ID

32947

Description

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (1)
  1. 11/21/18 11/21/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

English

Liver Imaging Form 2

1 forms  
  1. StudyEvent: ODM
    1. Liver Imaging Form 2
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Liver Size
Description

Liver Size

Indicate the liver size
Description

Indicate the liver size

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Liver texture
Description

Liver texture

Indicate the liver texture
Description

Indicate the liver texture

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Diffuse and Geographic Fatty Infiltrate
Description

Diffuse and Geographic Fatty Infiltrate

Grade the diffuse and geographic fatty infiltrate of the liver
Description

Check one

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Ascites present
Description

Ascites present

Ascites present
Description

Ascites present

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Focal Hepatic Lesions
Description

Focal Hepatic Lesions

Are focal hepatic lesions characterisable?
Description

check all that apply

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Gallstones or gallbladder lesions
Description

Gallstones or gallbladder lesions

Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions?

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Biliary Ductal Lesions
Description

Biliary Ductal Lesions

Biliary ductal lesions
Description

Biliary ductal lesions

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Abnormalities
Description

Abnormalities

Portal/Hepatic Vein Abnormalities
Description

Portal/Hepatic Vein Abnormalities

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

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Similar models

Liver Imaging Form 2

1 forms
  1. StudyEvent: ODM
    1. Liver Imaging Form 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Liver Size
Item
Indicate the liver size
text
Indicate the 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 (5)
If Other, specify
Item
If Other, specify
text
Item Group
Liver texture
Item
Indicate the liver texture
text
Indicate the liver texture
Code List
Indicate the liver texture
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
Item Group
Diffuse and Geographic Fatty Infiltrate
Item
Grade the diffuse and geographic fatty infiltrate of the liver
text
Grade the diffuse and geographic fatty infiltrate of the liver
Code List
Grade the diffuse and geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration  (1)
CL Item
Mild (<=25%) (2)
CL Item
Moderate (>25%to<75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
Item Group
Ascites present
Item
Ascites present
text
Ascites present
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 (4)
If Other, specify
Item
If Other, specify
text
Item Group
Focal Hepatic Lesions
Item
Are focal hepatic lesions characterisable?
text
Are focal hepatic lesions characterisable?
Code List
Are focal hepatic lesions characterisable?
CL Item
Not applicable (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal nodular hyperplasia (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
Item Group
Gallstones or gallbladder lesions
Item
Gallstones or gallbladder lesions?
text
Gallstones or gallbladder lesions?
Code List
Gallstones or gallbladder lesions?
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallblader polyps (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/Oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
CHolecystitis (7)
CL Item
Gallibladder wall calcification (8)
CL Item
Gallbladder Mass (9)
CL Item
Other (10)
If Other, specify
Item
If Other, specify
text
Item Group
Biliary Ductal Lesions
Item
Biliary ductal lesions
text
Biliary ductal lesions
Code List
Biliary ductal lesions
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
DIfuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute cholangitis (7)
CL Item
primary schlerosis cholangitis (8)
CL Item
choledocholithiasis (gallstone in duct) (9)
CL Item
Ductal filling defect(s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal Mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other (15)
If Other, specify
Item
If Other, specify
text
Item Group
Abnormalities
Item
Portal/Hepatic Vein Abnormalities
text
Portal/Hepatic Vein Abnormalities
Code List
Portal/Hepatic Vein Abnormalities
CL Item
Non (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis (4)
CL Item
Occlusive portal vein thrombosis - Bland (5)
CL Item
Hepatic vein thrombosis - Bland (6)
CL Item
Occlusive portal vein thrombosis - Malignant (7)
CL Item
Hepatic vein thrombosis - Malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
Involvement of the left portal vein (11)
CL Item
Budd-Chiari Syndrome (12)
CL Item
Other (13)
If Other, specify
Item
If Other, specify
text
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