ID

30168

Description

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Liver Event - Liver Imaging

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 16, 2018

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Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

English

Liver Imaging

1 forms  
  1. StudyEvent: ODM
    1. Liver Imaging
Liver Imaging
Description

Liver Imaging

Alias
UMLS CUI-1
C2711860
Date of hepatic or liver Imaging test
Description

Liver Imaging Date

Data type

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
Liver Imaging: Method
Description

Method

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
If Other method, specify
Description

Liver Imaging method

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Are images technically adequate?
Description

images technically adequate

Data type

integer

Alias
UMLS CUI [1]
C0806487
If Other image quality, specify
Description

images technically adequate

Data type

text

Alias
UMLS CUI [1]
C0806487
Indicate the liver size
Description

liver size

Data type

integer

Alias
UMLS CUI [1]
C0426688
If other liver size, specify
Description

liver size

Data type

text

Alias
UMLS CUI [1]
C0426688
Indicate the liver texture
Description

liver texture

Data type

integer

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
If other liver texture , specify
Description

liver texture

Data type

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

fatty infiltrate of the liver

Data type

integer

Alias
UMLS CUI [1]
C0015695
If other fatty infiltrate of the liver, specify
Description

fatty infiltrate of the liver

Data type

text

Alias
UMLS CUI [1]
C0015695
Ascites present
Description

Ascites

Data type

integer

Alias
UMLS CUI [1]
C0003962
If other ascites, specify
Description

ascites

Data type

text

Alias
UMLS CUI [1]
C0003962
Are Focal Hepatic Lesions characterisable?
Description

Focal hepatic lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If Yes, focal hepatic lesions, specify Check all that apply
Description

Focal hepatic lesions

Data type

integer

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If Other, specify
Description

Focal hepatic lesions

Data type

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
Gallstones or gallbladder lesions
Description

Gallstones or gallbladder lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If Gallstones or gallbladder lesions, specify Check all that apply
Description

Gallstones or gallbladder lesions

Data type

integer

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If Other Gallstones or gallbladder lesions, specify
Description

Gallstones or gallbladder lesions

Data type

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
Biliary ductal lesions?
Description

Biliary ductal lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If Biliary ductal lesions, specify Check all that apply
Description

Biliary ductal lesions

Data type

integer

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If Other Biliary ductal lesions, specify
Description

Biliary ductal lesions

Data type

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0032718
If Yes, Portal/Hepatic vein abnormalities, specify Check all that apply
Description

Portal/Hepatic vein abnormalities

Data type

integer

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0032718
If Other Portal/Hepatic vein abnormalities, specify
Description

Portal/Hepatic vein abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0032718
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Similar models

