ID

38158

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

  1. 9/23/19 9/23/19 -
  2. 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)

Visit 4; Visit 7/ Final Assessment - Haematology/ Clinical Chemistry; AED Plasma Concentration

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
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0018941
Haematology - Date sample collected
Description

Haematology - Date sample collected

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology - Laboratory number
Description

Haematology - Laboratory number

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0018941
Haemoglobin
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0518015
Quantitative platelet count
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0032181
WBC
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0023508
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Clinical Chemistry - Date sample collected
Description

Clinical Chemistry - Date sample collected

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Clinical Chemistry - Laboratory number
Description

Clinical Chemistry - Laboratory number

Data type

text

Alias
UMLS CUI [1,1]
C2986056
UMLS CUI [1,2]
C0008000
Creatinine
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201976
ALT (SGPT)
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201836
AST (SGOT)
Description

If any of the values are outside the Normal Ranges, please detail as follows: NCS = value outside Normal Range but not clinically significant CS = value outside Normal Range and clinically significant

Data type

text

Alias
UMLS CUI [1]
C0201899
Plasma Concentrations of AEDs
Description

Plasma Concentrations of AEDs

Alias
UMLS CUI-1
C0003299
UMLS CUI-2
C0683150
AED plasma concentration - Date of sample
Description

AED plasma concentration - Date of sample

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0003299
UMLS CUI [1,3]
C0683150
Drug NOT including Study Medication
Description

Drug NOT including Study Medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
Time since last dose
Description

Time since last dose

Data type

integer

Measurement units
  • hrs
Alias
UMLS CUI [1,1]
C0946444
UMLS CUI [1,2]
C1711239
hrs
Medication Concentration Value
Description

Medication Concentration Value

Data type

float

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1522609
Medication Concentration Units
Description

Medication Concentration Units

Data type

text

Alias
UMLS CUI [1,1]
C0683150
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1519795

Similar models

Visit 4; Visit 7/ Final Assessment - Haematology/ Clinical Chemistry; AED Plasma Concentration

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
Haematology
C0018941 (UMLS CUI-1)
Haematology - Date sample collected
Item
Haematology - Date sample collected
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory number
Item
Haematology - Laboratory number
text
C2986056 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haemoglobin
Item
Haemoglobin
text
C0518015 (UMLS CUI [1])
Quantitative platelet count
Item
Quantitative platelet count
text
C0032181 (UMLS CUI [1])
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry - Date sample collected
Item
Clinical Chemistry - Date sample collected
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Clinical Chemistry - Laboratory number
Item
Clinical Chemistry - Laboratory number
text
C2986056 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
text
C0201976 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
text
C0201836 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
text
C0201899 (UMLS CUI [1])
Item Group
Plasma Concentrations of AEDs
C0003299 (UMLS CUI-1)
C0683150 (UMLS CUI-2)
AED plasma concentration - Date of sample
Item
AED plasma concentration - Date of sample
date
C1302413 (UMLS CUI [1,1])
C0003299 (UMLS CUI [1,2])
C0683150 (UMLS CUI [1,3])
Item
Drug NOT including Study Medication
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Drug NOT including Study Medication
CL Item
Acetazoiamide  (ACE)
CL Item
Carbamazepine  (CBZ)
CL Item
Carbamazepine Retard (CBZR)
CL Item
Clobazam  (CLB)
CL Item
Clonazepam  (CZP)
CL Item
Diazepam  (DZP)
CL Item
Ethosuximide  (ESM)
CL Item
Flunarizine  (FNR)
CL Item
Hydrocortisone  (HC)
CL Item
Lorazepam  (LZP)
CL Item
Nitrazepam  (NZP)
CL Item
Oxcarbazepine  (OCZ)
CL Item
Phenobarbitone  (PB)
CL Item
Phenytoin  (PHT)
CL Item
Primidone  (PRM)
CL Item
Sulthiame  (SUL)
CL Item
Valproate Sodium  (VPA)
CL Item
Vigabatrin (VGB)
Time since last dose
Item
Time since last dose
integer
C0946444 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
Medication Concentration Value
Item
Medication Concentration Value
float
C0683150 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Medication Concentration Units
Item
Medication Concentration Units
text
C0683150 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])

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