Information:
Fel:
ID
31944
Beskrivning
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
Nyckelord
Versioner (4)
- 2018-09-14 2018-09-14 -
- 2018-09-27 2018-09-27 -
- 2018-10-08 2018-10-08 -
- 2018-10-08 2018-10-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Admission Criteria/ Demography - Screen
- StudyEvent: ODM
Similar models
Admission Criteria/ Demography - Screen
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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)
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])
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])
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])
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)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (m)
CL Item
Female (f)
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)