ID

32700

Beschreibung

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Stichworte

Versionen (1)
  1. 13.11.18 13.11.18 -
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GlaxoSmithKline

Hochgeladen am

13. November 2018

DOI

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Creative Commons BY-NC 3.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

Englisch

Liver Imaging

1 Formulare  
  1. StudyEvent: ODM
    1. Liver Imaging
Liver Imaging
Beschreibung

Liver Imaging

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

Imaging of liver, Date in time

Datentyp

date

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

Imaging of liver, Imaging modality

Datentyp

text

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

Imaging of liver, Image quality

Datentyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0806487
Indicate the liver size
Beschreibung

Imaging of liver, Liver size

Datentyp

text

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

Imaging of liver, Texture perception

Datentyp

text

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

Imaging of liver, Fatty liver

Datentyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0015695
Ascites present
Beschreibung

Imaging of liver, Ascites

Datentyp

text

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

Imaging of liver, Lesion of liver, Focal

Datentyp

text

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

Imaging of liver, Gallstones, Gallbladder problems, Lesion

Datentyp

text

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

Imaging of liver, Biliary tract structure, Lesion

Datentyp

text

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

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Liver Imaging

1 Formulare
  1. StudyEvent: ODM
    1. Liver Imaging
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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 (8)
Item
Are images technically adequate?
text
C2711860 (UMLS CUI [1,1])
C0806487 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
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 (4)
Item
Indicate the liver size
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
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 (5)
Item
Indicate the liver texture
text
C2711860 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
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 (5)
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C2711860 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
Imaging of liver, Imaging modality
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 (5)
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 (4)
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, Ascites
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 (6)
Item
Gallstones or gallbladder lesions?
text
C2711860 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Ascites
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 (10)
Item
Biliary ductal lesions?
text
C2711860 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Imaging of liver, Ascites
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  (8)
CL Item
Choledocholithiasis (gallstone in duct)  (9)
CL Item
Ductal filling defect(s), other than gallstone  (10)
CL Item
Ductal wall thickening or oedema  (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other (15)
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, Ascites
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 (13)
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