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ID

32700

Description

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

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Versions (1)
  1. 11/13/18 11/13/18 -
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GlaxoSmithKline

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November 13, 2018

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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

    English

    Liver Imaging

    1 forms  
    1. StudyEvent: ODM
      1. Liver Imaging
    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
    Are images technically adequate?
    Description

    Imaging of liver, Image quality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C0806487
    Indicate the liver size
    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
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    Description

    Imaging of liver, Fatty liver

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C0015695
    Ascites present
    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
    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
    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
    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
    Back to the top of the page

    Similar models

    Liver Imaging

    1 forms
    1. StudyEvent: ODM
      1. Liver Imaging
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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)
    Back to the top of the page 

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