ID

38278

Description

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Keywords

Versions (2)
  1. 10/6/19 10/6/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

English

Common CRF: Liver Imaging

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Liver Imaging
Description

Liver Imaging

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

Imaging of liver, Date in time

Data type

date

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

Imaging of liver, Imaging modality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Other, specify
Description

Imaging of liver, Imaging modality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Are images technically adequate?
Description

Imaging of liver, Quality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0332306
Other, specify
Description

Imaging of liver, Quality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0332306
Indicate the liver size
Description

Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0426688
Other, specify
Description

Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0426688
Indicate the liver texture
Description

Imaging of liver, Texture Perception

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0679033
Other, specify
Description

Imaging of liver, Texture Perceiption

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0679033
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

Imaging of liver, Fatty Liver, Grade

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0015695
UMLS CUI [1,3]
C0441800
Other, specify
Description

Imaging of liver, Fatty Liver, Grade

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0015695
UMLS CUI [1,3]
C0441800
Ascites present
Description

Imaging of liver, Ascites

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0003962
Other, specify
Description

Imaging of liver, Ascites

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0003962
Are Focal Hepatic Lesions characterisable?
Description

Imaging of liver, Lesion of liver, Focal

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0577053
UMLS CUI [1,3]
C0205234
Other, specify
Description

Imaging of liver, Lesion of liver, Focal

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0577053
UMLS CUI [1,3]
C0205234
Gallstones or gallbladder lesions?
Description

Imaging of liver, Gallstones/gallbladder problems, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C3842395
UMLS CUI [1,3]
C0221198
Other, specify
Description

Imaging of liver, Gallstones/gallbladder problems, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C3842395
UMLS CUI [1,3]
C0221198
Biliary ductal lesions?
Description

Imaging of liver, Biliary tract structure, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0005423
UMLS CUI [1,3]
C0221198
Other, specify
Description

Imaging of liver, Biliary tract structure, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0005423
UMLS CUI [1,3]
C0221198
Portal/Hepatic vein abnormalities?
Description

Imaging of liver, Structure of hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0019155
UMLS CUI [1,3]
C1704258
UMLS CUI [2,1]
C2711860
UMLS CUI [2,2]
C0032718
UMLS CUI [2,3]
C1704258
Other, specify
Description

Imaging of liver, Structure of hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0019155
UMLS CUI [1,3]
C1704258
UMLS CUI [2,1]
C2711860
UMLS CUI [2,2]
C0032718
UMLS CUI [2,3]
C1704258
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Similar models

Common CRF: Liver Imaging

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Liver Imaging
C2711860 (UMLS CUI-1)
Imaging of liver, Date in time
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
Code List
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, specify (8)
Imaging of liver, Imaging modality
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Item
Are images technically adequate?
text
C2711860 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Imaging of liver, Quality
Code List
Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal  (2)
CL Item
Not readable (3)
CL Item
Other, specify (4)
Imaging of liver, Quality
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Item
Indicate the liver size
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
Imaging of liver, Liver size
Code List
Indicate the liver size
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, specify (5)
Imaging of liver, Liver size
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
Item
Indicate the liver texture
text
C2711860 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Imaging of liver, Texture Perception
Code List
Indicate the liver texture
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, specify (5)
Imaging of liver, Texture Perceiption
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C2711860 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Imaging of liver, Fatty Liver, Grade
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
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, specify (5)
Imaging of liver, Fatty Liver, Grade
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Item
Ascites present
text
C2711860 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
Imaging of liver, Ascites
Code List
Ascites present
CL Item
None present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (4)
Imaging of liver, Ascites
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
Item
Are Focal Hepatic Lesions characterisable?
text
C2711860 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
Imaging of liver, Lesion of liver, Focal
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions  (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (6)
Imaging of liver, Lesion of liver, Focal
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
Item
Gallstones or gallbladder lesions?
text
C2711860 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Gallstones/gallbladder problems, Lesion
Code List
Gallstones or gallbladder lesions?
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, specify (10)
Imaging of liver, Gallstones/gallbladder problems, Lesion
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Item
Biliary ductal lesions?
text
C2711860 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Biliary tract structure, Lesion
Code List
Biliary ductal lesions?
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
Extrahepatic 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 Choledocholithiasis (gallstone in duct)  (8)
CL Item
Ductal filling defect(s), other than gallstone  (9)
CL Item
Ductal wall thickening or oedema  (10)
CL Item
Choledochal cyst (11)
CL Item
Ductal mass (12)
CL Item
Extrinsic mass compressing bile duct(s) (13)
CL Item
Other, specify (14)
Imaging of liver, Biliary tract structure, Lesion
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Item
Portal/Hepatic vein abnormalities?
text
C2711860 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2711860 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
Imaging of liver, Structure of hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive 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
Hepatic vein thrombosis - malignant  (8)
CL Item
Involvement of the main portal vein  (9)
CL Item
Involvement of the right portal vein  (10)
CL Item
Involvement of the left portal vein  (11)
CL Item
Budd-Chiari syndrome (12)
CL Item
Other, specify (13)
Imaging of liver, Structure of hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality
Item
Other, specify
text
C2711860 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2711860 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
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