ID

31705

Beschrijving

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

Trefwoorden

Versies (6)
  1. 21/09/18 21/09/18 -
  2. 22/09/18 22/09/18 -
  3. 22/09/18 22/09/18 -
  4. 27/09/18 27/09/18 -
  5. 08/10/18 08/10/18 -
  6. 11/10/18 11/10/18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 settembre 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschrijving

Study Site; Numbers

Datatype

text

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

Person Initials

Datatype

text

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

Clinical Trial Subject Unique Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Additional medications
Beschrijving

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.)
Beschrijving

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

Datatype

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
Beschrijving

Record Additional medications

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

Date in time; Pharmaceutical Preparations; Taken

Datatype

date

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

Medication name | Generic drug name

Datatype

text

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

AED Prescription Record

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

Antiepileptic Agents; Medication name

Datatype

text

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

Antiepileptic Agents; Start Date

Datatype

date

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

Antiepileptic Agents; End date

Datatype

text

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

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 2
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 3
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 4
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 5
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
AED entire day's dosing information
Beschrijving

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
Beschrijving

Antiepileptic Agents; Medication name

Datatype

text

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

Antiepileptic Agents; Start Date

Datatype

date

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

Antiepileptic Agents; End date

Datatype

date

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

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 2
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 3
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 4
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Time of dose 5
Beschrijving

Dosage; Time

Datatype

time

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

Dosage

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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