ID

26733

Description

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver imaging - Repeating form (Unscheduled/Dynamic visit)

Keywords

Versions (8)
  1. 10/11/17 10/11/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 1/5/18 1/5/18 -
  5. 1/10/18 1/10/18 -
  6. 1/10/18 1/10/18 -
  7. 6/16/20 6/16/20 -
  8. 6/17/20 6/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

English

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Date of hepatic or liver imaging test
Description

Date of hepatic or liver imaging test

1. Date of hepatic or liver imaging test
Description

Date of hepatic or liver imaging test

Data type

date

What method was used for this imaging test?
Description

What method was used for this imaging test?

2. What method was used for this imaging test?
Description

method used for imaging test

Data type

text

Other, specify:
Description

other method used for imaging test

Data type

text

Are images technically adequate?
Description

Are images technically adequate?

3. Are images technically adequate?
Description

images technically adequate

Data type

text

Other, specify:
Description

images technically adequate other

Data type

text

Indicate the liver size
Description

Indicate the liver size

4. Indicate the liver size
Description

liver size

Data type

text

Other, specify:
Description

other liver size

Data type

text

Indicate the liver texture
Description

Indicate the liver texture

5. Indicate the liver texture
Description

liver texture

Data type

text

Other, specify:
Description

other liver texture

Data type

text

Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

Grade the diffuse and/or geographic fatty infiltrate of the liver

6. Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

diffuse and/or geographic fatty infiltrate of the liver

Data type

text

Other, specify
Description

other grade of diffuse and/or geographic fatty infiltrate of the liver

Data type

text

Ascites present
Description

Ascites present

7. Ascites present
Description

Ascites present

Data type

text

Other, specify:
Description

ascites present other amount

Data type

text

Are Focal Hepatic Lesions characterisable?
Description

Are Focal Hepatic Lesions characterisable?

8. Are Focal Hepatic Lesions characterisable?
Description

Focal Hepatic Lesions characterisable

Data type

text

[E1] Solid
Description

Solid Focal Hepatic Lesions

Data type

boolean

[E2] Cystic
Description

Cystic Focal Hepatic Lesions

Data type

boolean

[E3] Hemangioma
Description

Hemangioma Focal Hepatic Lesions

Data type

boolean

[E4] Focal Nodular Hyperplasia
Description

Focal Nodular Hyperplasia

Data type

boolean

[E99] Other
Description

Other Focal Hepatic Lesions

Data type

boolean

Other, specify:
Description

Other Focal Hepatic Lesions specification

Data type

text

Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions?

9. Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions

Data type

text

[F1] Gallstones
Description

Gallstones

Data type

boolean

[F2] Gallbladder polyp(s)
Description

Gallbladder polyps

Data type

boolean

[F3] Sludge
Description

Sludge

Data type

boolean

[F4] Gallbladder wall thickening/oedema
Description

Gallbladder wall thickening/oedema

Data type

boolean

[F5] Gallbladder wall gas
Description

Gallbladder wall gas

Data type

boolean

[F6] Cholecystitis
Description

Cholecystitis

Data type

boolean

[F7] Gallbladder wall calcification
Description

Gallbladder wall calcification

Data type

boolean

[F8] Gallbladder mass
Description

Gallbladder mass

Data type

boolean

[F99] Other
Description

Other gallbladder lesions

Data type

boolean

Other, specify
Description

Other gallbladder lesions specification

Data type

text

Biliary ductal lesions?
Description

Biliary ductal lesions?

10. Biliary ductal lesions?
Description

Biliary ductal lesions

Data type

text

[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
Description

Intrahepatic ductal dilation

Data type

boolean

[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
Description

Intrahepatic ductal dilation

Data type

boolean

[G4] Extrahepatic ductal dilation
Description

Extrahepatic ductal dilation

Data type

boolean

[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
Description

Diffuse ductal dilation

Data type

boolean

[G6] Acute Cholangitis
Description

Acute Cholangitis

Data type

boolean

[G7] Primary sclerosing cholangitis
Description

Primary sclerosing cholangitis

Data type

boolean

[G8] Choledocholithiasis (gallstone in duct)
Description

Choledocholithiasis

Data type

boolean

[G9] Ductal filling defect(s), other than gallstone
Description

Ductal filling defect other than gallstone

Data type

boolean

[G10] Ductal wall thickening or oedema
Description

Ductal wall thickening or oedema

Data type

boolean

[G11] Choledochal cyst
Description

Choledochal cyst

Data type

boolean

[G12] Ductal mass
Description

Ductal mass

Data type

boolean

[G13] Extrinsic mass compressing bile duct(s)
Description

Extrinsic mass compressing bile duct

Data type

boolean

[G99] Other
Description

Other Biliary ductal lesions

Data type

boolean

Other, specify:
Description

Other Biliary ductal lesions specification

Data type

text

Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities?

11. Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities?

Data type

text

[H1] Portal vein enlargement
Description

Portal vein enlargement

Data type

boolean

[H2] Hepatic vein enlargement
Description

Hepatic vein enlargement

Data type

boolean

[H3] Nonocclusive portal vein thrombosis
Description

Nonocclusive portal vein thrombosis

Data type

boolean

[H4] Occlusive portal vein thrombosis - bland
Description

Occlusive portal vein thrombosis - bland

Data type

boolean

[H5] Hepatic vein thrombosis - bland
Description

Hepatic vein thrombosis - bland

Data type

boolean

[H6] Occlusive portal vein thrombosis - malignant
Description

Occlusive portal vein thrombosis - malignant

Data type

boolean

[H7] Hepatic vein thrombosis - malignant
Description

Hepatic vein thrombosis - malignant

Data type

text

[H8] Involvement of the main portal vein
Description

Involvement of the main portal vein

Data type

boolean

[H9] Involvement of the right portal vein
Description

Involvement of the right portal vein

Data type

boolean

[H10] Involvement of the left portal vein
Description

Involvement of the left portal vein

Data type

boolean

[H11] Budd-Chiari syndrome
Description

Budd-Chiari syndrome

Data type

boolean

[H99] Other
Description

Other Portal/Hepatic vein abnormalities

Data type

boolean

Other, specify:
Description

Other Portal/Hepatic vein abnormalities specification

Data type

text

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Similar models

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of hepatic or liver imaging test
Date of hepatic or liver imaging test
Item
1. Date of hepatic or liver imaging test
date
Item Group
What method was used for this imaging test?
Item
2. What method was used for this imaging test?
text
method used for imaging test
Code List
2. What method was used for this imaging test?
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 Cholangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
CL Item
Other (OT)
other method used for imaging test
Item
Other, specify:
text
Item Group
Are images technically adequate?
Item
3. Are images technically adequate?
text
images technically adequate
Code List
3. Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other (OT)
images technically adequate other
Item
Other, specify:
text
Item Group
Indicate the liver size
Item
4. Indicate the liver size
text
liver size
Code List
4. Indicate the liver size
CL Item
Normal size (A1)
CL Item
Hypertrophy (or enlarged) (A2)
CL Item
Atrophy (or smaller than normal) (A3)
CL Item
Segmental hypertrophy (A4)
CL Item
Other (A99)
other liver size
Item
Other, specify:
text
Item Group
Indicate the liver texture
Item
5. Indicate the liver texture
text
liver texture
Code List
5. Indicate the liver texture
CL Item
Normal (B1)
CL Item
Heterogenous (B2)
CL Item
Suggestive of fibrosis (B3)
CL Item
Nodular or suggestive of cirrhosis (B4)
CL Item
Other, (B99)
other liver texture
Item
Other, specify:
text
Item Group
Grade the diffuse and/or geographic fatty infiltrate of the liver
Item
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
text
diffuse and/or geographic fatty infiltrate of the liver
Code List
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (C1)
CL Item
Mild (<=25%) (C2)
CL Item
Moderate (>25% to <75%) (C3)
CL Item
Severe (>=75%) (C4)
CL Item
Other (C99)
other grade of diffuse and/or geographic fatty infiltrate of the liver
Item
Other, specify
text
Item Group
Ascites present
Item
7. Ascites present
text
Ascites present
Code List
7. Ascites present
CL Item
None present (D1)
CL Item
Yes - small amount (D2)
CL Item
Yes - moderate or severe amount (D3)
CL Item
Other (D99)
ascites present other amount
Item
Other, specify:
text
Item Group
Are Focal Hepatic Lesions characterisable?
Item
8. Are Focal Hepatic Lesions characterisable?
text
Focal Hepatic Lesions characterisable
Code List
8. Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
CL Item
Check all that apply (E)
Solid Focal Hepatic Lesions
Item
[E1] Solid
boolean
Cystic Focal Hepatic Lesions
Item
[E2] Cystic
boolean
Hemangioma Focal Hepatic Lesions
Item
[E3] Hemangioma
boolean
Focal Nodular Hyperplasia
Item
[E4] Focal Nodular Hyperplasia
boolean
Other Focal Hepatic Lesions
Item
[E99] Other
boolean
Other Focal Hepatic Lesions specification
Item
Other, specify:
text
Item Group
Gallstones or gallbladder lesions?
Item
9. Gallstones or gallbladder lesions?
text
Gallstones or gallbladder lesions
Code List
9. Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Check all that apply (F)
Gallstones
Item
[F1] Gallstones
boolean
Gallbladder polyps
Item
[F2] Gallbladder polyp(s)
boolean
Sludge
Item
[F3] Sludge
boolean
Gallbladder wall thickening/oedema
Item
[F4] Gallbladder wall thickening/oedema
boolean
Gallbladder wall gas
Item
[F5] Gallbladder wall gas
boolean
Cholecystitis
Item
[F6] Cholecystitis
boolean
Gallbladder wall calcification
Item
[F7] Gallbladder wall calcification
boolean
Gallbladder mass
Item
[F8] Gallbladder mass
boolean
Other gallbladder lesions
Item
[F99] Other
boolean
Other gallbladder lesions specification
Item
Other, specify
text
Item Group
Biliary ductal lesions?
Item
10. Biliary ductal lesions?
text
Biliary ductal lesions
Code List
10. Biliary ductal lesions?
CL Item
None (G0)
CL Item
Check all that apply (G)
Intrahepatic ductal dilation
Item
[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
boolean
Intrahepatic ductal dilation
Item
[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
boolean
Extrahepatic ductal dilation
Item
[G4] Extrahepatic ductal dilation
boolean
Diffuse ductal dilation
Item
[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
boolean
Acute Cholangitis
Item
[G6] Acute Cholangitis
boolean
Primary sclerosing cholangitis
Item
[G7] Primary sclerosing cholangitis
boolean
Choledocholithiasis
Item
[G8] Choledocholithiasis (gallstone in duct)
boolean
Ductal filling defect other than gallstone
Item
[G9] Ductal filling defect(s), other than gallstone
boolean
Ductal wall thickening or oedema
Item
[G10] Ductal wall thickening or oedema
boolean
Choledochal cyst
Item
[G11] Choledochal cyst
boolean
Ductal mass
Item
[G12] Ductal mass
boolean
Extrinsic mass compressing bile duct
Item
[G13] Extrinsic mass compressing bile duct(s)
boolean
Other Biliary ductal lesions
Item
[G99] Other
boolean
Other Biliary ductal lesions specification
Item
Other, specify:
text
Item Group
Portal/Hepatic vein abnormalities?
Item
11. Portal/Hepatic vein abnormalities?
text
Portal/Hepatic vein abnormalities?
Code List
11. Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Check all that apply (H)
Portal vein enlargement
Item
[H1] Portal vein enlargement
boolean
Hepatic vein enlargement
Item
[H2] Hepatic vein enlargement
boolean
Nonocclusive portal vein thrombosis
Item
[H3] Nonocclusive portal vein thrombosis
boolean
Occlusive portal vein thrombosis - bland
Item
[H4] Occlusive portal vein thrombosis - bland
boolean
Hepatic vein thrombosis - bland
Item
[H5] Hepatic vein thrombosis - bland
boolean
Occlusive portal vein thrombosis - malignant
Item
[H6] Occlusive portal vein thrombosis - malignant
boolean
Hepatic vein thrombosis - malignant
Item
[H7] Hepatic vein thrombosis - malignant
text
Involvement of the main portal vein
Item
[H8] Involvement of the main portal vein
boolean
Involvement of the right portal vein
Item
[H9] Involvement of the right portal vein
boolean
Involvement of the left portal vein
Item
[H10] Involvement of the left portal vein
boolean
Budd-Chiari syndrome
Item
[H11] Budd-Chiari syndrome
boolean
Other Portal/Hepatic vein abnormalities
Item
[H99] Other
boolean
Other Portal/Hepatic vein abnormalities specification
Item
Other, specify:
text
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