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

Für eine Beantragung loggen Sie sich ein.

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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