ID

31641

Description

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Mots-clés

Versions (4)
  1. 16/09/2018 16/09/2018 -
  2. 27/09/2018 27/09/2018 -
  3. 08/10/2018 08/10/2018 -
  4. 08/10/2018 08/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 septembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients

Anglais

Seizure history and information/ Epilepsy information - Screen

1 Formulaires  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site; Numbers

Type de données

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient's initials
Description

Person Initials

Type de données

text

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

Clinical Trial Subject Unique Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of assessment
Description

Assessment Date

Type de données

date

Alias
UMLS CUI [1]
C2985720
Seizure history
Description

Seizure history

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0262926
Etiology - check one.
Description

Etiology

Type de données

integer

Alias
UMLS CUI [1]
C1314792
If etiology is symptomatic, specify.
Description

Etiology; Symptomatic

Type de données

text

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0231220
Age at first seizure (excluding febrile seizures)
Description

Age; Seizures; First (number) | Febrile Convulsions

Type de données

float

Unités de mesure
  • years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C0205435
UMLS CUI [2]
C0009952
years
Seizure information
Description

Seizure information

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C1533716
Seizure code
Description

Codes: A. Simple partial seizures (Consciousness not impaired) 1. With motor signs A1a = focal motor without march A1b = focal motor with march (Jacksonian) A1c = Versive A1d = Postural 2. With somatosensory or soecial- sensory symptoms (simple hallucinations, e. g. tingling, light flashes, buzzing) A2a = Somatosensory A2b = Visual A2c = Auditory A2d = Olfactory A2e = Gustatory A2f = Vertiginous 3. A3 = With autonomic symptoms or signs (including epigastric sensation, pallor, sweating, flushing, piloerection, and pupillary dilatation) 4. With psychic symptoms (disturbance of higher cerebral function). These symptoms rarely occur without impairment of consciousness and are much more commonly experienced as complex partial seizures. A4a = Dysphasic A4b = Dysmnesic (e. g. deja- vu) A4c = Cognitive (e. g. dreamy states and distortions of time sense) A4d = Affective (fear, anger, etc.) A4e = Illusions (e. g. macropsia) A4f = Structured hallucinations (e. g. music, scenes) B. Complex partial seizures (Generally with impairment of consciousness; may sometimes begin with simple symtomatology) 1. Simple partial onset followed by impairment of consciousness B1a = With simple partial features (A1- A4) followed by impaired consciousness B1b = With automatisms 2. With impairment of consciousness at onset B2a = With impairment of consciousness only B2b = With automatism C. Partial seizures evolving to secondarily generalized seizures (GS) (Generalized seizures may be manifested as tonic- clonic, clonic or tonic) C1 = Simple partial seizures (A) evolving to GS C2 = Complex partial (B) evolving to GS C3 = Simple partial seizures (A) evolving to complex partial seizures (B) evolving to GS D. Generalized seizures (Convulsive or Non- convulsive) Generalized seizures are those in which the first clinical changes indicate initial involvement of both hemispheres. Consciousness may be impaired and this impairment may be the initial manifestation. Motor manifestations are bilateral. The ictal electroencephalo- graphic patterns initially are bilateral and presumably reflect neuronal discharge which is widespread in both hemispheres. D1a = Typical Abscence D1ai = Impairment of consciousness only D1aii = With mild clonic component D1aiii = With atonic component D1aiv = With tonic component D1av = With automatisms D1avi = With autonomic components (Mixed forms of D1ai- D1avi may occur and should be dosumented by using all applicable code numbers) D1b = Atypical Absence D1bi = Changes in tone that are more pronounced than D1a D1bii = Onset and/ or cessation that is not abrupt D2 =Myoclonic seizures (myoclonic jerks- single or multiple) D3 = Clonic seizures D4 = Tonic seizures D5 = Tonic- clonic seizures D6 = Atonic seizures (astatic) Combination of any of the above generalized seizured may occur and should be documented by using all applicable codde numbers. E = Unclassified Seizures

Type de données

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0805701
Date of last occurence
Description

Occurrence; Last; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Number of seizures
Description

Seizures; Count

Type de données

float

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0750480
Unit (specify unit as: day, week, month [4 weeks] or year)
Description

Unit | day | week | month | year

Type de données

text

Alias
UMLS CUI [1]
C0439148
UMLS CUI [2]
C0439228
UMLS CUI [3]
C0439230
UMLS CUI [4]
C0439231
UMLS CUI [5]
C0439234
Epilepsy information
Description

