ID

38049

Descripción

Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Palabras clave

Versiones (2)
  1. 12/9/19 12/9/19 -
  2. 12/9/19 12/9/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

Inglés

Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Descripción

Patient's initials

Tipo de datos

text

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

Patient's trial number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Center number
Descripción

Center number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Present Medication - Present chronic AED Therapy
Descripción

Present Medication - Present chronic AED Therapy

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0150312
UMLS CUI-3
C0003299
UMLS CUI-4
C0205191
Present chronic AED Therapy - Drug
Descripción

Present chronic AED Therapy - Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0205191
UMLS CUI [2]
C0013227
Present Chronic AED Therapy - Total Daily Dose
Descripción

Present Chronic AED Therapy - Total Daily Dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
mg
Present chronic AED Therapy - Date present dose started
Descripción

Present chronic AED Therapy - Date present dose started

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C3174092
UMLS CUI [2,3]
C0150312
Present Medication - Emergency AED Therapy used irregularly as required
Descripción

Present Medication - Emergency AED Therapy used irregularly as required

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0150312
UMLS CUI-3
C0013956
UMLS CUI-4
C0003299
Emergency AED Therapy used irregularly as required - Drug
Descripción

Emergency AED Therapy used irregularly as required - Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C0003299
UMLS CUI [2]
C0013227
Emergency AED Therapy used irregularly as required - Total Daily Dose
Descripción

Emergency AED Therapy used irregularly as required - Total Daily Dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C0003299
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
mg
Emergency AED Therapy used irregularly as required - Route
Descripción

Emergency AED Therapy used irregularly as required - Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C0003299
UMLS CUI [2]
C0013153
Present Medication - Other Medication
Descripción

Present Medication - Other Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0150312
UMLS CUI-3
C0205394
Other Medication - Drug
Descripción

Other Medication - Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0205394
Other Medication - Total Daily Dose
Descripción

Other Medication - Total Daily Dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C2348070
UMLS CUI [2,2]
C0439810
mg
Other Medication - Date present dose started
Descripción

Other Medication - Date present dose started

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C3174092
UMLS CUI [2,3]
C0150312
Other Medication - Indication
Descripción

Other Medication - Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C3146298
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic blood pressure sitting
Descripción

Systolic blood pressure sitting

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mm[Hg]
Diastolic blood pressure sitting
Descripción

Diastolic blood pressure sitting

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mm[Hg]
Pulse sitting
Descripción

Pulse sitting

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C2029904
beats/min
Weight
Descripción

Weight

Tipo de datos

integer

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Eyes
Descripción

Eyes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015392
Eyes - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0015392
Ears, Nose, Throat
Descripción

Ears, Nose, Throat

Tipo de datos

integer

Alias
UMLS CUI [1]
C0278350
Ears, Nose, Throat - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0278350
Cardiovascular
Descripción

Cardiovascular

Tipo de datos

integer

Alias
UMLS CUI [1]
C0007226
Cardiovascular - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0007226
Pulmonary
Descripción

Pulmonary

Tipo de datos

integer

Alias
UMLS CUI [1]
C2709248
Pulmonary - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C2709248
Abdomen
Descripción

Abdomen

Tipo de datos

integer

Alias
UMLS CUI [1]
C0000726
Abdomen - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0000726
Lymph nodes
Descripción

Lymph nodes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0024204
Lymph nodes - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0024204
Extremities
Descripción

Extremities

Tipo de datos

integer

Alias
UMLS CUI [1]
C0436150
Extremities - Abnormal physical finding
Descripción

Please give brief details.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0436150
Other examination
Descripción

Please specify.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
Other examination
Descripción

Other examination

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
Other examination - Abnormal physical finding
Descripción

Other examination - Abnormal physical finding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826636
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205394
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Similar models

Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient's initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Present Medication - Present chronic AED Therapy
C0013227 (UMLS CUI-1)
C0150312 (UMLS CUI-2)
C0003299 (UMLS CUI-3)
C0205191 (UMLS CUI-4)
Item
Present chronic AED Therapy - Drug
text
C0150312 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Drug
Code List
Present chronic AED Therapy - Drug
CL Item
Acetazoiamide  (ACE)
CL Item
Carbamazepine  (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Clobazam  (CLB)
CL Item
Clonazepam  (CZP)
CL Item
Diazepam  (DZP)
CL Item
Ethosuximide  (ESM)
CL Item
Flunarizine  (FNR)
CL Item
Hydrocortisone  (HC)
CL Item
Lamotrigine (LTG)
CL Item
Lorazepam  (LZP)
CL Item
Nitrazepam  (NZP)
CL Item
Oxcarbazepine  (OCZ)
CL Item
Phenobarbitone  (PB)
CL Item
Phenytoin  (PHT)
CL Item
Primidone  (PRM)
CL Item
Sulthiame  (SUL)
CL Item
Valproate Sodium  (VPA)
CL Item
Vigabatrin (VGB)
Present Chronic AED Therapy - Total Daily Dose
Item
Present Chronic AED Therapy - Total Daily Dose
float
C0150312 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Present chronic AED Therapy - Date present dose started
Item
Present chronic AED Therapy - Date present dose started
date
C0150312 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0808070 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Item Group
Present Medication - Emergency AED Therapy used irregularly as required
C0013227 (UMLS CUI-1)
C0150312 (UMLS CUI-2)
C0013956 (UMLS CUI-3)
C0003299 (UMLS CUI-4)
Item
Emergency AED Therapy used irregularly as required - Drug
text
C0013956 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2])
Emergency AED Therapy used irregularly as required - Drug
Code List
Emergency AED Therapy used irregularly as required - Drug
CL Item
Acetazoiamide  (ACE)
CL Item
Carbamazepine  (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Clobazam  (CLB)
CL Item
Clonazepam  (CZP)
CL Item
Diazepam  (DZP)
CL Item
Ethosuximide  (ESM)
CL Item
Flunarizine  (FNR)
CL Item
Hydrocortisone  (HC)
CL Item
Lamotrigine (LTG)
CL Item
Lorazepam  (LZP)
CL Item
Nitrazepam  (NZP)
CL Item
Oxcarbazepine  (OCZ)
CL Item
Phenobarbitone  (PB)
CL Item
Phenytoin  (PHT)
CL Item
Primidone  (PRM)
CL Item
Sulthiame  (SUL)
CL Item
Valproate Sodium  (VPA)
CL Item
Vigabatrin (VGB)
Emergency AED Therapy used irregularly as required - Total Daily Dose
Item
Emergency AED Therapy used irregularly as required - Total Daily Dose
float
C0013956 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Item
Emergency AED Therapy used irregularly as required - Route
text
C0013956 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
Emergency AED Therapy used irregularly as required - Route
Code List
Emergency AED Therapy used irregularly as required - Route
CL Item
By mouth (PO)
CL Item
By rectum (PR)
CL Item
Intravenous (IV)
CL Item
Intramuscular (IM)
CL Item
Infusion (INF)
Item Group
Present Medication - Other Medication
C0013227 (UMLS CUI-1)
C0150312 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other Medication - Drug
Item
Other Medication - Drug
text
C0013227 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other Medication - Total Daily Dose
Item
Other Medication - Total Daily Dose
float
C0013227 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Other Medication - Date present dose started
Item
Other Medication - Date present dose started
date
C0013227 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Other Medication - Indication
Item
Other Medication - Indication
text
C0013227 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Systolic blood pressure sitting
Item
Systolic blood pressure sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure sitting
Item
Diastolic blood pressure sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse sitting
Item
Pulse sitting
integer
C2029904 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Eyes
integer
C0015392 (UMLS CUI [1])
Eyes
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Eyes - Abnormal physical finding
Item
Eyes - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Item
Ears, Nose, Throat
integer
C0278350 (UMLS CUI [1])
Ears, Nose, Throat
Code List
Ears, Nose, Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Ears, Nose, Throat - Abnormal physical finding
Item
Ears, Nose, Throat - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Item
Cardiovascular
integer
C0007226 (UMLS CUI [1])
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Cardiovascular - Abnormal physical finding
Item
Cardiovascular - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Item
Pulmonary
integer
C2709248 (UMLS CUI [1])
Pulmonary
Code List
Pulmonary
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Pulmonary - Abnormal physical finding
Item
Pulmonary - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C2709248 (UMLS CUI [1,2])
Item
Abdomen
integer
C0000726 (UMLS CUI [1])
Abdomen
Code List
Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Abdomen - Abnormal physical finding
Item
Abdomen - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
Lymph nodes
integer
C0024204 (UMLS CUI [1])
Lymph nodes
Code List
Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Lymph nodes - Abnormal physical finding
Item
Lymph nodes - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Item
Extremities
integer
C0436150 (UMLS CUI [1])
Extremities
Code List
Extremities
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Extremities - Abnormal physical finding
Item
Extremities - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0436150 (UMLS CUI [1,2])
Other examination
Item
Other examination
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other examination
integer
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other examination
Code List
Other examination
CL Item
Normal (1)
CL Item
Abnormal (2)
Other examination - Abnormal physical finding
Item
Other examination - Abnormal physical finding
text
C2826636 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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