ID

30926

Beschreibung

This ODM file contains Information about Liver Events. Use separate forms for each liver event. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Stichworte

Versionen (1)
  1. 03-07-18 03-07-18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

3 juli 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    Englisch

    Liver Events

    1 Formulare  
    1. StudyEvent: ODM
      1. Liver Events
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beschreibung

    Centre Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Beschreibung

    Please enter the date of the lab sample collection which resulted in the subject meeting protocol defined liver event criteria. (This is likely to be a scheduled sample collection, so this 'Visit Date' may be the same as the visit date of that collection.)

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    Beschreibung

    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?

    Alias
    UMLS CUI-1
    C0232741
    UMLS CUI-2
    C0008000
    UMLS CUI-3
    C0587081
    UMLS CUI-4
    C0304229
    UMLS CUI-5
    C2746065
    [1] ALT (alanine aminotransferase)
    Beschreibung

    alanine aminotransferase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0151905
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [2] AST (aspartate aminotransferase)
    Beschreibung

    aspartate aminotransferase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0151904
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [3] Total bilirubin
    Beschreibung

    Total bilirubin increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0741494
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [4] Alkaline phosphatase
    Beschreibung

    Alkaline phosphatase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0151849
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [5] 5’ nucleotidase
    Beschreibung

    5’ nucleotidase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0740292
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [6] Gammaglutamyltranspeptidase
    Beschreibung

    Gammaglutamyltranspeptidase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0541979
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C2746065
    [OT] other
    Beschreibung

    other laboratory finding increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0304229
    UMLS CUI [1,4]
    C2746065
    Start and End Date of Investigational Product
    Beschreibung

    Start and End Date of Investigational Product

    Alias
    UMLS CUI-1
    C0808070
    UMLS CUI-2
    C0806020
    UMLS CUI-3
    C0304229
    UMLS CUI-4
    C1556667
    Liver event occurence relative to investigational product period
    Beschreibung

    Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1556667
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C0304229
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Stop Date
    Beschreibung

    Stop Date, liver event during treatment period

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0304229
    Subject Factors
    Beschreibung

    Subject Factors

    Alias
    UMLS CUI-1
    C0035648
    UMLS CUI-2
    C1556667
    Is the subject age 55 or older?
    Beschreibung

    Age above 55y

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0001779
    If female, is the subject pregnant?
    Beschreibung

    If Yes, ensure Pregnancy Notification Form has been completed.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C1556667
    Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
    Beschreibung

    If Yes, record on the appropriate Concomitant Medication form.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2240391
    UMLS CUI [2]
    C1148474
    UMLS CUI [3]
    C0002346
    UMLS CUI [4]
    C0242295
    UMLS CUI [5]
    C0281875
    Did the subject fast or undergo significant dietary change in the past week?
    Beschreibung

    Fasting, significant dietary change

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3671772
    UMLS CUI [2]
    C0015663
    Record the average number of units of alcohol1 consumed per week
    Beschreibung

    If the subject does not drink enter '0'. ALCOHOL CONVERTER 1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml)

    Datentyp

    integer

    Maßeinheiten
    • units / week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1556667
    units / week
    Diagnostics
    Beschreibung

    Diagnostics

    Alias
    UMLS CUI-1
    C0430022
    UMLS CUI-2
    C1556667
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    Beschreibung

    liver or hepatobiliary system diagnostic imaging

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1711359
    UMLS CUI [1,3]
    C1556667
    UMLS CUI [2,1]
    C0011923
    UMLS CUI [2,2]
    C0023884
    UMLS CUI [2,3]
    C1556667
    If yes, were the results normal?
    Beschreibung

    If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C1556667
    Were any liver biopsies performed?
    Beschreibung

    If Yes, complete Liver Biopsy form.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0193388
    UMLS CUI [1,2]
    C1556667
    Unscheduled PK blood sample
    Beschreibung

    Unscheduled PK blood sample

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0201734
    UMLS CUI-3
    C1556667
    Was a pharmacokinetic blood sample obtained?
    Beschreibung

    An unscheduled PK blood sample must be obtained within 24 hours of last dose.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C1556667
    If Yes, date and time sample taken
    Beschreibung

    date and time sample taken

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0201734
    UMLS CUI [1,3]
    C1556667
    UMLS CUI [1,4]
    C1264639
    If Yes, date and time of last investigational product dose prior to PK sample
    Beschreibung

    Date and time of last dose of experimental drug

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C1556667
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C1762893
    UMLS CUI [3,1]
    C0304229
    UMLS CUI [3,2]
    C0946444
    If Yes, date and time of last dose prior to PK sample 1
    Beschreibung

    last dose prior to PK sample 1

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C1556667
    UMLS CUI [2]
    C1762893
    UMLS CUI [3]
    C0946444
    If Yes, date and time of last dose prior to PK sample 2
    Beschreibung

    last dose prior to PK sample 2

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C1556667
    UMLS CUI [2]
    C1762893
    UMLS CUI [3]
    C0946444
    Attach Sample Identifier Label Here
    Beschreibung

    Sample Identifier Label

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C0201734
    UMLS CUI [1,4]
    C1556667
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1299222
    UMLS CUI [1,2]
    C0201734
    UMLS CUI [1,3]
    C1556667
    Specific Medical Conditions at onset of liver event
    Beschreibung

    Specific Medical Conditions at onset of liver event

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C1556667
    Specific Condition
    Beschreibung

    DRUG RELATED LIVER DISEASE CONDITIONS: All drugs including Investigational Product

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C1556667
    Status of medical condition
    Beschreibung

    Option 5 not for Option 15 or 16 of "Specific condition" item

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3176928
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C1556667
    If other Liver disease Condition, specify
    Beschreibung

    Specify Condition, if chosen 15 or 16 in "Specific Condition" item.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0023895
    UMLS CUI [1,3]
    C0262926
    UMLS CUI [1,4]
    C1556667
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    Ähnliche Modelle

