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ID
32576
Description
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
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Versions (2)
- 11/7/18 11/7/18 -
- 12/7/18 12/7/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 7, 2018
DOI
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License
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
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Liver Imaging Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date
Item
Date
date
CL Item
Ultrasound - transabdominal (1)
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Ultrasound - endoscopic (2)
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Magnetic resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreacreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
CL Item
Other (8)
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Item
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text
CL Item
Optimal (1)
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Readable, but not optimal (2)
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Not readable (3)
CL Item
Other (4)
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Item
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text
CL Item
Normal size (1)
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Hypertrophy (or enlarged) (2)
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Atrophy (or smaller than normal) (3)
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Segmental hypertrophy (4)
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Other (5)
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Item
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text
CL Item
Normal (1)
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Heterogenous (2)
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Suggestive of fibrosis (3)
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Nodular or suggestive of cirrhosis (4)
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Other (5)
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Item
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text
Item Group
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
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Mild (<=25%) (2)
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Moderate (>25% to <75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other (5)
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Item
text
CL Item
None present (1)
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Yes - small amount (2)
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Yes - moderate or severe amount (3)
CL Item
Other (4)
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Item
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text
CL Item
Chack all that apply (1)
CL Item
Solid (2)
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Cystic (3)
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Hemangioma (4)
CL Item
Focal modular hyperplasia (5)
CL Item
Other (6)
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Item
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text
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyp(s) (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystitis (7)
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Gallbladder wall calcification (8)
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Gallbladder mass (9)
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Other (10)
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Item
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text
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
Extrahipatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholitiasis (gullstone in duct) (9)
CL Item
Ductal wall thickening or oedema (10)
CL Item
Choledocal cyst (11)
CL Item
Ductal mass (12)
CL Item
Extrinsic mass compressing bile duct(s) (13)
CL Item
Other (14)
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Item
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text
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonoclussive 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
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-Chiari syndrome (11)
CL Item
Other (12)
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Item
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text