ID

31945

Descrição

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 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

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Versões (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 -
Titular dos direitos

GlaxoSmithKline

Transferido a

8 de outubro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

Inglês

Seizure history and information/ Epilepsy information - Screen

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Descrição

Study Site; Numbers

Tipo de dados

text

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

Person Initials

Tipo de dados

text

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

Clinical Trial Subject Unique Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Date of assessment
Descrição

Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2985720
Seizure history
Descrição

Seizure history

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

Etiology

Tipo de dados

integer

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

Etiology; Symptomatic

Tipo de dados

text

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

Age; Seizures; First (number) | Febrile Convulsions

Tipo de dados

float

Unidades de medida
  • years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C0205435
UMLS CUI [2]
C0009952
years
Seizure information
Descrição

Seizure information

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

Seizures; Code

Tipo de dados

text

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

Occurrence; Last; Date in time

Tipo de dados

date

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

Seizures; Count

Tipo de dados

float

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

Unit | day | week | month | year

Tipo de dados

text

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

Epilepsy information

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

Seizures; Classification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0008902
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Similar models

Seizure history and information/ Epilepsy information - Screen

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Item
Seizure code
text
C0036572 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Seizures; Code
Code List
Seizure code
CL Item
Simple partial seizures (Consciousness not impaired)- With motor signs - focal motor without march (A1a)
CL Item
Simple partial seizures (Consciousness not impaired)- With motor signs - focal motor with march (Jacksonian) (A1b)
CL Item
Simple partial seizures (Consciousness not impaired)- With motor signs - Versive (A1c)
CL Item
Simple partial seizures (Consciousness not impaired)- With motor signs - Postural (A1d)
CL Item
With somatosensory or special- sensory symptoms - Somatosensory (A2a)
CL Item
With somatosensory or special- sensory symptoms - Visual (A2b)
CL Item
With somatosensory or special- sensory symptoms - Auditory (A2c)
CL Item
With somatosensory or special- sensory symptoms - Olfactory (A2d)
CL Item
With somatosensory or special- sensory symptoms - Gustatory (A2e)
CL Item
With somatosensory or special- sensory symptoms - Vertiginous (A2f)
CL Item
With autonomic symptoms or signs (including epigastric sensation, pallor, sweating, flushing, piloerection, and pupillary dilatation) (A3)
CL Item
With psychic symptoms - Dysphasic (A4a)
CL Item
With psychic symptoms - Dysmnesic (e. g. deja- vu) (A4b)
CL Item
With psychic symptoms - Cognitive (e. g. dreamy states and distortions of time sense) (A4c)
CL Item
With psychic symptoms - Affective (fear, anger, etc.) (A4d)
CL Item
With psychic symptoms - Illusions (e. g. macropsia) (A4e)
CL Item
With psychic symptoms - Structured hallucinations (e. g. music, scenes) (A4f)
CL Item
Simple partial onset followed by impairment of consciousness - With simple partial features (A1- A4) followed by impaired consciousness (B1a)
CL Item
Simple partial onset followed by impairment of consciousness - With automatisms (B1b)
CL Item
With impairment of consciousness at onset - With impairment of consciousness only (B2a)
CL Item
With impairment of consciousness at onset - With automatism (B2b)
CL Item
Partial seizures evolving to secondarily generalized seizures (GS) - Simple partial seizures (A) evolving to GS (C1)
CL Item
Partial seizures evolving to secondarily generalized seizures (GS) - Complex partial (B) evolving to GS (C2)
CL Item
Partial seizures evolving to secondarily generalized seizures (GS) - Simple partial seizures (A) evolving to complex partial seizures (B) evolving to GS (C3)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - Typical Abscence (D1a)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - Impairment of consciousness only (D1ai)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - With mild clonic component (D1aii)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - With atonic component (D1aiii)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - With tonic component (D1aiv)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - With automatisms (D1av)
CL Item
Generalized seizures (Convulsive or Non- convulsive) - With autonomic components (Mixed forms of D1ai- D1avi may occur and should be dosumented by using all applicable code numbers) (D1avi)
CL Item
Atypical Absence (D1b)
CL Item
Changes in tone that are more pronounced than D1a (D1bi)
CL Item
Onset and/ or cessation that is not abrupt (D1bii)
CL Item
Myoclonic seizures (myoclonic jerks- single or multiple) (D2)
CL Item
Clonic seizures (D3)
CL Item
Tonic seizures (D4)
CL Item
Tonic- clonic seizures (D5)
CL Item
Atonic seizures (astatic) (D6)
CL Item
Combination of any of the above generalized seizured may occur and should be documented by using all applicable codde numbers. (Combination of any of the above generalized seizured may occur and should be documented by using all applicable codde numbers.)
CL Item
Unclassified Seizures (E)
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)
Item
Seizure Classification (Use ICE CODES)
text
C0036572 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Seizures; Classification
Code List
Seizure Classification (Use ICE CODES)
CL Item
Benign childhood epilepsy with centro- temporal spike (1.1.1)
CL Item
Childhood epilepsy with occipital paroxysms (1.1.2)
CL Item
Primary reading epilepsy (1.1.3)
CL Item
Temporal lobe epilepsies (1.2.1)
CL Item
Frontal lobe epilepsies (1.2.2)
CL Item
Parietal lobe epilepsies (1.2.3)
CL Item
Occipital lobe epilepsies (1.2.4)
CL Item
Chronic progressive epilepsia partialis continua of childhood (1.2.5)
CL Item
Syndromes characterized by seizures with specific modes of precipitation (1.2.6)
CL Item
Benign neonatal familial convulsions (2.1.1)
CL Item
Benign neonatal convulsions (2.1.2)
CL Item
Benign myoclonic epilepsy in infancy (2.1.3)
CL Item
Childhood absence epilepsy (pyknolepsy) (2.1.4)
CL Item
Juvenile absence epilepsy (2.1.5)
CL Item
Juvenile myoclonic epilepsy (impulsive petit mal) (2.1.6)
CL Item
Epilepsies with grand mal seizures (GTCS) on awakening (2.1.7)
CL Item
Other generalized idiopathic epilepsies (2.1.8)
CL Item
Epilepsies with seizures precipitated by specific modes of activation (2.1.9)
CL Item
West syndrome (infantile spasms, Blitz- Nick- Salaam Krämpfe) (2.2.1)
CL Item
Lennox- Gastaut syndrome (2.2.2)
CL Item
Epilepsy with myoclonic- astatic seizures (2.2.3)
CL Item
Epilepsy with myoclonic absences (2.2.4)
CL Item
Early myoclonic encephalopathy (2.3.1.1)
CL Item
Early infantile epileptic encephalopathy with suppression bursts (2.3.1.2)
CL Item
Other symptomatic generalized epilepsies (2.3.1.3)
CL Item
Epileptic seizures may complicate many disease states (2.3.2.1)
CL Item
Neonatal seizures (3.1.1)
CL Item
Severe myoclonic epilepsy in infancy (3.1.2)
CL Item
Epilepsy with continous spike- waves during slow wave sleep (3.1.3)
CL Item
Acquired epileptic aphasia (Landau- Kleffner syndrome) (3.1.4)
CL Item
Other undetermined epilepsies (3.1.5)
CL Item
Febrile convulsions (4.1.1)
CL Item
Isolated seizures or isolated status epilepticus (4.1.2)
CL Item
Seizures occurring only when there is an acute or toxic event due to factors such as alcohol, drugs, eclampsia, nonketotic hyperglycemia (4.1.3)
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