    Liver Events

    1 Formulare
    1. StudyEvent: ODM
      1. Liver Events
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    C0232741 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    C0587081 (UMLS CUI-3)
    C0304229 (UMLS CUI-4)
    C2746065 (UMLS CUI-5)
    alanine aminotransferase increased
    Item
    [1] ALT (alanine aminotransferase)
    boolean
    C0151905 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    aspartate aminotransferase increased
    Item
    [2] AST (aspartate aminotransferase)
    boolean
    C0151904 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    Total bilirubin increased
    Item
    [3] Total bilirubin
    boolean
    C0741494 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    Alkaline phosphatase increased
    Item
    [4] Alkaline phosphatase
    boolean
    C0151849 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    5’ nucleotidase increased
    Item
    [5] 5’ nucleotidase
    boolean
    C0740292 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    Gammaglutamyltranspeptidase increased
    Item
    [6] Gammaglutamyltranspeptidase
    boolean
    C0541979 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    other laboratory finding increased
    Item
    [OT] other
    boolean
    C0587081 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    C2746065 (UMLS CUI [1,4])
    Item Group
    Start and End Date of Investigational Product
    C0808070 (UMLS CUI-1)
    C0806020 (UMLS CUI-2)
    C0304229 (UMLS CUI-3)
    C1556667 (UMLS CUI-4)
    Item
    Liver event occurence relative to investigational product period
    text
    C1556667 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Liver event occurence relative to investigational product period
    Code List
    Liver event occurence relative to investigational product period
    CL Item
    Event during treatment period (Event during treatment period)
    CL Item
    Event after treatment period (Event after treatment period)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Stop Date, liver event during treatment period
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item Group
    Subject Factors
    C0035648 (UMLS CUI-1)
    C1556667 (UMLS CUI-2)
    Item
    Is the subject age 55 or older?
    text
    C0001779 (UMLS CUI [1])
    Age above 55y
    Code List
    Is the subject age 55 or older?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If female, is the subject pregnant?
    text
    C0032961 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    Pregnancy
    Code List
    If female, is the subject pregnant?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (X)
    Item
    Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
    text
    C2240391 (UMLS CUI [1])
    C1148474 (UMLS CUI [2])
    C0002346 (UMLS CUI [3])
    C0242295 (UMLS CUI [4])
    C0281875 (UMLS CUI [5])
    Age above 55y
    Code List
    Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the subject fast or undergo significant dietary change in the past week?
    text
    C3671772 (UMLS CUI [1])
    C0015663 (UMLS CUI [2])
    Age above 55y
    Code List
    Did the subject fast or undergo significant dietary change in the past week?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Alcohol intake at onset of liver Event
    Item
    Record the average number of units of alcohol1 consumed per week
    integer
    C0001948 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    Item Group
    Diagnostics
    C0430022 (UMLS CUI-1)
    C1556667 (UMLS CUI-2)
    Item
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    text
    C0011923 (UMLS CUI [1,1])
    C1711359 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    C0011923 (UMLS CUI [2,1])
    C0023884 (UMLS CUI [2,2])
    C1556667 (UMLS CUI [2,3])
    Age above 55y
    Code List
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If yes, were the results normal?
    text
    C2711860 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    Age above 55y
    Code List
    If yes, were the results normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any liver biopsies performed?
    text
    C0193388 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    Age above 55y
    Code List
    Were any liver biopsies performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Unscheduled PK blood sample
    C0005834 (UMLS CUI-1)
    C0201734 (UMLS CUI-2)
    C1556667 (UMLS CUI-3)
    Item
    Was a pharmacokinetic blood sample obtained?
    text
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    Age above 55y
    Code List
    Was a pharmacokinetic blood sample obtained?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    date and time sample taken
    Item
    If Yes, date and time sample taken
    datetime
    C0005834 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    C1264639 (UMLS CUI [1,4])
    Date and time of last dose of experimental drug
    Item
    If Yes, date and time of last investigational product dose prior to PK sample
    datetime
    C0201734 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [2,1])
    C1762893 (UMLS CUI [2,2])
    C0304229 (UMLS CUI [3,1])
    C0946444 (UMLS CUI [3,2])
    last dose prior to PK sample 1
    Item
    If Yes, date and time of last dose prior to PK sample 1
    datetime
    C0201734 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    C1762893 (UMLS CUI [2])
    C0946444 (UMLS CUI [3])
    last dose prior to PK sample 2
    Item
    If Yes, date and time of last dose prior to PK sample 2
    datetime
    C0201734 (UMLS CUI [1,1])
    C1556667 (UMLS CUI [1,2])
    C1762893 (UMLS CUI [2])
    C0946444 (UMLS CUI [3])
    Sample Identifier Label
    Item
    Attach Sample Identifier Label Here
    text
    C0178913 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    C1556667 (UMLS CUI [1,4])
    Sample Number
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    Item Group
    Specific Medical Conditions at onset of liver event
    C0012634 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C1556667 (UMLS CUI-3)
    Item
    Specific Condition
    integer
    C0012634 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    Specific Condition
    Code List
    Specific Condition
    CL Item
    Acute Viral Hepatitis A (1)
    CL Item
    Chronic Hepatitis B (2)
    CL Item
    Chronic Hepatitis C (3)
    CL Item
    Cytomegalovirus Hepatitis (4)
    CL Item
    Epstein Barr Virus Infectious Mononucleosis (5)
    CL Item
    Herpes Simplex Hepatitis (6)
    CL Item
    Alcoholic Liver Disease (7)
    CL Item
    Non-alcoholic Steatohepatitis (8)
    CL Item
    Fatty Liver (9)
    CL Item
    Hepatic Cirrhosis (10)
    CL Item
    Hemochromatosis (11)
    CL Item
    Autoimmune Hepatitis (12)
    CL Item
    Gallbladder disease (13)
    CL Item
    Drug related liver disease (14)
    CL Item
    Other Liver disease Condition (15)
    CL Item
    Other Liver disease Condition (16)
    CL Item
    Drug Allergies (17)
    CL Item
    Rheumatoid Arthritis (18)
    CL Item
    Psoriasis (19)
    CL Item
    Thyroid Disease (20)
    CL Item
    Inflammatory Bowel Disease (21)
    CL Item
    Lupus (22)
    CL Item
    Sjogren's Syndrome (23)
    CL Item
    Vitiligo (24)
    Item
    Status of medical condition
    integer
    C3176928 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C1556667 (UMLS CUI [1,3])
    Status of medical condition
    Code List
    Status of medical condition
    CL Item
    Current (1)
    CL Item
    past (2)
    CL Item
    no medical condition (5)
    other liver disease Condition
    Item
    If other Liver disease Condition, specify
    text
    C3843040 (UMLS CUI [1,1])
    C0023895 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    C1556667 (UMLS CUI [1,4])
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    Hilfe

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