ID

38162

Description

Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

English

Comment Log; Investigator's Statement

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Description

Patient's initials

Data type

text

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

Patient's trial number

Data type

text

Alias
UMLS CUI [1]
C2348585
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Comment Log
Description

Comment Log

Alias
UMLS CUI-1
C0947611
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator's Statement
Description

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Principal Investigator's signature
Description

I confirm that I have carefully examined all entries on the Case Report Forms for this patient. All Information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521895
Principal Investigator's Name
Description

Principal Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature Date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Comment Log; Investigator's Statement

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient's initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Patient's trial number
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Comment Log
C0947611 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Principal Investigator's signature
Item
Principal Investigator's signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Principal Investigator's Name
Item
Principal Investigator's Name
text
C2826892 (UMLS CUI [1])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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