ID

31665

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

Keywords

Versions (3)
  1. 9/18/18 9/18/18 -
  2. 9/27/18 9/27/18 -
  3. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 18, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients

English

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

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site; Numbers

Data type

text

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

Person Initials

Data type

text

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

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Seizure record - Baseline
Description

Seizure record - Baseline

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

Seizures; Date in time

Data type

date

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

Data type

text

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

Seizures; Count; Daily

Data type

integer

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

Seizure record - Treatment Phase

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

Seizures; Date in time

Data type

date

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

Data type

text

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

Seizure record - Taper and Follow- up

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

Seizures; Date in time

Data type

date

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

Data type

text

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

Innumerable seizure activity

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

Seizures; Date in time

Data type

date

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

Duration of seizure

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1]
C0730597
min
Major seizure type (i.e., code A, B, or C)
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

Data type

text

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0332307
Back to the top of the page

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Seizures; Type - attribute
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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])
Seizures; Type - attribute
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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])
Seizures; Type - attribute
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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])
Seizures; Type - attribute
Item
Major seizure type (i.e., code A, B, or C)
text
C0036572 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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