ID

38024

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. 09.09.19 09.09.19 -
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GlaxoSmithKline

Hochgeladen am

9. September 2019

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

Englisch

Visit 1/ Screen - Demography; Neurological History

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
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Check only one.

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Neurological History
Beschreibung

Neurological History

Alias
UMLS CUI-1
C0027765
UMLS CUI-2
C0262926
Age of the patient at first seizure
Beschreibung

Age of the patient at first seizure

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C0205435
years
Age of the patient at first seizure
Beschreibung

Age of the patient at first seizure

Datentyp

integer

Maßeinheiten
  • months
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C0205435
months
Does the patient have a history of an infantile spasms syndrome?
Beschreibung

Does the patient have a history of an infantile spasms syndrome?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037763
UMLS CUI [1,2]
C0231330
UMLS CUI [1,3]
C0039082
Is the aetiology Cryptogenic or Symptomatic?
Beschreibung

Is the aetiology Cryptogenic or Symptomatic?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0086237
UMLS CUI [2,1]
C1314792
UMLS CUI [2,2]
C0231220
If aetiology is symptomatic and there is a definitive specific aetiology, please check all that apply
Beschreibung

If aetiology is symptomatic and there is a definitive specific aetiology, please check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1314792
UMLS CUI [2,2]
C2348235
Specify, if aetiology is congenital infection, specific dysmorphology, identifiable chromosomal abnormality, single gene defect, neonatal seizures indentifiable cause or other
Beschreibung

Specify aetiology

Datentyp

text

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0000768
UMLS CUI [3,1]
C0814936
UMLS CUI [3,2]
C2348235
UMLS CUI [4]
C0008625
UMLS CUI [5]
C0037176
UMLS CUI [6,1]
C0036572
UMLS CUI [6,2]
C2939425
Other major neurological diagnoses
Beschreibung

Please specify briefly.

Datentyp

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0205394
How is the patient's intellectual function?
Beschreibung

Please check one.

Datentyp

integer

Alias
UMLS CUI [1]
C0233821
If normal or mildly impaired intellectual function, is there a clinical impression of deterioration?
Beschreibung

If normal or mildly impaired intellectual function, is there a clinical impression of deterioration?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C1279889
Does the patient have a history of status epilepticus?
Beschreibung

Does the patient have a history of status epilepticus?

Datentyp

text

Alias
UMLS CUI [1,1]
C0038220
UMLS CUI [1,2]
C0262926
Date of last occurence (status epilepticus)
Beschreibung

Date of last occurence (status epilepticus)

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0038220
Status epilepticus
Beschreibung

Check all that apply.

Datentyp

integer

Alias
UMLS CUI [1]
C0038220
If other status epilepticus, please specify
Beschreibung

If other status epilepticus, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0038220
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Has the patient had epilepsy surgery?
Beschreibung

Has the patient had epilepsy surgery?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0543467
If the patient had epilepsy surgery, check all that apply.
Beschreibung

If the patient had epilepsy surgery, check all that apply.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0543467
If other epilepsy surgery, please specify
Beschreibung

If other epilepsy surgery, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
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Ähnliche Modelle

