ID
38052
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)
- 2019-09-12 2019-09-12 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 september 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)
Visit 1 / Screen - Neurological Examination; EEG
- StudyEvent: ODM
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]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0004927
Beskrivning
Vision
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042789
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0042789
Beskrivning
Hearing
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018767
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0018767
Beskrivning
Speech
Datatyp
integer
Alias
- UMLS CUI [1]
- C0037817
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0037817
Beskrivning
Non-verbal Communication
Datatyp
integer
Alias
- UMLS CUI [1]
- C0558264
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0558264
Beskrivning
Cranial Nerves
Datatyp
integer
Alias
- UMLS CUI [1]
- C0010268
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0010268
Beskrivning
Upper limb motor function
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C1140618
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0234130
- UMLS CUI [1,4]
- C1140618
Beskrivning
Lower limb motor function
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0234130
- UMLS CUI [1,2]
- C0023216
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0234130
- UMLS CUI [1,4]
- C0023216
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]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0242414
- UMLS CUI [1,4]
- C0439806
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]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0242414
- UMLS CUI [1,4]
- C0205232
Beskrivning
Please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other neurological examination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0205394
Beskrivning
Please give brief details.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C0205394
Beskrivning
Electroencephalography
Alias
- UMLS CUI-1
- C0013819
Beskrivning
EEG Recording Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013819
Beskrivning
Number of recording channels
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439799
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0013819
Beskrivning
If continuous ambulatory.
Datatyp
durationDatetime
Måttenheter
- hrs
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C0013819
Beskrivning
Please check one.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1706907
- UMLS CUI [1,2]
- C0026606
- UMLS CUI [1,3]
- C0205246
Beskrivning
Sleep - Are approximately 10Hz poly spike and wave discharges present?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037313
- UMLS CUI [1,2]
- C3806403
Beskrivning
Sleep - If approximately 10Hz poly spike and wave discharges are not present, state principal finding.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037313
- UMLS CUI [1,2]
- C3806403
- UMLS CUI [2]
- C0243095
Beskrivning
Awake - Are paroxysms of generalised irregular <2.5Hz slow spike wave discharges present?
Datatyp
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
Beskrivning
Awake - If paroxysms of generalised irregular <2.5Hz slow spike wave discharges are not present, state principal finding.
Datatyp
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
Similar models
Visit 1 / Screen - Neurological Examination; EEG
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0004927 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C0042789 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C0018767 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C0037817 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C0558264 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
C1140618 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,3])
C1140618 (UMLS CUI [1,4])
C0023216 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,3])
C0023216 (UMLS CUI [1,4])
C0439806 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C0439806 (UMLS CUI [1,4])
C0205232 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C0205232 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0013819 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0013819 (UMLS CUI [1,3])
C0013819 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
C3806403 (UMLS CUI [1,2])
C3806403 (UMLS CUI [1,2])
C0243095 (UMLS CUI [2])
C0036572 (UMLS CUI [2,1])
C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
C0036572 (UMLS CUI [2,1])
C2206302 (UMLS CUI [2,2])
C0205246 (UMLS CUI [2,3])
C0205271 (UMLS CUI [2,4])
C0243095 (UMLS CUI [3])