ID

31944

Description

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

Keywords

Versions (4)
  1. 9/14/18 9/14/18 -
  2. 9/27/18 9/27/18 -
  3. 10/8/18 10/8/18 -
  4. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 2018

DOI

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License

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

English

Admission Criteria/ Demography - Screen

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site Number

Data type

integer

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

Person Initials

Data type

text

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

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Admission Criteria
Description

Admission Criteria

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

Assessment Date

Data type

date

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

Inclusion; Exclusion Criteria

Data type

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.
Description

Inclusion

Data type

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.
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

integer

Alias
UMLS CUI [1]
C0034510
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Similar models

Admission Criteria/ Demography - Screen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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