ID

26203

Descrizione

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

versioni (8)
  1. 11/10/17 11/10/17 -
  2. 16/10/17 16/10/17 -
  3. 23/10/17 23/10/17 -
  4. 05/01/18 05/01/18 -
  5. 10/01/18 10/01/18 -
  6. 10/01/18 10/01/18 -
  7. 16/06/20 16/06/20 -
  8. 17/06/20 17/06/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

11 ottobre 2017

DOI

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Licenza

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

Inglese

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli  
Date of hepatic or liver imaging test
Descrizione

Date of hepatic or liver imaging test

1. Date of hepatic or liver imaging test
Descrizione

Date of hepatic or liver imaging test

Tipo di dati

date

What method was used for this imaging test?
Descrizione

What method was used for this imaging test?

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

method used for imaging test

Tipo di dati

text

Other, specify:
Descrizione

other method used for imaging test

Tipo di dati

text

Are images technically adequate?
Descrizione

Are images technically adequate?

3. Are images technically adequate?
Descrizione

images technically adequate

Tipo di dati

text

Other, specify:
Descrizione

images technically adequate other

Tipo di dati

text

Indicate the liver size
Descrizione

Indicate the liver size

4. Indicate the liver size
Descrizione

liver size

Tipo di dati

text

Other, specify:
Descrizione

other liver size

Tipo di dati

text

Indicate the liver texture
Descrizione

Indicate the liver texture

5. Indicate the liver texture
Descrizione

liver texture

Tipo di dati

text

Other, specify:
Descrizione

other liver texture

Tipo di dati

text

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

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

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

diffuse and/or geographic fatty infiltrate of the liver

Tipo di dati

text

Other, specify
Descrizione

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

Tipo di dati

text

Ascites present
Descrizione

Ascites present

7. Ascites present
Descrizione

Ascites present

Tipo di dati

text

Other, specify:
Descrizione

ascites present other amount

Tipo di dati

text

Are Focal Hepatic Lesions characterisable?
Descrizione

Are Focal Hepatic Lesions characterisable?

8. Are Focal Hepatic Lesions characterisable?
Descrizione

Focal Hepatic Lesions characterisable

Tipo di dati

text

[E1] Solid
Descrizione

Solid Focal Hepatic Lesions

Tipo di dati

boolean

[E2] Cystic
Descrizione

Cystic Focal Hepatic Lesions

Tipo di dati

boolean

[E3] Hemangioma
Descrizione

Hemangioma Focal Hepatic Lesions

Tipo di dati

boolean

[E4] Focal Nodular Hyperplasia
Descrizione

Focal Nodular Hyperplasia

Tipo di dati

boolean

[E99] Other
Descrizione

Other Focal Hepatic Lesions

Tipo di dati

boolean

Other, specify:
Descrizione

Other Focal Hepatic Lesions specification

Tipo di dati

text

Gallstones or gallbladder lesions?
Descrizione

Gallstones or gallbladder lesions?

9. Gallstones or gallbladder lesions?
Descrizione

Gallstones or gallbladder lesions

Tipo di dati

text

[F1] Gallstones
Descrizione

Gallstones

Tipo di dati

boolean

[F2] Gallbladder polyp(s)
Descrizione

Gallbladder polyps

Tipo di dati

boolean

[F3] Sludge
Descrizione

Sludge

Tipo di dati

boolean

[F4] Gallbladder wall thickening/oedema
Descrizione

Gallbladder wall thickening/oedema

Tipo di dati

boolean

[F5] Gallbladder wall gas
Descrizione

Gallbladder wall gas

Tipo di dati

boolean

[F6] Cholecystitis
Descrizione

Cholecystitis

Tipo di dati

boolean

[F7] Gallbladder wall calcification
Descrizione

Gallbladder wall calcification

Tipo di dati

boolean

[F8] Gallbladder mass
Descrizione

Gallbladder mass

Tipo di dati

boolean

[F99] Other
Descrizione

Other gallbladder lesions

Tipo di dati

boolean

Other, specify
Descrizione

Other gallbladder lesions specification

Tipo di dati

text

Biliary ductal lesions?
Descrizione

Biliary ductal lesions?

10. Biliary ductal lesions?
Descrizione

Biliary ductal lesions

Tipo di dati

text

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

Intrahepatic ductal dilation

Tipo di dati

boolean

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

Intrahepatic ductal dilation

Tipo di dati

boolean

[G4] Extrahepatic ductal dilation
Descrizione

Extrahepatic ductal dilation

Tipo di dati

boolean

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

Diffuse ductal dilation

Tipo di dati

boolean

[G6] Acute Cholangitis
Descrizione

Acute Cholangitis

Tipo di dati

boolean

[G7] Primary sclerosing cholangitis
Descrizione

Primary sclerosing cholangitis

Tipo di dati

boolean

[G8] Choledocholithiasis (gallstone in duct)
Descrizione

Choledocholithiasis

Tipo di dati

boolean

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

Ductal filling defect other than gallstone

Tipo di dati

boolean

[G10] Ductal wall thickening or oedema
Descrizione

Ductal wall thickening or oedema

Tipo di dati

boolean

[G11] Choledochal cyst
Descrizione

Choledochal cyst

Tipo di dati

boolean

[G12] Ductal mass
Descrizione

Ductal mass

Tipo di dati

boolean

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

Extrinsic mass compressing bile duct

Tipo di dati

boolean

[G99] Other
Descrizione

Other Biliary ductal lesions

Tipo di dati

boolean

Other, specify:
Descrizione

Other Biliary ductal lesions specification

Tipo di dati

text

Portal/Hepatic vein abnormalities?
Descrizione

Portal/Hepatic vein abnormalities?

11. Portal/Hepatic vein abnormalities?
Descrizione

Portal/Hepatic vein abnormalities?

Tipo di dati

text

[H1] Portal vein enlargement
Descrizione

Portal vein enlargement

Tipo di dati

boolean

[H2] Hepatic vein enlargement
Descrizione

Hepatic vein enlargement

Tipo di dati

boolean

[H3] Nonocclusive portal vein thrombosis
Descrizione

Nonocclusive portal vein thrombosis

Tipo di dati

boolean

[H4] Occlusive portal vein thrombosis - bland
Descrizione

Occlusive portal vein thrombosis - bland

Tipo di dati

boolean

[H5] Hepatic vein thrombosis - bland
Descrizione

Hepatic vein thrombosis - bland

Tipo di dati

boolean

[H6] Occlusive portal vein thrombosis - malignant
Descrizione

Occlusive portal vein thrombosis - malignant

Tipo di dati

boolean

[H7] Hepatic vein thrombosis - malignant
Descrizione

Hepatic vein thrombosis - malignant

Tipo di dati

text

[H8] Involvement of the main portal vein
Descrizione

Involvement of the main portal vein

Tipo di dati

boolean

[H9] Involvement of the right portal vein
Descrizione

Involvement of the right portal vein

Tipo di dati

boolean

[H10] Involvement of the left portal vein
Descrizione

Involvement of the left portal vein

Tipo di dati

boolean

[H11] Budd-Chiari syndrome
Descrizione

Budd-Chiari syndrome

Tipo di dati

boolean

[H99] Other
Descrizione

Other Portal/Hepatic vein abnormalities

Tipo di dati

boolean

Other, specify:
Descrizione

Other Portal/Hepatic vein abnormalities specification

Tipo di dati

text

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Similar models

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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