Visit 1/ Screen - Demography; Neurological History

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])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
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 peoples 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 Eskimoes, Pacific Islanders, North and South American Indians and Hispanics of South American origin. Also includes people whose predominant origin canto be determined) (5)
Item Group
Neurological History
C0027765 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Age of the patient at first seizure
Item
Age of the patient at first seizure
integer
C0001779 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Age of the patient at first seizure
Item
Age of the patient at first seizure
integer
C0001779 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Does the patient have a history of an infantile spasms syndrome?
Item
Does the patient have a history of an infantile spasms syndrome?
boolean
C0037763 (UMLS CUI [1,1])
C0231330 (UMLS CUI [1,2])
C0039082 (UMLS CUI [1,3])
Item
Is the aetiology Cryptogenic or Symptomatic?
integer
C1314792 (UMLS CUI [1,1])
C0086237 (UMLS CUI [1,2])
C1314792 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Is the aetiology Cryptogenic or Symptomatic?
Code List
Is the aetiology Cryptogenic or Symptomatic?
CL Item
Cryptogenic (1)
CL Item
Symptomatic (2)
Item
If aetiology is symptomatic and there is a definitive specific aetiology, please check all that apply
integer
C1314792 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1314792 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If aetiology is symptomatic and there is a definitive specific aetiology, please check all that apply
Code List
If aetiology is symptomatic and there is a definitive specific aetiology, please check all that apply
CL Item
Prenatal - congenital infection, specify (1)
CL Item
Prenatal - non specific dysmorphology (2)
CL Item
Prenatal - specific dysmorphology, specify (3)
CL Item
Prenatal - identifiable chromosomal abnormality, specify (4)
CL Item
Prenatal - single gene defect, specify (5)
CL Item
Prenatal - other, specify (6)
CL Item
Perinatal - extreme prematurity (7)
CL Item
Perinatal - definite perinatal asphyxia (8)
CL Item
Perinatal - definite cerebral haemorrhage (9)
CL Item
Perinatal - neonatal seizures of unknown cause (10)
CL Item
Perinatal - neonatal seizures identifiable cause, specify (11)
CL Item
Perinatal - neonatal sepsis (12)
CL Item
Perinatal - other, specify (13)
CL Item
Postnatal - CNS infection (14)
CL Item
Postnatal - CNS injury/ trauma (15)
CL Item
Postnatal - Other, specify (16)
Specify aetiology
Item
Specify, if aetiology is congenital infection, specific dysmorphology, identifiable chromosomal abnormality, single gene defect, neonatal seizures indentifiable cause or other
text
C1314792 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0000768 (UMLS CUI [2,2])
C0814936 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
C0008625 (UMLS CUI [4])
C0037176 (UMLS CUI [5])
C0036572 (UMLS CUI [6,1])
C2939425 (UMLS CUI [6,2])
Other major neurological diagnoses
Item
Other major neurological diagnoses
text
C0027765 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
How is the patient's intellectual function?
integer
C0233821 (UMLS CUI [1])
How is the patient's intellectual function?
Code List
How is the patient's intellectual function?
CL Item
Normal (1)
CL Item
Mildly impaired (2)
CL Item
Moderately impaired (3)
CL Item
Severely impaired (4)
If normal or mildly impaired intellectual function, is there a clinical impression of deterioration?
Item
If normal or mildly impaired intellectual function, is there a clinical impression of deterioration?
boolean
C0683322 (UMLS CUI [1,1])
C1279889 (UMLS CUI [1,2])
Item
Does the patient have a history of status epilepticus?
text
C0038220 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Does the patient have a history of status epilepticus?
Code List
Does the patient have a history of status epilepticus?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurence (status epilepticus)
Item
Date of last occurence (status epilepticus)
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0038220 (UMLS CUI [1,4])
Item
Status epilepticus
integer
C0038220 (UMLS CUI [1])
Status epilepticus
Code List
Status epilepticus
CL Item
major tonic-clonic (1)
CL Item
minor motor status (2)
CL Item
absence status (3)
CL Item
other (4)
If other status epilepticus, please specify
Item
If other status epilepticus, please specify
text
C0038220 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Has the patient had epilepsy surgery?
Item
Has the patient had epilepsy surgery?
boolean
C0014544 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item
If the patient had epilepsy surgery, check all that apply.
integer
C0014544 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
If the patient had epilepsy surgery, check all that apply.
Code List
If the patient had epilepsy surgery, check all that apply.
CL Item
callostomy (1)
CL Item
resection (2)
CL Item
other (3)
If other epilepsy surgery, please specify
Item
If other epilepsy surgery, please specify
text
C0014544 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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