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32723

Descrição

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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Versões (1)
  1. 2018-11-13 2018-11-13 -
Titular dos direitos

GlaxoSmithKline

Transferido a

13 november 2018

DOI

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Licença

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

    Inglês

    Liver Biopsy

    1 Formulários  
    1. StudyEvent: ODM
      1. Liver Biopsy
    Liver Biopsy
    Descrição

    Liver Biopsy

    Alias
    UMLS CUI-1
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    Date of liver biopsy
    Descrição

    Biopsy of liver, Date in time

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Approximate size of liver biopsy
    Descrição

    Biopsy of liver, Specimen size

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C1299482 (Specimen size)
    SNOMED
    371475003
    mmHg
    Final Diagnosis
    Descrição

    Biopsy of liver, Diagnosis

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Liver Architecture
    Descrição

    Biopsy of liver, Cellular structure aspects

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0935919 (Cellular structure aspects)
    Description of Liver Cells or Hepatocytes
    Descrição

    Biopsy of liver, Hepatocyte, Description

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0227525 (Hepatocyte)
    SNOMED
    30396005
    LOINC
    LP68387-7
    UMLS CUI [1,3]
    C0678257 (Description)
    LOINC
    LP6800-9
    Liver Cell or Hepatocyte Inclusions or Vacuoles
    Descrição

    Biopsy of liver, Hepatocyte, Inclusion, Vacuole

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0227525 (Hepatocyte)
    SNOMED
    30396005
    LOINC
    LP68387-7
    UMLS CUI [1,3]
    C1512693 (Inclusion)
    UMLS CUI [1,4]
    C0042219 (Vacuole)
    Hepatocyte or Liver Cell Nuclear Abnormalities
    Descrição

    Biopsy of liver, Hepatocyte, Abnormal nuclear morphology

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0227525 (Hepatocyte)
    SNOMED
    30396005
    LOINC
    LP68387-7
    UMLS CUI [1,3]
    C1849376 (Abnormal nuclear morphology)
    Liver or Lobular Infiltrates
    Descrição

    Biopsy of liver, Liver infiltrate; Biopsy of liver, Lobular, Infiltration

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C1400896 (liver; infiltrate)
    UMLS CUI [2,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [2,2]
    C0205417 (Lobular)
    SNOMED
    40266001
    UMLS CUI [2,3]
    C0332448 (Infiltration)
    SNOMED
    47351003
    Portal Tract Inflammation
    Descrição

    Biopsy of liver, Portal Tract Inflammation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C3854488 (Portal tract inflammation)
    Bile Ducts
    Descrição

    Biopsy of liver, Bile Duct Structure

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0005400 (Bile duct structure)
    SNOMED
    28273000
    LOINC
    LP7053-4
    Portal Veins
    Descrição

    Biopsy of lover, Portal Vein Structure

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0032718 (Portal vein structure)
    SNOMED
    32764006
    Liver Infections
    Descrição

    Biopsy of liver, Hepatic infection

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C1112211 (Hepatic Infection)
    Parasites or Ova
    Descrição

    Biopsy of liver, Parasite, Ova in feces

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0030498 (Parasites)
    SNOMED
    37763007
    LOINC
    LP14835-0
    UMLS CUI [1,3]
    C0555117 (Ova in feces)
    SNOMED
    275743006
    Histologic Staining or Additional Studies Obtained
    Descrição

    Biopsy of liver, Staining method, Other

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    UMLS CUI [1,2]
    C0487602 (Staining method)
    SNOMED
    127790008
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
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    Similar models

