ID

38052

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)
  1. 12/9/19 12/9/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Visit 1 / Screen - Neurological Examination; EEG

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Descripción

Patient's initials

Tipo de datos

text

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

Patient's trial number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Center number
Descripción

Center number

Tipo de datos

text

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

Neurological Examination

Alias
UMLS CUI-1
C0027853
Behaviour
Descripción

Behaviour

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Vision

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Hearing

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Speech

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Non-verbal Communication

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Cranial Nerves

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Upper limb motor function

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

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
Descripción

Lower limb motor function

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

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
Descripción

Gross Co-ordination

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

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
Descripción

Fine Co-ordination

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

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
Descripción

Please specify.

Tipo de datos

text

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

Other neurological examination

Tipo de datos

integer

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

Please give brief details.

Tipo de datos

text

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

Electroencephalography

Alias
UMLS CUI-1
C0013819
EEG Recording Date
Descripción

EEG Recording Date

Tipo de datos

date

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

Number of recording channels

Tipo de datos

integer

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

If continuous ambulatory.

Tipo de datos

durationDatetime

Unidades de medida
  • hrs
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0013819
hrs
General background activity
Descripción

Please check one.

Tipo de datos

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?
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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?
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Visit 1 / Screen - Neurological Examination; EEG

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial