ID

32723

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

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

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 Biopsy

1 forms  
  1. StudyEvent: ODM
    1. Liver Biopsy
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Biopsy of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Description

Biopsy of liver, Specimen size

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1299482
mmHg
Final Diagnosis
Description

Biopsy of liver, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011900
Liver Architecture
Description

Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0935919
Description of Liver Cells or Hepatocytes
Description

Biopsy of liver, Hepatocyte, Description

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0678257
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Biopsy of liver, Hepatocyte, Inclusion, Vacuole

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1512693
UMLS CUI [1,4]
C0042219
Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Biopsy of liver, Hepatocyte, Abnormal nuclear morphology

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1849376
Liver or Lobular Infiltrates
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1400896
UMLS CUI [2,1]
C0193388
UMLS CUI [2,2]
C0205417
UMLS CUI [2,3]
C0332448
Portal Tract Inflammation
Description

Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C3854488
Bile Ducts
Description

Biopsy of liver, Bile Duct Structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0005400
Portal Veins
Description

Biopsy of lover, Portal Vein Structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0032718
Liver Infections
Description

Biopsy of liver, Hepatic infection

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1112211
Parasites or Ova
Description

Biopsy of liver, Parasite, Ova in feces

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0030498
UMLS CUI [1,3]
C0555117
Histologic Staining or Additional Studies Obtained
Description

Biopsy of liver, Staining method, Other

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0487602
UMLS CUI [1,3]
C0205394
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Similar models

Liver Biopsy

1 forms
  1. StudyEvent: ODM
    1. Liver Biopsy
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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