ID

33409

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

Keywords

Versions (2)
  1. 11/7/18 11/7/18 -
  2. 12/7/18 12/7/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 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

English

Liver Imaging Form

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

Date of hepatic or liver imaging test

Alias
UMLS CUI-1
C2711860
UMLS CUI-2
C0011008
Date of hepatic or liver imaging test
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
What method was used for this imaging test?
Description

What method was used for this imaging test?

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C1275506
check one
Description

check one

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1275506
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Are images technically adequate?
Description

Are images technically adequate?

Alias
UMLS CUI-1
C0806487
Check one
Description

Check one

Data type

text

Alias
UMLS CUI [1]
C0806487
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0806487
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver size
Description

Indicate the liver size

Alias
UMLS CUI-1
C0426688
check one
Description

check one

Data type

text

Alias
UMLS CUI [1]
C0426688
if OTHER, specify
Description

if OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver texture
Description

Indicate the liver texture

Alias
UMLS CUI-1
C0679033
UMLS CUI-2
C0023884
check one
Description

check one

Data type

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

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

Alias
UMLS CUI-1
C0015695
UMLS CUI-2
C0205219
UMLS CUI-3
C1517526
check one grade
Description

check one grade

Data type

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [1,4]
C0441800
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Ascites present
Description

Ascites present

Alias
UMLS CUI-1
C0003962
check one
Description

check one

Data type

text

Alias
UMLS CUI [1]
C0003962
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Are focal hepatic lesions characterisable?
Description

Are focal hepatic lesions characterisable?

Alias
UMLS CUI-1
C0577053
UMLS CUI-2
C0205234
check one
Description

check one

Data type

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions?

Alias
UMLS CUI-1
C3842395
UMLS CUI-2
C0221198
check all that apply
Description

check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Billary ductal lesions
Description

Billary ductal lesions

Alias
UMLS CUI-1
C0005423
UMLS CUI-2
C0221198
check all that apply
Description

check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities?

Alias
UMLS CUI-1
C0019155
UMLS CUI-2
C1704258
UMLS CUI-3
C0032718
UMLS CUI-4
C1704258
check all that apply
Description

check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235
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Similar models

Liver Imaging Form

1 forms
  1. StudyEvent: ODM
    1. Liver Imaging Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of hepatic or liver imaging test
C2711860 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Date
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
What method was used for this imaging test?
C0011923 (UMLS CUI-1)
C1275506 (UMLS CUI-2)
Item
check one
text
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
check one
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
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Are images technically adequate?
C0806487 (UMLS CUI-1)
Item
Check one
text
C0806487 (UMLS CUI [1])
Are images technically adequate?
Code List
Check one
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
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Indicate the liver size
C0426688 (UMLS CUI-1)
Item
check one
text
C0426688 (UMLS CUI [1])
Liver size
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
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Indicate the liver texture
C0679033 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
check one
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
check one
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
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Grade the diffuse and/or geographic fatty infiltrate of the liver
C0015695 (UMLS CUI-1)
C0205219 (UMLS CUI-2)
C1517526 (UMLS CUI-3)
Item
check one grade
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
check one grade
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
If OTHER, specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Ascites present
C0003962 (UMLS CUI-1)
Item
check one
text
C0003962 (UMLS CUI [1])
check one
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
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Are focal hepatic lesions characterisable?
C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
Item
check one
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
check one
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
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Gallstones or gallbladder lesions?
C3842395 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
check all that apply
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
check all that apply
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
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Billary ductal lesions
C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
check all that apply
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
check all that apply
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
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Portal/Hepatic vein abnormalities?
C0019155 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)
C1704258 (UMLS CUI-4)
Item
check all that apply
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
check all that apply
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
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
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