ID

31944

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 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)
  1. 14.09.18 14.09.18 -
  2. 27.09.18 27.09.18 -
  3. 08.10.18 08.10.18 -
  4. 08.10.18 08.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Oktober 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

Englisch

Admission Criteria/ Demography - Screen

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Beschreibung

Study Site Number

Datentyp

integer

Alias
UMLS CUI [1]
C2826711
Patient's initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient's tiral number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Admission Criteria
Beschreibung

Admission Criteria

Alias
UMLS CUI-1
C0030673
UMLS CUI-2
C0243161
Date of assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Does this patient meet all study inclusion/ exclusion criteria?
Beschreibung

Inclusion; Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
If patient doesn't meet all study inclusion/ exclusion criteria, please check the inclusion criteria that were not met.
Beschreibung

Inclusion

Datentyp

integer

Alias
UMLS CUI [1]
C1512693
If patient doesn't meet all study inclusion/ exclusion criteria, please check the exclusion criteria that were not met.
Beschreibung

Exclusion Criteria

Datentyp

text

Alias
UMLS CUI [1]
C0680251
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Racial group

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Admission Criteria/ Demography - Screen

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Site Number
Item
Site number
integer
C2826711 (UMLS CUI [1])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's tiral number
text
C2348585 (UMLS CUI [1])
Item Group
Admission Criteria
C0030673 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Inclusion; Exclusion Criteria
Item
Does this patient meet all study inclusion/ exclusion criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Item
If patient doesn't meet all study inclusion/ exclusion criteria, please check the inclusion criteria that were not met.
integer
C1512693 (UMLS CUI [1])
Inclusion; Exclusion Criteria
Code List
If patient doesn't meet all study inclusion/ exclusion criteria, please check the inclusion criteria that were not met.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
Item
If patient doesn't meet all study inclusion/ exclusion criteria, please check the exclusion criteria that were not met.
text
C0680251 (UMLS CUI [1])
undefined item
Code List
If patient doesn't meet all study inclusion/ exclusion criteria, please check the exclusion criteria that were not met.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
Item Group
Demography
C0011298 (UMLS CUI-1)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (m)
CL Item
Female (f)
Item
Race
integer
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
White (origins in any of the original peoples of Europe, Middle East, North Africa [Arabic stock], Western Russia [including Afghanistan and Southern Russia] and Hispanics of European origin.) (1)
CL Item
Black (origins in any of the black racial groups of Africa) (2)
CL Item
Asian (Indian) (origins in the original peoplöes of the Indian sub- continent. Includes for example India, Pakistan, Bangladesh) (3)
CL Item
Asian (Oriental) (origins in the original peoples of the Far East and South- East Asia. Includes for example China, Japan, Korea, Philippine Islands, Eastern Russia and Samoa.) (4)
CL Item
Other (includes people whose racial group is not represented above; for example Eskimos, Pacific Islanders, North and South American Indians and Hispanics of South American origin. Also includes people whose predominant origin cannot be determined.) (5)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video