ID

38162

Beschrijving

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

Trefwoorden

  1. 23-09-19 23-09-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

23 september 2019

DOI

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Licentie

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)

Comment Log; Investigator's Statement

Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Beschrijving

Patient's initials

Datatype

text

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

Patient's trial number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Center number
Beschrijving

Center number

Datatype

text

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

Comment Log

Alias
UMLS CUI-1
C0947611
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Comments
Beschrijving

Comments

Datatype

text

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

Investigator's Statement

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

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.

Datatype

text

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

Principal Investigator's Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Signature Date
Beschrijving

Signature Date

Datatype

date

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

Similar models

Comment Log; Investigator's Statement

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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