Liver Imaging

1 forms
  1. StudyEvent: ODM
    1. Liver Imaging
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Liver Imaging
C2711860 (UMLS CUI-1)
Liver Imaging Date
Item
Date of hepatic or liver Imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Liver Imaging: Method
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Liver Imaging: Method
Code List
Liver Imaging: Method
CL Item
Ultrasound, transabdominal (1)
CL Item
Ultrasound, endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholanglopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
CL Item
Other, specify (8)
Liver Imaging method
Item
If Other method, specify
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Item
Are images technically adequate?
integer
C0806487 (UMLS CUI [1])
images technically adequate
Code List
Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other, specify (4)
images technically adequate
Item
If Other image quality, specify
text
C0806487 (UMLS CUI [1])
Item
Indicate the liver size
integer
C0426688 (UMLS CUI [1])
liver size
Code List
Indicate the liver size
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other, specify (5)
liver size
Item
If other liver size, specify
text
C0426688 (UMLS CUI [1])
Item
Indicate the liver texture
integer
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
liver texture
Code List
Indicate the liver texture
CL Item
Normal (1)
CL Item
Heterogenous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
liver texture
Item
If other liver texture , specify
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
integer
C0015695 (UMLS CUI [1])
fatty infiltrate of the liver
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable· no fatty infiltration (1)
CL Item
Mlld (<=25%) (2)
CL Item
Moderate (>2 5% to <7 5%) (3)
CL Item
5evere (>=75%) (4)
CL Item
Other, specify (5)
fatty infiltrate of the liver
Item
If other fatty infiltrate of the liver, specify
text
C0015695 (UMLS CUI [1])
Item
Ascites present
integer
C0003962 (UMLS CUI [1])
Ascites
Code List
Ascites present
CL Item
None present (1)
CL Item
Yes, small amount (2)
CL Item
Yes, moderate or severe amount (3)
CL Item
Other, specify (4)
ascites
Item
If other ascites, specify
text
C0003962 (UMLS CUI [1])
Focal hepatic lesions
Item
Are Focal Hepatic Lesions characterisable?
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Item
If Yes, focal hepatic lesions, specify Check all that apply
integer
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Focal hepatic ledsions
Code List
If Yes, focal hepatic lesions, specify Check all that apply
CL Item
Solid (1)
CL Item
Cystic (2)
CL Item
Hemangioma (3)
CL Item
Focal Nodular Hyperplasia (4)
CL Item
Other, specify (5)
Focal hepatic lesions
Item
If Other, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Gallstones or gallbladder lesions
Item
Gallstones or gallbladder lesions
boolean
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
If Gallstones or gallbladder lesions, specify Check all that apply
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Gallstones or gallbladder lesions
Code List
If Gallstones or gallbladder lesions, specify Check all that apply
CL Item
Gallstones (1)
CL Item
Gallbladder polyp(s) (2)
CL Item
Sludge (3)
CL Item
Gallbladder wall thickening/oedema (4)
CL Item
Gallbladder wall gas (5)
CL Item
Cholecystitis (6)
CL Item
Gallbladder wall calcification (7)
CL Item
Gallbladder mass (8)
CL Item
Other, specify (9)
Gallstones or gallbladder lesions
Item
If Other Gallstones or gallbladder lesions, specify
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions
Item
Biliary ductal lesions?
boolean
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
If Biliary ductal lesions, specify Check all that apply
integer
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions
Code List
If Biliary ductal lesions, specify Check all that apply
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe ) (1)
CL Item
Intrahepatlc ductal dilation (focal Involving the left hepatic lobe) (2)
CL Item
lntrahepatic ductal dilation (involving both right and left hepatic lobes) (3)
CL Item
Extrahepatic ductal dilation (4)
CL Item
Diffuse ductal dilation (lnvolvlng both intra hepatic and extrahepatic ducts) (5)
CL Item
Acute Cholangitis (6)
CL Item
Primary sclerosing cholangitis (7)
CL Item
Choledocholithlasis (gallstone In duct) (8)
CL Item
Ductal filling defect(s), other than gallstone (9)
CL Item
Ductal wall thickening or oedema (10)
CL Item
Choledochal cyst (11)
CL Item
Ductal mass (12)
CL Item
Extrinsic mass compressingbile duct(s) (13)
CL Item
Other, specify (14)
Biliary ductal lesions
Item
If Other Biliary ductal lesions, specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Portal/Hepatic vein abnormalities
Item
Portal/Hepatic vein abnormalities?
boolean
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2])
Item
If Yes, Portal/Hepatic vein abnormalities, specify Check all that apply
integer
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2])
Portal/Hepatic vein abnormalities
Code List
If Yes, Portal/Hepatic vein abnormalities, specify Check all that apply
CL Item
Portal vein enlargement (1)
CL Item
Hepatic vein enlargement (2)
CL Item
Nonocclusive portal vein thrombosis (3)
CL Item
Occlusive portal vein thrombosis (4)
CL Item
Hepatic vein thrombosis (5)
CL Item
Occlusive portal vein thrombosis - malignant (6)
CL Item
Hepatic vein thrombosis - malignant (7)
CL Item
Involvement of the main portal vein (8)
CL Item
Involvement of the right portal vein (9)
CL Item
Involvement of the left portal vein (10)
CL Item
Budd Chlari syndrome (11)
CL Item
Other,specify (12)
Portal/Hepatic vein abnormalities
Item
If Other Portal/Hepatic vein abnormalities, specify
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2])
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