ID

32576

Beskrivning

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

Nyckelord

  1. 2018-11-07 2018-11-07 -
  2. 2018-12-07 2018-12-07 -
Rättsinnehavare

GSK group of companies

Uppladdad den

7 november 2018

DOI

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Creative Commons BY-NC 3.0

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Liver Imaging Form

  1. StudyEvent: ODM
    1. Liver Imaging Form
Date of hepatic or liver imaging test
Beskrivning

Date of hepatic or liver imaging test

Date
Beskrivning

Date

Datatyp

date

What method was used for this imaging test?
Beskrivning

What method was used for this imaging test?

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Beskrivning

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Datatyp

text

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Beskrivning

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Datatyp

text

Are images technically adequate?
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Are images technically adequate?

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Beskrivning

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Datatyp

text

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Datatyp

text

Indicate the liver size
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Indicate the liver size

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Beskrivning

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Datatyp

text

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Beskrivning

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Datatyp

text

Indicate the liver texture
Beskrivning

Indicate the liver texture

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Beskrivning

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Datatyp

text

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Beskrivning

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Datatyp

text

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

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Beskrivning

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Datatyp

text

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Datatyp

text

Ascites present
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Ascites present

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Beskrivning

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text

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text

Are focal hepatic lesions characterisable?
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Are focal hepatic lesions characterisable?

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Beskrivning

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Datatyp

text

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text

Gallstones or gallbladder lesions?
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Gallstones or gallbladder lesions?

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Datatyp

text

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text

Billary ductal lesions
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Billary ductal lesions

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text

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Portal/Hepatic vein abnormalities?
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Portal/Hepatic vein abnormalities?

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Similar models

Liver Imaging Form

  1. StudyEvent: ODM
    1. Liver Imaging Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of hepatic or liver imaging test
Date
Item
Date
date
Item Group
What method was used for this imaging test?
Item
check one
text
Code List
check one
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 Cholangiopancreacreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
CL Item
Other (8)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Are images technically adequate?
Item
Check one
text
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other (4)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Indicate the liver size
Item
check one
text
Code List
check one
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
Indicate the liver texture
Item
check one
text
Code List
check one
CL Item
Normal (1)
CL Item
Heterogenous (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
Grade the diffuse and/or geographic fatty infiltrate of the liver
Item
check one grade
text
Code List
check one grade
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
text
Item Group
Ascites present
Item
check one
text
Code List
check one
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
Are focal hepatic lesions characterisable?
Item
check one
text
Code List
check one
CL Item
Chack all that apply (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal modular hyperplasia (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Gallstones or gallbladder lesions?
Item
check all that apply
text
Code List
check all that apply
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)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other (10)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Billary ductal lesions
Item
check all that apply
text
Code List
check all that apply
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)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Portal/Hepatic vein abnormalities?
Item
check all that apply
text
Code List
check all that apply
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)
If OTHER, specify
Item
If OTHER, specify
text

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