ID
31641
Beschreibung
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
Stichworte
Versionen (4)
- 16.09.18 16.09.18 -
- 27.09.18 27.09.18 -
- 08.10.18 08.10.18 -
- 08.10.18 08.10.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. September 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients
Seizure history and information/ Epilepsy information - Screen
- StudyEvent: ODM
Beschreibung
Seizure history
Alias
- UMLS CUI-1
- C0036572
- UMLS CUI-2
- C0262926
Beschreibung
Etiology
Datentyp
integer
Alias
- UMLS CUI [1]
- C1314792
Beschreibung
Etiology; Symptomatic
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1314792
- UMLS CUI [1,2]
- C0231220
Beschreibung
Age; Seizures; First (number) | Febrile Convulsions
Datentyp
float
Maßeinheiten
- years
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0036572
- UMLS CUI [1,3]
- C0205435
- UMLS CUI [2]
- C0009952
Beschreibung
Seizure information
Alias
- UMLS CUI-1
- C0036572
- UMLS CUI-2
- C1533716
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0036572
- UMLS CUI [1,2]
- C0805701
Beschreibung
Occurrence; Last; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0011008
Beschreibung
Seizures; Count
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0036572
- UMLS CUI [1,2]
- C0750480
Beschreibung
Unit | day | week | month | year
Datentyp
text
Alias
- UMLS CUI [1]
- C0439148
- UMLS CUI [2]
- C0439228
- UMLS CUI [3]
- C0439230
- UMLS CUI [4]
- C0439231
- UMLS CUI [5]
- C0439234
Beschreibung
Epilepsy information
Alias
- UMLS CUI-1
- C0014544
- UMLS CUI-2
- C1533716
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0036572
- UMLS CUI [1,2]
- C0008902
Ähnliche Modelle
Seizure history and information/ Epilepsy information - Screen
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0009952 (UMLS CUI [2])
C0805701 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0439228 (UMLS CUI [2])
C0439230 (UMLS CUI [3])
C0439231 (UMLS CUI [4])
C0439234 (UMLS CUI [5])
C0008902 (UMLS CUI [1,2])