ID

38158

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

Versies (2)
  1. 23-09-19 23-09-19 -
  2. 23-09-19 23-09-19 -
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GlaxoSmithKline

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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)

Engels

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

1 Formulieren  
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
Haematology
Beschrijving

Haematology

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

Haematology - Date sample collected

Datatype

date

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

Haematology - Laboratory number

Datatype

text

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

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

Datatype

text

Alias
UMLS CUI [1]
C0518015
Quantitative platelet count
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0032181
WBC
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0023508
Clinical Chemistry
Beschrijving

Clinical Chemistry

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

Clinical Chemistry - Date sample collected

Datatype

date

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

Clinical Chemistry - Laboratory number

Datatype

text

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

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

Datatype

text

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

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

Datatype

text

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

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

Datatype

text

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

Plasma Concentrations of AEDs

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

AED plasma concentration - Date of sample

Datatype

date

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

Drug NOT including Study Medication

Datatype

text

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

Time since last dose

Datatype

integer

Maateenheden
  • hrs
Alias
UMLS CUI [1,1]
C0946444
UMLS CUI [1,2]
C1711239
hrs
Medication Concentration Value
Beschrijving

Medication Concentration Value

Datatype

float

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

Medication Concentration Units

Datatype

text

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

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

1 Formulieren
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
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])
Drug NOT including Study Medication
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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