0 Ratings
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

Versions (2)
  1. 9/23/19 9/23/19 -
  2. 9/23/19 9/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 23, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

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

    English

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

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient's initials
    Description

    Patient's initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Patient's trial number
    Description

    Patient's trial number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Center number
    Description

    Center number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Haematology
    Description

    Haematology

    Alias
    UMLS CUI-1
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Haematology - Date sample collected
    Description

    Haematology - Date sample collected

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Haematology - Laboratory number
    Description

    Haematology - Laboratory number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986056 (Laboratory Identifier)
    UMLS CUI [1,2]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    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 (Hemoglobin measurement)
    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 (Platelet Count measurement)
    SNOMED
    61928009
    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 (White Blood Cell Count procedure)
    SNOMED
    767002
    Clinical Chemistry
    Description

    Clinical Chemistry

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

    Clinical Chemistry - Date sample collected

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0008000 (Chemistry, Clinical)
    Clinical Chemistry - Laboratory number
    Description

    Clinical Chemistry - Laboratory number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986056 (Laboratory Identifier)
    UMLS CUI [1,2]
    C0008000 (Chemistry, Clinical)
    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 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    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 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    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 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    Plasma Concentrations of AEDs
    Description

    Plasma Concentrations of AEDs

    Alias
    UMLS CUI-1
    C0003299 (Antiepileptic Agents)
    UMLS CUI-2
    C0683150 (plasma concentration)
    AED plasma concentration - Date of sample
    Description

    AED plasma concentration - Date of sample

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0003299 (Antiepileptic Agents)
    UMLS CUI [1,3]
    C0683150 (plasma concentration)
    Drug NOT including Study Medication
    Description

    Drug NOT including Study Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    Time since last dose
    Description

    Time since last dose

    Data type

    integer

    Measurement units
    • hrs
    Alias
    UMLS CUI [1,1]
    C0946444 (Time last dose)
    LOINC
    LP29120-0
    UMLS CUI [1,2]
    C1711239 (Since)
    hrs
    Medication Concentration Value
    Description

    Medication Concentration Value

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0683150 (plasma concentration)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C1522609 (Numerical value)
    Medication Concentration Units
    Description

    Medication Concentration Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0683150 (plasma concentration)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Back to the top of the page

    Similar models

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

    1 forms
    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])
    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial