Informazione:
Errore:
ID
32700
Descrizione
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
Keywords
versioni (1)
- 13/11/18 13/11/18 -
Titolare del copyright
GlaxoSmithKline
Caricato su
13 novembre 2018
DOI
Per favore, per richiedere un accesso.
Licenza
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
Similar models
Liver Imaging
- StudyEvent: ODM
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
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])
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])
C1275506 (UMLS CUI [1,2])
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])
C0806487 (UMLS CUI [1,2])
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])
C0426688 (UMLS CUI [1,2])
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])
C0679033 (UMLS CUI [1,2])
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])
C0015695 (UMLS CUI [1,2])
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])
C0003962 (UMLS CUI [1,2])
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])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
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])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
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])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
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])
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])
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)