ID

38024

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

Mots-clés

Versions (1)
  1. 09/09/2019 09/09/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 septembre 2019

DOI

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Licence

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)

Anglais

Visit 1/ Screen - Demography; Neurological History

1 Formulaires  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient's initials
Description

Patient's initials

Type de données

text

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

Patient's trial number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Center number
Description

Center number

Type de données

text

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

Date of Assessment

Type de données

date

Alias
UMLS CUI [1]
C2985720
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Check only one.

Type de données

integer

Alias
UMLS CUI [1]
C0034510
Neurological History
Description

Neurological History

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

Age of the patient at first seizure

Type de données

integer

Unités de mesure
  • 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
Description

Age of the patient at first seizure

Type de données

integer

Unités de mesure
  • 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?
Description

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

Type de données

boolean

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

Is the aetiology Cryptogenic or Symptomatic?

Type de données

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
Description

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

Type de données

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
Description

Specify aetiology

Type de données

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
Description

Please specify briefly.

Type de données

text

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

Please check one.

Type de données

integer

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

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

Type de données

boolean

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

Does the patient have a history of status epilepticus?

Type de données

text

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

Date of last occurence (status epilepticus)

Type de données

date

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

Check all that apply.

Type de données

integer

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

If other status epilepticus, please specify

Type de données

text

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

Has the patient had epilepsy surgery?

Type de données

boolean

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

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

Type de données

integer

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

If other epilepsy surgery, please specify

Type de données

text

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Retour au début de la page

Similar models

Visit 1/ Screen - Demography; Neurological History

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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