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Information:
Fel:
ID
26352
Beskrivning
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)
Nyckelord
Versioner (8)
- 2017-10-11 2017-10-11 -
- 2017-10-16 2017-10-16 -
- 2017-10-23 2017-10-23 -
- 2018-01-05 2018-01-05 -
- 2018-01-10 2018-01-10 -
- 2018-01-10 2018-01-10 -
- 2020-06-16 2020-06-16 -
- 2020-06-17 2020-06-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903
Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903
Similar models
Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of hepatic or liver imaging test
Item
1. Date of hepatic or liver imaging test
date
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
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
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
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
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
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
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
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
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
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