    Liver Biopsy

    1 Formulários
    1. StudyEvent: ODM
      1. Liver Biopsy
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Liver Biopsy
    C0193388 (UMLS CUI-1)
    Biopsy of liver, Date in time
    Item
    Date of liver biopsy
    date
    C0193388 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Biopsy of liver, Specimen size
    Item
    Approximate size of liver biopsy
    integer
    C0193388 (UMLS CUI [1,1])
    C1299482 (UMLS CUI [1,2])
    Item
    Final Diagnosis
    text
    C0193388 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Biopsy of liver, Diagnosis
    Code List
    Final Diagnosis
    CL Item
    Normal (1)
    CL Item
    Acute hepatitis (2)
    CL Item
    Chronic hepatitis (3)
    CL Item
    Cholestatic hepatitis (Cholestatic hepatitis)
    CL Item
    Drug-induced cholestasis  (4)
    CL Item
    Acute viral hepatitis (5)
    CL Item
    Chronic viral hepatitis  (6)
    CL Item
    Drug-induced hepatitis  (7)
    CL Item
    Autoimmune hepatitis  (8)
    CL Item
    Bridging necrosis  (9)
    CL Item
    Submassive hepatic necrosis  (10)
    CL Item
    Massive hepatic necrosis  (11)
    CL Item
    Steatosis - microvesicular  (12)
    CL Item
    Steatosis - macrovesicular  (13)
    CL Item
    Steatosis - mixed  (14)
    CL Item
    Non-alcoholic steatohepatitis  (15)
    CL Item
    Alcoholic hepatitis (16)
    CL Item
    Hepatic granulomas  (17)
    CL Item
    Sarcoidosis Fibrosis (18)
    CL Item
    Cirrhosis (19)
    CL Item
    Primary biliary cirrhosis  (20)
    CL Item
    Primary sclerosing cholangitis  (21)
    CL Item
    Autoimmune overlap syndrome  (22)
    CL Item
    Hemochromatosis  (23)
    CL Item
    Alpha-1-antitrypsin deficiency  (24)
    CL Item
    Wilson's disease  (25)
    CL Item
    Veno-occlusive disease  (26)
    CL Item
    Budd-Chiari syndrome  (27)
    CL Item
    Neoplasia (28)
    CL Item
    Other (29)
    Item
    Liver Architecture
    text
    C0193388 (UMLS CUI [1,1])
    C0935919 (UMLS CUI [1,2])
    Biopsy of liver, Cellular structural aspects
    Code List
    Liver Architecture
    CL Item
    Normal (1)
    CL Item
    Bridging fibrosis (2)
    CL Item
    Diffuse fibrosis (3)
    CL Item
    Nodular regenerative hyperplasia (4)
    CL Item
    Congenital hepatic fibrosis (5)
    CL Item
    Cirrhosis (6)
    CL Item
    Centrilobular congestion (7)
    CL Item
    Endophlebitis (8)
    CL Item
    Veno-occlusive disease (9)
    CL Item
    Canalicular cholestasis (10)
    CL Item
    Apoptosis (11)
    CL Item
    Focal (or spotty or mild) hepatocellular necrosis (12)
    CL Item
    Interface hepatitis (periportal hepatitis or piecemeal necrosis)  (13)
    CL Item
    Ischaemic necrosis (14)
    CL Item
    Centrolobular (Zone 3) necrosis (15)
    CL Item
    Focal coagulative necrosis (16)
    CL Item
    Centrolobular (Zone 3) coagulative necrosis (17)
    CL Item
    Bridging hepatocellular necrosis (18)
    CL Item
    Massive or panlobular hepatocellular necrosis (19)
    CL Item
    Dysplasia (20)
    CL Item
    Neoplasia (21)
    CL Item
    Other (22)
    Item
    Description of Liver Cells or Hepatocytes
    text
    C0193388 (UMLS CUI [1,1])
    C0227525 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Biopsy of liver, Hepatocyte, Description
    Code List
    Description of Liver Cells or Hepatocytes
    CL Item
    Normal (1)
    CL Item
    Ballooning (2)
    CL Item
    Acidophilic  (3)
    CL Item
    Pseudoxanthomatous  (4)
    CL Item
    Multinucleated giant hepatocytes (5)
    CL Item
    Other (6)
    Item
    Liver Cell or Hepatocyte Inclusions or Vacuoles
    text
    C0193388 (UMLS CUI [1,1])
    C0227525 (UMLS CUI [1,2])
    C1512693 (UMLS CUI [1,3])
    C0042219 (UMLS CUI [1,4])
    Biopsy of liver, Hepatocyte, Inclusion, Vacuole
    Code List
    Liver Cell or Hepatocyte Inclusions or Vacuoles
    CL Item
    No inclusions  (1)
    CL Item
    Macrovesicular steatosis (2)
    CL Item
    Microvesicular steatosis (3)
    CL Item
    Bile accumulation (4)
    CL Item
    Diastase-resistant, PAS-positive cytoplasmic inclusions  (5)
    CL Item
    Alpha-1-antitrypsin inclusions (6)
    CL Item
    Megamitochondria (7)
    CL Item
    Mallory bodies (8)
    CL Item
    "Ground Glass" inclusions (9)
    CL Item
    Lipofuscin pigment (10)
    CL Item
    Hemosiderin granules (11)
    CL Item
    Orcein-positive cytoplasmin granules (12)
    CL Item
    Protoporphyrin crystals (birefringent under polarised light)  (13)
    CL Item
    Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
    CL Item
    Other (15)
    Item
