C0010268 (UMLS CUI [1])
Cranial Nerves
Code List
Cranial Nerves
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Cranial nerves - Abnromal neurological finding
Item
Cranial nerves - Abnromal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
Item
Upper limb motor function
integer
C0234130 (UMLS CUI [1,1])
C1140618 (UMLS CUI [1,2])
Upper limb motor function
Code List
Upper limb motor function
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Upper limb motor function - Abnormal neurological finding
Item
Upper limb motor function - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,3])
C1140618 (UMLS CUI [1,4])
Item
Lower limb motor function
integer
C0234130 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
Lower limb motor function
Code List
Lower limb motor function
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Lower limb motor function - Abnormal neurological finding
Item
Lower limb motor function - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,3])
C0023216 (UMLS CUI [1,4])
Item
Gross Co-ordination
integer
C0242414 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Gross Co-ordination
Code List
Gross Co-ordination
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Gross Co-ordination - Abnormal neurological finding
Item
Gross Co-ordination - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C0439806 (UMLS CUI [1,4])
Item
Fine Co-ordination
integer
C0242414 (UMLS CUI [1,1])
C0205232 (UMLS CUI [1,2])
Fine Co-ordination
Code List
Fine Co-ordination
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Fine Co-ordination - Abnormal neurological finding
Item
Fine Co-ordination - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C0205232 (UMLS CUI [1,4])
Other neurological examination
Item
Other neurological examination
text
C0027853 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other neurological examination
integer
C0027853 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other neurological examination
Code List
Other neurological examination
CL Item
Normal (1)
CL Item
Abnormal (2)
Other neurological examination - Abnormal neurological finding
Item
Other neurological examination - Abnormal neurological finding
text
C0027853 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Electroencephalography
C0013819 (UMLS CUI-1)
EEG Recording Date
Item
EEG Recording Date
date
C0011008 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
Number of recording channels
Item
Number of recording channels
integer
C0439799 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0013819 (UMLS CUI [1,3])
Duration of EEG
Item
Duration of EEG
durationDatetime
C0449238 (UMLS CUI [1,1])
C0013819 (UMLS CUI [1,2])
Item
General background activity
integer
C1706907 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
General background activity
Code List
General background activity
CL Item
Normal (1)
CL Item
Abnormal generalised (2)
CL Item
Abnormal localised (3)
Sleep - Are approximately 10Hz poly spike and wave discharges present?
Item
Sleep - Are approximately 10Hz poly spike and wave discharges present?
boolean
C0037313 (UMLS CUI [1,1])
C3806403 (UMLS CUI [1,2])
Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.
Item
Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.
text
C0037313 (UMLS CUI [1,1])
C3806403 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2])
Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?
Item
Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?
boolean
C0234422 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.
Item
Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.
text
C0234422 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
C0243095 (UMLS CUI [3])
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