ID

31935

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 (3)
  1. 9/18/18 9/18/18 -
  2. 9/27/18 9/27/18 -
  3. 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

Adverse Experiences

1 forms  
  1. StudyEvent: ODM
    1. Adverse Experiences
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site number
Description

Study Site; Numbers

Data type

text

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

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Paritient's trial number
Description

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Occurence of Adverse Experiences
Description

Occurence of Adverse Experiences

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2745955
Did any adverse experiences occur during Baseline through Taper and Follow- up?
Description

If yes, record below- one adverse experience per section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1522577
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Specification of Adverse Experience
Description

Adverse event; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
Adverse Experience start date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Adverse Experience stop date
Description

Adverse event; End date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
If Adverse Experience is ongoing at end of study, check.
Description

Adverse Event Ongoing

Data type

integer

Alias
UMLS CUI [1]
C2826663
Maximum intensity of Adverse Experience, check one.
Description

Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Maximum seriousness of Adverse Experience
Description

Seriousness of Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1710056
Is the Adverse Experience caused by study drug? Check one.
Description

Adverse event; Experimental drug

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
Action taken due to adverse experience - Study drug dose; check one.
Description

Adverse Event Action Taken with Study Treatment; Drug dose

Data type

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0678766
Action taken due to Adverse Experience - Other action taken
Description

Adverse Event Action Taken with Study Treatment; Other

Data type

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0205394
If other action taken due to Adverse Experience, specify
Description

Adverse Event Action Taken with Study Treatment; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Adverse Experiences

1 forms
  1. StudyEvent: ODM
    1. Adverse Experiences
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Paritient's trial number
text
C2348585 (UMLS CUI [1])
Item Group
Occurence of Adverse Experiences
C0877248 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
Adverse event; Baseline | Adverse event; follow-up
Item
Did any adverse experiences occur during Baseline through Taper and Follow- up?
boolean
C0877248 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse event; Specification
Item
Specification of Adverse Experience
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Adverse Event Start Date
Item
Adverse Experience start date
date
C2697888 (UMLS CUI [1])
Adverse event; End date
Item
Adverse Experience stop date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
If Adverse Experience is ongoing at end of study, check.
integer
C2826663 (UMLS CUI [1])
Adverse Event Ongoing
Code List
If Adverse Experience is ongoing at end of study, check.
CL Item
Ongoing Adverse Experience at end of study (1)
Item
Maximum intensity of Adverse Experience, check one.
integer
C1710066 (UMLS CUI [1])
Severity of Adverse Event
Code List
Maximum intensity of Adverse Experience, check one.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Maximum seriousness of Adverse Experience
integer
C1710056 (UMLS CUI [1])
Seriousness of Adverse Event
Code List
Maximum seriousness of Adverse Experience
CL Item
Not serious (1)
CL Item
Serious (2)
Item
Is the Adverse Experience caused by study drug? Check one.
integer
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Adverse event; Experimental drug
Code List
Is the Adverse Experience caused by study drug? Check one.
CL Item
Not a reasonable possibility (1)
CL Item
A reasonable possibility (2)
Item
Action taken due to adverse experience - Study drug dose; check one.
integer
C2826626 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
undefined item
Code List
Action taken due to adverse experience - Study drug dose; check one.
CL Item
Unchanged (1)
CL Item
Increased (2)
CL Item
Decreased and/ or stopped temporarily (3)
CL Item
Stopped permanently (4)
Item
Action taken due to Adverse Experience - Other action taken
integer
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
undefined item
Code List
Action taken due to Adverse Experience - Other action taken
CL Item
No (1)
CL Item
Hosp. (2)
CL Item
Other, specify (3)
Adverse Event Action Taken with Study Treatment; Other; Specification
Item
If other action taken due to Adverse Experience, specify
text
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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