Epilepsy information

Alias
UMLS CUI-1
C0014544
UMLS CUI-2
C1533716
Seizure Classification (Use ICE CODES)
Description

Codes: A. Simple partial seizures (Consciousness not impaired) 1. With motor signs A1a = focal motor without march A1b = focal motor with march (Jacksonian) A1c = Versive A1d = Postural 2. With somatosensory or soecial- sensory symptoms (simple hallucinations, e. g. tingling, light flashes, buzzing) A2a = Somatosensory A2b = Visual A2c = Auditory A2d = Olfactory A2e = Gustatory A2f = Vertiginous 3. A3 = With autonomic symptoms or signs (including epigastric sensation, pallor, sweating, flushing, piloerection, and pupillary dilatation) 4. With psychic symptoms (disturbance of higher cerebral function). These symptoms rarely occur without impairment of consciousness and are much more commonly experienced as complex partial seizures. A4a = Dysphasic A4b = Dysmnesic (e. g. deja- vu) A4c = Cognitive (e. g. dreamy states and distortions of time sense) A4d = Affective (fear, anger, etc.) A4e = Illusions (e. g. macropsia) A4f = Structured hallucinations (e. g. music, scenes) B. Complex partial seizures (Generally with impairment of consciousness; may sometimes begin with simple symtomatology) 1. Simple partial onset followed by impairment of consciousness B1a = With simple partial features (A1- A4) followed by impaired consciousness B1b = With automatisms 2. With impairment of consciousness at onset B2a = With impairment of consciousness only B2b = With automatism C. Partial seizures evolving to secondarily generalized seizures (GS) (Generalized seizures may be manifested as tonic- clonic, clonic or tonic) C1 = Simple partial seizures (A) evolving to GS C2 = Complex partial (B) evolving to GS C3 = Simple partial seizures (A) evolving to complex partial seizures (B) evolving to GS D. Generalized seizures (Convulsive or Non- convulsive) Generalized seizures are those in which the first clinical changes indicate initial involvement of both hemispheres. Consciousness may be impaired and this impairment may be the initial manifestation. Motor manifestations are bilateral. The ictal electroencephalo- graphic patterns initially are bilateral and presumably reflect neuronal discharge which is widespread in both hemispheres. D1a = Typical Abscence D1ai = Impairment of consciousness only D1aii = With mild clonic component D1aiii = With atonic component D1aiv = With tonic component D1av = With automatisms D1avi = With autonomic components (Mixed forms of D1ai- D1avi may occur and should be dosumented by using all applicable code numbers) D1b = Atypical Absence D1bi = Changes in tone that are more pronounced than D1a D1bii = Onset and/ or cessation that is not abrupt D2 =Myoclonic seizures (myoclonic jerks- single or multiple) D3 = Clonic seizures D4 = Tonic seizures D5 = Tonic- clonic seizures D6 = Atonic seizures (astatic) Combination of any of the above generalized seizured may occur and should be documented by using all applicable codde numbers. E = Unclassified Seizures

Type de données

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0008902
Retour au début de la page

Similar models

Seizure history and information/ Epilepsy information - Screen

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Seizure history
C0036572 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Etiology - check one.
integer
C1314792 (UMLS CUI [1])
Etiology
Code List
Etiology - check one.
CL Item
Idiopathic (1)
CL Item
Symptomatic (2)
Etiology; Symptomatic
Item
If etiology is symptomatic, specify.
text
C1314792 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Age; Seizures; First (number) | Febrile Convulsions
Item
Age at first seizure (excluding febrile seizures)
float
C0001779 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0009952 (UMLS CUI [2])
Item Group
Seizure information
C0036572 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Seizures; Code
Item
Seizure code
text
C0036572 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Occurrence; Last; Date in time
Item
Date of last occurence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Seizures; Count
Item
Number of seizures
float
C0036572 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Unit | day | week | month | year
Item
Unit (specify unit as: day, week, month [4 weeks] or year)
text
C0439148 (UMLS CUI [1])
C0439228 (UMLS CUI [2])
C0439230 (UMLS CUI [3])
C0439231 (UMLS CUI [4])
C0439234 (UMLS CUI [5])
Item Group
Epilepsy information
C0014544 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Seizures; Classification
Item
Seizure Classification (Use ICE CODES)
text
C0036572 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Retour au début de la page 

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