ID

38164

Beschreibung

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

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  1. 23.09.19 23.09.19 -
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GlaxoSmithKline

Hochgeladen am

23. September 2019

DOI

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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)

Englisch

Study Termination Record

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Beschreibung

Patient's initials

Datentyp

text

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

Patient's trial number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre number
Beschreibung

Centre number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date the patient took last full dose of study medication
Beschreibung

Date the patient took last full dose of study medication

Datentyp

date

Alias
UMLS CUI [1]
C1762893
Date of last assessment
Beschreibung

Date of last assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1517741
Study Termination
Beschreibung

Study Termination

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0013135
Did the patient complete 16 weeks of the study?
Beschreibung

Did the patient complete 16 weeks of the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
Did the patient discontinued prematurely?
Beschreibung

Did the patient discontinued prematurely?

Datentyp

boolean

Alias
UMLS CUI [1]
C2718058
If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
Beschreibung

If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
UMLS CUI [2,1]
C0064636
UMLS CUI [2,2]
C0549178
UMLS CUI [3,1]
C0064636
UMLS CUI [3,2]
C0439659
If the patient completed 16 weeks did he/ she taper off study medication from week 16?
Beschreibung

If the patient completed 16 weeks did he/ she taper off study medication from week 16?

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
UMLS CUI [2,1]
C0441640
UMLS CUI [2,2]
C0304229
If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
Beschreibung

If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?

Datentyp

boolean

Alias
UMLS CUI [1]
C2718058
UMLS CUI [2]
C0877248
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0439849
Did the patient die during the study?
Beschreibung

Did the patient die during the study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
If patient died, enter date of Death
Beschreibung

If patient died, enter date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Cause of Death
Beschreibung

Cause of Death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Other reasons for premature discontinuation
Beschreibung

Please chek on only.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2718058
UMLS CUI [1,2]
C3840932
Investigator's Statement
Beschreibung

Investigator's Statement

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

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521895
Prinicpal Investigator's Name
Beschreibung

Prinicpal Investigator's Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Study Termination Record

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date the patient took last full dose of study medication
Item
Date the patient took last full dose of study medication
date
C1762893 (UMLS CUI [1])
Date of last assessment
Item
Date of last assessment
date
C2985720 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Item Group
Study Termination
C0008972 (UMLS CUI-1)
C0013135 (UMLS CUI-2)
Did the patient complete 16 weeks of the study?
Item
Did the patient complete 16 weeks of the study?
boolean
C2348577 (UMLS CUI [1])
Did the patient discontinued prematurely?
Item
Did the patient discontinued prematurely?
boolean
C2718058 (UMLS CUI [1])
If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
Item
If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
boolean
C2348577 (UMLS CUI [1])
C0064636 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0064636 (UMLS CUI [3,1])
C0439659 (UMLS CUI [3,2])
If the patient completed 16 weeks did he/ she taper off study medication from week 16?
Item
If the patient completed 16 weeks did he/ she taper off study medication from week 16?
boolean
C2348577 (UMLS CUI [1])
C0441640 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
Item
If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
boolean
C2718058 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
Did the patient die during the study?
Item
Did the patient die during the study?
boolean
C0011065 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
If patient died, enter date of Death
Item
If patient died, enter date of Death
date
C1148348 (UMLS CUI [1])
Cause of Death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Item
Other reasons for premature discontinuation
integer
C2718058 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Other reasons for premature discontinuation
Code List
Other reasons for premature discontinuation
CL Item
Patient failed to return (1)
CL Item
Parent/ guardian withdrew consent (2)
CL Item
Protocol violation (3)
CL Item
General condition deteriorated (4)
CL Item
Clinically significant deterioration of seizure control (5)
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])
Prinicpal Investigator's Name
Item
Prinicpal Investigator's Name
text
C2826892 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

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