ID

31934

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

Palavras-chave

Versões (3)
  1. 18/09/2018 18/09/2018 -
  2. 27/09/2018 27/09/2018 -
  3. 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 record - Baseline, Treatment Phase, Taper and Follow- up and innumerable seizure activity record - Study week 1 through Taper and Follow-up

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
Seizure record - Baseline
Descrição

Seizure record - Baseline

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0034869
UMLS CUI-4
C1442488
Seizure date
Descrição

Seizures; Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0011008
Major seizure type (i.e., code A, B, or C)
Descrição

Seizures; Type - attribute

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0332307
Total daily counts of seizures
Descrição

Seizures; Count; Daily

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0332173
Seizure record - Treatment Phase
Descrição

Seizure record - Treatment Phase

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0034869
UMLS CUI-3
C3538994
Seizure date
Descrição

Seizures; Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0011008
Major seizure type (i.e., code A, B, or C)
Descrição

Seizures; Type - attribute

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0332307
Seizure record - Taper and Follow- up
Descrição

Seizure record - Taper and Follow- up

Alias
UMLS CUI-1
C0036572
UMLS CUI-2
C0034869
UMLS CUI-3
C1522577
Seizure date
Descrição

Seizures; Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0011008
Major seizure type (i.e., code A, B, or C)
Descrição

Seizures; Type - attribute

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0332307
Innumerable seizure activity
Descrição

Innumerable seizure activity

Alias
UMLS CUI-1
C1148454
UMLS CUI-2
C3846158
Seizure date
Descrição

Seizures; Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0011008
Seizure duration
Descrição

Duration of seizure

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1]
C0730597
min
Major seizure type (i.e., code A, B, or C)
Descrição

Seizures; Type - attribute

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0332307
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Similar models

Seizure record - Baseline, Treatment Phase, Taper and Follow- up and innumerable seizure activity record - Study week 1 through Taper and Follow-up

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])
Item Group
Seizure record - Baseline
C0036572 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
C1442488 (UMLS CUI-4)
Seizures; Date in time
Item
Seizure date
date
C0036572 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Seizures; Type - attribute
Code List
Major seizure type (i.e., code A, B, or C)
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)
Seizures; Count; Daily
Item
Total daily counts of seizures
integer
C0036572 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Item Group
Seizure record - Treatment Phase
C0036572 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
C3538994 (UMLS CUI-3)
Seizures; Date in time
Item
Seizure date
date
C0036572 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Seizures; Type - attribute
Code List
Major seizure type (i.e., code A, B, or C)
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)
Item Group
Seizure record - Taper and Follow- up
C0036572 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Seizures; Date in time
Item
Seizure date
date
C0036572 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Seizures; Type - attribute
Code List
Major seizure type (i.e., code A, B, or C)
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)
Item Group
Innumerable seizure activity
C1148454 (UMLS CUI-1)
C3846158 (UMLS CUI-2)
Seizures; Date in time
Item
Seizure date
date
C0036572 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Duration of seizure
Item
Seizure duration
integer
C0730597 (UMLS CUI [1])
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Seizures; Type - attribute
Code List
Major seizure type (i.e., code A, B, or C)
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)
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