ID

31705

Descripción

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

Palabras clave

Versiones (6)
  1. 21/9/18 21/9/18 -
  2. 22/9/18 22/9/18 -
  3. 22/9/18 22/9/18 -
  4. 27/9/18 27/9/18 -
  5. 8/10/18 8/10/18 -
  6. 11/10/18 11/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de septiembre de 2018

DOI

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Licencia

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

Inglés

Concomitant Medications - Study Week 1 Through Taper and Follow- up and AED Prescription Taper and Follow- Up

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Descripción

Study Site; Numbers

Tipo de datos

text

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

Person Initials

Tipo de datos

text

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

Clinical Trial Subject Unique Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Additional medications
Descripción

Additional medications

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1706712
Were any additional medications other than antiepileptic drugs taken during the study? (If yes, record below.)
Descripción

Pharmaceutical Preparations; Additional Therapy; Taken; Clinical Trials; During

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1706712
UMLS CUI [1,3]
C1883727
UMLS CUI [1,4]
C0008976
UMLS CUI [1,5]
C0347984
Record Additional medications
Descripción

Record Additional medications

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1706712
UMLS CUI-3
C0034869
Date medication first taken during study
Descripción

Date in time; Pharmaceutical Preparations; Taken

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1883727
Name of drug/ Generic
Descripción

Medication name | Generic drug name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C0592502
AED Prescription Record
Descripción

AED Prescription Record

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C1521941
Name of antiepileptic drug
Descripción

Antiepileptic Agents; Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C2360065
Start date antiepileptic drug
Descripción

Antiepileptic Agents; Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0808070
Stop date antiepileptic drug
Descripción

Antiepileptic Agents; End date

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0806020
Time of dose 1
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 1
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 2
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 2
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 3
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 3
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 4
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 4
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 5
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 5
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
AED entire day's dosing information
Descripción

AED entire day's dosing information

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0678766
UMLS CUI-3
C1533716
UMLS CUI-4
C0439228
UMLS CUI-5
C0439751
Name of antiepileptic drug
Descripción

Antiepileptic Agents; Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C2360065
Start date antiepileptic drug
Descripción

Antiepileptic Agents; Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0808070
Stop date antiepileptic drug
Descripción

Antiepileptic Agents; End date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0806020
Time of dose 1
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 1
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 2
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 2
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 3
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 3
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 4
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 4
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 5
Descripción

Dosage; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Amount of dose 5
Descripción

Dosage

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C0178602
mg
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Similar models

Concomitant Medications - Study Week 1 Through Taper and Follow- up and AED Prescription Taper and Follow- Up

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Additional medications
C0013227 (UMLS CUI-1)
C1706712 (UMLS CUI-2)
Pharmaceutical Preparations; Additional Therapy; Taken; Clinical Trials; During
Item
Were any additional medications other than antiepileptic drugs taken during the study? (If yes, record below.)
boolean
C0013227 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
Item Group
Record Additional medications
C0013227 (UMLS CUI-1)
C1706712 (UMLS CUI-2)
C0034869 (UMLS CUI-3)
Date in time; Pharmaceutical Preparations; Taken
Item
Date medication first taken during study
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Medication name | Generic drug name
Item
Name of drug/ Generic
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item Group
AED Prescription Record
C0003299 (UMLS CUI-1)
C1521941 (UMLS CUI-2)
Antiepileptic Agents; Medication name
Item
Name of antiepileptic drug
text
C0003299 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Antiepileptic Agents; Start Date
Item
Start date antiepileptic drug
date
C0003299 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Antiepileptic Agents; End date
Item
Stop date antiepileptic drug
text
C0003299 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Dosage; Time
Item
Time of dose 1
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 1
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 2
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 2
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 3
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 3
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 4
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 4
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 5
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 5
float
C0178602 (UMLS CUI [1])
Item Group
AED entire day's dosing information
C0003299 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C0439228 (UMLS CUI-4)
C0439751 (UMLS CUI-5)
Antiepileptic Agents; Medication name
Item
Name of antiepileptic drug
text
C0003299 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Antiepileptic Agents; Start Date
Item
Start date antiepileptic drug
date
C0003299 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Antiepileptic Agents; End date
Item
Stop date antiepileptic drug
date
C0003299 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Dosage; Time
Item
Time of dose 1
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 1
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 2
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 2
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 3
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 3
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 4
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 4
float
C0178602 (UMLS CUI [1])
Dosage; Time
Item
Time of dose 5
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosage
Item
Amount of dose 5
float
C0178602 (UMLS CUI [1])
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