    Hepatocyte or Liver Cell Nuclear Abnormalities
    text
    C0193388 (UMLS CUI [1,1])
    C0227525 (UMLS CUI [1,2])
    C1849376 (UMLS CUI [1,3])
    Biopsy of liver, Hepatocyte, Nuclear Abnormality
    Code List
    Hepatocyte or Liver Cell Nuclear Abnormalities
    CL Item
    None (1)
    CL Item
    Hepatocellular mitosis (2)
    CL Item
    Binucleated or multinucleated hepatocytes  (3)
    CL Item
    CMV inclusion bodies (4)
    CL Item
    HSV inclusions (5)
    CL Item
    Varicella inclusions (6)
    CL Item
    Other (7)
    Item
    Liver or Lobular Infiltrates
    text
    C0193388 (UMLS CUI [1,1])
    C1400896 (UMLS CUI [1,2])
    C0193388 (UMLS CUI [2,1])
    C0205417 (UMLS CUI [2,2])
    C0332448 (UMLS CUI [2,3])
    Biopsy of liver, Liver infiltrate; Biopsy of liver, Lobular, Infiltration
    Code List
    Liver or Lobular Infiltrates
    CL Item
    None (1)
    CL Item
    Eosinophils (2)
    CL Item
    Lymphocytes (3)
    CL Item
    Plasma cells (4)
    CL Item
    Neutrophils (5)
    CL Item
    Macrophages and proliferating Kupffer cells  (6)
    CL Item
    Granulomas (7)
    CL Item
    Other (8)
    Item
    Portal Tract Inflammation
    text
    C0193388 (UMLS CUI [1,1])
    C3854488 (UMLS CUI [1,2])
    Biopsy of liver, Portal Tract Inflammation
    Code List
    Portal Tract Inflammation
    CL Item
    None (1)
    CL Item
    Eosinophils (2)
    CL Item
    Lymphoid aggregates and/or follicles  (3)
    CL Item
    Plasma cells (4)
    CL Item
    Neutrophils (5)
    CL Item
    Histocytes and macrophages (6)
    CL Item
    Other (7)
    Item
    Bile Ducts
    text
    C0193388 (UMLS CUI [1,1])
    C0005400 (UMLS CUI [1,2])
    Biopsy of liver, Bile Duct Structure
    Code List
    Bile Ducts
    CL Item
    Normal (1)
    CL Item
    Proliferation of bile ducts (bile ductular reaction)  (2)
    CL Item
    Dilation, degeneration or disruption of portal bile ducts  (3)
    CL Item
    Paucity of bile ducts (4)
    CL Item
    Periductal fibrosis (5)
    CL Item
    Other (6)
    Item
    Portal Veins
    text
    C0193388 (UMLS CUI [1,1])
    C0032718 (UMLS CUI [1,2])
    Biopsy of lover, Portal Vein Structure
    Code List
    Portal Veins
    CL Item
    Normal (1)
    CL Item
    Pyelophlebitis (2)
    CL Item
    Thrombosis, sclerosis or occlusion of portal vein  (3)
    CL Item
    Neoplastic invasion of portal vein  (4)
    CL Item
    Granulomatous compression of portal vein (5)
    CL Item
    Other (6)
    Item
    Liver Infections
    text
    C0193388 (UMLS CUI [1,1])
    C1112211 (UMLS CUI [1,2])
    Biopsy of liver, Hepatic infection
    Code List
    Liver Infections
    CL Item
    Normal (1)
    CL Item
    Leishmaniasis donovani  (2)
    CL Item
    Plasmodium falciparum  (3)
    CL Item
    Toxoplasmosis  (4)
    CL Item
    Cryptococcus neoformans  (5)
    CL Item
    Histoplasma capsulatum  (6)
    CL Item
    Mycobacterium tuberculois  (7)
    CL Item
    Other mycobacterial species (8)
    CL Item
    Other (9)
    Item
    Parasites or Ova
    text
    C0193388 (UMLS CUI [1,1])
    C0030498 (UMLS CUI [1,2])
    C0555117 (UMLS CUI [1,3])
    Biopsy of liver, Parasite, Ova in feces
    Code List
    Parasites or Ova
    CL Item
    None (1)
    CL Item
    Schistosome and/or ova (2)
    CL Item
    Ascaris and/or ova (3)
    CL Item
    Toxocara and/or ova (4)
    CL Item
    Echinococcus cysts (5)
    CL Item
    Hepatic capillariasis worms and/or ova (6)
    CL Item
    Other (7)
    Item
    Histologic Staining or Additional Studies Obtained
    text
    C0193388 (UMLS CUI [1,1])
    C0487602 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Biopsy of liver, Histologic staining, additional studies
    Code List
    Histologic Staining or Additional Studies Obtained
    CL Item
    Haematoxylin and eosin (or H & E)  (1)
    CL Item
    Masson (2)
    CL Item
    Toluidine blue or Giemsa (3)
    CL Item
    Prussian blue (4)
    CL Item
    Periodic Acidic Schiff (PAS), with or without diastase  (5)
    CL Item
    Oil red O (6)
    CL Item
    Congo red (7)
    CL Item
    Hall's stain (8)
    CL Item
    Gridley's stain (9)
    CL Item
    Rhodanine (copper) (10)
    CL Item
    Rubeanic acid (copper) (11)
    CL Item
    Orcein, aldehyde fuchsin or Victoria blue  (12)
    CL Item
    Electron microscopy (13)
    CL Item
    Hepatitis A immunostains positive (14)
    CL Item
    Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
    CL Item
    Hepatitis D immunostains (16)
    CL Item
    Other immunostains (17)
    CL Item
    Other (18)
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